QbD Design, Formulation, Optimization and Evaluation of Trans-Tympanic Reverse Gelatination Gel of Norfloxacin: Investigating Gene-Gene Interactions to Enhance Therapeutic Efficacy
Amit Budhori,
Abhishek Tiwari,
Varsha Tiwari,
Ajay Sharma,
Manish Kumar,
Girendra Gautam,
Tarun Virmani,
Girish Kumar,
Abdulsalam Alhalmi,
Omar Mohammed Noman,
Sidgi Hasson,
Ramzi A. Mothana
Affiliations
Amit Budhori
Devsthali Vidyapeeth Institute of Pharmacy, Lalpur, Rudrapur 263148, India
Abhishek Tiwari
Pharmacy Academy, IFTM University, Moradabad 244102, India
Varsha Tiwari
Pharmacy Academy, IFTM University, Moradabad 244102, India
Ajay Sharma
School of Pharmaceutical Sciences, Delhi Pharmaceutical Sciences and Research University, Pushp Vihar, New Delhi 110017, India
Manish Kumar
School of Pharmaceutical Sciences, CT University, Ludhiana 142024, India
Girendra Gautam
Shri Ram College of Pharmacy, Muzaffarnagar 251001, India
Tarun Virmani
School of Pharmaceutical Sciences, MVN University, Palwal 121105, India
Girish Kumar
School of Pharmaceutical Sciences, MVN University, Palwal 121105, India
Abdulsalam Alhalmi
Department of Pharmaceutics, School of Pharmaceutical Education and Research, Jamia Hamdard, New Delhi 110062, India
Omar Mohammed Noman
Department of Pharmacognosy, College of Pharmacy, King Saud University, P.O. Box 2457, Riyadh 11451, Saudi Arabia
Sidgi Hasson
School of Pharmacy and Biomolecular Sciences, Liverpool John Moores University, Liverpool L3 5UG, UK
Ramzi A. Mothana
Department of Pharmacognosy, College of Pharmacy, King Saud University, P.O. Box 2457, Riyadh 11451, Saudi Arabia
Traditional otic drug delivery methods lack controlled release capabilities, making reverse gelatination gels a promising alternative. Reverse gelatination gels are colloidal systems that transition from a sol to a gel phase at the target site, providing controlled drug release over an extended period. Thermosensitive norfloxacin reverse gelatination gels were developed using a Quality by Design (QbD)-based optimization approach. The formulations were evaluated for their in vitro release profile, rheological behavior, visual appearance, pH, gelling time, and sol–gel transition temperature. The results show that the gelation temperatures of the formulations ranged from 33 to 37 °C, with gelling durations between 35 and 90 s. The drug content in the formulations was uniform, with entrapment efficiency ranging from 55% to 95%. Among the formulations, F10 exhibited the most favorable properties and was selected for a stability study lasting 60 days. Ex-vivo release data demonstrate that the F10 formulation achieved 95.6percentage of drug release at 360 min. This study successfully developed thermosensitive norfloxacin reverse gelatination gels using a QbD-based optimization approach. The selected formulation, F10, exhibited desirable properties in terms of gelling temperature, drug content, and release profile. These gels hold potential for the controlled delivery of norfloxacin in the treatment of ear infections.
