Topical Insulin in Artificial Tears Stability Study: Short-term Physical, Chemical and Microbiological Stability Study of 0.5 Units (25 IU/mL) of Topical Insulin in Artificial Tears.

IF 2 4区医学 Q2 OPHTHALMOLOGY

Eye & Contact Lens-Science and Clinical Practice Pub Date : 2025-03-04 DOI:10.1097/ICL.0000000000001175

Mae-Lynn Catherine Bastion, Wan Haslina Wan Abdul Halim, Mazlina Mohd Said, Birinder Kaur Sadu Singh, Azura Abdul Ghani

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引用次数: 0

Abstract

Objectives: Topical insulin (TI) at 25 IU/mL effectively normalizes healing of corneal epithelium and dry eye in diabetic patients. We aim to determine physicochemical stability and sterility of TI in sodium hyaluronate 0.18% (TI-artificial tears [AT]) in an eye drop formulation.

Methods: The physicochemical stability of TI-AT at 5°C±3°C and 30°C±2°C in sterile low-density polyethylene bottles was studied. Samples were put in conditions of simulated use and analyzed weekly for stability parameters (visual inspection, turbidity, ultraviolet spectral absorption, osmolality, and pH) and culture growth. Insulin was quantified using the stability-indicating high-performance liquid chromatographic method with diode-array detection with RP-C18 column, o-nitrophenol as an internal standard, and ultraviolet detection at 214 nm. Stability was set according to British Pharmacopoeia with 90% to 110% of initial concentration (with 95% confidence interval) considered acceptable.

Results: All tested physicochemical and sterility parameters remained stable for 1 month in both temperature conditions with stable TI concentrations.

Conclusion: Topical insulin-artificial tears is stable in both room temperature and refrigeration. Topical insulin-artificial tears can be prescribed with a 1-month shelf life.

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来源期刊

Eye & Contact Lens-Science and Clinical Practice OPHTHALMOLOGY-

CiteScore

4.50

自引率

4.30%

发文量

150

审稿时长

6-12 weeks

期刊介绍： Eye & Contact Lens: Science and Clinical Practice is the official journal of the Contact Lens Association of Ophthalmologists (CLAO), an international educational association for anterior segment research and clinical practice of interest to ophthalmologists, optometrists, and other vision care providers and researchers. Focusing especially on contact lenses, it also covers dry eye disease, MGD, infections, toxicity of drops and contact lens care solutions, topography, cornea surgery and post-operative care, optics, refractive surgery and corneal stability (eg, UV cross-linking). Peer-reviewed and published six times annually, it is a highly respected scientific journal in its field.