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Mouth dissolving tablets of salbutamol sulphate: A novel drug delivery system
Abstract
New era is an era of Novel Drug Delivery system. Formulation research is oriented towards increasing safety and efficacy of existing drug molecule through novel concepts of drug delivery. Salbutamol sulphate is a selective β2 receptor agonist widely used as bronchodilator. It forms part of initial therapy of acute as well as chronic asthma. In present work an attempt has been made to formulate and evaluate mouth dissolving tablets of salbutamol sulphate. Formulations were designed by factorial design technique. Sodium starch glycolate, crosscarmellose sodium and treated agar were used as super-disintegrants while microcrystalline cellulose was used as diluent. Direct compression technique was used as it requires conventional tablet machinery and thus economical process. Formulations containing sodium starch glycolate alongwith other super-disintegrants, showed rapid in-vitro and in-vivo dispersion time, as compared to other formulations.
... Using mucilage instead of synthetic superdisintegrants has gained interest in recent years. [3][4][5][6][7][8][9][10][11] In tablet development, selecting consistent superdisintegrants is crucial. They improve drug release in FDT. ...
... It is important to ensure that the extracted starch powder is of high quality and free from any impurities. [3][4][5][6] ...
... A violet ring will appear at the interface between the two liquids if the sample contains starch. [4][5][6][7][8] Organoleptic Evaluation of Isolated Starch [3][4][5][6][7][8][9][10][11] Organoleptic evaluation entails employing the human senses (sight, smell, taste, and touch) to assess the characteristics of a sample. In the case of isolated starch, the following organoleptic evaluations can be performed: ...
organoleptic characteristics, hydration, swelling capacity, and pasting temperature of breadfruit starch were determined. It was found that breadfruit starch exhibited partial solubility in warm water, a pH of 5.8, and good hydration and swelling capacities. Furthermore, a compatibility test using differential scanning calorimetry confirmed the compatibility of losartan and breadfruit starch. It was determined that the formulated losartan tablets were satisfactory in terms of flow properties as well as consistent drug content both before and after compression. Dissolution studies in-vitro showed improved drug release profiles than those of losartan tablets marketed on the market. According to stability studies, the physical appearance and color of the drug did not change over 3 months, but there was a slight decrease in the amount of the drug and the rate of drug release during that period. Overall, breadfruit starch showed promise as an excipient for losartan tablets, offering potential benefits in terms of enhanced drug release characteristics. Further investigations are necessary to optimize the formulation and evaluate its clinical efficacy and safety.
... When dealing with mentally ill and uncooperative patients, traditional oral dose forms might be inconvenient. Due to a lack of water, it can be difficult to swallow conventional items at times [7], [8]. As a result, the goal of this study was to use crospovidone, sodium starch glycolate, and croscarmellose sodium as super disintegrants in the formulation of sulindac orodispersible tablets. ...
... From this, an optimized formulation will be selected. C. Precompression Evaluation Studies [8], [11]- [13] 1) Bulk Density Powders were accurately weighed and lightly shook to break up any agglomerates before being placed in a 25 ml measuring cylinder. Without disturbing the cylinder, the amount of space occupied by the powder was calculated, and the bulk density was determined using the equation, ...
... D. Evaluation of Post Compression Study: [8], [11], [13]- [15] 1) Appearance ...
Oral administration of dosage form is the most recommended mode of administration, because of its self-medication, accurate dose of the drug, and ease of administration. However, trouble swallowing in geriatric patients is one major negative of this route, which can mentally disrupt patients. The goal of this study was to use the direct compression method to make orodispersible tablets of sulindac utilizing various doses of super disintegrant agents such as Sodium starch glycolate Crospovidone and Croscarmellose sodium. Three distinct super disintegrants were used to create nine formulations with varying concentration levels. The preformulation, precompression, and post-compression properties of the powder combinations were assessed. In comparison to the other formulations, tablets from batch F3 containing crospovidone had superior organoleptic qualities, as well as outstanding drug release and in-vitro disintegration time. The super disntegrants addition technique was shown to be a viable method for manufacturing orodispersible tablets using the direct compression method.
... Percentage friability was calculated from the loss in weight as given in equation as below. The weight loss should not more than 1% .Determination was made in triplicate (Kuchekar et al., 2003). ...
... Separately produced in tablet form, the push, active, and plug layers were then placed within the capsule. An opening was formed in the cap toward the plug side after a semi porous membrane was functional to these preparation units 9 . ...
The core Eighty tablets were evaluated for their drug concentration, hardness weight fluctuation thickness, friability, and disintegration speed. Identify the tablet actual thickness, followed by its diameter, was determined by calipers like vernier calipers, where a sample of 5 to 6 tablets was randomly selected and the average values of thickness and diameter were determined. The standard USP method was used to test the pills' different weights. From the batch, 20 pills were arbitrarily selected, and each one was weighed to ensure for weight. variance. A percentage deviation from the average weight was calculated. Keywords: Phenytoin, polyethylene glycol 4000, sodium chloride, purified talc, magnesium stearate, microcrystalline cellulose
... They are looking for new ways to produce ODTs that will improve their quality, stability, bioavailability and safety, as well as increase productivity and reduce the cost of production. Some of the innovative technologies for the production of ODTs include extrusion technology, which can be used to create ODTs of different shapes and sizes, and the use of nanoparticles, polymers, solvents and other excipients that improve the bioavailability, solubility and stability of the drug substance [4][5][6][7]. ...
Modern approaches to the treatment of patients based on a high degree of individualization of therapy, attention to patient compliance and ease of use of drugs determine the vector for the development and further improvement of traditional dosage forms, such as tablets. Optimization of the composition and technological processes allows the creation of highly effective, stable and easy-to-use tablets dispersed in the oral cavity (orodispersible tablets, ODT). To obtain them, both traditional tablet manufacturing technologies, such as direct compression, compression with preliminary wet or structural granulation, and some innovative technological processes are applicable. The composition of excipients in ODT is maximally unified with conventional tablets, differing mainly in the quantitative ratios of the components, in particular, a significant increase in the proportion of disintegrants and the use of superdisintegrants. A reasonable expansion of the range of tablet dosage forms due to ODT is a rather promising direction in the development of tablet technology.
... Ризатриптан доступен как в виде таблеток для перорального применения, так и в виде ОДТ, которые могут быть оптимальной альтернативой для пациентов, которым трудно глотать таблетки или жидкость либо которые испытывают тошноту и рвоту во время приступов, а также для ситуаций, когда жидкость недоступна, необходим незаметный прием препарата или во время путешествий [57,73]. ...
Migraine is characterized by severe headache attacks with the development of accompanying symptoms. Among the most common are nausea and vomiting, which limit the intake of oral medications and thus reduce the speed of onset of pain relief and the efficacy of treatment in general. The development of gastric stasis in migraine is considered to be one of the most important reasons for the delayed absorption and inconsistent effect of oral triptans. The rapid action of triptans in the form of orally dispersible tablets, efficacy in relieving pain and accompanying symptoms, and ease of administration make this form favorable as a first-line agent for the relief of migraine attacks.
