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A Review of Comparative study of In-Process Quality Control Tests as Per IP, BP and USP for Solid Dosage Forms
Abstract
Comparative analysis of the quality control tests for in-process and finished oral solid dosage form specifically tablets and capsules across the recent editions of the Indian Pharmacopoeia (IP), British Pharmacopoeia (BP) United States Pharmacopoeia (USP). This study provides a detailed examination of the in-process quality control (IPQC) tests as per the recent editions of Indian Pharmacopoeia (IP) 2022 (Addendum 2024), British Pharmacopoeia (BP) 2025, and United States Pharmacopoeia (USP) 2024 (Issue 3) for oral solid dosage forms, primarily tablets and capsules. It highlights the quality control measures implemented to ensure that the final products confirm to established pharmacopoeial standards. The concept of total quality control involves a comprehensive approach to producing a high-quality product by implementing various measures to eliminate errors at every stage of production. In-process testing is conducted to ensure that the final product meets the compendial standards outlined in pharmacopoeias. Since the final sample used for testing is only a representative sample from a larger batch, there may still be variability. Pharmacopoeias define specific limits within which values must fall to comply with the established standards. These official pharmacopoeias, recognized globally, outline the quality requirements for pharmaceutical products. The purpose of this review is to list the quality control tests, their differences, and similarities in relation to the pharmacopoeias stated above. The review covers various IPQC tests, including those related to physical, chemical, and microbiological attributes, and discusses the specific limits and criteria set by each pharmacopoeia. The study underscores both the similarities and differences in quality requirements among these pharmacopoeias. The review shows that IP, BP, and USP have similar quality control tests, but they each have their own specific requirements and methods for these tests. This divergence reflects the individual pharmacopoeias’ unique approaches to ensuring product quality. Understanding these differences is crucial for pharmaceutical manufacturers to ensure compliance with relevant pharmacopoeial standards and to maintain the quality and safety of oral solid dosage forms across different markets.
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The goal of all Pharmaceutical industry is to make a good quality product and for this it is necessary to allow In-Process Quality Control (IPQC) Approaches. In-process quality control tests are done before the manufacturing process is completed. The function of in-process controls is to monitor and if necessary, adaptation of the manufacturing process to achieve the required specification. This may incorporate control of equipment and environment too. In-process materials should be tested for their physical parameters and its quality attributes which are later approved or rejected by the quality control department. The reason of IPQC is to deliver a cumulative finished product by avoiding or eliminating mistakes at every stage in production. The objective of this study is the comparison of In-process quality control test of India Pharmacopoeia, British Pharmacopoeia and the United state Pharmacopoeia. It was observed from various studies that quality control tests for tablet and capsule listed in different pharmacopoeias have slight similarities and differences
The gelatin cap-sule shell may be soft or hard depending on their formulation. Capsules are intended to be swallowed whole by the patient. In instances where patients (especially children) are unable to swallow capsules, the contents of the capsule can be removed and added (e.g., sprinkled) on soft food immediately before ingestion. In the manufacture of pharmaceuticals, encapsulation refers to a range of techniques used to enclose medicines in a relatively stable shell known as a capsule, allowing them to, for example, be taken orally or be used as suppositories. Hard-shelled capsules, which are normally used for dry, powdered ingredients or miniature pellets, Both of these classes of capsules are made from aqueous solutions of gelling agents like:Animal protein mainly gelatine And Non-gelatin such as Plant polysaccharides or their derivatives like carrageenans and modified forms of starch and cellulose. Despite the great advantages, of gelatin capsules’, gelatin has several drawbacks that limit its use for capsules. The animal source of gelatin can be a problem for certain consumers such as vegetarians or vegans and religious or ethnic groups, Since unmodified gelatin is prone to cross linking
when in contact with aldehydes, solubility problems might be expected with certain fill formulations. The non-gelatin capsule shells are made up of such as Starch, HPMC, PVA, and Alginate.
