Indian Journal of Clinical and Experimental Ophthalmology
Official Publication of Innovative Education and Scientific Research Foundation
Official Publication of Innovative Education and Scientific Research Foundation
Print ISSN: 2395-1443
Online ISSN: 2395-1451
CODEN : IJCEKF
Indian Journal of Clinical and Experimental Ophthalmology (IJCEO) is open access, a peer-reviewed medical journal, published quarterly, online, and in print, by the Innovative Education and Scientific Research Foundation (IESRF) since 2015. To fulfil our aim of rapid dissemination of knowledge, we publish articles ‘Ahead of Print’ on acceptance. In addition, the journal allows free access (Open Access) to its content, which is likely to attract more readers and citations of articles published in IJCEO. Manuscripts must be prepared in more...Original Article
Author Details :
Volume : 7, Issue : 2, Year : 2021
Article Page : 321-326
https://doi.org/10.18231/j.ijceo.2021.064
Abstract
Purpose: This study was undertaken with an objective to compare the aqueous humor pharmacokinetics (PKs) of bimatoprost and bimatoprost free acid of innovator bimatoprost 0.01% (BAK-Bimatoprost) and the novel formulation, Tight Junction Modulation technology based bimatoprost 0.01% (TJM-bimatoprost) containing polyhexamethylene Biguanide hydrochloride (PHMB) as a preservative.
Materials and Methods: All animals in the study were assigned to one of two treatment arms: either a single dose of BAK-Bimatoprost (n=28) or a TJM-bimatoprost ophthalmic solution (n=28). Time points for aqueous humor collection were 0.5, 1, 2, 4, 8, 12 and 24 Hrs after drug administration.
Results: The mean Cmax of 11.93± 2.70 vs 10.92± 3.84 ng/ml was comparable (P>0.05, one-way ANOVA) across TJM bimatoprost and BAK-bimatoprost treatment arms. Results of other PK parameters pertaining to bimatoprost+ bimatoprost free acid concentration were as follows: time to maximum concentration (T_max) was 1.75± 2.0 vs 1.50 ± 1.16 hr and half-live (T_half) was 2.13 ± 0.58 vs 2.47 ± 0.79 hr in the TJM- bimatoprost and BAK-bimatoprost treatment arms respectively. Overall, there was no difference between TJM-bimatoprost and BAK-bimatoprost treatment arms in the PK end points.
Conclusions: The results taken in totality support the hypothesis that pharmacokinetics TJM-bimatoprost 0.01%, containing PHMB preservative, is comparable to BAK-bimatoprost 0.01%.
Key messages: A new formulation of bimatoprost 0.01% using Tight Junction Modulation technology is pharmacokinetically comparable to marketed formulation of bimatoprost containing benzalkonium chloride preservative.
Keywords: Aqueous humor, Bimatoprost 0.01%, Gel free reservoir technology, Glaucoma, Pharmacokinetics, Polyhexamethylene biguanide, Tight junction modulator.
How to cite : Halder A, Burade V, Khopade A J, Vakharia M, Aqueous humor pharmacokinetics of Benzalkonium chloride free bimatoprost formulated in tight junction modulation technology compared to Benzalkonium chloride preserved bimatoprost 0.01% ophthalmic solution in rabbit eyes. Indian J Clin Exp Ophthalmol 2021;7(2):321-326
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