Injection moulded controlled release amorphous solid dispersions: Synchronized drug and polymer release for robust performance
Publication date
2020-02Keyword
Oral solid dosage (OSD)Polymer release
Release robustness
Poorly soluble drug
Polyethylene oxide (PEO)
Hot melt extrusion (HME)
Injection moulding (IM)
Controlled release
Amorphous solid dispersion (ASD)
Rights
© 2019 Elsevier B.V. All rights reserved. Reproduced in accordance with the publisher's self-archiving policy. This manuscript version is made available under the CC-BY-NC-ND 4.0 license.Peer-Reviewed
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Show full item recordAbstract
A study has been carried out to investigate controlled release performance of caplet shaped injection moulded (IM) amorphous solid dispersion (ASD) tablets based on the model drug AZD0837 and polyethylene oxide (PEO). The physical/chemical storage stability and release robustness of the IM tablets were characterized and compared to that of conventional extended release (ER) hydrophilic matrix tablets of the same raw materials and compositions manufactured via direct compression (DC). To gain an improved understanding of the release mechanisms, the dissolution of both the polymer and the drug were studied. Under conditions where the amount of dissolution media was limited, the controlled release ASD IM tablets demonstrated complete and synchronized release of both PEO and AZD0837 whereas the release of AZD0837 was found to be slower and incomplete from conventional direct compressed ER hydrophilic matrix tablets. Results clearly indicated that AZD0837 remained amorphous throughout the dissolution process and was maintained in a supersaturated state and hence kept stable with the aid of the polymeric carrier when released in a synchronized manner. In addition, it was found that the IM tablets were robust to variation in hydrodynamics of the environment and PEO molecular weight.Version
Accepted manuscriptCitation
Deshmukh S, Paradkar A, Abrahmsén-Alami S (2020) Injection moulded controlled release amorphous solid dispersions: Synchronized drug and polymer release for robust performance. International Journal of Pharmaceutics. 575: 118908.Link to publisher’s version
https://doi.org/10.1016/j.ijpharm.2019.118908Type
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