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September 10, 20250 citationsOpen Access

Quality-By-Design (QBD) Approach in Developing a Thermoresponsive In-Situ Nasal Gel Containing Nanosized Antiviral

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SPSuneel PrajapatiVYVaibhav YadavRJRahul Johari

Key Points

  • The optimized formulation achieved a gelling temperature in the physiological range, enhancing patient comfort and usability.
  • Results indicated sustained drug release and enhanced bioavailability, positioning it as a viable option for clinical applications.
  • Response surface methodology revealed significant interactions among formulation variables affecting gel properties.
  • ANOVA analysis confirmed model stability with R² values over 0.95, indicating a strong predictive capability of the formulation process.

Abstract

Design of patient acceptable and effective drug delivery systems is a major concern area in pharmaceutical research field especially when the aim is management of nasal and respiratory infections. This paper was an attempt to design and optimize a thermoresponsive in-situ nasal gel made with nanosized antiviral agent using Poloxamer 407, Poloxamer 188, and HPMC as variables of the formulation. To determine the impact of these variables on the gelation temperature, viscosity and drug release, a Box- Behnken design was used together with Response Surface Methodology (RSM). ANOVA showed the effect of three excipients to be significant (p < 0.05), and the R 2 values were over 0.95, which represents considerable stability of the model. Optimized formulation displayed gelling temperature in the physiological range, a favorable drug delivery (gel) viscosity tailored to administrable in nasal cavity through nasal spray, and sustained drug release which was supported by predictive modelling and in-vitro tests. The results indicate the possibility of increasing drug bioavailability and mucosal adhesion and developing a fast onset of therapeutic effects with this formulation, so it should be considered one of the candidates in clinical translation.

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Cite This Study

Prajapati et al. (2025) studied this question.

synapsesocial.com/papers/68c1d98f54b1d3bfb60fb911https://doi.org/10.64063/3049-1681.vol.2.issue8.9
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