Sunday , 23 January 2022

Formulation and Evaluation of Fast Dissolving Tablets of Amlodipine Besylate Using Different Super Disintegrants and Camphor as Sublimating Agent


About author :
Abhilash A*, Ajay kumar A, Prabhu Raj KJ,Hemalatha M, Dr. Hindustan Abdul Ahad
B. Pharmacy, Balaji College of Pharmacy, Anantapur, AP, India
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Amlodipine Besylate is used commonly for the treatment angina pectoris, commonly known asangina, is chest pain due to ischemia of the heart muscle, generally due to obstruction or spasm of the coronaryarteries (the heart’s blood vessels). Dosing to elderly patients is improved by mouth dissolving tablets it alsoprovides convenience to whom that have trouble in swallowing tablets. The objective of the present study wasto prepare the mouth dissolving tablet of Amlodipine using different super disintegrants by sublimation method. Different concentrations (2%, 4% and 6%) of superdisintegrants such as Ac-Di-Sol, sodium starch glycolate,Kollidon-CL were used respectively. Camphor was used as a sublimating agent. Tablets are prepared by directcompression and mannitol is used as bulking agent. The compressed tablets are dried for 5 hours to allow sublimation of camphor to increase the porosity of the fast dissolving tablets to improve the dissolution. Thetablets wereevaluated for hardness, friability, weight variation, wetting time, thickness, water absorption ratio, disintegrating time, uniformity of content and in-vitro drug release. All the tablets had hardness 2.3-3.7 kg/cm2 and friability of all formulations was less than 1%, weight variation and drug content were within official limit. Amongst all formulations, formulation F9 prepared by 6% Ac-Di-Sol showed least disintegrating time of 11sec. and faster dissolution. Formulation F9 was then studied for accelerated stability studies as per ICH guidelines for 60 days that shows no remarkable change in the formulation.

Key words: ICH guidelines, Sodium starch glycolate, Angina pectoris, Kollidon-CL, Amlodipine

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