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Influence of dissolution media composition on drug release and in-vitro/in-vivo correlation for paracetamol matrix tablets prepared with novel carbomer polymers.
J Pharm Pharmacol. 2004 Jun; 56(6):735-41.JP

Abstract

The influence of dissolution media composition on drug release kinetics and in-vitro/in-vivo correlation (IVIVC) for hydrophilic matrix tablets based on Carbopol 971P and Carbopol 71G was investigated. A number of buffered and unbuffered media differing with respect to their pH value, ionic strength and ionic species was evaluated. The observed in-vitro drug release profiles were compared with the hypothetical drug release profiles in-vivo calculated by numerical deconvolution from the results of an in-vivo study. The obtained IVIVC plots were examined using linear and non-linear (proportional odds, proportional hazards and proportional reversed hazards) mathematical models. Although the studied sustained release agents were chemically identical, they exhibited pronounced differences in drug product behaviour both in-vitro and in-vivo. The use of non-linear modelling resulted in an improved level of correlation, especially in the case of Carbopol 71G matrices. The obtained results indicated the susceptibility of drug release kinetics and hence IVIVC in the case of anionic polymer matrices to media composition, and emphasized the need for thorough evaluation of applied media during the development of biorelevant dissolution methodology. Although the use of non-linear modelling could be advantageous, the need for a simple and meaningful non-linear relationship is pointed out.

Authors+Show Affiliations

Department of Pharmaceutical Technology, Faculty of Pharmacy, University of Belgrade, Vojvode Stepe 450, 11221 Belgrade, Serbia and Montenegro. sptasha@ptt.yuNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

15231038

Citation

Parojcić, J, et al. "Influence of Dissolution Media Composition On Drug Release and In-vitro/in-vivo Correlation for Paracetamol Matrix Tablets Prepared With Novel Carbomer Polymers." The Journal of Pharmacy and Pharmacology, vol. 56, no. 6, 2004, pp. 735-41.
Parojcić J, Ethurić Z, Jovanović M, et al. Influence of dissolution media composition on drug release and in-vitro/in-vivo correlation for paracetamol matrix tablets prepared with novel carbomer polymers. J Pharm Pharmacol. 2004;56(6):735-41.
Parojcić, J., Ethurić, Z., Jovanović, M., Ibrić, S., & Jovanović, D. (2004). Influence of dissolution media composition on drug release and in-vitro/in-vivo correlation for paracetamol matrix tablets prepared with novel carbomer polymers. The Journal of Pharmacy and Pharmacology, 56(6), 735-41.
Parojcić J, et al. Influence of Dissolution Media Composition On Drug Release and In-vitro/in-vivo Correlation for Paracetamol Matrix Tablets Prepared With Novel Carbomer Polymers. J Pharm Pharmacol. 2004;56(6):735-41. PubMed PMID: 15231038.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Influence of dissolution media composition on drug release and in-vitro/in-vivo correlation for paracetamol matrix tablets prepared with novel carbomer polymers. AU - Parojcić,J, AU - Ethurić,Z, AU - Jovanović,M, AU - Ibrić,S, AU - Jovanović,D, PY - 2004/7/3/pubmed PY - 2004/11/13/medline PY - 2004/7/3/entrez SP - 735 EP - 41 JF - The Journal of pharmacy and pharmacology JO - J Pharm Pharmacol VL - 56 IS - 6 N2 - The influence of dissolution media composition on drug release kinetics and in-vitro/in-vivo correlation (IVIVC) for hydrophilic matrix tablets based on Carbopol 971P and Carbopol 71G was investigated. A number of buffered and unbuffered media differing with respect to their pH value, ionic strength and ionic species was evaluated. The observed in-vitro drug release profiles were compared with the hypothetical drug release profiles in-vivo calculated by numerical deconvolution from the results of an in-vivo study. The obtained IVIVC plots were examined using linear and non-linear (proportional odds, proportional hazards and proportional reversed hazards) mathematical models. Although the studied sustained release agents were chemically identical, they exhibited pronounced differences in drug product behaviour both in-vitro and in-vivo. The use of non-linear modelling resulted in an improved level of correlation, especially in the case of Carbopol 71G matrices. The obtained results indicated the susceptibility of drug release kinetics and hence IVIVC in the case of anionic polymer matrices to media composition, and emphasized the need for thorough evaluation of applied media during the development of biorelevant dissolution methodology. Although the use of non-linear modelling could be advantageous, the need for a simple and meaningful non-linear relationship is pointed out. SN - 0022-3573 UR - https://www.unboundmedicine.com/medline/citation/15231038/Influence_of_dissolution_media_composition_on_drug_release_and_in_vitro/in_vivo_correlation_for_paracetamol_matrix_tablets_prepared_with_novel_carbomer_polymers_ DB - PRIME DP - Unbound Medicine ER -