European Journal of Biomedical and Pharmaceutical Sciences

IMPROVE OF DISSOLUTION SHIFT OF BCS CLASS II DRUG PRODUCT (BICALUTAMIDE TABLETS)

Santanu Roy*, Gurpreet Singh and Naresh Kalra

ABSTRACT

Poor bioavailability is a major impediment in the development of an effective dosage form of poorly soluble BCS class II drugs. The present study aimed to improve the dissolution rate of a poorly soluble BCS class II drug product (Bicalutamide Tablets). The absorption rate of a poorly water-soluble drug, from the orally administered solid dosage form is controlled by its dissolution rate and it’s often the rate-determining step in drug absorption. In the present work, the BCS class II drug substances were formulated into granules by slugging and compaction techniques. The process variables selected are the hardness of the slug, the Screen size of the mill, and the Speed of the mill. 23 factorial designs were applied in this study. Process parameters were reproducible having minimal impact on tablet properties in the case of different roller speeds of mill. The relationship between one or more response variables and set quantitative parameters can be examined well by using response surface models. The study concludes that Dry granulation was chosen as an appropriate granulation technique to enhance the dissolution shift of poorly water-soluble BCS class II drugs.

Keywords: Bicalutamide Aqueous Solubility, Bicalutamide Tablets, Factorial Design, Critical Slugging Process, Quality Attributes (CQA), Dissolution.