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IN-VITRO EVALUATION STUDIES OF SEVERAL BRANDS OF DESLORATADINE AVAILABLE IN KARACHI, PAKISTAN WITH APPLICATION OF MODEL DEPENDENT & MODEL INDEPENDENT APPROACHES: KINETIC MODELS

. Hira Akhtar, Muhammad Azan Khan, Zubair Shah, Muhammad Akmal, Muhammad junaid, Aqsa Nasir, Muzammil, Habiba Khan, Kinza Khan, Syeda Himum Batool, Dua Batool, Noman Haneef, Mubashir Imran, Sahibzada Bilal Ahmed, Amna Parvaiz, Afreen Naz, Anila Rahim,


Abstract

Objective: The basic purpose of this study is to evaluate different brands of Desloratadine 5mg tablets available in local market of Karachi Pakistan through various pharmacopeial and non pharmacopeial test, for this study only random 3 brands were selected. Methodology: Twenty tablets were selected from each brand and different test suggests weight variations, hardness thickness, diameter, disintegration, friability, assay and their data analysed through MS excel (2013) and multiple point dissolution studies were conducted and dissolution studies were subjected to several models such as model dependent approaches and model independent approaches. Results: Study revealed that weight variation of selected brand coded as P1, P2, P3 were found to be (224.58±0.90, 224.48±0.94 and 224.27±0.98), thickness and diameter were found to be with in the limit of 5%, hardness of all the three brands were found to be within the limit according to USP 3 to 6 kg, disintegration of selected brands P1, P2 and P3 were found to be 4 min 7 sec, 5 min 9 sec and 7 min 20 seconds. All the selected brands friability were found to be less than 1%, assay of three selected brands were performed in 0.1N HCL and the results were found to be 101.8%, 100.9% and 101.9%. Multiple point Dissolution studies were performed such as 5 min, 10min, 15 min, 20 min, 30 min and 45 min according to USP more than 80% of the drug must be released at 45 minutes results reveals that at 45 minutes percentage of Drug release for P1, P2 and P3 were found to be 99.9%, 98.9% and 98.6% then the dissolution data were subjected to several kinetic models such as model independent and model dependent approaches. Model independent consist of similarity (f2) and dissimilarity (f1) factors by choosing P1 as reference formulation on the basis of high drug release at 45 minutes. Results of P2 and P3, (f2) were found to be

66.75 and 64.56 and (f1) were found to be 4.67 and 4.95. Model dependent approaches consist of several kinetic models such as First order kinetics, Higuchi Kinetics, Hixon Crowell cube root law and Weibull model which were calculated using DD solver on the basis of r2 value it was concluded that all the three brands P1,P2 and P3 followed First order and Weibull kinetics. Conclusion: Successful In-vitro Pharmacopieal and Non-Pharmacopieal tests were applied to three different brands of Desloratadine available in Karachi, Pakistan and large sample size need to be analysed.

Key Words: Desloratidine, Multiple point Dissolution, Independent & Dependent approaches, In- vitro studies of Desloratidine.

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