Inclusion Complexation in Sulfobutyl Ether Beta Cyclodextrin and Dispersion in Gelucire for Sustained Release of Nifedipine Employing Almond Gum

Abstract

In the present research investigation, the utility of employing high dissolving forms of nifedipine for sustained release from matrix tablets with almond gum as major release retardant is explored. A poorly soluble BCS class II drug nifedipine is chosen as a model drug. Efforts were made to alter the dissolution characteristics of the drug before it is entrapped in the polymer matrix of almond gum. Inclusion complexation in sulfobutyl ether beta cyclodextrin or solid dispersion in gelucire (50/13) resulted in enhanced dissolution of nifedipine. The high dissolving forms are characterized by x-ray diffraction, differential scanning calorimetry and infra-red spectroscopy. The matrix tablets prepared employing the high dissolving forms exhibited satisfactory characteristics such as hardness, friability, swelling index. The drug release is found to be slow and spread over a period of 12 hours and the release could be modified with changes in nature of high dissolving form and the proportion of almond gum as the major release retardant. Employing high dissolving forms in matrix tablets of almond gum is found to be a novel approach in obtaining slow and complete release of poorly soluble drug such as nifedipine.
 Keywords: sulfobutyl ether beta cyclodextrin, solid dispersion, nifedipine