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An Advanced Twin-Screw Granulation Technology: The use of Non-Volatile Solvents with High Solubilizing Capacity.
Kolipaka, Siva Satyanarayana; Junqueira, Laura Andrade; Ross, Steven; Garg, Vivek; Mithu, Md Sadeque Hossein; Bhatt, Saumil; Douroumis, Dennis.
Afiliación
  • Kolipaka SS; Centre for Research Innovation (CRI), University of Greenwich, Chatham Maritime Kent, Chatham, ME4 4TB, UK.
  • Junqueira LA; Delta Pharmaceutics Ltd., 1-3 Manor Road, Chatham, Kent, ME4 6AG, UK. laura.deandrade@hotmail.com.
  • Ross S; Custom Pharma Services, Conway St, Brighton and Hove, Hove, BN3 3LW, UK.
  • Garg V; Wolfson Centre for Bulk Solids Handling Technology, Faculty of Engineering & Science, University of Greenwich, Central Avenue, Chatham, ME4 4TB, UK.
  • Mithu MSH; Custom Pharma Services, Conway St, Brighton and Hove, Hove, BN3 3LW, UK.
  • Bhatt S; Cubi-Tech Extrusion Ltd., Unit 3, Neptune Close, Medway City Estate, Rochester, Kent, ME2 4LU, UK.
  • Douroumis D; Centre for Research Innovation (CRI), University of Greenwich, Chatham Maritime Kent, Chatham, ME4 4TB, UK. D.Douroumis@gre.ac.uk.
AAPS PharmSciTech ; 25(6): 174, 2024 Jul 31.
Article en En | MEDLINE | ID: mdl-39085532
ABSTRACT

PURPOSE:

Twin-screw wet granulation (TSWG) is a manufacturing process that offers several advantages for the processing of water-insoluble active pharmaceutical ingredients (APIs) and has been used for increasing the solubility and dissolution rates. Here we introduce a novel TSWG approach with reduced downstream processing steps by using non-volatile solvents as granulating binders.

METHODS:

Herein, TSWG was carried out using Transcutol a non-volatile protic solvent as a granulating binder and dissolution enhancer of ibuprofen (IBU) blends with cellulose polymer grades (Pharmacoat® 603, Affinisol™, and AQOAT®).

RESULTS:

The physicochemical characterisation of the produced granules showed excellent powder flow and the complete transformation of IBU into the amorphous state. Dissolution studies presented immediate release rates for all IBU formulations due to the high drug-polymer miscibility and the Transcutol solubilising capacity.

CONCLUSIONS:

Overall, the study demonstrated an innovative approach for the development of extruded granules by processing water-insoluble APIs with non-volatile solvents for enhanced dissolution rates at high drug loadings.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Solubilidad / Solventes / Celulosa / Química Farmacéutica / Ibuprofeno / Tecnología Farmacéutica / Composición de Medicamentos / Excipientes Idioma: En Revista: AAPS PharmSciTech Asunto de la revista: FARMACOLOGIA Año: 2024 Tipo del documento: Article País de afiliación: Reino Unido Pais de publicación: Estados Unidos
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Solubilidad / Solventes / Celulosa / Química Farmacéutica / Ibuprofeno / Tecnología Farmacéutica / Composición de Medicamentos / Excipientes Idioma: En Revista: AAPS PharmSciTech Asunto de la revista: FARMACOLOGIA Año: 2024 Tipo del documento: Article País de afiliación: Reino Unido Pais de publicación: Estados Unidos