FORMULATION AND IN VITRO EVALUATION OF APREMILAST PULSINCAP DRUG DELIVERY

Abstract

The purpose of the present study was to design and evaluate an Oral, site specific, Pulsatile drug delivery system containing Apremilast as a model drug, which can be time dependent manner, to modulate the drug level in synchrony is a member of the drug class known as corticosteroid prodrug with an active metabolite. Apremilast is a non-steroidal medication used for the treatment of inflammatory conditions such as psoriasis and psoriatic arthritis. The basic design consists of an insoluble hard gelatin capsule body, filled with powder blend and sealed with a hydrogel plug. The powder blend containing Apremilast, Lactose. Karaya Gum, Lycoat, Ludiflash, Croscarmellose sodium, MCC and talc was prepared and evaluated for flow properties and FTIR studies. From the obtained results, F12 powder blend formulation was selected for further fabrication of pulsatile capsules. Hydrogel plug was formulated in a lone and in combination of hydrophobic polymer like ethyl cellulose with hydrophilic polymers like Ethyl Lactose and Karaya Gum in 1:1, 1:2, and 2:1 ratio to maintain a suitable lag period and it was found that the drug release was controlled by the proportion of polymers used. The prepared formulations were evaluated for drug content, weight variation and Invitro release studies. FTIR studies confirmed that there was no interaction between drug and polymers and Invitro release studies of pulsatile device revealed that increasing hydrophilic polymer content resulted in delayed release of Apremilast from the pulsincap after a predetermined lag time of 6hrs. Based on invitro studies performed, P3F12 was found to be optimized formulation.