Abstract

DEVELOPMENT AND OPTIMIZATION OF HALOPERIDOL EXTENDED-RELEASE MINI TABLET BY USING DOE APPROACH

Tejas J. Patel*, Zinal A. Patel and Dhruvin R. Maisuria

ABSTRACT

Haloperidol is antipsychotic drug and belongs to BCS II drug and it is absorbed in orally having 60% bioavailability. In this present research work was aimed to prepare Haloperidol minitablet using different polymer as a release modifier with purpose of developing extended release of Haloperidol minitablet. Main objective of designing this Haloperidol minitablet is to improve oral absorption, to minimize risk of dose dumping and intra-inter variability, and to provide desired concentration of drug plasma level oven an extended period of time. Minitablets are prepared by direct compression method. All preliminary trial batches prepared and evaluated (pre-post compression parameters). 32 factorial design is employed to study effect of independent variables, i.e., conc. Of polymer and conc. Of diluent on dependent variables i.e., hardness and %CDR. Primary identification of drug showed that the drug is in pure form. FT-IR and DSC study result shows no interaction between drug and excipients and that means drug is compatible with the ingredients. Result of Optimized batch hardness 6 kg/cm2 and it shows invitro drug release 88.6% up to 12 hr for extended period of time. from above results it can be concluded that extended release minitablets of Haloperidol can be use as alternative dosage form for the treatment of psychosis patient with good patient compliance for longer period of time.

Keywords: Haloperidol, Antipsychotic, Minitablet, Direct Compression Method, 32 factorial designs, %CDR.