Formulation and evaluation of fast dissolving sublingual film of aripiprazole

The oral route is the most preferred route, though preoral administration of drug has disadvantage like hepatic first pass metabolism ana enzymatic degradation within the GI tract however trans mucosal routes of drug delivery (i.e.Mucosal lining of nasal, rectal, ocular & oral cavities) offer distinct advantage over preoral administration.Aripiprazole is an antipsychotic also primarily used in the treatment of schizophrenia and bipolar disorder. Fast dissolving sublingual films of Aripiprazole were prepared by solvent casting technique. HPMC E-15 was selected as polymer because of its good water solubility. Polyvinyl pyrrolidone K-30(PVP K-30) as superdisintegrant and Polyvinyl alcohol as film forming agent. Mannitol as sweetner and saliva stimulating agent used in the formulation. Chitosan as permeability enhancer. The compatibility of the drug in the formulation was confirmed by FTIR studies. A various concentration of polymers was conducted in order to optimize API concentration of the new dosage form. The FDSF was characterized for weight, thickness, folding endurance, tensile strength and dissolution using In-vitro experimentations. The effect of PVA and PVP K-30 on drug release profile and film forming properties was investigated. Estimation of drug content of films was performed and the results were satisfactory. In-vitro dissolution studies revealed higher drug release from formulation F7 batch.