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Abstract

DESIGN, DEVELOPMENT AND CHARACTERIZATION OF MOUTH DISSOLVING FILMS FOR THE TREATMENT OF PSYCHOSIS

Dr. Dhiren P. Shah* and Megha Agarwal

ABSTRACT

Quetiapine is a psychotropic substance used for the management of the bipolar disorder, schizophrenia and major depressive disorder. Mouth dissolving film of Quetiapine was prepared using HPMC, PEG 400, Citric acid, aspartame, Mannitol, orange flavor, vanillin etc. The stability and dissolution was compared with one marketed formulation or brand AZONA-40 capsules. The film exhibited excellent stability when stored at 40°C and 75% humidity. Strip forming polymer PVP was used in the range of 100 to 500mg. The strips formed were non-sticky but were semi-transparent in appearance due to formation of lumps in the strips. ZMDF5 doesn’t show significant difference for appearance, thickness, surface pH, Folding endurance, disintegrating Time, tensile strength, % drug content uniformity, % uniform drug distribution and % drug release study. This result indicates that all the excipients used are compatible and stable. Quality by design approach and design of experiment were used to develop batches of mouth dissolving film. Result suggests that the Quetiapine mouth dissolving films is likely to become one of the choices to treat different psychotic disorders.

Keywords: Psychosis, Quetiapine FMT, mouth dissolving film, Quality by Design (QbD), Design of experiment.


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