Formulation and evaluation of biphasic Delivery system of aceclofenac mini-tablets in Hard gelatin capsules

Abstract

Investigated the feasibility of formulating a biphasic delivery system using mini-tablets in hard gelatin capsules delivering drug with a variety of release profiles. Aceclofenac (NSAID analgesic) were chosen as model drug. Immediate release minitablets (IRMT) were manufactured by direct compression using microcrystalline cellulose and cross carmellose as a superdisintegrant, each mini-tablet containing approximately 25 mg Aceclofenac (AFC). Sustained release mini-tablets (SRMT) were formulated using various ratios of HPMC K4M and HPMC K100M. Capsules were filled with individual mini-tablets to deliver 100 mg of AFC. The IR and SRMT were combined in the capsule designed to provide a pulsatile or multi-phase delivery of drug as immediate and sustained dissolution release profiles. Capsules containing AFC immediate release mini-tabs were shown to release nearly 100% of the drug within 60 minutes. Capsules containing SRMT released 98 % of AFC over 12 hours. The feasibility of delivering a drug in biphasic immediate sustained release manner was reputable by combining mini-tablets in a hard gelatin capsule.