K. Girish Pai

Manipal College of Pharmaceutical Sciences, MAHE · Pharmaceutics

Objective: Evidence Based Medicine (EBM) knowledge and skills have been recommended as a core competency of healthcare professionals worldwide. However, EBM teaching and learning approaches is quite heterogeneous. Hence, we aimed to conduct a meta-synthesis to identify various teaching and learning aspects of EBM from the learners and instructors p...

Objective This review evaluates the effectiveness of smartphone applications in improving academic performance and clinical practice among healthcare professionals and students. Methods This study followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Articles were retrieved from PubMed, Scopus, and Co...

The present study is aimed to formulate lapatinib nanosponges (LPT NSs) to enhance its aqueous solubility and bioavailability. LPT loaded NSs were fabricated using Eudragit RS100 as polymer and polyvinyl alcohol as a stabilizer. The optimized formulation was evaluated for morphological characterization, solid-state characterization, accelerated sta...

In the current research work, a new co-crystal of ceritinib with nicotinamide and quercetin hydrate was prepared with increased solubility. Ceritinib belongs to BCS class IV drug which having poor permeability and low aqueous solubility that leads to poor oral bioavailability. Thus, an endeavor has been made by the co-crystal technique to increase...

The existence of 3D printing (3DP) ways back to 1992, and its sound presence in the pharmaceutical industry was made in 2015 by the launch of 1 st 3D printed drug, Spritam was manufactured by Aprecia Pharmaceuticals. Implementation of 3DP is escalating in the number of industries, including the pharmaceutical industry. The purpose of this review pa...

Introduction: Any defects in pharmaceutical products lead to minor, major, or critical deviation and if such a product is released, it also leads to product recalls and legal actions. In such cases, the concern is about patient's safety rather than the company's economy and fame. This study aimed to investigate the various quality defects which hav...

The objective of the present study was to develop a robust, simple, economical and sensitive HPLC-UV method using the “quality-by-design” approach for the estimation of irinotecan (IRI) in marketed formulations. RP-HPLC method was developed by applying Box-Behnken design with HyperClone (Phenomenex®) C18 column (250 × 4.6 mm id, particle size 5 μm,...

World Health Organization recommends doctor population ratio as 1: 1000 and in India the ratio is 0.62: 1000. With the ever growing population and tremendous patient pool in India the significant challenge faced by clinicians is lack of skilled allied health professionals who can assist in providing timely, unbiased, critically appraised health inf...

Introduction: The main aim of this project was to study the patient information leaflets (PIL), primary labels (PL) and primary cartons for their adequacy, harmonization of printed text matter meeting regulatory requirements. Methods: The study involved comparative evaluation of PIL, PL and primary cartons of generic and innovator brands. Three dif...

Due to lack of facilities and expensive medicines most of the patients in developing courtiers do not get adequate treatment for HIV/AIDS. Hence it was an immediate requirement that the developed countries and the developing countries walk hand in hand on the path of defeating this epidemic monster. President’s Emergency Plan for AIDS Relief is the...

Manufacturing of solid dosage forms which should be performed accordance with the Good Manufacturing Guidelines as per the local regulatory requirements, Product quality cannot be adequately ensured only by inspecting and testing a finished product because finished-product testing cannot detect all defects, quality must be built into a product with...

Both competency level and training plays a major role in pharmaceutical industries. Pharmaceutical industry employs technical people from various streams or fields like graduates and post graduates in pharmacy, engineering, science, management etc. On one hand, competency or basic education is a prerequisite for recruiting technical staff to perfor...

Aim of present study was to determine the causes of a broken film coated tablet with black spots and a twisted tablet in blister pack of marketed product containing aceclofenac and paracetamol. Tablets of the complaint batch (batch No.22) and another batch (batch No.49) manufactured at the same facility of the company were procured and evaluated to...

This present UV Spectrophotometric method developed using methanol as a solvent is simple, rapid, specific, precise and sensitive to estimation Etoricoxib in bulk in day to day analysis. The method was validated as per ICH Q2R1 guideline. Etoricoxib is the newest addition to the group of Non-Steroidal Anti-Inflammatory Drugs-highly selective COX-2...

An HPLC method was developed and validated as per ICH guidelines for nicardipine analysis in lipid nanoparticles. Nicardipine was quantified using methanol and 40 mM ammonium formate (pH 3.5) with a ratio 65:35% v/v and BDS C18 column as a stationary phase. Detection of drug was carried out using UV detector at 240 nm by maintaining the flow rate a...

