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Development and evaluation of orally disintegrating tablets (ODTs) containing Ibuprofen granules prepared by hot melt extrusion
Authors:Gryczke Andreas  Schminke Silke  Maniruzzaman Mohammed  Beck Julien  Douroumis Dennis
Institution:1. Freeze Drying Focus Group (FDFG), Division of Pharmaceutics, University of Erlangen, Erlangen 91058, Germany;2. Niederbronner Pharmacy, N¨urnberg 90491, Germany;3. GILYOS GmbH, W¨urzburg 97076, Germany;1. Laboratory of Pharmaceutical Engineering, Gifu Pharmaceutical University, 1-25-4 Daigaku-Nishi, Gifu 501–1196, Japan;2. Drug Formulation Research and Development Laboratories, Kyowa Hakko Kirin Co., Ltd., 1188 Shimotogari, Nagaizumi-cho, Sunto-gun, Shizuoka 411–8731 Japan
Abstract:In the current study Ibuprofen was embedded in a methacrylate copolymer (Eudragit® EPO) matrix to produce solid dispersions by hot-melt extrusion (HME) processing. The obtained granules were incorporated in orally disintegrating tablets (ODTs). The tablets were developed by varying the ratio of superdisintegrants such as sodium croscarmellose and crosslinked polyvinylpyrrolidone grades while a direct compression process was used to compress the ODTs under various compaction forces to optimize tablet robustness. The properties of the compressed tablets which included porosity, hardness, friability and dissolution profiles were further evaluated and compared with Nurofen® Meltlet ODTs. The taste and sensory evaluation in human volunteers demonstrated excellence in masking the bitter active and improved tablet palatability.
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