... Many drugs are well absorbed through the gastrointestinal tract, allowing for rapid onset of action and predictable pharmacokinetics. [1,2] Orodispersible tablets represent a versatile and patient-friendly dosage form that has gained significant popularity in the pharmaceutical industry. These tablets are designed to disperse rapidly in water or other liquids, forming a uniform suspension or solution, thus offering a convenient alternative for individuals who have difficulty swallowing solid dosage forms like conventional tablets or capsules. ...
The present research was aimed to prepare orodispersible tablets for kids using model drug cefixime. Orodispersible tablets were prepared using different concentration of superdisintegrant addition method by direct compression technique. Tablets were evaluated for various evaluation parameter likes drug content, weight variation, friability, hardness, wetting time and invitro disintegration time. Evaluation results for all batch of formulation showed obey of pharmaceutical standards. Batch F3 showed shortest in-vitro disintegration time and fast drug release. From the study it was concluded that use of superdisintegrant addition method was observed to be good choice for preparation of Orodispersible tablets of cefixime for kids.
... Bulk density is determined by pouring the powder blend into a graduated cylinder and measuring the volume and weight of the powder [26]. It provides information about the packing behavior of the powder. ...
Fast dissolving tablets (FDTs) have gained significant popularity as a convenient and patient-friendly dosage form, particularly beneficial for pediatric, geriatric, and patients with swallowing difficulties. These tablets are formulated to disintegrate or dissolve rapidly in the oral cavity, eliminating the need for water and enhancing patient compliance. This review article provides a comprehensive overview of FDTs, covering various aspects such as their definition, ideal characteristics, advantages, and formulation techniques. The manufacturing methods employed in the development of FDTs are discussed in detail, including direct compression, lyophilization, tablet molding, mass extrusion, spray drying, nanotization, sublimation, and the cotton candy process. Special emphasis is placed on the critical role of superdisintegrants, such as croscarmellose sodium, crospovidone, and sodium starch glycolate, in achieving rapid disintegration of the tablets. The review also highlights the essential pre-compression and post-compression evaluation parameters for FDTs, ensuring their quality and performance. These parameters include angle of repose, bulk density, tapped density, compressibility index, Hausner's ratio, tablet hardness, thickness, friability, drug content uniformity, weight variation, wetting time, water absorption ratio, in-vitro disintegration time, and in-vitro dissolution studies. The advantages of FDTs include patient compliance, rapid onset of action, increased bioavailability, and improved stability
... Carvedilol is a poorly water-soluble oral antihypertensive agent, with problems of variable bioavailability and bio-equivalence related to its poor watersolubility. In present work attempt will be made to design and evaluation of Fast dissolving tablets of Carvedilol for the effective management of angina pectoris, hypertension etc. 1 In view of substantial first pass effect and its shorter plasma half life therefore is an ideal drug candidate for Fast dissolving drug delivery system. 2 To formulate the fast dissolving dosage form of Carvedilol to Improve patient compliance, Ease of administration, Increase bioavailability of drug and avoid first pass effect. 3 Fast Dissolving Tablet is solid unit dosage form which disintegrates or dissolves rapidly in the mouth without chewing and water. ...
Carvedilol a poorly water soluble drug undergoes extensive first pass metabolism, which reduces its bioavailability to 25-30%. Fast dissolving tablets of Carvedilol were prepared with the purpose of delivering the drug directly into the systemic circulation and bypassing the hepatic first pass metabolism with a concomitant increase in bioavailability. The solubility of Carvedilol was improved by forming inclusion complex with cyclodextrin which was then further used for the formulation of Fast dissolving tablet. Keywords: Carvedilol, Superdisintegrats, Fast dissolving Tablets and FDTs.
... In conclusion, oral administration of bitter active ingredients by ODT formulations ought to increase patient compliance, improve palatability, and have a positive therapeutic effect.[1, 4,5] Several techniques, including lyophilization, moulding, freeze drying, sublimation, rapid dissolving films, and direct compression, are used to create commercially available ODT. moulding and lyophilization. The WOW tab technology, flash tab technique, Zydus, and orosoly procedures are a few recent examples of unique preparation methods for orodispersible tablets that have been developed as patent technology for ODT. ...
Optimizing medication administration to achieve maximum therapeutic effectiveness while minimizing adverse effects is pivotal for desired outcomes. This study delves into the development of a viable dosage form through a comprehensive exploration of physicochemical mechanisms governing a specific medication. Orally dissolving tablets (ODTs) have emerged as a promising option, especially for individuals facing difficulties swallowing conventional pills due to dysphagia, a condition prevalent among various age groups, notably the elderly and those with neurological disorders. ODTs offer advantages by dissolving in saliva without the need for water, enhancing accessibility for diverse patient populations. They have been studied extensively for their potential to modify drug-dissolving profiles, enhance bioavailability, and improve patient compliance, particularly by masking the unpleasant taste of active compounds. Numerous techniques, including lyophilization, molding, freeze-drying, and direct compression, have been utilized to develop commercially available ODTs. Recent advancements such as the WOW tab technology, flash tab technique, and orosoly procedures showcase innovative approaches protected by patents. In this investigation, Alverine orodispersible tablets were formulated using specific disintegrants and the direct compression method, yielding nine formulations meeting acceptable pre-compression parameters. Compatibility studies confirmed the integrity of Alverine without any drug-excipient interactions. Among the formulations, P4 and P7 exhibited superior characteristics such as high hardness, low friability, and rapid disintegration, aligning with the desired attributes of an orodispersible tablet. Dissolution tests indicated optimal drug release profiles, suggesting enhanced bioavailability from these formulations. The study concludes that Alverine orodispersible tablets meet the criteria for an effective orodispersible dosage form, presenting a viable alternative to conventional tablets, ensuring potential therapeutic benefits and improved patient acceptability.
... Microgranules of drug, taste masking agents, disintegrating agent, and swelling agents are used to formulate drugs. These tablets have good physical resistance, and highly suggested for hygroscopic materials for blister packing as materials like polyvinyl chloride/aluminum foils cater better moisture protection in comparison to conventional 43 polyvinyl chloride or polypropylene foils . ...
Rapimelt tablets oral drug delivery is currently the gold standard in the pharmaceutical industry where it is regarded as the safest, most convenient and most economical method of drug delivery having the highest patient compliance. Methods to improve patient's compliance have always attracted scientists towards the development of fancy oral drug delivery systems. Among them, Rapimelt tablets drug delivery systems (RmDDS) have acquired an important position in the market by overcoming previously encountered administration problems and contributing to extension of patent life. (RmDDS) have the unique property of rapidly disintegrating and/or dissolving and releasing the drug as soon as they come in contact with saliva, thus obviating the requirement of water during administration. Therefore, these dosage forms have lured the market for a certain section of the patient population which includes dysphagic, bed ridden, psychic, and geriatric and paediatric patients. Research in developing repadily disintegrating systems has been aimed at investigating excipients as well as technique to meet these challenges. Technologies used for manufacturing of Rapimelt tablets are either conventional technologies or patented technologies. In conventional freeze drying, tablet molding, sublimation, spray drying etc. and in patented Zydis technology, Orasolv technology, Durasolv technology, Wowtab technology, Flashdose technology are important. Important ingredients that are used in the formulation of ODTs should allow quick release of the drug, resulting in faster dissolution.
