Development of Paediatric Formulation of Baclofen for Improved Safety and Palatability
Purpose The aim of present investigation was to develop oral jelly containing Baclofen-loaded chitosan microspheres for bioavailability enhancement, sustained release, and improved palatability. This is expected to improve the patient compliance by overcoming the difficulties in swallowing. Preformulation studies were performed for drug authentication. Methods Microspheres were prepared by emulsification thermal crosslinking method, and optimization of the parameters was done using $ 3^{2} $ factorial design. The optimized formulation of microspheres was characterized for size, shape, drug content, in vitro drug dissolution, surface morphology, mucoadhesion, and micromeritic properties. The Baclofen microspheres were loaded in an oral jelly which possessed all the desired characteristics. In vivo pharmacokinetic study for the optimized batch and the marketed dosage form were performed in rabbits. Results The in vivo result suggested that the oral bioavailability of jelly of Baclofen-loaded microspheres was 3.77 folds higher than that of the marketed formulation. Stability study of final optimized formulation indicated that the prepared formulation was stable at the storage conditions used. Conclusion The developed formulation is a promising and paediatric patient compliant dosage form for improved safety and palatability of Baclofen..
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2023 |
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| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:18 |
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| Enthalten in: |
Journal of pharmaceutical innovation - 18(2023), 3 vom: 21. Feb., Seite 1229-1240 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Shetty, Kiran [VerfasserIn] |
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| Links: |
Volltext [lizenzpflichtig] |
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| Themen: |
Baclofen |
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| Anmerkungen: |
© The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature 2023. Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law. |
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| doi: |
10.1007/s12247-023-09715-8 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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SPR05414616X |
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| 520 | |a Purpose The aim of present investigation was to develop oral jelly containing Baclofen-loaded chitosan microspheres for bioavailability enhancement, sustained release, and improved palatability. This is expected to improve the patient compliance by overcoming the difficulties in swallowing. Preformulation studies were performed for drug authentication. Methods Microspheres were prepared by emulsification thermal crosslinking method, and optimization of the parameters was done using $ 3^{2} $ factorial design. The optimized formulation of microspheres was characterized for size, shape, drug content, in vitro drug dissolution, surface morphology, mucoadhesion, and micromeritic properties. The Baclofen microspheres were loaded in an oral jelly which possessed all the desired characteristics. In vivo pharmacokinetic study for the optimized batch and the marketed dosage form were performed in rabbits. Results The in vivo result suggested that the oral bioavailability of jelly of Baclofen-loaded microspheres was 3.77 folds higher than that of the marketed formulation. Stability study of final optimized formulation indicated that the prepared formulation was stable at the storage conditions used. Conclusion The developed formulation is a promising and paediatric patient compliant dosage form for improved safety and palatability of Baclofen. | ||
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| 650 | 4 | |a Pharmacokinetic study |7 (dpeaa)DE-He213 | |
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