Physical and chemical characterisation of thermosoftened bases for molten filled hard gelatin capsule formulations

Hawley, A.R., Rowley, G., Lough, John and Chatham, S.M. (1992) Physical and chemical characterisation of thermosoftened bases for molten filled hard gelatin capsule formulations. Drug Development and Industrial Pharmacy, 18 (1719). pp. 1719-1739. ISSN 0363-9045

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Abstract

Dynafill, Dynasan-114, Lutrol-F68, PEG-10000 and PEG-20000 have been examined as potential bases for the preparation of fusion formed solid dispersions for molten filling into hard gelatin capsules. Investigations included, an examination of thermal effects on crystal structure by DSC and XRD, a theological study to evaluate capsule filling characteristics, dissolution studies on drug/base formulations, chemical analysis for free fatty acid impurities in Dynafill and Dynasan-114, and detailed studies on selected drug/base formulations. PEG-20000 and Dynasan-114 were not examined in detail, after preliminary investigations had shown high viscosity and poor filling characteristics for PEG-20000 and poor dissolution characteristics for Dynasan-114. Dynafill provided good release profiles when formulated with a variety of model drugs (Acetohexamide, Ibuprofen, Indomethacin, Quinidine sulphate and Theophylline). Results from hot stage photomicrography supported by DSC and XRD were used to construct a phase diagram of the Ibuprofen/Lutrol-F68 system. The evidence from the phase diagram indicated the formulation of a simple eutectic system with no solid solubility and a eutectic composition at approximately 35% w/w Ibuprofen.

Item Type: Article
Subjects: Sciences
Divisions: Faculty of Applied Sciences
Faculty of Applied Sciences > Department of Pharmacy Health and Wellbeing
Depositing User: Paula Normington
Date Deposited: 24 Nov 2017 09:57
Last Modified: 24 Nov 2017 09:57
URI: http://sure.sunderland.ac.uk/id/eprint/6400

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