... Thus, the bioavailability of the drug is significantly higher than in conventional tablet dosage forms. Mouth dissolving tablets usually take less than 1 minute or 60 seconds to disintegrate [14,15]. ...
Mouth dissolving tablet have better accessibility and tolerability for patients, mouth dissolving tablet is the most essential and recommended way of drug delivery. One more difficulty can be solved by administering the new drug with the mouth dissolving tablet formulation so that the drug quickly dissolves and breaks in the mouth in fewer minute due to the effect of super disintegrating agents that maximize the pore structure of the formulation. The purpose of this research work was to develop mouth-dissolving tablet of Ascorbic Acid. Tablet containing drug and excipients were prepared by direct compression method. Excipients in combinations were merged to achieve the aim. Effect of different combinations was studied to optimize the best formulation. Drug excipients interaction studies were carried out by FTIR spectral analysis. The tablets were evaluated for their hardness, disintegrating time, wetting time, and dissolution parameters. It was determined that the tablets having the combination of Crosspovidone, Croscarmellose sodium, and microcrystalline cellulose fulfilled all the evaluation parameters and thus selected as the optimized formulation. Optimized formulation was undergone for stability testing as a parameter to expect the shelf life. The major role produced by the superdisintegrant and inactive substances for improving the bioavailability of drug and advances the drug release in the oral cavities.
... T his allo ws ger iatr ic pa tien ts to swallow their medication easily. Other properties of FMTs include high palatability, cost-effectiveness and high drug loading [ 4 ]. Currently, a variety of methods, such as dir ect compr ession, sublimation, molding, freeze drying or lyophilization, spray drying, etc., are utilized to pr epar e FM Ts. ...
Aim: The objective of this study was to develop and characterize the physical properties of fast-melting tablets (FMTs) using cocoa butter as the base and caffeine as the model drug. Method: The simple refrigerator freezing method was employed to prepare caffeine-loaded, FMTs from cocoa butter bases. Results: The F3 chosen formulation achieved a disintegration time of 1.20 min ± 0.035, which falls within the specified limit set by the European Pharmacopoeia. The cumulative drug release data of F3, was 88.52 and 94.08% within 60 and 75 min, respectively (NLT 85% as per US FDA requirement). All the other physical test standards for FMTs met the pharmacopeial specifications. Conclusion: Based on the findings, the simple refrigerator freezing method could be used to formulate FMTs.
... Mouth dissolving tablets with highly porous structure and good mechanical strength have been developed by this method. 23,24 Spray drying A highly porous and fine powder is prepared by spray drying an aqueous composition containing support matrix and other components. This is then mixed with active ingredient and compressed into tablet. ...
Researchers throughout the world are focusing intensively on the methods for the development of
new drug delivery systems to enhance patient’s compliance. The oral route however still remained as
the best administration route of therapeutic agents for its ease of ingestion, pain avoidance and
versatility. Hence, fast dissolving tablets become an emerging trend in the pharmaceutical industry.
Fast dissolving tablets are ideal for all types of people, including for people who have swallowing
difficulties, paediatric, geriatric, and bedridden patients. It is also for active patients who are busy,
travelling and may not have access to water. Fast dissolving tablets are also known as orodispersible
tablets, mouth-dissolving tablets, orally disintegrating tablets, melt-in mouth tablets, rapimelts,
porous tablets, quick dissolving etc. This type of tablets disintegrates quickly once introduced into the
mouth in the absence of additional water for easy administration of active pharmaceutical
ingredients. In this review article, drug candidates suitable for fast dissolving drug delivery and the
available marketed products have been listed.
... The disintegration time for ODTs generally ranges from several seconds to about a minute. [5] Overview of Oral Mucosa ...
Linagliptin is an anti-diabetic drug used for the treatment of type 2 diabetes, it is belongs to the class of dpp-4 inhibitor. It has long half-life of about 8.6-23.9 hours and hence to achieve immediate therapeutic action it needs immediate release tablet formulation. Among the various techniques using superdisintegrants is a simple approach to formulate immediate release tablets. It undergoes an extensive hepatic first pass metabolism leads to low oral bioavailability (30%). ODT can overcome this problem through improving its bioavailability with an immediate drug release. In the present work, Oral disintegrating tablets of Linagliptin were prepared by direct compression method using superdisintegrants such as Crosspovidone lycoat, and Tulsion. The dispersion time of tablets were reduced with increase in the concentration of super disintegrants like Crosspovidone, lycoat, and Tulsion. From the results obtained, it was concluded that Tulsion was found to be the best among the superdisintegrants, the highest drug release of F9 is 99.45% of the drug in 20 min
... Using a mechanical stirrer, stirring was carried out for 10 minutes at a speed of 500 RPM. Then, this solution is passed using a 710 µm sieve [29]. ...
Introduction: Orally Disintegrating Tablets (ODTs) have garnered significant attention in the pharmaceutical industry, particularly for medications with delayed dissolution and low oral bioavailability. These tablets offer advantages, especially for patients with swallowing difficulties, both young and elderly, and those who may face dehydration during extended periods on the road. This study focuses on the use of super-disintegrants as part of a novel approach to manufacturing ODTs containing chlorpheniramine maleate (CPM), with additional consideration given to the impact of sweeteners on the formulation. Objective: The primary objective of this work is to create CPM-ODTs using a direct compression method, emphasizing fast disintegration qualities to enhance patient compliance. The study aims to assess various parameters, including drug content, hardness, friability, disintegration time, wetting duration, water absorption ratio, and in vitro release of drugs, to evaluate the performance of the manufactured tablets. Methods: The method employed in this study involves the use of two super-disintegrants, namely sodium starch glycolate and croscarmellose sodium, in the formulation of CPM-ODTs. The direct compression method is utilized, and the tablets are subjected to a comprehensive analysis to measure their key characteristics and performance. Stability analysis is also conducted on the final trial formulation to ensure both chemical and physical sustainability. Results: The results of the study reveal that the formulation incorporating 10mg Croscarmellose Sodium (CCS) exhibits the quickest disintegration time and the fastest drug release among the tested formulations. Additionally, stability analysis demonstrates that formulation ODT6, which includes 10 mg CCS, sucralose, and menthol powder, is both chemically and physically sustainable. Conclusion: In conclusion, the use of super-disintegrants, specifically CCS, in the direct compression method for CPM-ODTs proves to be effective in achieving fast disintegration and drug release. The optimized formulation (ODT6) with 10 mg CCS, sucralose, and menthol powder is identified as both chemically and physically sustainable, indicating its potential for further development as a patient-friendly oral medication.
