title: Discriminatory dissolution method for quality control measurements of carbamazepine immediate release tablets based on in vitro--in vivo investigations.
abstract: The purpose of this study was to identify a discriminatory dissolution method able to predict the in vivo performance of tablet formulations designed for carbamazepine (CBZ). After evaluation of dissolution medium and rotation speed using a 2⁵ central composite design and investigation of the in vivo release behaviors in beagle dogs, the dissolution method of CBZ 100 mg tablets was validated using a USP apparatus II, at a rotation speed of 75 rpm, and 900 ml deaerated water with 0.5% sodium lauryl sulfate (w/v) as the dissolution medium. Dissolution profiles were evaluated by the Weibull parameters and the modified fit factor, ƒ^(1,area). The in vitro-in vivo relationship of CBZ tablets was examined. Compared with the results from the USP and Chinese Pharmacopoeia monograph, the proposed system provides a superior discriminatory method. Since the dissolution method in pharmacopoeia for CBZ tablets is unable to distinguish between a good and a bad product, the method presented here can be used for the quality control testing of CBZ tablets.
authors: School of Pharmacy, Shenyang Pharmaceutical University, Shenyang, 110016 China.
authors: Caihong
authors: C
authors: Xu
authors: Meijuan
authors: M
authors: Zou
authors: Yiping
authors: Y
authors: Wang
authors: Yi
authors: Y
authors: Liu
authors: Jing
authors: J
authors: Yan
authors: Yi
authors: Y
authors: Wu
authors: Gang
authors: G
authors: Cheng
mesh_terms: D000818:Animals; D000927:Anticonvulsants / Q000737:chemistry* / Q000493:pharmacokinetics*; D002220:Carbamazepine / Q000737:chemistry* / Q000493:pharmacokinetics*; D004285:Dogs; D004353:Drug Evaluation, Preclinical / Q000379:methods*; D005260:Female; D006207:Half-Life; D008297:Male; D011786:Quality Control; D012995:Solubility; D013607:Tablets; D013678:Technology, Pharmaceutical
chemical_list: D000927:Anticonvulsants; D013607:Tablets; D002220:Carbamazepine