Abstract

FORMULATION AND IN-VITRO CHARACTERIZATION OF CALCITRIOL SOFT GELATIN CAPSULE

Agrasen G. Moon*, Dr. Pranita P. Kashyap, Prashant L. Takdhat, Gajanan M. Jawalkar and Anup R. Thakre

Abstract

The scenario of pharmaceutical drug delivery is rapidly changing conventional pharmaceutical dosage forms are being replaced by new drug delivery systems. These new drug delivery systems are having edge over conventional ones in terms of many biopharmaceutical parameters. The basic of formulation of such a soft gelatine capsules should be to produce the smallest possible capsule consistent with the maximum stability, therapeutic effectiveness, and manufacture efficiency. Calcitriol Soft gelatin capsule formulation strategies are to develop proper shell formula with respect to gelatin/plasticizer combination, to develop a proper fill composition i.e. development of a clear solution of Calcitriol yet it is small enough to be encapsulated easily, to study the effect of various parameters on rate of release, to check the release rate of drug from shell by rapture test. These parameters are crucial to the physical stability of the capsule during manufacture, drying and on storage. The technologically important factors to be born in mind are temperature, viscosity and surface activity of the fill material and, in the case of suspensions, the particle size of the suspended drug.

Keywords: Calcitriol, Soft gelatin capsule, stability, biopharmaceutical parameters, plasticizer.