... Ease of management to sufferers of all ages [55]. Drugs are greater quickly and punctiliously absorbed from pre-gastric quantities of the GIT, which will increase their bioavailability and effectiveness [56]. Costpowerful due to the fact only a few additives are needed. ...
Oral drug delivery is still the preferred method for administering many medications. Recent technological advancements have led to the development of orally disintegrating drugs, which offer improved patient compliance and convenience. Orodispersible(ODTs) drugs are a unique dosage form that dissolves in the mouth within 1-3 min without the need for chewing or water. Over the past three decades, orodispersible drugs have gained popularity as an alternative to traditional drugs due to their increased patient compliance, solubility, and stability. This new technology meets both the pharmaceutical and patient demands and provides a comfortable dosage method for pediatric, geriatric, and psychiatric patients with dysphagia. Natural substances are preferred over synthetic ones because they are more accessible, less expensive, non-toxic, and chemically inert. Natural polymers, such as locust bean gum, banana powder, mango peel pectin, and Mangifera indica gum, enhance drug characteristics and are used as binders, diluents, and super disintegrants to speed up disintegration, increase solubility, and provide supplements. Manufacturers are increasingly using natural polymers due to various issues with medication release and adverse effects. This review article views the development of ODTs, challenges in formulation, new ODT technologies, and our suspects.
... Tablets were evaluated for various tablet parameters. [5,6] (Table No. 1). ...
Cilnidipine is poorly water soluble antihypertensive drug (BCS class II). This study was conducted to increase solubility of drug. An attempt was made to formulate fast dissolving tablet of Cilnidipine by solid dispersion using melting method with Pluronic F-68. The API: carrier was taken as 1:1, 1:2 and 1:3. Effect of several variables such as concentration of superdisintegrant, drug: carrier ratios were studied. Formulations were analyzed using Differential Scanning Calorimetry (DSC), X-ray Diffraction (XRD) analysis, Fourier Transform-Infrared spectroscopy (FT-IR) and in-vitro release studies followed by various release kinetics. Drug release profile of pure drug was found 8% within 15 minutes whereas tablet of Cilnidipine: Pluronic F-68(1:3) prepared by melting method showed NLT 85% drug release in 15 minutes. Accelerated stability study was carried out for period of 3 months, which indicated that tablets were unaffected at all the exposed conditions.
... This delivery system offers better patient compliance than conventional tablet dosage form 2 . Bioavailability of drug from this delivery system is significantly greater than from conventional tablet 3 . Ziprasidone Hydrochloride is a newer atypical antipsychotic drug used in treatment of schizophrenia, which is an ongoing mental disease 4 . ...
Ziprasidone Hydrochloride, a Class II drug is an atypical antipsychotic agent, which is poorly water soluble with only 60% bioavailability. In present study attempt has been made to prepare Ziprasidone Hydrochloride fast disintegrating/ dissolving tablets. For enhancing solubility of drug, inclusion complexes of drug were prepared using ȕCD and HPβCD. These complexes were characterized by solubility study, differential scanning calorimetry and X-ray diffractometry. To aid in faster disintegration of tablets, superdisintegrants in different proportions were used and their effect on disintegration was studied. The inclusion complexes with HPȕCD prepared by microwave method exhibited highest enhancement in solubility (0.024g/100ml) and also showed fastest dissolution profile (100% drug release in 5 min.). So this complex was worked further for formulation of Ziprasidone Hydrochloride fast disintegrating/ dissolving tablets. Among the tablet formulations prepared using different superdisintegrants, those with 5 % w/w Polyplasdone showed the lowest disintegration time (21 sec.) and fastest dissolution profile.
... Mouth dissolving tablets avoid first pass metabolism and enhance bioavailability of active ingredient 3 . ...
The objective of the current study is to develop salbutamol sulphate fast dissolving tablet possessing higher degree of bioavailability due to presence of superdisintegrants, which tend to dissolve tablet rapidly in the saliva of mouth, rendering higher rate of dissolution. A 32 factorial design was used to investigate effect of amount of crospovidone and superdisintegrants namely cross-linked carboxyl methyl cellulose as independent variable. Friability, disintegration time, percent drug release was taken as dependent variables. Different concentrations (3yo, 4yo, 5%) of superdisintegrants cross-linked carboxyl methyl cellulose and crospovidone (5%, lTyo, ls%o) were used respectively. Tablets were prepared by direct compression method; the compressed tablets were dried for 6hours to allow sublimation of camphor and to increase the porosity of the tablets hence to improve their dissolution. The tablets were evaluated for hardness, thickness, friability, weight variation, porosity, weffing time, disintegration time, drug content and in-vitro drug release. Drug-excipient interaction was investigated by FTIR study. Optimized formulation was further evaluated for stability as per ICH guideline. All tablets had hardness in the range of 3-3.5 kg/cm2 and friability was less than |.08%. Weight variation and drug content were within USP prescribed limits. FTIR study revealed no drug-excipient interaction. SEM study showed that the tablet surface morphology was porous. A stability study for optimized F3 formulation as per ICH guideline fbr 90 days showed no changes in drug content. Therefore, it may be concluded that optimized tablets of salbutamol sulphate possess high porosity which dissolve rapidly in mouth and hold high degree of bioavailability.
... Administration of highly ionic drug and high dose of drug is impossible. [4] 1. ...
Novel drug delivery system assists to achieve better patient compliance. Sublingual tablets are one of them. Drug delivery via the oral mucous membrane is considered to be a promising alternative to the oral route. Sublingual literally meaning is "under the tongue", refers to a method of administrating substance via mouth in such a way that the substance is rapidly absorbed via blood vessels under tongue. Due to rapid onset of action, ease of administration, versatility, painless and paramount patient compliance oral administration is considered as most satisfactory route for the administration of drug.
... The benefit of utilizing the stop drying procedure is that pharmaceutical substances prepared in a non-raised temperature along these lines dispensing with antagonistic agents done efficiently. The use of hardware and costly handling methods limits the utilization of this procedure 29,30 . ...
Despite advancements in science and technology and newer innovations in drug delivery, the oral route is still the most popular route for administering the drugs. The tremendous measures are adopted to make it as cost-effective, non-invasive, and self-administrative process for improving patient compliance. It has found acceptance from people of all ages, especially children and old age, as there is difficulty in swallowing the tablet. The longing efforts have made to improve the flavor and taste of orally managed tablets that prompted the advancement of numerous medicines with improved acceptance and palatability. Mouth dissolving tablets (MDTs) have become progressively prominent in recent decades, and this field has turned into a quickly developing territory in the pharmaceutical industries. One of the promising characteristics of MDTs is the quick disintegration in the mouth when mixed with saliva and provides a pleasant and sweet taste for disagreeable medicines. This article surveys the past utilizations and newer techniques adopted by descriptors for taste concealing. It projects the most recent improvements and strategies taken for diminishing the sharpness for oral pharmaceuticals. It further highlights the problems faced by paediatrics and geriatrics patients in the swallowing of tablets and also adopted for the disintegration of the tablet in the mouth to enhance patient compliance and acceptability through ease of administration at an affordable cost. The incorporation of superdisintegrants employed for the development of the MDTs and other formulation aspects promotes the use of MDTs in pharmaceutical industries from a research point of view.
