QbD Approach for Development of a Mucoadhesive Thermosensitive Gel for Oral Application: Risk Assessment Followed by
Elena Dinte1, Ioan Tomuță1, Rareș Iuliu Iovanov1
1Department of Pharmaceutical Technology and Biopharmacy, Faculty of Pharmacy, "Iuliu Haţieganu" University of Medicine and Pharmacy, 41 V. Babes Street, 400012 Cluj-Napoca, Romania.
Gels (Basel, Switzerland)
|April 27, 2026
Summary
This study developed a novel mucoadhesive gel for dental extraction sockets, providing prolonged release of metronidazole and ibuprofen to prevent alveolar osteitis and enhance healing.
Area of Science:
- Pharmaceutical Sciences
- Biomaterials Engineering
- Drug Delivery Systems
Background:
- Alveolar osteitis, a common post-extraction complication, necessitates effective preventative and therapeutic strategies.
- Current treatments often lack sustained drug release and optimal socket adherence.
- Developing advanced drug delivery systems is crucial for improving post-surgical outcomes.
Purpose of the Study:
- To formulate and characterize a mucoadhesive, thermosensitive buccal gel for enhanced metronidazole and ibuprofen delivery.
- To evaluate the gel's potential for artificial clot formation and prolonged drug release in extraction sockets.
- To identify and optimize critical formulation and process parameters for product efficacy and stability.
Main Methods:
- Systematic risk assessment using Ishikawa diagrams and Failure Mode and Effects Analysis (FMEA).
- Experimental designs (screening and optimization) to investigate formulation variables.
- Evaluation of rheological, mucoadhesive, in vitro drug release, and stability properties.
Main Results:
- An optimized formulation containing Poloxamer 407 (20.99%) and HPMC K100M:K4M (0.74%) demonstrated prolonged release of metronidazole and ibuprofen over 8 hours, following Peppas kinetics.
- The gel exhibited suitable pH, ex vivo mucoadhesion, and maintained mechanical properties and drug recovery (>90%) after 12 months of storage.
- Risk assessment tools identified critical parameters influencing product performance.
Conclusions:
- The developed mucoadhesive thermosensitive gel shows significant potential as a therapeutic agent for preventing alveolar osteitis.
- The formulation ensures sustained drug release and stability, addressing key limitations of current treatments.
- This innovative gel offers a promising approach to improve post-dental extraction socket management.
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