FORMULATION AND IN VITRO EVALUATION OF ROFLUMILAST PULSATILE DRUG DELIVERY
Keywords:
Pulsatile system; time dependent delivery; Roflumilast; Chrono pharmaceutics; In vitro release studies.Abstract
The purpose of the present study was to design and evaluate an Oral, site specific, Pulsatile drug delivery system containing Roflumilast 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 statins It is used for lowering cholesterol based on chrono pharmaceutical considerations. 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 Roflumilast, Crospovidone, Lycoat, 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 lactose with hydrophilic polymers like HPMC K15M in 1:1, 2:1, and 1:2 ratios 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 In vitro release studies. FTIR studies confirmed that there was no interaction between drug and polymers and In vitro release studies of pulsatile device revealed that increasing hydrophilic polymer content resulted in delayed release of Roflumilast from the pulsincap after a predetermined lag time of 6hrs. Based on in vitro studies performed, PC4F12 was found to be optimized formulation.
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