... Formulating a drug as FDT has the added advantage of increased bioavailability due to pre-gastric absorption of the drug in the oral cavity and oesophagus leading to faster onset of action. Also the amount of drug subjected to first-pass metabolism is reduced as compared to standard tablet (Kuchekar et al., 2003). Emergency drugs that are absorbed sublingually are the best candidates for FDTs but other drugs with short biologic half-life and undergo heavy first-pass metabolism have been formulated and studied (Narmada et al., 2009, Shirsand et al., 2009, Biswajit et al., 2011, Eraga et al., 2014. ...
... Studies of the Granulation [14][15][16][17][18][19][20] Preformulation studies are the first step in the rational development of dosage form of a drug substance. The objectives of preformulation studies are to develop a portfolio of information about the drug substance, so that this information is useful to develop formulation. ...
The objective of proposed work was to develop, formulate and evaluate bi-layer
tablet containing Metoprolol succinate as extended release form and Ramipril as immediate release form. Acting by different mechanisms, metoprolol succinate and ramipril in combination would produce an additive antihypertensive effect. Although an enhanced antihypertensive effect can be obtained by using a larger dose of a single drug, this may increase the incidence of side effects. Using low doses of the two drugs in combination would achieve better reduction in BP without compromising tolerability. Both extended release and immediate release part were formulated by wet granulation method. The granules were evaluated and compressed by using Bilayer compression machine. The prepared bilayer tablets were evaluated and in vitro dissolution test was carried out separately for Ramipril and Metoprolol succinate. Different formulations were developed for Metoprolol succinate and Ramipril separately, based on trial and error basis and evaluated. The optimized formulation was found to be comparable in drug release profile as per USP 2007 in case of metoprolol succinate layer and as per IP 2007 in case of ramipril layer. A broad range of drug release pattern could be achieved by varying polymer ratio in extended release part; binder and disintegrant ratio in immediate release part. Utilizing the experimental design concept, an effective formulation has been developed with extended release Metoprolol succinate and immediate release Ramipril in the form of Bilayer tablet to optimize therapy of Hypertension and Myocardial Infarction.
... Studies of the Granulation [14][15][16][17][18][19][20] Preformulation studies are the first step in the rational development of dosage form of a drug substance. The objectives of preformulation studies are to develop a portfolio of information about the drug substance, so that this information is useful to develop formulation. ...
The objective of proposed work was to develop, formulate and evaluate bi-layer
tablet containing Metoprolol succinate as extended release form and Ramipril as immediate release form. Acting by different mechanisms, metoprolol succinate and ramipril in combination would produce an additive antihypertensive effect. Although an enhanced antihypertensive effect can be obtained by using a larger dose of a single drug, this may increase the incidence of side effects. Using low doses of the two drugs in combination would achieve better reduction in BP without compromising tolerability. Both extended release and immediate release part were formulated by wet granulation method. The granules were evaluated and compressed by using Bilayer compression machine. The prepared bilayer tablets were evaluated and in vitro dissolution test was carried out separately for Ramipril and Metoprolol succinate. Different formulations were developed for Metoprolol succinate and Ramipril separately, based on trial and error basis and evaluated. The optimized formulation was found to be comparable in drug release profile as per USP 2007 in case of metoprolol succinate layer and as per IP 2007 in case of ramipril layer. A broad range of drug release pattern could be achieved by varying polymer ratio in extended release part; binder and disintegrant ratio in immediate release part. Utilizing the experimental design concept, an effective formulation has been developed with extended release Metoprolol succinate and immediate release Ramipril in the form of Bilayer tablet to optimize therapy of Hypertension and Myocardial Infarction.
... Swallowing is also a common problem in the young individuals because of their under developed muscular and skeletal system. Other groups that may experience problems using conventional oral dosage form include mentally ill, developmentally disabled patients and patients who are uncooperative or who are suffering from severe nausea [4,5] . For the administration of suspension to children a special oral syringe or dossator needs to be provided which requires care during administration such as proper calculation of dose, cleaning of the syringe after use, etc. ...
Now-a-days, dispersible drug delivery systems are extensively used to improve bioavailability and patient compliance. Over the past three decades, dispersible tablets have gained considerable attention as a preferred alternative to conventional tablets and capsules due to better patient compliance, improved solubility and stability profiles. Dispersible tablets could be preferred choice especially with those drugs sensitive to GI fluids, for masking bitter taste of drug and for patients under category of pediatrics, geriatrics, bedridden, postoperative and who may have difficulty in swallowing the conventional tablets and capsules. These types of tablets disintegrate quickly in the water to produce the suspension. The superdisintegrants are the important constituent of dispersible tablet. Dispersible tablet on contact with water get wet and swell extensively so that the tablet disintegrate quickly. This review includes a detail updated concept on dispersible tablet.
... The need for non-invasive drug delivery systems continues due to patient's poor acceptance and compliance with existing delivery regimes, limited market size for drug companies and drug uses coupled with high cost of disease management. MDT is one such dosage form which is useful for:[4] 2. Geriatric patients mainly suffering from conditions like hand tremors and dysphasia.[5] 3. Pediatric patients who are unable to swallow easily because their central nervous system and internal muscles are not developed completely.[6] 4. Traveling patients suffering from motion sickness and diarrhea that do not have easy access to water[7] ...
Tablet dosage form is the most popular among all existing conventional dosage forms because of its convenience of self-administration, compactness and easy manufacturing. Many patients find it difficult to swallow tablets and capsules. The difficulty is experienced in particular by pediatric and geriatric patients, but it also applies to people who are ill on bed and to those active working patients who are busy or traveling, especially those who have no access to water. Mouth dissolving tablet was prepared by addition of superdisintegrants (Ac-Di-Sol, Sodium starch glycolate and Crospovidone). The tablets were evaluated for their organoleptic (Color, Odor, Taste), physical (Size, Shape and Texture) and quality control parameters (Diameter, Thickness, Hardness, Friability, Disintegration Time and Wetting Time). Hence, mouth dissolving tablets of resinate can be successfully prepared by superdisintegrants, maintaining their disintegration time less than 1 minute, which provide faster effect and better patient compliance. These tablets may be helpful for geriatric and pediatric patients experience difficulty in swallowing conventional tablets, which leads to poor patient compliance. Thus, it was concluded that the method designed for drug resinate complexation and tablet formulation is simple, rapid, cost effective and highly efficient.
