Abstract
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.
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Acknowledgements
The authors also acknowledge the technical support by STEERLife India Pvt Ltd, Bangalore.
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The present work was partially funded by Pfizer Inc, USA and by Topical Products Testing LLC, Oxford, MS.
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Conceptualization: [S Narasimha Murthy], [Yeoh Thean], [Abu Zayed Badruddoza], [Jaymin Shah]; methodology: [Anusha Echanur V], [Anusha V Matadh], [Pragathi S G], [Sarasija S]; formal analysis and investigation: [Vijay Kulkarni], [H N Shivakumar], [Sarasija S]; writing—original draft preparation: [S Narasimha Murthy], [Anusha V Matadh], [Srinivas Ajjarapu]; writing—review and editing: [Howard Maibach], [S Narasimha Murthy], [Shivakumar H N], [Reena N. M]; supervision and advise: [S Narasimha Murthy], [Sarasija S].
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Communicated by: Jayachandra Babu Ramapuram and Ashana Puri
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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
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DOI: https://doi.org/10.1208/s12249-023-02530-x