Content Uniformity and Invitro Dissolution of Amlodipine Half Tablets

Abstract

Tablet splitting technique is a practice that is carried out in hospitals and community pharmacies. The aim is to achieve dose flexibility, reduce tablet size, ease swallowing and save cost. This technique is prone to variation in the weight of split tablets, mass loss and content uniformity. Its effectiveness is subject to the tablet characteristics, method of splitting and patient’s knowledge and skill. This practice increases the risk of inaccurate dosing, uneven distribution of drug substances and potential loss of efficacy or adverse effects. This study aimed to determine the effect of splitting amlodipine tablets on weight variation, content uniformity and in-vitro dissolution. Four brands of amlodipine 10mg tablets from the Kenya pharmaceutical market were evaluated. For each brand, weight variation and content uniformity tests were conducted as per the European Pharmacopoeia. Dissolution test was performed on 6 split tablets according to the British Pharmacopoeia. All the brands of amlodipine half tablets tested for weight variation were within acceptable limits. Only one individual mass was outside the 85-115% limit of the average weight, being 83.87%. Three of the four brands complied with the content uniformity test. One brand had 2 split tablets having amlodipine content out of the limit of 85-115%. Three brands complied with the dissolution test requirement for amlodipine tablets at the S1 stage. One brand had at least 75% of the amount of amlodipine (5mg) dissolved for the half tablets that were tested. The study shows variation in content uniformity and dissolution test for one brand each. All the brands met the pharmacopeia requirements for the tablet weight variation test.