The mouth dissolving tablets are prepared and formulated utilizing different additives like plasticizers, polymers and other bulk forming agents. There are many different batches are manufactured and tested for their evaluation parameters like disintegration test, dissolution test, content uniformity test and weight variation tests. The many bateches are tested and one of the optimized batch is selected for pharmacological action and marketing purpose. The analytical method was developed as according to calibration curve. Oral dispersible tablets of perampenal have been prepared and formulated utilizing xanthen gum and super disintigrant sodium crosscarmilose and sodium starach glycolate with crospovidone with multi-stationary punching machine. The phosphate buffer is also utilized for mainting buffer pH of the intestine. The natural polymers are preffered as compared to synthetic polymers. The different batches of tablets have been prepared and evaluated with official dissolution time, disintegration time, weight variation and content of uniformity tests and unofficial firability testing with Roche friabilator and hardness or tensile strength of the the prepared tablets with Pfizer hardeness tester. Keywords: Perampanel, xanthen gum, crosscarmilose, crosspovidone, sodium starch glycolate, mouth dissolving tablets
The purpose of the article is to review potential advancements of ODT technology in drug delivery applications. Now-a-days, orodispersible drug delivery systems are extensively used to improve bioavailability and patient compliance. Over the past three decades, orodispersible tablets (ODTs) have gained considerable attention as a preferred alternative to conventional tablets and capsules due to better patient compliance, improved solubility and stability profiles. Orally disintegrating tablets (ODTs) are solid dosage forms containing drugs that disintegrate in the oral cavity within less than 1 minute leaving an easy-to-swallow residue. ODTs could be preferred choice especially with those drugs sensitive to GI and for patients under category of pediatrics, geriatrics, bedridden, postoperative and who may have difficulty in swallowing the conventional tablets and capsules. The current article is focused on ideal characteristics, recent trends undertaken to develop ODTs, advantages and disadvantages, various technologies developed for ODT, evaluation methods along with recent research and future potential.
Oral drug administration is more widely accepted because it is used to provide between 50 and 60 percent of medications. The solid dosage forms are commonly utilized since they are simple to administer, precise in their dosage forms, beneficial for self-medication, and preventive of discomfort, and last but not least, the excellent level of patient adherence. The capsules and tablets are the most widely used solid dose form administered orally. Aside from ingesting it does not possess any noteworthy drawbacks. Water plays a crucial function in this swallowing process. Even following this, some people had difficulty swallowing. In order to prevent these issues, mouth dissolving tablets were developed. They have the benefit of not requiring water and don't require swallowing because they dissolve or disintegrate in saliva. In light of the design it began to behave in two ways: first, some tablets disintegrated quickly, taking just a few moments in saliva. Another kind of tablet is known as a "first disintegration tablet" since it contains some substances that slowed down the tablet's rate of breakdown. Review attention was drawn to the concise talk about mouth dissolving tablets and the most recent versions available.
The oral route of administration remains the most convenient route of administration but the major disadvantage is dysphagia (difficulty in swallowing) to overcome these problems novel drug delivery systems have developed mouth dissolving tablets with improved patient compliance. Mouth dissolving tablets are solid dosage forms which dissolve rapidly when kept in mouth. The first choice of drugs for pediatric, geriatric, mentally disable patients and also for patients who are traveling can administer the tablet any time without the need for water. conventional technologies and patented technologies are the two different technologies used in the manufacturing of MDTs. This review describes the various aspects of MDT formulation, super disintegrants, and technologies used for developing MDT, along with evaluation.
Especially for patients who have dysphagia or difficulty swallowing, oral disintegrating tablets (ODTs) have developed as a novel dosage form to address a number of issues related to traditional solid dosage forms. An overview of the formulation techniques, assessment criteria, and uses of ODTs in pharmaceutical research are given in this study. In order to accomplish quick disintegration and dissolution of the tablet matrix upon contact with saliva, formulation processes such as sublimation, lyophilization, and direct compression have been thoroughly investigated. When evaluating the quality qualities of ODTs, evaluation metrics such as drug content homogeneity, hardness, friability, and disintegration time are essential. To improve patient acceptance and palatability, superdisintegrants and a variety of taste-masking techniques have been used. Furthermore, ODTs adaptability goes beyond traditional oral administration they may be used for emergency and travel medicine, as well as in paediatric and geriatric populations. All things considered, ODTs present a viable platform for enhancing patient convenience and compliance, which maximises therapeutic results. ODTs provide a number of benefits, such as improved patient compliance, simplicity of administration, and greater bioavailability because of their quick dissolving and larger surface area. To sum up, oral disintegrating tablets offer a potentially effective option for individuals who need readily administrable and comfortable dose forms. ODTs will be further optimised by ongoing research and development into manufacturing and formulation processes, increasing their applicability to a wider range of patient demographics and therapeutic areas.
Mouth dissolving tablet are solid dosage form containing drugs disintegrate in oral cavity with in less than one minute. Mouth dissolving tablet are conventional dosage form like tablet .mouth dissolving tablet are developed of good hardness, dose uniformity and easy administration .the serve as first choice of dosage form for pediatrics, geriatrics and travelling patient. MDTs aim are sufficient hardness, integrity and faster disintegration without water. Mouth dissolving tablet are the including content significant, advantages, disadvantages, ideal properties formulation of mouth dissolving tablet, evaluation parameter and selection of super disintegrating agents. Tablet are readily dissolve in saliva within 60 sec
Fast dissolving tablets have emerged as a popular dosage form, particularly beneficial for pediatric and geriatric patients facing challenges such as dysphagia or hand tremors. These tablets dissolve quickly in saliva without needing water, enhancing compliance and effectiveness of therapy. They offer advantages like easy portability, accurate dosing, and improved bioavailability. Various technologies, including spray drying and melt granulation, have been developed for their manufacturing. This review provides comprehensive information on fast dissolving tablets, covering their definition, advantages, limitations, challenges, and available formulations. The design of an oral drug delivery system prioritizes convenience in administration and improved patient compliance, making it the preferred route of drug delivery despite certain drawbacks. Over the last decade, there has been a growing demand for Fast Disintegrating Tablets (FDTS), turning this field into a rapidly expanding area within the pharmaceutical industry. The formulation’s popularity and effectiveness have led to the development of various FDT technologies. These technologies aim to achieve rapid tablet disintegration and mouth dissolution within five seconds, eliminating the need for chewing or water intake. This characteristic is particularly advantageous for populations such as pediatrics, geriatrics, and patients facing difficulties in swallowing conventional tablets and capsules. The formulation of an easily administrable dosage form, considering challenges like swallowing difficulties and low patient compliance, has driven the creation of orally disintegrating tablets. Traditional preparation methods include spray drying, freeze drying, direct compression, molding, and sublimation. In addition, new technologies have been devised to enhance the production of orodispersible tablets.
Demand for ODT is increasing day by day particularly in pediatric, geriatric and patients with some sort of disabilities in swallowing. ODTs are those tablets which gets rapidly dissolved in saliva. They do not need water for administration. Oral dispersible tablets are also known as fast melting tablets. The current article reviews the introduction, ideal characteristics, advantages and disadvantages, limitations, challenges in formulating ODTs, formulations of ODTs, technologies used in ODTs, selection of superdisintegrants and evaluation methods.
