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Container closure selection and stability studies of developed multistimuli-responsive ocular sustained in situ hydrogel formulation of timolol maleate

  • Original Paper: Sol-gel and hybrid materials for biological and health (medical) applications
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Abstract

Timolol Maleate is used as a first-line treatment for open-angle glaucoma. It has low bioavailability and poor therapeutic effects because of the rapid precorneal removal of the conventional formulation. A study has found a selection of container closure that was safe, efficient, and stable for the formulation of multi-stimuli-responsive ocular sustained in situ hydrogels. The timolol maleate in situ gelling method was optimized and characterized in order to obtain desired quality attributes. Bulk preparations were autoclave sterilized (121 °C, 15 pressure for 20 min) and then filled into a specified container closing system. An accelerated stability analysis was carried out on optimized ocular formulation in accordance with ICH guidelines. The degradation rate for the optimized ocular formulation was found to be exceptionally low (1998 × 10−4 day−1) during stability testing. From the stability results, in situ gelling systems may assigned two years of shelf life.

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Acknowledgements

The authors are thankful to Ms. Bindu Yadav & Ms. Riya Patel, PhD scholars of Ramanbhai Patel College of Pharmacy, Charotar University of Science and Technology (CHARUSAT) for their extended support.

Author contributions

All authors contributed to the study conception, material preparation, and data analysis. The first draft of the manuscript was written by Priya Patel and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.

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Authors and Affiliations

  1. Ramanbhai Patel College of Pharmacy, Charotar University of Science and Technology, CHARUSAT – Campus, Changa – 388421, Anand, Gujarat, India

    Priya Patel, Prigneshkumar Patel & Gayatri Patel

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  1. Priya Patel
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  2. Prigneshkumar Patel
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  3. Gayatri Patel
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Correspondence to Gayatri Patel.

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Patel, P., Patel, P. & Patel, G. Container closure selection and stability studies of developed multistimuli-responsive ocular sustained in situ hydrogel formulation of timolol maleate. J Sol-Gel Sci Technol 105, 443–450 (2023). https://doi.org/10.1007/s10971-022-06006-5

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  • DOI: https://doi.org/10.1007/s10971-022-06006-5

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