Continuous Manufacturing of Oil in Water (O/W) Emulgel by Extrusion Process

Pharmaceutical industries and drug regulatory agencies are inclining towards continuous manufacturing due to better control over the processing conditions and in view to improve product quality. In the present work, continuous manufacturing of O/W emulgel by melt extrusion process was explored using lidocaine as an active pharmaceutical ingredient. Emulgel was characterized for pH, water activity, globule size distribution, and in vitro release rate.

Additionally, effect of temperature (25°C and 60°C) and screw speed (100, 300, and 600 rpm) on the globule size and in vitro release rate was studied. Results indicated that at a given temperature, emulgel prepared under screw speed of 300 rpm resulted in products with smaller globules and faster drug release.

Echanur, V.A., Matadh, A.V., Pragathi, S.G. et al. Continuous Manufacturing of Oil in Water (O/W) Emulgel by Extrusion Process. AAPS PharmSciTech 24, 76 (2023). https://doi.org/10.1208/s12249-023-02530-x

See also our article on the FDA Guidance from March 2023 on Continues Manufacturing here:

Continuous Manufacturing of Drug Substances and Drug Products – FDA announces guidance for Industry

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