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Testing lyoequivalency for three commercially sustained-release tablets containing diltiazem hydrochloride.
Acta Pol Pharm. 2010 Jan-Feb; 67(1):93-7.AP

Abstract

In vitro release kinetics of three commercially available sustained release tablets (SR) diltiazem hydrochloride were studied at pH 1.1 for 2 h and for another 6 h at pH 6.8 using the USP dissolution apparatus with the paddle assemble. The kinetics of the dissolution process was studied by analyzing the dissolution data using five kinetic equations: the zero-order equation, the first-order equation, the Higuchi square root equation, the Hixson-Crowell cube root law and the Peppas equation. Analyses of the dissolution kinetic data for diltiazem hydrochloride commercial SR tablets showed that both Dilzacard and Dilzem SR tablets released drug by Non-Fickian (Anomalous transport) release with release exponent (n) equal to 0.59 and 0.54, respectively, which indicate the summation of both diffusion and dissolution controlled drug release. Bi-Tildiem SR tablets released drug by super case II (n = 1.29) which indicate zero-order release due to the dissolution of polymeric matrix and relaxation of the polymer chain. This finding was also in agreement with results obtained from application of zero-order and Hixson-Crowell equations. A dissolution profile comparative study was done to test the lyoequivelancy of the three products by using the mean dissolution time (MDT), dissimilarity factor f1 and similarity factor f2. Results showed that the three products are different and not lyoequivalent.

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Authors+Show Affiliations

Maswadeh HA
Department of Pharmacy, Faculty of Pharmacy and Medical Sciences, Al-Ahliyya Amman University, 19328 Amman, Jordan. maswadehhamza@hotmail.com
Al-Hanbali OA
No affiliation info available
Kanaan RA
No affiliation info available
Shakya AK
No affiliation info available
Maraqa A
No affiliation info available

MeSH

Calcium Channel BlockersChemistry, PharmaceuticalDelayed-Action PreparationsDiffusionDiltiazemHydrogen-Ion ConcentrationKineticsModels, ChemicalQuality ControlSolubilityTabletsTechnology, Pharmaceutical

Pub Type(s)

Comparative Study
Journal Article

Language

eng

PubMed ID

20210085

Citation

Maswadeh, Hamzah A., et al. "Testing Lyoequivalency for Three Commercially Sustained-release Tablets Containing Diltiazem Hydrochloride." Acta Poloniae Pharmaceutica, vol. 67, no. 1, 2010, pp. 93-7.
Maswadeh HA, Al-Hanbali OA, Kanaan RA, et al. Testing lyoequivalency for three commercially sustained-release tablets containing diltiazem hydrochloride. Acta Pol Pharm. 2010;67(1):93-7.
Maswadeh, H. A., Al-Hanbali, O. A., Kanaan, R. A., Shakya, A. K., & Maraqa, A. (2010). Testing lyoequivalency for three commercially sustained-release tablets containing diltiazem hydrochloride. Acta Poloniae Pharmaceutica, 67(1), 93-7.
Maswadeh HA, et al. Testing Lyoequivalency for Three Commercially Sustained-release Tablets Containing Diltiazem Hydrochloride. Acta Pol Pharm. 2010 Jan-Feb;67(1):93-7. PubMed PMID: 20210085.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Testing lyoequivalency for three commercially sustained-release tablets containing diltiazem hydrochloride. AU - Maswadeh,Hamzah A, AU - Al-Hanbali,Othman A, AU - Kanaan,Reem A, AU - Shakya,Ashok K, AU - Maraqa,Anwar, PY - 2010/3/10/entrez PY - 2010/3/10/pubmed PY - 2010/4/2/medline SP - 93 EP - 7 JF - Acta poloniae pharmaceutica JO - Acta Pol Pharm VL - 67 IS - 1 N2 - In vitro release kinetics of three commercially available sustained release tablets (SR) diltiazem hydrochloride were studied at pH 1.1 for 2 h and for another 6 h at pH 6.8 using the USP dissolution apparatus with the paddle assemble. The kinetics of the dissolution process was studied by analyzing the dissolution data using five kinetic equations: the zero-order equation, the first-order equation, the Higuchi square root equation, the Hixson-Crowell cube root law and the Peppas equation. Analyses of the dissolution kinetic data for diltiazem hydrochloride commercial SR tablets showed that both Dilzacard and Dilzem SR tablets released drug by Non-Fickian (Anomalous transport) release with release exponent (n) equal to 0.59 and 0.54, respectively, which indicate the summation of both diffusion and dissolution controlled drug release. Bi-Tildiem SR tablets released drug by super case II (n = 1.29) which indicate zero-order release due to the dissolution of polymeric matrix and relaxation of the polymer chain. This finding was also in agreement with results obtained from application of zero-order and Hixson-Crowell equations. A dissolution profile comparative study was done to test the lyoequivelancy of the three products by using the mean dissolution time (MDT), dissimilarity factor f1 and similarity factor f2. Results showed that the three products are different and not lyoequivalent. SN - 0001-6837 UR - https://www.unboundmedicine.com/medline/citation/20210085/Testing_lyoequivalency_for_three_commercially_sustained_release_tablets_containing_diltiazem_hydrochloride_ L2 - http://www.ptfarm.pl/pub/File/Acta_Poloniae/2010/1/093.pdf DB - PRIME DP - Unbound Medicine ER -