Abstract

DESIGN AND OPTIMIZATION OF AMLODIPINE BESYLATE TABLETS USING PULSATILE DRUG DELIVERY SYSTEM

Addanki Anusha*, Dr. Jagadeesh Induru and T. Vijay Kumar

ABSTRACT

The present study deals with the design and optimization of amlodipine besylate tablets using pulsatile drug delivery system intended for chrono-pharmacotherapy in hypertension and angina. Constant weight 5mg drug containing core tablets were coated with polymers to get desired lag time of 2-6 hrs. The full factorial design with two variables CAP and HPMC. Optimization studies were extended using SigmaTech software by taking dissolution at 2 hr (D%2hr) and 6 hr (D%6hr) as response. The simulation studies by SigmaTech software predicted that HPMC at 200 mg and CAP at 40 mg level can meet the objectives. The compression coating with CAP and HPMC in 1:1 ratio produced sustained release of the drug for fisrt 5 hours and pulsed relase after 5 hours can be used as chornodelivery device to treat the diseased states like heart attack which aggrevate in early hours of morning. The compression coating of core tablet with 1:5 ratio of CAP and HPMC K 15M resulted in 2 hr lag period with less than 10 % of drug release before lag time and complete drug relase at 7 hr can be used for novel pupose to have delay of 2 hr. In conclusion these solvent free compression caoted formulations can be used to prepare delayed/ timed and pulsatile relase devices by altering the coating compostion.

Keywords: chrono delivery, compression coating, lag time, amlodipine besylate, delayed drug delivery, drug release kinetics.