Abstract
The present research work aim was to formulate a fast-dissolving sublingual film containing Aripiprazole, which is used in the treatment of schizophrenia and bipolar disorder. Fast Dissolving Sublingual Film Containing Aripiprazole prepared by using the solvent casting method. Aripiprazole is a BCS IV drug with poor solubility and poor permeability causing poor systemic absorption. Fast dissolving sublingual film prepared by using Design-Expert® version13 software with 32 full factorial designs in which Film-forming polymer HPMC K4M and plasticizers like PEG 400, and PVA are used in different concentrations. The formulated batches was evaluated for mechanical properties, surface pH, folding endurance, drug content, swelling property, SEM analysis, and in vitro % drug release. The characterization of the film shows satisfactory results following mechanical properties of a film like weight variation and thickness. The formulation (F4, F12) containing the highest concentration of plasticizer shows a high folding endurance ranges from 90-100%. FTIR and DCS studies reveal that there are no interactions means drugs and excipients are compatible with each other. Formulation F4 is optimized batch passes evaluation parameters and maximum % drug release i.e. 98.79 % ±0.36 within 1.5 min. Therefore, the sublingual film is an effective approach for BCS IV and III class drugs by avoiding first-pass metabolism with rapid onset of action and better patient compliance in psychotic disorders.
Published Version
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