DEVELOPMENT AND IN VITRO EVALUATION OF MOUTH DISSOLVING FILMS OF CAPTOPRIL

Abstract

Captopril is a potent, competitive inhibitor of angiotensin-converting enzyme (ACE), the enzyme responsible for the conversion of angiotensin I (AT I) to angiotensin II (AT II). Captopril may be used in the treatment of hypertension. Thus formulating Captopril into a fast dissolving dosage form would provide fast relief. The bitter taste of Captopril was masked with $\bete$-cyclodextrin. Inclusion complexes of drug $\bete$-cyclodextrin were prepared by kneading method in 1:1 molar ratios. The prepared inclusion complexes were characterized by FTIR spectroscopy suggesting no interaction. The oral fast dissolving films were prepared by using different polymers like HPMC, PVA, PVP and carbopol 934P with super disintegrants like micro crystalline cellulose (MCC) and croscarmellose sodium (CCS). The prepared films evaluated for folding endurance, swelling index, surface pH, in-vitro disintegration time, drug content, FTIR study, and in- vitro drug release. The physical appearance and folding endurance properties were found to be good with the films having clear, colorless and smooth surface without any scratches. The average folding endurance time was found within the range of 123 to 196 times. The drug content was found in the range of 92.21% to 98.97%. The in-vitro disintegration time was found to be in the range of 15 to 48 sec and the surface pH of the all formulations was in the range of 6.02 to

6.79. The in-vitro drug release showed 83.49 to 96.79% drug release within 10 minutes. The formulations F4, F5, F8 showed the highest amount of drug release as these formulations were having croscarmellose sodium as superdisintegrants.