OPTIMIZATION & VALIDATION OF BILAYER TABLET FABRICATED BY ANTIHYPERTENSIVE DRUGS

Abstract

The objective of this study was to systematically conduct the process validation studies pertaining to the manufacturing activities of Bilayer tablet. The optimization of critical process steps and acceptance criteria at various stages of the process is referred in the validation report. The specifications of raw materials used in the manufacturing of Bilayer tablets of antihypertensive drugs have been derived from the monograph or previous history. The tolerance limits for the process parameters and the acceptance criteria for the various tests performed on in-process samples are derived from the FRND inputs. The physical characteristics of the final product are based on actual production scale, as some of these processes cannot be simulated in the laboratory. This research was carried out to produce a Bilayer tablet of antihypertensive drug. The immediate release Bilayer tablet of Telmisartan, Amlodipine besylate & Hydrochlorothiazide (40+5+12.5 mg) was successfully prepared. This combination Therapy indicated for the treatment of severe hypertension & coronary heart disease. Therefore, the purpose of performing optimization study for Antihypertensive drug form facility to provide necessary assurance for consistent quality product has been fulfilled.
 Keywords: Telmisartan, Amlodipine besylate, Bilayer tablet, Hydrochlorothiazide, optimization and validation.