FORMULASI FAST DISSOLVING FILM AMLODIPIN BESILAT SERTA OPTIMASI KOMPOSISI HPMC-E5 DAN MALTODEKSTRIN DENGAN DESAIN FAKTORIAL
Daftar Isi:
- Hypertension is one of disease attacked patients over 55 years with a prevalence of 68% . Single therapy that is often used is amlodipine besylate with a percentage of 52,3%. Formulation fast dissolving film of amlodipine besylate to enhance the acceptability because it‟s used easly and suitable to be consumed every day, escpesially for patients over 55 years. The preparation of fast dissolving film amlodipine besylate formulated by HPMC-E5 and maltodextrin as polymer used Design-Expert®10 program with factorial design 32. Factorial design optimization method which is appropriate to study the effect of several factors and interaction between factors. This research aims to determine the influence of polymer composition to organoleptic, pH, weight, thickness, folding endurance, percent elongation, and disintegration time of film. Results were analyzed by Design-Expert®10, which then were employed to determine the optimum formula. Optimum formula consist of 115,67 mg HPMC-E5 and 100 mg maltodextrin. The optimum formula had RSD uniformity of weight values of 2,55±1,00%, thickness of 0,09±0,002 mm, folding endurance values of 154±3,595, percent elongation of 9,166±1,443%, and disintegration time of 184±28,58 seconds. Besides the optimum formula had a drug content of 98,935±0,243%, percent drug release values of 105,179±0,707% on 11 minutes of dissolution test, and the degree of similarity in texture is low compared the fast dissolving film that has been circulated in the market. Study of stability at 60°C for 6 hours to compared between of optimum formula and pure active substance amlodipine besylates stability show that preparation of fast dissolving film has not been able to improve the stability of amlodipine besylate. FTIR test results show that no chemical interaction between fast dissolving film of amlodipine besylate component, so amlodipine besylate can be formulated in fast dissolving film.