Critical Quality Attributes Analysis Study For Formulation Of Quetiapine Mouth Dissolving Film
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Author:
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MEGHA AGRAWAL, SHAH DHIREN P
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Abstract:
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The objective of the current work is to evaluate critical quality attributes (CQAs) of the mouth dissolving film of Quetiapine. It is ideally suitable for the treatment of emesis. Mouth dissolving dosage forms are gaining popularity in recent times, as these dosage forms requires no water for administration. To develop mouth dissolving films (MDF) of Quetiapine with aim of fast disintegration, dissolution and mechanical strength. Various types and concentration of Polymers, Plasticizers and disintegrating agent were used to check their effect on MDF. Films were prepared by solvent casting technique. Parameters like in-vitro disintegration time, tensile strength, content uniformity, folding endurance, swelling index, and in-vitro drug release were evaluated. The optimized film containing HPMC E5 & PEG- 400 was taken for further evaluation. In-vitro dissolution studies showed that of 96.37±1.21 of Quetiapine was released within 5 min with an average disintegration time of 25 sec. FTIR spectrophotometry were used to identify drug-excipient interactions.
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Keyword:
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Quetiapine, Mouth Dissolving Films (MDF), Critical Quality Attributes (CQAs), In-vitro dissolution studies
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EOI:
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-
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DOI:
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https://doi.org/10.31838/ijpr/2020.12.03.524
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