Over a decade, the demand for development of orally disintegrating tablets (ODTs) has enormously increased as it has significant impact on the patient compliance. Orally disintegrating tablets offer an advantage for populations who have difficulty in swallowing. Prescription ODT products initially were developed to overcome the difficulty in swallowing conventional tablets with water among pediatric, geriatric, and psychiatric patients with dysphagia. Today, ODTs are more widely available as over-the-counter products for the treatment of allergies and cold and flu symptoms. Technologies used for manufacturing of orally disintegrating tablets are either conventional technologies or patented technologies. In conventional freeze drying, tablet molding, sublimation, spray drying etc. and in patented Zydis technology, Orasolv technology, Durasolv technology, Wowtab technology, Flashdose technology are important. Important ingredients that are used in the formulation of ODTs should allow quick release of the drug, resulting in faster dissolution. Evaluation of these tablets are done by following weight variation, friability, tensile strength, wetting time, water absorption ratio,
To prepare fast dissolving tablet of Irbesartan an Angiotensin Receptor Blocker (ARB), direct compression method was utilised, and it comprised several steps. The main focus was to improve the disintergation time as well as the dissolution rate of the drug as it comes into contact with water. Lactose and Microcrystalline sodium (MCC) were used as diluents and fillers, Aspartame and Magnesium Stearate were used as lubricants, Crospovidone, Croscarmellose sodium (CCS), Sodium Starch Glycolate (SSG) were used as superdisintergrants as they increase the hydraulic pressure when the come into contact with water. The post compression properties of the tablet; disintergration time, wetting time and the drug release profile of the prepared table were investigated. The drug release of the prepared formulation was compared to the marketed formulation. 5 formulations were prepared using different ratios of the excipients and the optimized formulations were subjected to characterization. Hardness of the tablet was controlled by compression during the manufacturing process. Following FTIR studies, it was found that there were no interaction between the drug and the excipients and that the drug release depended on the type of the excipients used in the formulation. Direct compression was found to be a suitable, easy and efficient technique for designing fast dissolving tablet (FDT) for oral use.
The aim of the present work was the preparation and optimization of mouth-dissolving tablets (MDTs) of Ivabradine hydrochloride by using natural super disintegrants. The tablets were prepared using microcrystalline cellulose as diluent and aspartame as a sweetening agent along with Natural super disintegrants. The natural super disintegrants used in this study were Guar Gum and Banana powder. By using natural superdisintegrants we had saved the environment and protected our bodies from the harmful effect of synthetic superdisintegrants. The tablet was prepared by the direct compression method. The 6mm of punch was used and the tablet weight is 110 mg. The tablets were evaluated for weight variation, hardness, friability, wetting time, disintegration time (DT), and dissolution study. Different concentration of superdisintegrants was used in this formulation as 6%, 8%, and 10%. The three batches of guar gum and 3 batches of banana powder were prepared i.e., a Total of six batches were prepared. From the results obtained, it can be concluded that the tablet formulation prepared with 10% banana powder i.e., 10 mg showed fast and higher drug release (98.66%) during in vitro dissolution study. Also, the hardness, friability, dissolution rate, and assay of prepared tablets (batch F6) were found to be acceptable according to standard limits. The result was the F6 batch was optimized batch from all the batches.
: Aim of present study was to formulate, optimize and evaluate mouth dissolving tablet of palonosetron hydrochloride.
Tablet was formulated by direct compression method by using different super disintegrating agents like crospovidone,
croscarmellose sodium and sodium starch glycollate. For optimization of final formulation 32 factorial design was applied. The
concentration of microcrystalline cellulose and crospovidone were selected as an independent variable and disintegration time,
wetting time and in-vitro drug release as dependent variable. Formulations were evaluated for parameters like hardness,
disintegration time, in-vitro drug release study, wetting time, drug content and drug excipients compatibility study. Study
demonstrates that the release profile depends on the concentration of crospovidone. The optimized formula obtained from
different factorial batches of experimental design matches with the predicted value from design expert software. The optimized
batch was evaluated for the parameters like hardness, disintegration time, in-vitro drug release study, wetting time and drug
content. The final formulation was stable after 3 months stability study as per ICH guideline conditions. The studies indicate that
the formulation was having less disintegration time as well as fast in-vitro drug release. Crospovidone is the key ingredient
which significantly affects disintegration time as well as fast drug release effect. Fast dissolving formulation of palonosetrone
HCl can be successfully formulated and used for patients who refuse to swallow conventional tablets such as pediatric, geriatric
and psychiatric patients
In this research work based on solubility enhancement method useful of use less water soluble drug of etoricoxib pure drug and use with water soluble carrier different PEG3350,PEG4000,PEG6000,PEG8000,PEG 20000 grade and drug and water soluble carrier ratio 1:1,1:2,1:4 and 1:6 and urea in different ratio1:1,1:2,1:4 and 1:6 and use physical fusion method and evolution of solid dispersion and I was observed drug solubility increases it useful in development of novel formulation use though solid dispersion method drugs that are poorly water soluble, which accelerates dissolving and can significantly improve bioavailability. Amorphous drug forms typically have substantially higher enthalpy than their crystalline counterparts. By transforming the medicine into an amorphous molecular dispersion using a hydrophilic carrier matrix, crystallization can be prevented. During the formulation development process, one of the most difficult aspects of drug delivery is enhancing the bioavailability of the weak aqueous drug. The pace and quantity of the drugs that leaves the dose form and enters the systemic circulation before it reaches the site of action to have the desired effect is known as bioavailability.
Key word: solid dispersion, etoricoxib, bioavailability, PEG, solubility enhancement etc.
Despite advancements in science and technology and newer innovations in drug delivery, the oral route is still the most popular route for administering the drugs. The tremendous measures are adopted to make it as cost-effective, non-invasive, and self-administrative process for improving patient compliance. It has found acceptance from people of all ages, especially children and old age, as there is difficulty in swallowing the tablet. The longing efforts have made to improve the flavor and taste of orally managed tablets that prompted the advancement of numerous medicines with improved acceptance and palatability. Mouth dissolving tablets (MDTs) have become progressively prominent in recent decades, and this field has turned into a quickly developing territory in the pharmaceutical industries. One of the promising characteristics of MDTs is the quick disintegration in the mouth when mixed with saliva and provides a pleasant and sweet taste for disagreeable medicines. This article surveys the past utilizations and newer techniques adopted by descriptors for taste concealing. It projects the most recent improvements and strategies taken for diminishing the sharpness for oral pharmaceuticals. It further highlights the problems faced by paediatrics and geriatrics patients in the swallowing of tablets and also adopted for the disintegration of the tablet in the mouth to enhance patient compliance and acceptability through ease of administration at an affordable cost. The incorporation of superdisintegrants employed for the development of the MDTs and other formulation aspects promotes the use of MDTs in pharmaceutical industries from a research point of view.
