Development, characterization and Evaluation of Doxycycline containing novel In-situ Gel for effective Ocular Drug Delivery

Author: Patel L.K. and Naresh Kalra

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Abstract

Aim of the present study was to select the suitable pharmaceutical ingredients which provides suitable aqueous based system for designing and developing the in-situ gel-forming formulation containing Doxycycline Hyclate (DOX). Pharmaceutical ingredients specially used in ophthalmic formulation like Polymers (Gellan gum, Xanthan gum, Hypromellose, Povidone and etc.), Tonicity modifiers (Sodium chloride, Mannitol and etc.), Preservatives (Benzalkonium chloride, Oxychlorocomplex, Benzododecinium bromide and etc.), Buffers (Tromethamine, Sodium citrate, disodium hydrogen phosphate and etc.) stabilizing agents or Antioxidants (Sodium metabisulfite, Citric acid and Sodium thiosulfate and etc.). The pre-formulation studies were performed with selected pharmaceutical ingredients. Drug-Excipients compatibility studies were performed at 25°C and 40°C. Stability of Doxycycline Hyclate at different pH 5.5-7.4 were checked to finalize the pH of final formulation. The obtained results indicated that, the selected ingredients were suitable and provide stable system for in-situ gel formulation containing Doxycycline Hyclate. Results showed that a suitable combination of polymers (Gellan gum, Povidone K30 & Hypromellose), Preservative (Benzalkonium chloride), Buffer (Tromethamine), Tonicity modifier (Mannitol) and Antioxidant (Sodium metabisulfite) were found compatible. This could be the better and stable hydrogel system for Doxycycline Hyclate for in situ gel formulation.

Keywords

Dry eye disease, In-situ gel, doxycycline Hyclate, drug delivery, polymer, Gellan gum, Benzalkonium chloride, Antioxidant

Conclusion

In the present study, stability study of Doxycycline with five different antioxidants were studied and found that, the Doxycycline Hyclate was more stable with sodium thiosulfate at a concentration of 5mg/mL at selected temperature 25°C & 40°C, pH -5.5 & 7.4. However, Doxycycline Hyclate was found more stable at a temperature 25 °C as compared to 40°C. Doxycycline Hyclate was found compatible with all selected excipients mentioned in Table 2. Further same qualitative composition shall be used to develop in situ gel forming solution. However, Quantitative composition shall be further optimized as per requirement.

References

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How to cite this article

Patel L.K. and Naresh Kalra (2023). Development, characterization and Evaluation of Doxycycline containing novel In-situ Gel for effective Ocular Drug Delivery. Biological Forum – An International Journal, 15(5): 1730-1733.