An Evaluation of Wet Granulation Process Selection for API Prone to Polymorphic Form Conversion in the Presence of Moisture and Heat

Arce, Freddy; Schuman, Yue; Gawel, John; Garmise, Robert; Abebe, Admassu; Desai, Divyakant

doi:10.1007/s11095-024-03667-5

Pharm Res

2024

DOI: 10.1007/s11095-024-03667-5

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An Evaluation of Wet Granulation Process Selection for API Prone to Polymorphic Form Conversion in the Presence of Moisture and Heat

Freddy Arce,

Yue Schuman,

John Gawel

et al.

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2024

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Cited by 2 publications

References 35 publications

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Insight into the Manipulation Mechanism of Polymorphic Transformation by Polymers: A Case of Cimetidine

Tian,

Wang,

Yang

et al. 2024

Pharm Res

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Insight into the Manipulation Mechanism of Polymorphic Transformation by Polymers: A Case of Cimetidine

Tian,

Wang,

Yang

et al. 2024

Pharm Res

View full text Add to dashboard Cite

An Advanced Twin-Screw Granulation Technology: The use of Non-Volatile Solvents with High Solubilizing Capacity

Kolipaka,

Junqueira,

Ross

et al. 2024

AAPS PharmSciTech

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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. Graphical Abstract

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An Evaluation of Wet Granulation Process Selection for API Prone to Polymorphic Form Conversion in the Presence of Moisture and Heat

Cited by 2 publications

References 35 publications

Insight into the Manipulation Mechanism of Polymorphic Transformation by Polymers: A Case of Cimetidine

Insight into the Manipulation Mechanism of Polymorphic Transformation by Polymers: A Case of Cimetidine

An Advanced Twin-Screw Granulation Technology: The use of Non-Volatile Solvents with High Solubilizing Capacity

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