| Summary: | An oral controlled release (CR) matrix system of Ambroxol hydrochloride was developed using a binary hydrophilic polymer mixture of chitosan (CH) and xanthan gum (XG) (1:1 w/w ratio). Two test tablet formulations were prepared using drug to polymer mixture ratios (D:P) of 1:1 and 1:3 (w/w), designated as
T1 and T2, respectively. The in vitro drug release data was best fitted to the Higuchi equation. The 1:1 ratio (T1) demonstrated in vitro dissolution similarity with the commercial product, Mucosolvan LA. A preliminary
in vivo study was performed using six volunteers. The study was designed to include open, randomized, singledose, three-treatment, six-sequence, crossover (Williams design) under fasting conditions. The data showed
that T1 was bioequivalent to Mucosolvan LA ® after the administration of a single 75mg oral dose. Two in vivo, in vitro correlations (IVIVC) were established between Cmax versus the fraction of drug dissolved (FRD)
after 4 hours, and AUC versus the ratio of fraction of drug dissolved (FRD) after 10 hours where a multiple point level C correlation of IVIVC was obtained.
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