DEVELOPMENT AND OPTIMIZATION OF FAST DISSOLVING ORODISPERSIBLE FILM OF BACLOFEN USING 32 CENTRAL COMPOSITE DESIGNAbstract
The aim of present research work to develop and optimize orodispersible film of baclofen to improve bioavailability and patient compliance. Orodispersible films of baclofen were prepared by solvent casting method using HPMC E5 LV as a film forming polymer and propylene glycol as a plasticizer, crospovidone as a superdisintegrant and sucralose was added as a sweetener. The physical mixture of drug and polymer characterized by FT-IR showed no incompatibility. A 32 central composite design was applied using two independent variables such as X1 (Polymer) and X2 (Propylene glycol) and folding endurance (Y1), T90% (Y2), In-vitro Disintegration time (Y3).The prepared films were evaluated for weight, thickness, folding endurance, disintegration time, in vitro drug release, drug content and their mechanical properties such as tensile strength and % elongation. From the result obtained optimized formulation was prepared with 2.58% w/v HPMC E5 LV and 2.02 % w/v of propylene glycol showed folding endurance of 68.59, disintegration time 53.4 seconds,T90% of 9.12 minutes. A stability study result reveals that there was no significant change after one month.
Patel Priyanka*, Limbashiya Rikisha, Chavda Mayur and Shah Ujjaval
Bhagwan Mahavir College of Pharmacy, Surat, Gujrat, India
04 May, 2014
16 July, 2014
28 August, 2014
01 December 2014