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Continuous Manufacture and Scale-Up of Theophylline-Nicotinamide Cocrystals.

ABSTRACT: The aim of the study was the manufacturing and scale-up of theophylline-nicotinamide (THL-NIC) pharmaceutical cocrystals processed by hot-melt extrusion (HME). The barrel temperature profile, feed rate and screw speed were found to be the critical processing parameters with a residence time of approximately 47 s for the scaled-up batches. Physicochemical characterization using scanning electron microscopy (SEM), differential scanning calorimetry (DSC), and X-ray diffraction of bulk and extruded materials revealed the formation of high purity cocrystals (98.6%). The quality of THL-NIC remained unchanged under accelerated stability conditions.

SUBMITTER: Ross SA

PROVIDER: S-EPMC8004052 | biostudies-literature | 2021 Mar

REPOSITORIES: biostudies-literature

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Continuous Manufacture and Scale-Up of Theophylline-Nicotinamide Cocrystals.

Ross Steven A SA Hurt Andrew P AP Antonijevic Milan M Bouropoulos Nicolaos N Ward Adam A Basford Pat P McAllister Mark M Douroumis Dennis D

Pharmaceutics 20210320 3

The aim of the study was the manufacturing and scale-up of theophylline-nicotinamide (THL-NIC) pharmaceutical cocrystals processed by hot-melt extrusion (HME). The barrel temperature profile, feed rate and screw speed were found to be the critical processing parameters with a residence time of approximately 47 s for the scaled-up batches. Physicochemical characterization using scanning electron microscopy (SEM), differential scanning calorimetry (DSC), and X-ray diffraction of bulk and extruded ...[more]

PMID: 33804705

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