Duloxetine hydrochloride is an approved treatment option for fibromyalgia since 2004. But it has 2 hr lag time and low bioavailability. The objective of present work was to develop sublingual film of Duloxetine hydrochloride to provide quick relief in fibromyalgia. Film was prepared by solvent casting method using PVA as hydrophilic polymer and PEG-400 as plasticizer. Various batches were prepared with different concentrations of polymer and plasticizer. The formed films were evaluated for physical characteristics, thickness, weight, surface pH, disintegration time, tensile strength, folding endurance, drug content, in-vitro dissolution profile, ex-vivo permeation and stability. A thin and transparent film, formed by casting a solution containing 3% w/v polymer and 2.5% w/v plasticizer, showed disintegration time of about 437 seconds and higher in-vitro drug release (97.23 in 7 min). Ex-vivo permeation study of optimized batch exhibited that 92.16% drug was permeated in 8 minutes. The optimized batch showed good folding endurance and by tensile strength (332 gm/mm2). Accelerated stability study confirmed that batch was stable at ambient conditions of storage.
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