Formulation design, in vitro evaluation and stability studies on mucoadhesive buccal films of anti-anginal calcium channel blocker.
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Date
2011-08
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Abstract
Diltiazem hydrochloride has poor oral bioavailability, easily undergo first passage
effect in the liver. Hence, an attempt was made to prepare and evaluate mucoadhesive buccal
films containing diltiazem hydrochloride by employing HPMC, eudragit, ethyl cellulose alone
and in combination with PVP. The I.R and DSC studies showed that there was no interaction
between drug and the utilized polymer. The prepared mucoadhesive buccal films showed uniform
thickness, weight, folding endurance, surface pH, drug content and swelling index. The drug
content of all the formulation was found to be uniform. In vitro drug release studies indicated that
the films prepared with HPMC (3%) and ethyl cellulose (4%) has shown fast and slow release
respectively. The formulations incorporated with SLS and sodium glycocholate indicated
significant drug release from F11 and F15. Later the in-situ diffusion studies using goat cheek
pouch showed faster drug release from film with 1% (SLS). About 93.04% and 91.83% of drug
release profile were observed during in situ diffusion studies at the end of 9hrs and 18 hrs
respectively. The formulated films were stable during stability studies at 45ÂșC and 75%RH with
respect to drug content.
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Keywords
Diltiazem hydrochloride, HPMC, Eudragit, Ethyl cellulose, Permeation enhancers and In situ diffusion studies
Citation
Kumar V Bharath, Kumar A Ashok, Sudheer B, Kumar K Suresh, Rao V Srinivasa, Kirtinidhi K, Patel Hitesh R, Kumar Putta Rajesh. Formulation design, in vitro evaluation and stability studies on mucoadhesive buccal films of anti-anginal calcium channel blocker. Journal of Applied Pharmaceutical Science. 2011 Aug; 1(6): 136-142.