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Discriminatory dissolution method for quality control measurements of carbamazepine immediate release tablets based on in vitro--in vivo investigations.
Drug Dev Ind Pharm. 2012 Jun; 38(6):679-88.DD

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+Show Affiliations

School of Pharmacy, Shenyang Pharmaceutical University, Shenyang, 110016 China.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article

Language

eng

PubMed ID

21988132

Citation

Xu, Caihong, et al. "Discriminatory Dissolution Method for Quality Control Measurements of Carbamazepine Immediate Release Tablets Based On in Vitro--in Vivo Investigations." Drug Development and Industrial Pharmacy, vol. 38, no. 6, 2012, pp. 679-88.
Xu C, Zou M, Wang Y, et al. Discriminatory dissolution method for quality control measurements of carbamazepine immediate release tablets based on in vitro--in vivo investigations. Drug Dev Ind Pharm. 2012;38(6):679-88.
Xu, C., Zou, M., Wang, Y., Liu, Y., Yan, J., Wu, Y., & Cheng, G. (2012). Discriminatory dissolution method for quality control measurements of carbamazepine immediate release tablets based on in vitro--in vivo investigations. Drug Development and Industrial Pharmacy, 38(6), 679-88. https://doi.org/10.3109/03639045.2011.621433
Xu C, et al. Discriminatory Dissolution Method for Quality Control Measurements of Carbamazepine Immediate Release Tablets Based On in Vitro--in Vivo Investigations. Drug Dev Ind Pharm. 2012;38(6):679-88. PubMed PMID: 21988132.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Discriminatory dissolution method for quality control measurements of carbamazepine immediate release tablets based on in vitro--in vivo investigations. AU - Xu,Caihong, AU - Zou,Meijuan, AU - Wang,Yiping, AU - Liu,Yi, AU - Yan,Jing, AU - Wu,Yi, AU - Cheng,Gang, Y1 - 2011/10/11/ PY - 2011/10/13/entrez PY - 2011/10/13/pubmed PY - 2012/8/17/medline SP - 679 EP - 88 JF - Drug development and industrial pharmacy JO - Drug Dev Ind Pharm VL - 38 IS - 6 N2 - 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. SN - 1520-5762 UR - https://www.unboundmedicine.com/medline/citation/21988132/Discriminatory_dissolution_method_for_quality_control_measurements_of_carbamazepine_immediate_release_tablets_based_on_in_vitro__in_vivo_investigations_ L2 - https://www.tandfonline.com/doi/full/10.3109/03639045.2011.621433 DB - PRIME DP - Unbound Medicine ER -