STATISTICAL OPTIMIZATION AND EVALUATION OF IN SITU GEL FOR THE OCULAR DELIVERY OF CROMOLYN SODIUM

DEVIKA NAYAK; HARSHA VARDHANI KONDEPATI; MAHALAXMI RATHNANAND; VAMSHI KRISHNA TIPPAVAJHALA

doi:10.22159/ijap.2024v16i2.49781

Authors

DEVIKA NAYAK Department of Pharmaceutics, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal, Karnataka, India https://orcid.org/0000-0001-6869-9004
HARSHA VARDHANI KONDEPATI Department of Pharmaceutics, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal, Karnataka, India
MAHALAXMI RATHNANAND Department of Pharmaceutics, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal, Karnataka, India https://orcid.org/0000-0002-6339-2836
VAMSHI KRISHNA TIPPAVAJHALA Department of Pharmaceutics, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal, Karnataka, India https://orcid.org/0000-0001-6540-9550

DOI:

https://doi.org/10.22159/ijap.2024v16i2.49781

Keywords:

In situ gel, Cromolyn sodium, Conjunctivitis, Ocular delivery

Abstract

Objective: The study aimed to develop and optimize cromolyn sodium-based ocular in situ gel to improve the ophthalmic contact period and provide sustained drug release for treating allergic conjunctivitis.

Methods: Formulations were prepared using sodium alginate and HPMC K4M (Hydroxypropyl Methylcellulose) polymers and were characterized and evaluated for viscosity, gelling time, in vitro drug release, and optimized using a factorial 3²DOE design (Version 11; Design Expert^® software). The resulting cromolyn sodium-based formulation was tested for hyperemia and eye-scratching behavior in Wistar albino rats.

Results: Increased polymer concentrations resulted in higher viscosity with decreased gelling time and in vitro drug release. The optimized formulation achieved a viscosity of 15.350 cps, a gelling time of 55.137 s, and sustained drug release of 92.61% over 12 h. The in vivo pharmacodynamic study of the optimized formulation showed a significant decrease in the frequency of eye-scratching behaviour (7.525) at a significance level of (**p<0.01) and hyperemia (1.125) (***p<0.001, *p<0.05) compared to negative and positive control indicating that the developed in situ formulation improved the drug's therapeutic effectiveness by extending its duration within the cul de sac.

Conclusion: In light of these findings, this optimized cromolyn sodium in situ gel holds promise as a viable alternative to conventional eye drops

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