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Exploring of Taguchi Design in the Optimization of Brinzolamide and Timolol Maleate Ophthalmic in-situ Gel used in Treatment of Glaucoma

Author(s):

Purvi Shah, Vaishali Thakkar*, Vishvas Anjana, Jenee Christiana, Roma Trivedi , Kalpana Patel, Mukesh Gohel and Tejal Gandhi   Pages 1 - 19 ( 19 )

Abstract:


Objective: The present research work focuses on experimental design assisted In-situ gel for fixed dose combination.

Significance: Brinzolamide(BZ) BCS class II drug and timolol maleate(TM), a BCS class I drug is formulated for obtaining sustained effect, increased ocular bioavailability and reduction of dose leading to better patient compliance.

Methods: The material attributes were gelrite, hydroxy propyl methyl cellulose K4M(HPMC K4M) and HP-β-CD and critical quality attribute identified were gel strength, mucoadhesive index and percent of drug release of both drugs. BZ and TM were successfully formulated in ion-triggered In-situ gelling system using Taguchi design with minimum trials.

Results: The final optimized formula 0.5 %w/v gelrite, 0.5 %w/v HPMC K4M, 1:2.5 Ratio of drug to HP-β-CD as well as 150rpm stirring rate exhibited acceptable results with enhanced solubility of BZ. Pharmacodynamic study revealed decrease in intraocular pressure for In-situ gel (17.3) compared to conventional formulation. Moreover, delayed mean residence time and high AUC(61.237 and 4523.65) of In-situ gel indicates prolonged residence time with sustained release.

Conclusion: In conclusion, an excellent ocular tolerance and longer action of gelrite and HPMC K4M. In-situ gel for BZ and TM can be explored as potential alternative to marketed formulation reducing frequency of administration and improving patient compliance in glaucoma.

Keywords:

In-situ Gel; HP-β-CD; Taguchi Design; In-vivo animal study

Affiliation:

Departmentof Quality Assurance, Anand Pharmacy College, Anand, Departmentof Pharmaceutics, Anand Pharmacy College, Anand, Departmentof Pharmaceutics, Anand Pharmacy College, Anand, Departmentof Quality Assurance, Anand Pharmacy College, Anand, Departmentof Pharmaceutics, Anand Pharmacy College, Anand, Departmentof Quality Assurance, Anand Pharmacy College, Anand, Departmentof Pharmaceutics, Anand Pharmacy College, Anand, Departmentof Pharmacology, Anand Pharmacy College, Anand



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