Irbesartan, an angiotensin receptor blocker, a BCS class II drug is effective in lowering blood pressure but is having low aqueous solubility and low bioavailability. Hence, the present study was aimed to prepare and evaluate nanosuspension of Irbesartan for enhancement of dissolution. Preformulation studies like, DSC, FTIR was performed to evaluat...

Gefitinib was determined quantitatively in a nanoformulation using the proposed HPLC method. Effective elution was achieved by using a stationary phase of HyperClone (Phenomenex ®) C 18 column (250 mm´4mm´mm´4.6 mm i.d., 5 mm, BDS 130 Å) and a mobile phase composed of acetonitrile and 40 mM ammo-nium formate buffer pH 2.5 (30 : 70, %v/v) at a flow...

The subsequent artefact entail of extremely subtle and informal Reversed phase HPLC (RP-HPLC) technique for approximation ofMethylcobalamin in large quantity. Shimadzu LC-20-AD(Kyoto, Japan), with auto sampler and (PDA/UV) detector was used for the separation of Methylcobalamin.C18 Hypersil BDS (5.0 micron,150 x 4.6mm) column was aimed at the separ...

In the present study a new co-crystal of Ticagrelor with L-Tartaric acid has been prepared with improved solubility. Ticagrelor is a class VI drug with poor solubility and permeability; hence an attempt has been made to improve its solubility by co-crystallization technology.A co-crystal is a structurally homogeneous crystalline material containing...

The subsequent artefact entail of extremely subtle and informal Reversed phase HPLC (RP-HPLC) technique for approximation ofMethylcobalamin in large quantity. Shimadzu LC-20- AD(Kyoto, Japan), with auto sampler and (PDA/UV) detector was used for the separation of Methylcobalamin.C18 Hypersil BDS (5.0 micron,150 x 4.6mm) column was aimed at the sepa...

This study establishes that etraverine, an anti human immuno deficiency virus drug, is produced as cocrystals to improve the solubility of the same by cocrystallisation methods and characterization of the cocrystals formed. Etraverine belongs to the class IV category as per the Biopharmaceutical Classification System which are basically classified...

Initially drugs are available for consumption to the public only after consulting with a healthcare professional and obtaining a prescription for the same. However, to enhance consumer access to a safe and effective drug, it is possible to 'switch' the same to over-the-counter status after the initial prescription marketing if the post-marketing sa...

Gefitinib is an anticancer agent which acts by inhibiting epidermal growth factor receptor tyrosine kinase receptors. The aim of the present study was to prepare gefitinib nanosuspension. Gefitinib was encapsulated in Eudragit® RL100 and then dispersed in stabilizer solution, polyvinyl alcohol, and polyvinylpyrrolidone K30. Nanosuspension was prepa...

Purpose: The main aim of this article is to develop an alternate source for excipients manufactured by different manufacturers. Methods: Four different excipients were selected for this study and evaluated based on their functional characteristics. Results: From the results obtained, the both vendors of the materials were showing equivalent each ot...

ICH Q1 F guideline provided astability data package for the registration applications of drug substance and drug product in Climatic Zones III (hot and dry) and IV (hot and humid). These guidelines were adopted by the ICH in February 2003 and subsequently implemented in the ICH regions. Due to some reasons the guidelines were withdrawn. This review...

A sensitive, accurate, precise and stability indicating high-performance thin layer chromatographic method was developed and validated for analysis of triamcinalone acetonide (TRIA) in bulk drug and sterile injectable suspension. The method employed HPTLC aluminum precoated plates with silica gel 60F-254 as the stationary phase. The solvent system...

Eprosartan mesylate, an antihypertensive, exhibits low oral bioavailability due to its ionization at alkaline pH. An attempt has been made to prepare enteric coated capsule containing drug and maleic acid, as dosage form. Male-ic acid acts as pH-modifier, facilitates the absorption of drug by reducing the pH of intestinal environment (prefer-ably d...

Good personal hygiene is required in pharmaceutical industries to safeguard the product and avoid any type of contamination that effects quality of medicinal product. Individual persons are responsible for quality of a medicinal product and hence collectively can be termed as “personnel”. Even though controls are in place to manage equipment, incom...

