Formulation and In Vitro Evaluation of Mexiletine Hydrochloride Timed Release Capsules

AIM AND PLAN OF WORK:The aim of the present work was formulation and in-vitro evaluation of Mexiletine hydrochloride 200mg timed- release capsules. Which release the drug at different time intervals in the GI tract Objective of the work is to formulate timed release dosage form by adopting wet granulation method using synthetic polymers (HPMCE15), Croscormellose sodium and Eudragit L 100 at different ratios. Mexiletine Hydrochloride was selected as a drug due to its low biological half life (A.J.cammn 1990) it requires frequent administration, hence timed release dosage form are formulated to reduce the dosing frequency thereby improving patient compliance. To develop the timed release dosage form of the drug. To perform drug: excipient compatibility studies. To determine the drug content of the different granules of various dosage form. To evaluate parameters such as morphology of the granules, particle size. To reduce the systemic side effects, and to improve the patient compliance. It is delivered through timed-release dosage form. To conduct the in vitro release studies for the dosage form. In case of chronic treatment, where the drug is given in sustained release dosage form, continuous exposure of the drug to body may lead to adverse effects.In case of Mexiletine hydrochloride, it is advised to divide the daily dose of 600-800mg into three does which are given at different time intervals. This is done to reduce the adverse effect as well as it has been reported that clinical outcomes are better when three divided doses are given. Hence a timed-release dosage form of mexiletine hydrochloride will be investigated to deliver the doses at different time intervals in a pulsatile manner. Instead of taking three doses at three different time intervals per day, the patient will have to take two timed release capsule leading to better patient compliance.CONCLUSION:Suitable analytical method based on UV-Visible spectrophotometer was developed for Mexiletine Hydrochloride. 262 nm was identified as an ���� in purified water. Timed-release capsules of Mexiletine HC1 were successfully prepared using Lactose, HPMC E15 and Eudragit L 100 by wet granulation method. The timed-release capsules were evaluated for pharmacopoeial and non- Pharmacopoeial (industry specified) tests. Based on the results batch F4 was identified as better formulations amongst all formulations for delivering the drug in a pulsatile manner. Mexiletine HC1 release from the developed formulations has been observed to be directly proportional to the amount of polymer present in capsules. Capsules of batch F4 passed all official and unofficial quality control tests. Data obtained from kinetic treatment revealed F4 formulation follow Higuchi model. Accelerated stability developed formulations were found to be stable.