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Formulation of a extended release tablet containing dexibuprofen.
Arch Pharm Res. 2008 Dec; 31(12):1637-43.AP

Abstract

Dexibuprofen, or S(+)-ibuprofen, is the pharmacologically effective enantiomer of racemic ibuprofen. Since dexibuprofen has a low melting point, the amorphous form having a high melting point was prepared with the fused solid dispersion method. With the fused solid dispersion of dexibuprofen, immediate release tablets, extended release tablets, and dual release tablets were compressed and their dissolution profiles compared. The dissolution profiles of the extended release and the dual release tablet depended on the amount of used release modulators (PEO 5,000,000). The release profiles of extended release tablets and extended release part of dual release tablets were well fitted to zero-order release model. The correlation coefficient ranged from 0.982 to 0.995. A pharmacokinetic evaluation where healthy volunteers took tablets of DRT-1 (300 mg) once and the reference drug, two tablets of conventional immediate release tablet (Daxfen, 300 mg), with a 6-h interval between them was studied. The 90% confidence interval for the ratio of the logarithmically transformed AUC (0-24 h), Cmax (0-6 h), and Cmax (6-24 h) values of the dual release tablet compared to those of the conventional immediate release tablet were calculated to be between 0.9176 and 1.0007, 0.9240 and 1.1968, and 0.8713 and 1.1414, respectively. When the immediate release tablet was taken two times with a six hour interval between doses it showed a bioequivalent effect to taking the dual release tablet once within 12 h. The Cmax was reached due to the rapid absorption of the immediate release portion of the dual release tablet and the AUC was maintained due to continuous absorption of the extended release portion.

Authors+Show Affiliations

College of Pharmacy, Sungkyunkwan University, Suwon, 440-746, Korea.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

19099235

Citation

Yi, Hong Gi, et al. "Formulation of a Extended Release Tablet Containing Dexibuprofen." Archives of Pharmacal Research, vol. 31, no. 12, 2008, pp. 1637-43.
Yi HG, Chi MH, Kim YI, et al. Formulation of a extended release tablet containing dexibuprofen. Arch Pharm Res. 2008;31(12):1637-43.
Yi, H. G., Chi, M. H., Kim, Y. I., Woo, J. S., & Park, E. S. (2008). Formulation of a extended release tablet containing dexibuprofen. Archives of Pharmacal Research, 31(12), 1637-43. https://doi.org/10.1007/s12272-001-2162-6
Yi HG, et al. Formulation of a Extended Release Tablet Containing Dexibuprofen. Arch Pharm Res. 2008;31(12):1637-43. PubMed PMID: 19099235.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Formulation of a extended release tablet containing dexibuprofen. AU - Yi,Hong Gi, AU - Chi,Moon Hyuk, AU - Kim,Yong-Il, AU - Woo,Jong Soo, AU - Park,Eun-Seok, Y1 - 2008/12/20/ PY - 2008/04/21/received PY - 2008/11/30/accepted PY - 2008/07/30/revised PY - 2008/12/23/entrez PY - 2008/12/23/pubmed PY - 2009/2/4/medline SP - 1637 EP - 43 JF - Archives of pharmacal research JO - Arch Pharm Res VL - 31 IS - 12 N2 - Dexibuprofen, or S(+)-ibuprofen, is the pharmacologically effective enantiomer of racemic ibuprofen. Since dexibuprofen has a low melting point, the amorphous form having a high melting point was prepared with the fused solid dispersion method. With the fused solid dispersion of dexibuprofen, immediate release tablets, extended release tablets, and dual release tablets were compressed and their dissolution profiles compared. The dissolution profiles of the extended release and the dual release tablet depended on the amount of used release modulators (PEO 5,000,000). The release profiles of extended release tablets and extended release part of dual release tablets were well fitted to zero-order release model. The correlation coefficient ranged from 0.982 to 0.995. A pharmacokinetic evaluation where healthy volunteers took tablets of DRT-1 (300 mg) once and the reference drug, two tablets of conventional immediate release tablet (Daxfen, 300 mg), with a 6-h interval between them was studied. The 90% confidence interval for the ratio of the logarithmically transformed AUC (0-24 h), Cmax (0-6 h), and Cmax (6-24 h) values of the dual release tablet compared to those of the conventional immediate release tablet were calculated to be between 0.9176 and 1.0007, 0.9240 and 1.1968, and 0.8713 and 1.1414, respectively. When the immediate release tablet was taken two times with a six hour interval between doses it showed a bioequivalent effect to taking the dual release tablet once within 12 h. The Cmax was reached due to the rapid absorption of the immediate release portion of the dual release tablet and the AUC was maintained due to continuous absorption of the extended release portion. SN - 0253-6269 UR - https://www.unboundmedicine.com/medline/citation/19099235/Formulation_of_a_extended_release_tablet_containing_dexibuprofen_ L2 - https://dx.doi.org/10.1007/s12272-001-2162-6 DB - PRIME DP - Unbound Medicine ER -