Date of Award
M.S. in Pharmaceutical Science
Pharmaceutics and Drug Delivery
Michael A. Repka
Hot-melt extrusion is a viable technology in preparing the pharmaceutical delivery system and has been considered as an attractive alternative to conventional processing methods. The objective of this study was to utilize the advantage of continuous manufacturing in HME to design and evaluate a formulation of topical semisolid ointment. Melt fusion ointments containing 5% of acyclovir (ACV) in water-soluble base with PEG 400, PEG 1500, and PEG 3350 polymers at various ratio were prepared. A design of experiment using I-optimal design was conducted. This design was used to study the influence of polymer ratio on the physicochemical properties of the formulations. The desired formulation was selected according to the critical quality attributes (CQAs) including stiffness, adhesiveness, and pH. The selected formulation was then prepared through HME with an 11 mm modified twin screw configuration and evaluated through texture analysis, pH, drug content uniformity, differential scanning calorimetry (DSC), and in vitro drug release. The result demonstrated that the selected formulation shoideal properties required for ointments. The pH is suitable for topical administration, DSC profile indicated the API was completely dissolved in the base. in vitro drug release profile and drug content uniformity shono significant difference compared with the convention method under the same base ratio. Further, ointment prepared by HME has a lower standard deviation in characterization data and has better manufacturing efficiency compared with conventionally prepared ointment. In conclusion, hot-melt extrusion technology has been successfully applied to prepare water-soluble acyclovir ointment and could be a promising and time-saving process used to develop semi-solid formulations with better quality, consistency and manufacturing efficiency,
Wang, Rui, "Development of Continuous Manufacturing Process of Acyclovir Ointment Using Hot-Melt Extrusion" (2019). Electronic Theses and Dissertations. 1715.