HPMC/CMC Based Fast Dissolvable Oral Films of an Anxiolytic: In Vitro Drug Release and Texture Analysis
Keywords:
Fast dissolvable oral film (FDOF), Oral film, Buspirone Hydrochloride, HPMC/CMC, PlasticizerAbstract
Film forming capacity of a polymeric combination consisted of HPMC/CMC was investigated for fast dissolvable oral films (FDOFs) of an anxiolytic agent. Other non-film forming components were cross-povidone as disintegrant, and polyethylene glycol 400/ sorbitol in the ratio (1:1) as plasticizer, citric acid as saliva stimulating agent. Buspirone hydrochloride was selected as low dose anxiolytic agent with less than 5% oral bioavailability. Solvent casted films were physically evaluated for thickness, drug content, surface pH, swelling, disintegration and in vitro drug release. Mechanical properties of film viz. % elongation, tensile strength, Young modulus and elongation at break were determined using TXT texture analyzer. Drug loaded film (2.0ï2.0 cm2 size, average weight 60-70 mg) had average thickness in the range of 100-300 μm. Higher HPMC/CMC ratios resulted in lower folding endurance in films (100 turnings), shorter disintegration time (10 sec) and simulated swelling time of 15sec whereas films produced at lower HPMC/CMC ratios had affected film characteristics conversely. Mechanical properties of film were found to relate the plasticizer ratio. Folding endurance and tensile strength of the films prepared at higher PEG 400/sorbitol ratios, showed comparatively higher values than film prepared at lower ratio. It had also been determined that higher ratios of PEG400/sorbitol were of shorter disintegration time. No drug-exicipient interaction was observed from characterization studies conducted on films using FTIR and DSC methods. Films were stable at 30μ0.5 ÀC; 60μ5% RH. In vitro drug release showed that BH was released from film within ten minutes. It can be inferred that polymeric blend HPMC/CMC can be employed as fast dissolving oral film of BH for immediate release.
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