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- E-ISSN Number: 2277-7695
- P-ISSN Number: 2349-8242
- CODEN Code: PIHNBQ
- ZDB-Number: 2663038-2
- IC Journal ID: 7725
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Vol. 1, Issue 4 (2012)
In vitro – in vivo correlation of marketed formulations of cetirizine dihydrochloride
Author(s):
Kuldeep Malodia
Kuldeep Malodia
Abstract:
IVIVC can impart In vivo meaning to the in vitro dissolution test and can be useful as surrogate for bioequivalence. Further, IVIVC can also allow setting of more meaningful dissolution specifications. Ultimately conclusion is that IVIVC cannot be done for immediate release formulation. It can be done only in conventional products, where adsorption of drug is dissolution limited but in the case of mouth dissolving tablets of Cetirizine dihydrochloride tablets the ratio of dissolution was font and the absorption was dependent on the rate of permeation and therefore in case of permeation rate limited absorption the IVIVC correlation is very poor and mostly impossible. Cetirizine dihydrochloride is histamine H1-receptor antagonist. It is an anti allergic drug with selective inhibitory effect on peripheral H1 receptors.
IVIVC can impart In vivo meaning to the in vitro dissolution test and can be useful as surrogate for bioequivalence. Further, IVIVC can also allow setting of more meaningful dissolution specifications. Ultimately conclusion is that IVIVC cannot be done for immediate release formulation. It can be done only in conventional products, where adsorption of drug is dissolution limited but in the case of mouth dissolving tablets of Cetirizine dihydrochloride tablets the ratio of dissolution was font and the absorption was dependent on the rate of permeation and therefore in case of permeation rate limited absorption the IVIVC correlation is very poor and mostly impossible. Cetirizine dihydrochloride is histamine H1-receptor antagonist. It is an anti allergic drug with selective inhibitory effect on peripheral H1 receptors.
Experimental work on the cetirizine dihydrochloride 10 mg tablet shows the result of t-test for formulation A (2.35), formulation B (2.23), formulation C (2.35) respectively. It shows there is no correlation between plasma data v/s dissolution data. Another test also performed to confirm IVIVC to calculate the correlation coefficient (r) and found the results for different formulation between plasma data and dissolution data. From the results of all experimental works we can conclude that IVIVC are not possible in Cetirizine dihydrochloride tablets because the test don’t show the calculated value within the limit of tabulated value (at 5% level ± 2.228 on 10 degree of freedom). For cetirizine mouth dissolving tablets, Ethical Committee doesn’t give the permission to us because no anyone market formulation available. Similarly for SR tables which are not available in market the permission was not granted.
Pages: 95-101 | 427 Views 115 Downloads
How to cite this article:
Kuldeep Malodia. In vitro – in vivo correlation of marketed formulations of cetirizine dihydrochloride. Pharma Innovation 2012;1(4):95-101.
Journal code(s)
- E-ISSN Number: 2277-7695
- P-ISSN Number: 2349-8242
- CODEN Code: PIHNBQ
- ZDB-Number: 2663038-2
- IC Journal ID: 7725
Main Menu
Special Issue
Copyright Form
Identifier
The Pharma Innovation Journal
