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Published on:July 2019
Indian Journal of Pharmaceutical Education and Research, 2019; 53(3):480-493
Original Article | doi:10.5530/ijper.53.3.80

Formulation and Stability Studies of Fast Disintegrating Tablets of Amlodipine Besylate


Authors and affiliation (s):

Syed Furqan Ahsan1, Muhammad Ali Sheraz1,2,*, Marium Fatima Khan2, Zubair Anwar3, Sofia Ahmed1, Iqbal Ahmad3

1Department of Pharmaceutics, Baqai Institute of Pharmaceutical Sciences, Baqai Medical University, Karachi, PAKISTAN.

2Department of Pharmacy Practice, Baqai Institute of Pharmaceutical Sciences, Baqai Medical University, Karachi, PAKISTAN.

3Department of Pharmaceutical Chemistry, Baqai Institute of Pharmaceutical Sciences, Baqai Medical University, Karachi, PAKISTAN.

Abstract:

Introduction: Among tablets, fast dissolving technology has gained considerable popularity due to their rapid onset of action. Amlodipine besylate (ADB) is a longacting calcium channel blocker that is used in the treatment of angina and hypertension which are life-threatening conditions and require immediate relief. Currently, no fast dissolving tablet dosage form of ADB is commercially available. Methods: A total of seven fast disintegrating tablets of Amlodipine besylate (ADB) have been prepared by direct compression method employing various excipients (Disintegrants and binders) in different concentrations. Pre-compression and post-compression studies were performed along with the storage in the stability chambers under real (30±2ºC / 65±5% RH) and accelerated conditions (40±2ºC / 75±5% RH) for six months. The assay of ADB was performed using a validated UV spectrometric method at 361 nm. Results: The release of ADB from tablets has been found to be very fast with almost more than 85% drug released within 15 min. The release of drug from all the tablet formulations followed Higuchi model. Conclusion: The use of sodium bicarbonate as super disintegrant has greatly promoted the rapid release of the active drug. The binder has been shown to affect the tensile strength of the tablets. The stability studies for six months in aluminum blister packaging indicated no significant change in concentration in the majority of the formulations. This study provides basic groundwork related to the formulation of fast disintegrating tablets of ADB.

Key words: Amlodipine besylate, Direct compression, Drug release, Fast disintegrating tablets, Model dependent and independent methods, Pre-compression and postcompression studies.

 

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IJPER - An Official Publication of Association of Pharmaceutical Teachers of India is pleased to announce continued growth in the 2019 Release of Journal Citation Reports (source: 2018 Web of Science Data).

 

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The Official Journal of Association of Pharmaceutical Teachers of India (APTI)
(Registered under Registration of Societies Act XXI of 1860 No. 122 of 1966-1967, Lucknow)

Indian Journal of Pharmaceutical Education and Research (IJPER) [ISSN-0019-5464] is the official journal of Association of Pharmaceutical Teachers of India (APTI) and is being published since 1967.

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