Abstract
FORMULATION DEVELOPMENT AND INVITRO EVALUATION OF EPLERENONE PULSINCAP DRUG DELIVERY SYSTEM
Karukonda Kanchana*, Ch. Saibabu, K. Thejomoorthy and P. Sreenivasa Prasanna
ABSTRACT
The purpose of the present study was to design and evaluate an Oral, site specific, Pulsatile drug delivery system containing Eplerenone as a model drug, which can be time dependent manner, to modulate the drug level in synchrony. It is used for treat high blood pressure based on chronopharmaceutical 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 Eplerenone, Crospovidone, Lycoat, MCC and talc was prepared and evaluated for flow properties and FTIR studies. From the obtained results, F6 powder blend formulation was selected for further fabrication of pulsatile capsules. Hydrogel plug was formulated in a combination of hydrophobic polymer like ethyl cellulose with hydrophilic polymers like HPMC K200M in 1:1, 1:2, and 2:1 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 was 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 ethylcellulose polymer content resulted in delayed release of Eplerenone from the pulsincap after a predetermined lag time of 6hrs. Based on invitro studies performed, F9 was found to be optimized formulation.
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