DESIGN, DEVELOPMENT AND BIOLOGICAL EVALUATION OF NIFEDIPINE-LOADED ORAL FILM IN THE MANAGEMENT OF CARDIOVASCULAR DISEASES.

Autor: Bhaskar, Rajveer, Parjane, Ravi M., Ola, Monika, Singh, Balwan, Srivastava, Noopur, Dayal, Ram
Předmět:
Zdroj: Biochemical & Cellular Archives; Apr2024, Vol. 24 Issue 1, p653-661, 9p
Abstrakt: In the present study, a stable sublingual film of Nifedipine for treatment of cardiovascular disease (Angina pectoris, Hypertension) containing was prepared by using pullulan which released the drug over the 300 sec to prevent firstpass metabolism to a large possible extent. 32 level factorial design was used to study effect of formulation variables on drug release, disintegration time and folding endurance and analyzed by applying the computer optimization technique. Based on the results for dependent variables, formulation F4 was found to be optimal formulation with design quadratic model. Pullulan showed good film forming property. Natural polymer Pullulan which is cheap and abundantly available could be a promising vehicle for systemic delivery of an insoluble drug like NF through oral route. The in vitro studies have shown that this is a potential drug delivery system for NF with considerable good stability and release profile. The concentration of pullulan was optimized as (200 mg) and optimized IR film have Drug release 98% within 300 second of time, 127 times of folding endurance and 37 sec of disintegration time. The accelerated stability studies were carried for developed optimized formulation (F4) was analyzed for thickness, weight variation and drug content. Samples were withdrawn at 7 days interval. After 30 days studies, it is revealed that the formulation showed slight changes in thickness, weight variation but it was in acceptable limits (± 0.4). Study of drug content remaining in all formulations reveals that there is no definite change observed for drug degradation. [ABSTRACT FROM AUTHOR]
Databáze: Complementary Index