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Mayyas Al Remawia
Department of pharmaceutics and pharmaceutical technology, College of Pharmacy, Taif University, Taif, Saudi Arabia
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Faisal Al-Akayleh
Department of pharmaceutics and pharmaceutical technology, College of Pharmacy, Petra University, Amman, Jordan
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Mutaz Salem
Faculty of Pharmacy, Jordan University of Science and Technology, Irbid, Jordan
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Munther Al Shami
Faculty of Pharmacy, Jordan University of Science and Technology, Irbid, Jordan
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Adnan Badwan
Suwagh company for drug delivery systems subsidiary of the Jordanian Pharmaceutical Manufacturing Company (JPM), Naor, Jordan
Abstract
Abstract
Oral controlled release (CR) matrix system of Ambroxol HCl was developed using binary hydrophilic polymer mixture of chitosan (CH) and xanthan gum (XG). Drug to polymer ratios (D: P) tested were 1:1 and 1:3 (w/w). The in-vitro drug release data was best fitted to Higuchi equation. The 1:1 ratio showed in-vitro dissolution similarity with the commercial product, Mucosolvan LA ®. The in-vivo release study was conducted on six volunteers. The data showed that the D: P (1:1) ratio is bioequivalent to Mucosolvan LA ® after the administration of a single oral dose under fasting conditions. Two in-vivo in-vitro correlations (IVIVC) were established between Cmax versus fraction of drug dissolved (FRD) after 4 h, and AUC versus ratio of fraction of drug dissolved (FRD) after 10 h where a multiple C level of IVIVC was obtained.
Section
Original Research Articles
Keywords
Ambroxol HCl; Xanthan gum; Chitosan; Controlled release; Bioequivalence
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