A simple, precise, rapid and accurate reverse phase HPLC method was developed for the estimation of Nilotinib in capsule dosage form. A RP Inertsil ODS-3V C-18, 250x4.6 mm, 5m partical size, with mobile phase consisting of 0.02M Dipotassium hydrogen orthophosphate in water pH-2.5 with orthophosphoric acid and Acetonitrile in the ratio of 60:40 v/v was used. The flow rate was 1.0 ml/min and the effluents were monitored at 266 nm. The retention time was 8.508 min. The detector response was linear in the concentration of 80-240µg/ml. The respective linear regression equation being Y= 81268.215X+174323.3. The limit of detection and limit of quantification was 0.1µg and 0.3µg/ml respectively. The percentage assay of Nilotinib was 99.61%. The method was validated by determining its accuracy, precision and system suitability. The results of the study showed that the proposed RP-HPLC method is simple, rapid, precise and accurate, which is useful for the routine determination of Nilotinib in bulk drug and in its pharmaceutical dosage form.
The objective of the research work was to provide a gastroretentive system for sustained release of metformin HCl in proximal part gastrointestinal tract (GIT) in the form of oral floating tablet. Metformin HCl is an anti-diabetic biguanid with poor bioavailability and absorption window at the upper part of GIT. Floating tablets were prepared by wet granulation method incorporating natural polymers guar gum and k-Carrageen and a synthetic polymer HPMC K100 (HPMC) either alone or in combination. Sodium bicarbonate and citric acid was used as gas generating agent. Floating tablets were evaluated for weight variation, hardness, and friability, drug content, swelling index, in vitro buoyancy and in vitro drug release study. The formulation optimized based on floating ability, matrix integrity, and in vitro drug release in simulated gastric fluid pH 1.2. Formulation prepared with combination of 6% w/w k-carrageen and 11%w/w guar gum showed good gel strength, stable and persistent buoyancy for 12h, least floating lag time of 58 sec with good matrix integrity throughout dissolution period. The drug release of optimized formulation followed the Korsmeyer– Peppas model and the mechanism was non-Fickian/anomalous. PXRD and DSC studies revealed partial amorphization of drug. The mechanism of drug release was appears to be diffusion mechanism. Stability studies indicated absence of any drug degradation on storage for 3 months at 40 o C. Comparison study with Glutamet ® showed that the optimized formulation has better and complete release than the marketed product. Studies revealed usefulness of natural polymers over synthetic one. INTRODUCTION:
Jamu is an original Indonesian medicine, one of which is formulated in the form of capsules. The rise of products that are not certified halal is a problem that needs to be studied more deeply, especially regarding the halalness of a product. Capsules are produced from animal gelatin, the alleged use of pork gelatin is the core of the problem in this study. The purpose of this study was to determine the presence or absence of pork DNA in the shells of jamu capsules. The sample was taken through one of the e-commerce with certain criteria. From several products, 5 jamu capsules were selected, which were marked with samples A, B, C, D, and E. The five samples were isolated to obtain pure DNA which was then amplified using the right primer to form millions of DNA using the PCR method, and electrophoresis to see the DNA bands produced on agarose media and the number of base pairs (bp) which were then compared with positive controls. From the research conducted, it was found that there were 4 samples B, C, D, and E detected positive for containing pork DNA at 132 bp. Meanwhile, the jamu capsule shell preparation in sample A was negative for pork DNA.
Tablets are the most widely utilized solid oral dosage forms because of the advantages of self-administration, stability, ease of handling, transportation, and good patient compliance. Over time, extensive advances have been made in tableting technology. This review aims to provide an insight about the advances in tablet excipients, manufacturing, analytical techniques and deployment of Quality by Design (QbD). Various excipients offering novel functionalities such as solubility enhancement, super-disintegration, taste masking and drug release modifications have been developed. Furthermore, co-processed multifunctional ready-to-use excipients, particularly for tablet dosage forms, have benefitted manufacturing with shorter processing times. Advances in granulation methods, including moist, thermal adhesion, steam, melt, freeze, foam, reverse wet and pneumatic dry granulation, have been proposed to improve product and process performance. Furthermore, methods for particle engineering including hot melt extrusion, extrusion-spheronization, injection molding, spray drying / congealing, co-precipitation and nanotechnology-based approaches have been employed to produce robust tablet formulations. A wide range of tableting technologies including rapidly disintegrating, matrix, tablet-in-tablet, tablet-in-capsule, multilayer tablets and multiparticulate systems have been developed to achieve customized formulation performance. In addition to conventional invasive characterization methods, novel techniques based on laser, tomography, fluorescence, spectroscopy and acoustic approaches have been developed to assess the physical-mechanical attributes of tablet formulations in a non- or minimally invasive manner. Conventional UV-Visible spectroscopy method has been improved (e.g., fiber-optic probes and UV imaging-based approaches) to efficiently record the dissolution profile of tablet formulations. Numerous modifications in tableting presses have also been made to aid machine product changeover, cleaning, and enhance efficiency and productivity. Various process analytical technologies have been employed to track the formulation properties and critical process parameters. These advances will contribute to a strategy for robust tablet dosage forms with excellent performance attributes.
