A quality by design approach to develop topical creams via hot-melt extrusion technology

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Hot-Melt Extrusion Technique: A Review

Hot-melt extrusion is one of the most widely applied processing technologies in the plastic, rubber and food industry. Today this technology has found its place in the array of pharmaceutical manufacturing operations. Melt extrusion process are currently applied in the pharmaceutical field for the manufacture of a variety of dosage forms and formulations such as granules, pellets, tablets, supp...

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Hot-Melt Extrusion Technique: A Review

Hot-melt extrusion is one of the most widely applied processing technologies in the plastic, rubber and food industry. Today this technology has found its place in the array of pharmaceutical manufacturing operations. Melt extrusion process are currently applied in the pharmaceutical field for the manufacture of a variety of dosage forms and formulations such as granules, pellets, tablets, supp...

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Hot Melt Extrusion Technique

Various approaches have been adopted to address this including preparation of solid dispersions and solid solutions. Hot-melt extrusion is an efficient technology for producing solid molecular dispersions with considerable advantages over solvent-based processes such as spray drying and co-precipitation. Hot-melt extrusion has been demonstrated to provide sustained, modified, and targeted drug ...

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A quality by design approach to understand formulation and process variability in pharmaceutical melt extrusion processes.

OBJECTIVES In this study, the principles of quality by design (QbD) have been uniquely applied to a pharmaceutical melt extrusion process for an immediate release formulation with a low melting model drug, ibuprofen. METHODS Two qualitative risk assessment tools - Fishbone diagram and failure mode effect analysis - were utilized to strategically narrow down the most influential parameters. Se...

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ژورنال

عنوان ژورنال: European Journal of Pharmaceutical Sciences

سال: 2019

ISSN: 0928-0987

DOI: 10.1016/j.ejps.2019.06.002