The most common problem about conventional dosage form is dysphagia (difficulty in swallowing). So, we design a new approach in a conventional dosage form which is oral dispersible tablet. Oral dispersible tablet is also called as mouth dissolving tablet, fast dissolving tablet, or oral disintegrating tablet. Oral dispersible tablet has advantage as it quickly disintegrates into saliva when it is put on the tongue. The faster the drug disintegrates or is dissolved, the faster the absorption and the quicker the therapeutic effect of drug will be attained. The objective of present study was to formulate directly compressible orodispersible tablets of cimetidine with improved solubility and bioavailability by using solid dispersion technique. Cimetidine is a histamine H2-receptor antagonist. It is widely prescribed in active duodenal ulcers, gastric ulcers, Zollinger-Ellison syndrome, gastroesophageal reflux disease and erosive esophagitis. Solid dispersion of cimetidine was prepared by anti-solvent addition method and physical mixture using novel polymer eudragit E 100. Saturation solubility of drug was determined in physical mixture and solid dispersion formulation. The prepared solid dispersion formulations were further characterized by drug contents, HPLC, and encapsulation efficiency. Orodispersible tablets of cimetidine were prepared by direct compression method and blend was evaluated for the pre-compression parameters such as bulk density, compressibility, angle of repose etc. The tablets were prepared by using selected solid dispersion formulation and excipients with sodium starch glycolate as a superdisintegrant and evaluated for hardness, friability, weight variation, content uniformity, wetting time, dispersion time and in-vitro drug release. Orodispersible tablet shows wetting time 27±1 seconds and in-vitro drug release 93.20±3.181%, which is better as compare to tablet containing pure drug (82.36±1.986) within 20min. Thus formulation of orodispersible tablet of cimetidine solid dispersion showed increased solubility and bioavailability with patient complies and convenience. Keywords: Cimetidine, Orodispersible tablets, Solid dispersion, Anti solvent addition method, Superdisintegrant
The fast-dissolving drug delivery system is rapidly gaining interest in the pharmaceutical industry among the various novel drug delivery systems. The most convenient route for drug administration for pharmaceutical dosage forms is the oral route. More than 50% of pharmaceutical products are orally administered for several Reasons, and undesirable taste is one of the essential formulation problems encountered with such oral products. According to governing compliance, the taste of a pharmaceutical product is an important parameter. Hence taste masking of oral Pharmaceuticals has become an essential tool to improve patient compliance and the Quality of treatment. In pharmaceutical oral dosage forms have unpleasant or obnoxious tastes, including bitter, sour, salt, sweet and umami tastes founded by the majority of active pharmaceutical ingredients (APIs). Taste is now one of the most important factors influencing the Quality of the product, according to therapeutic value, compliance, and acceptance of the patient. This reason is an initiative for the development of various taste-masking technologies by which the characteristics of the dosage form are improved, and good patient compliance is achieved. The present article reviews the earlier applications and methodologies of taste masking and discusses the most recent developments and approaches to bitterness reduction to give an idea about the traditional and recent taste masking evaluation techniques whereby they increase palatability for oral pharmaceuticals.
The goal of this research is to prepare oral disintegration tablets of Sitagliptin utilising Synthetic Superdisintegrants. By utilising a direct compression approach, oral disintegrating tablets of Sitagliptin were prepared using various ratios of synthetic super disintegrates. The goal of this study was to create and optimise oral disintegrating tablets of Sitagliptin utilising synthetic superdisintegrants to provide a speedy start of action by quickly dissolving in a few seconds without the need for water and to improve patient compliance. In such cases, drug bioavailability is substantially higher and adverse events are significantly lower than in standard tablet dose form. By using IR spectroscopy, drug-excipient compatibility experiments were done, there was no drug-excipient interaction. The 9 formulations of Sitagliptin were prepared varying the concentrations of three super disintegrants: croscarmellose sodium, sodium starch glycollate, and starch 1500. As an immediately compressible vehicle, microcrystalline cellulose was employed. Overall, the results showed that the formulation containing croscarmellose sodium, i.e. CCS3, had a significant advantage over other formulations including the superdisintegrants.
Objective: Preparation of the drug-resins complex. Performing comparatives study on different resins. Formulate the complex into sustained release tablet. Evaluate the tablet for in-vitro drug release. To compare in vitro release between marketed formulation and drug resonate formulation. Method: Calibration curve of Salbutamol sulphate in methanol. Calibration curve of Salbutamol sulphate in simulated gastric fluid. Calibration curve of Salbutamol sulphate in intestinal fluid. Selection of resins. Preparation of drug-resins complex. Effect of various parameters on drug loading. Evaluation of resins and resinate. Physical properties. X-ray diffraction studies. I. R. Studies. Microsteriograph. In-vitro release of resinates. Formulation of tablet using INDION ® 244. Evaluation of physical properties of tablets. In-vitro release profile of formulated tablets. In-vitro release profile of marketed tablet. f2 similarity factor between formulated preparation and marketed preparation. Stability studies of formulated tablet. Result: The X-ray diffraction studies, I.R. studies, Microsteriograph confirms the formation of complex. The physical properties of drug, resin, and resinate, like shapes, flow properties. Bulk density, Tap density and Packing ability, were determine. Which were found to be satisfactory. In vitro release profile of resinate shows that more than 85% of drug release from INDION ® 254, INDION ® 404 in 5 and 6 hours respectively. Only 62.78% of drug was release from TULSION ® 344 in 8 hours. So it is not suitable to use TULSION ® 344 as sustained release. 91.14% of drug is release from INDION ® 244 so resinate prepared from INDION ® 244 is suitable for sustained release. Conclusion: Conclusion was drawn that the ion exchange resins INDION ® 244, coupled with tablet can serve as useful tool to sustained release of water soluble drug Salbutamol sulphate. Stability studies at 450c, RH 75%, for 1 month on tablet of batch B3 showed no significant effect on physical properties, drug content, and release profile. Abstract Introduction
This study reports the QbD on Pharmaceutical Development of Diazepam Oral Disintegrating Tablet. The concept of quality by design (QbD) has recently gained importance by application of design of experiments approach (DoE). QbD describes a pharmaceutical development approach especially in formulation design & development and manufacturing processes for the purpose of maintaining and improving the product quality. There are various elements of QbD are there such as Quality Target Product Profile (QTPP) ,Critical Quality Attributes (CQAS), Quality Risk (Assessment) Management (QRM), Design Space etc. The present work is aimed in the application of quality by design (QbD) concept especially Target Product profile in the formulation development of Diazepam tablet.
Tablet dosage form is the most popular among all existing conventional dosage forms because of its convenience of self-administration, compactness and easy manufacturing. Many patients find it difficult to swallow tablets and capsules. The difficulty is experienced in particular by pediatric and geriatric patients, but it also applies to people who are ill on bed and to those active working patients who are busy or traveling, especially those who have no access to water. The drug hydralazine HCl were used. The amount of drug was 35 mg. the different super disintegrates was used to make a suitable mouth dissolving tablet. All the other reagents which is used in analytical grade reagents. In the present study mouth dissolving tablets of hydralazine HCl were designed, prepared and evaluated. These tablets can disintegrate or dissolve rapidly once placed into the oral cavity. The feofenadine was analyzed for its organoleptic, physicochemical and spectral (IR, UV) properties. The obtained hydralazine HCl was concordant with reference specifications. A complex of hydralazine HCl was successfully formulated. The volunteers rated the resinate as tasteless and agreeable complex.
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