High performance liquid chromatographic method was optimized, developed and validated as per the ICH guidelines. In this study the 20 mM ammonium formate and acetonitrile in the 57:43 ratio were used as mobile phase for the analysis of valsartan. Full factorial design was used to optimize the effect of variable factors. The responses were peak area...

Solubility of the drug plays a crucial role in the formulation and development of the drug. Assessing the solubility of the drug is one of the most important parameter in pre-formulation. Parenteral formulations require sufficient solubility of the drug molecules. Correspondingly bioavailability from solid formulations like tablets and capsules is...

The main objective of this study was to find out the root cause for broken tablet and black spots on tablets in primary pack of the marketed product containing Diclofenac sodium 50 mg and Paracetamol 500 mg. In this study, we took tablets of same batch in which broken tablet (Batch A) was found and another batch (Batch B) from the same company was...

Objective: The objective of the study was to carry out the disintegration test and test for uniformity of dispersion for few marketed brands of Amoxicillin Trihydrate 250 mg dispersible tablets IP. Methods: Five different brands were randomly selected for this study, which were coded as brands A, brand B, brand C, brand D and brand E. The tests for...

Results: Phenomenal differences were observed in all evaluated parameters like appearance, thickness, drug content and drug release studies. Ocular inserts sized using punch die set had improved appearance, uniform thickness both near the edges & in the center of insert and accurate drug content when compared to ocular inserts that were sized manua...

Objective of this research was to formulate and evaluate extended release ocular inserts/ films of anti-conjunctival drug, Sodium Cromoglycate. Novel natural polymer namely, Pullulan and synthetic polymer namely, Hydroxy Ethyl Cellulose (HEC) were used as biodegradable, biocompatible polymers. Standardized glass mould was used to prepare ocular ins...

Standard operating procedures (SOPs) form the backbone of any pharmaceutical industry. It states the procedure to be followed for each and every activity that is carried out in the pharmaceutical industry. All the staffs are trained on each SOP. SOPs state the procedure to be followed, dos and don'ts etc. However most of the times, deviations do oc...

Compressed multiple unit pellet tablets/multiple unit particulate or pellet systemsare commonly called as Multiple Unit Particulate Systems (MUPS). MUPSare composed of polymer coated subunits namely pellets; which are embedded in an inert excipients matrix designed to overcome the difficulties in administering capsules and for improved physicochemi...

Objective of the present study was to develop and evaluate vaginal films with essential in vitro studies. Films were developed using hydroxypropyl methylcellulose as a polymer and formulations were coded. The developed films were evaluated with Fourier transform infrared spectroscopy, drug content, viscosity, surface pH, thickness, mechanical chara...

Introduction: One of the main reasons for the development of the resistance in the therapy for Tuberculosis is the mono drug therapy. This may be due to the drug-drug interactions as the therapy includes combination of various drugs leading to poor bioavailability of these drugs. One such reported interaction is between Rifampicin and Isoniazid whi...

Objective: The objective of the study was to compare marketed Generic and Innovator product of Meropenem for injectionnearing theshelf life. Method: The marketed samples of Generic and Innovator Company were tested for pH, Clarity, Appearance of the product and Reconstitution time. All the samples were reconstituted and pH was determined using cali...

Any product launched in the market can receive a "Market Complaint" if the product is not meeting the customer requirements or may be for the presence of any critical defects. For instance, it can be product of any area like fast moving consumer goods, electronic gadgets, cosmetics and medicinal product etc. When it comes to medicinal product, it i...

The objective of this study was to compare the physical parameters of uncoated tablets in strip, blister and alu-alu type of primary packages under prescribed storage conditions recommended by the manufacturer, and finally to conclude the efficient primary package. The strip, blister and alu-alu packaging of Anti-diabetic drug Glimepiride 1mg of th...

The study was conducted with an intention to evaluate student's ability to effectively use their positive strength, technical knowledge and to come out with innovative ideas. Students of Second year B. Pharm Class were grouped into different batches (5 students each) and were assigned the task of preparing a poster of the experiment specified for t...

The objective of this study was to compare the physical parameters of uncoated Telmisartan tablets in strip, blister and alualu packages under prescribed storage conditions by the manufacturer. The strip, blister and alu-alu packaging of same drug of same formulation (uncoated tablets of three different brands) were procured randomly from the pharm...