Among the various drug delivery routes, the oral route has long been the most popular and convenient route. In this chapter, we focus on the development of oral solid dosage forms including preformulation, drug product development, and manufacturing. Preformulation addresses the impact of physicochemical characteristics of the API and excipients on the goal of designing the optimum formulation. Formulation development outlines the key aspects of the different methods used for tablet production. Further development of the manufacturing process focuses on the process system engineering applied to unit operation design (process development and manufacturing of tablet formulation) and how particular unit operations can be optimized to drive down the cost and increase process robustness.
Metformin HCl is an anti-hyperglycaemic agent having oral bioavailability of 52±5% due to its selective absorption from upper part of gastrointestinal tract. It has biological half-life of 1.74±0.2 hours, hence the development of floating sustained release drug delivery system is recommended in order to enhance the bioavailability. The high dose of metformin HCl in the form of SR dosage form results in increased tablet weight and dimensions making the dosage form difficult to be swallowed by the patient. The present investigation deals with use of minimum proportions of natural polymers for drug release control by utilizing the advantage of interactions of gums resulting in enhanced matrix strength. Xanthan gum a heterodisperse system produces a highly ordered, helical or double helical molecular conformation and homodisperse system of locust bean gum is slowly soluble and ungelled at low temperatures. The xanthan gum component acts to produce a faster gelation of the homopolysaccharide component and the homopolysaccharide acts to cross-link the normally free heteropolysaccharide helices resulting in increased viscosity. The interaction of Xanthan and locust bean gum was confirmed by FT-IR spectroscopy and differential scanning calorimetry. Drug release from optimized batch containing metformin HCl: HPMC K100M in 1:1 and sodium bicarbonate 5, 10, 15% ratio has sustained the drug release for 12 hours. Metformin HCl: HPMC K100M in 1:1 and sodium bicarbonate 5, 10, 15% ratio with citric acid. Metformin: in combination of Xanthan and locust bean gum (2:8 optimum viscosity for synergism) in 1:0.5, 1:0.75 and 1:1 ratio with 5, 10, 15% sodium bicarbonate. Metformin: in combination of Xanthan and locust bean gum (2:8 optimum viscosity for synergism) in 1:0.5, 1:0.75 and 1:1 ratio with sodium bicarbonate and citric acid in 5, 10, 15% ratio respectively sustained the drug release upto 12 hours.
The present study was aimed at developing and evaluating fast disintegrating tablets of Granisetron HCl using natural superdisintegrants like Plantago ovata, gum karaya and agar and synthetic superdisintegrants like Indion 234, croscaramellose sodium and crospovidone in different concentration. Fast disintegrating tablets were prepared by direct compression method. Effect of superdisintegrants on wetting, disintegration and dissolution parameters were studied. Fast disintegrating tablets were characterized by Fourier Transform Infrared (FTIR) spectroscopy and Differential Scanning Calorimetry (DSC). Preformulation studies were found as per literature limits. Drug was compatible with superdisintegrants. The prepared tablets were evaluated for weight variation, thickness, hardness, friability, in vitro dispersion time, wetting time, in vitro disintegration time, drug content and in vitro drug release. Results revealed that Formulation F2 containing 5% of Plantago ovata shown disintegration time of 17.10 sec and the drug release was up to 99.66% in 3 minutes. In vitro disintegration time decreases with increase in concentration of all superdisintegrants. Hence the present study revealed that this natural super disintegrants like Plantago ovata, gum karaya and agar showed better release than the most widely used synthetic superdisintegrants like Indion 234, crospovidone, Croscaramellose sodium in the formulations of FDTs.
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