Formulation and Evaluation of Asymmetric Membrane Capsule Osmotic Pump of Gliclazide

Author(s)

Teraiya, S.R., Jadav, M.M., Patel, K.N., Patel, B.A., Patel, P.A.

Author's Affiliation

Abstract

The aim of this study was to demonstrate that the asymmetric membrane capsule can be used to deliver a poorly water soluble drug with a pH sensitive solubility such as gliclazide. In order to obtain the desired delivery duration, the drug was solubilized with the use of a pH-controlling excipient. The capsule wall membrane was made by a phase inversion process, in which asymmetric membrane was formed on glass mold pins by dipping the mold pins into a coating solution containing a polymeric material followed by dipping into a quench solution. This study evaluates the influence of coating formulation that was cellulose acetate (CA), ethyl cellulose (EC), and plasticizer (glycerin and PEG 600). Results show capsule that made by CA with glycerol and PEG 600(F8), which appear in asymmetric structure and are able to release gliclazide(GLZ) in significant percentage. Results show that sodium bicarbonate and D-mannitol is able to promote the release of GLZ from polymeric capsules prepared with CA with asymmetrical membrane. The addition of solubilizer, sodium lauryl sulphate (SLS) could enhance the release of GLZ by micelle formation of GLZ. Based on these results, influence of core formulation variables, including D-mannitol, sodium bicarbonate and the added amount of SLS were examined on the release of GLZ. It was found that HPMC 15cp was suitable to be a thickening agent and both added amount of HPMC and SLS showed a comparable and profoundly positive effect. In vitro release studies for all the prepared formulations were done (n=3). Statistical test (Dunnett’s multiple comparison test) was applied for in vitro drug release at P>0.05. The best formulation closely corresponded to the marketed formulation by a similarity (f₂) value of 78.36 and difference (f₁) value of 4.49. The drug release was independent of pH but dependent on the osmotic pressure of the dissolution medium. The release kinetics followed the First order model and the mechanism of release was anomalous type.

Keywords

Asymmetric membrane capsule, Osmotic pump, Antidiabetic agent, Gliclazide, Cellulose acetate, Ethyl cellulose

Cite This Article

Teraiya, S.R., Jadav, M.M., Patel, K.N., Patel, B.A., Patel, P.A. (2012). Formulation and Evaluation of Asymmetric Membrane Capsule Osmotic Pump of Gliclazide, International Journal for Pharmaceutical Research Scholars (IJPRS), 1(2), 155-165.