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Development of sustained release oral disintegrating tablet of fluvoxamine maleate.

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Title: Development of sustained release oral disintegrating tablet of fluvoxamine maleate.
Authors: Shetaa, Esraa A.1 (AUTHOR), Arafa, Mona F.1,2 (AUTHOR) mona.arafa@pharm.tanta.edu.eg, Abu-Risha, Sally E.3 (AUTHOR), El Maghraby, Gamal M.1 (AUTHOR)
Source: Pharmaceutical Development & Technology. Sep2025, Vol. 30 Issue 7, p1036-1046. 11p.
Subject Terms: CONTROLLED release preparations, OBSESSIVE-compulsive disorder, DRUG tablets, PHARMACEUTICAL chemistry, ANTIDEPRESSANTS, IN vivo studies
Abstract: Fluvoxamine maleate is efficient in treatment of depression and obsessive-compulsive disorder. However, it has several side effects which are believed to be minimized by administration of slow-release formulation. This work introduces geriatric friendly rapidly disintegrating sustained release (RDSR) tablets for fluvoxamine intraoral administration. Fluvoxamine was subjected to wet co-processing with increasing weight ratios of Eudragit S100 in presence and absence of avicel. Fluvoxamine release was monitored using continuous pH variation strategy using USP II dissolution apparatus. Formulations exhibiting acceptable sustained release pattern were subjected to different investigations. Optimized systems were fabricated as RDSR tablets. Optimized systems were also assessed in vivo using forced swimming test using albino rats. Incorporation of avicel in the co-processed formulations showed faster release with avicel-free systems sustaining fluvoxamine release. Optimum formulations contained fluvoxamine and Eudragit at weight ratios of 4:12 (F2), 4:15 (F4) and 4:16 (F6) liberated the drug with release efficiency of 61.65, 41.76 and 34.5%, respectively. Thermal analysis and XRD reflected dispersion of fluvoxamine in amorphous form in Eudragit with no significant chemical interaction being reflected from FTIR. The developed RDSR tablets showed acceptable sustained release. In vivo studies reflected the superiority of sustained release systems compared to unprocessed fluvoxamine. The study developed RDSR tablets for sustained delivery of fluvoxamine. [ABSTRACT FROM AUTHOR]
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Abstract:Fluvoxamine maleate is efficient in treatment of depression and obsessive-compulsive disorder. However, it has several side effects which are believed to be minimized by administration of slow-release formulation. This work introduces geriatric friendly rapidly disintegrating sustained release (RDSR) tablets for fluvoxamine intraoral administration. Fluvoxamine was subjected to wet co-processing with increasing weight ratios of Eudragit S100 in presence and absence of avicel. Fluvoxamine release was monitored using continuous pH variation strategy using USP II dissolution apparatus. Formulations exhibiting acceptable sustained release pattern were subjected to different investigations. Optimized systems were fabricated as RDSR tablets. Optimized systems were also assessed in vivo using forced swimming test using albino rats. Incorporation of avicel in the co-processed formulations showed faster release with avicel-free systems sustaining fluvoxamine release. Optimum formulations contained fluvoxamine and Eudragit at weight ratios of 4:12 (F2), 4:15 (F4) and 4:16 (F6) liberated the drug with release efficiency of 61.65, 41.76 and 34.5%, respectively. Thermal analysis and XRD reflected dispersion of fluvoxamine in amorphous form in Eudragit with no significant chemical interaction being reflected from FTIR. The developed RDSR tablets showed acceptable sustained release. In vivo studies reflected the superiority of sustained release systems compared to unprocessed fluvoxamine. The study developed RDSR tablets for sustained delivery of fluvoxamine. [ABSTRACT FROM AUTHOR]
ISSN:10837450
DOI:10.1080/10837450.2025.2546942