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QbD Design, Formulation, Optimization and Evaluation of Trans-Tympanic Reverse Gelatination Gel of Norfloxacin: Investigating Gene-Gene Interactions to Enhance Therapeutic Efficacy

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 peri...

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Autores principales: Budhori, Amit, Tiwari, Abhishek, Tiwari, Varsha, Sharma, Ajay, Kumar, Manish, Gautam, Girendra, Virmani, Tarun, Kumar, Girish, Alhalmi, Abdulsalam, Noman, Omar Mohammed, Hasson, Sidgi, Mothana, Ramzi A.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10454480/
https://www.ncbi.nlm.nih.gov/pubmed/37623112
http://dx.doi.org/10.3390/gels9080657
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author Budhori, Amit
Tiwari, Abhishek
Tiwari, Varsha
Sharma, Ajay
Kumar, Manish
Gautam, Girendra
Virmani, Tarun
Kumar, Girish
Alhalmi, Abdulsalam
Noman, Omar Mohammed
Hasson, Sidgi
Mothana, Ramzi A.
author_facet Budhori, Amit
Tiwari, Abhishek
Tiwari, Varsha
Sharma, Ajay
Kumar, Manish
Gautam, Girendra
Virmani, Tarun
Kumar, Girish
Alhalmi, Abdulsalam
Noman, Omar Mohammed
Hasson, Sidgi
Mothana, Ramzi A.
author_sort Budhori, Amit
collection PubMed
description 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.
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spelling pubmed-104544802023-08-26 QbD Design, Formulation, Optimization and Evaluation of Trans-Tympanic Reverse Gelatination Gel of Norfloxacin: Investigating Gene-Gene Interactions to Enhance Therapeutic Efficacy Budhori, Amit Tiwari, Abhishek Tiwari, Varsha Sharma, Ajay Kumar, Manish Gautam, Girendra Virmani, Tarun Kumar, Girish Alhalmi, Abdulsalam Noman, Omar Mohammed Hasson, Sidgi Mothana, Ramzi A. Gels Article 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. MDPI 2023-08-15 /pmc/articles/PMC10454480/ /pubmed/37623112 http://dx.doi.org/10.3390/gels9080657 Text en © 2023 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Budhori, Amit
Tiwari, Abhishek
Tiwari, Varsha
Sharma, Ajay
Kumar, Manish
Gautam, Girendra
Virmani, Tarun
Kumar, Girish
Alhalmi, Abdulsalam
Noman, Omar Mohammed
Hasson, Sidgi
Mothana, Ramzi A.
QbD Design, Formulation, Optimization and Evaluation of Trans-Tympanic Reverse Gelatination Gel of Norfloxacin: Investigating Gene-Gene Interactions to Enhance Therapeutic Efficacy
title QbD Design, Formulation, Optimization and Evaluation of Trans-Tympanic Reverse Gelatination Gel of Norfloxacin: Investigating Gene-Gene Interactions to Enhance Therapeutic Efficacy
title_full QbD Design, Formulation, Optimization and Evaluation of Trans-Tympanic Reverse Gelatination Gel of Norfloxacin: Investigating Gene-Gene Interactions to Enhance Therapeutic Efficacy
title_fullStr QbD Design, Formulation, Optimization and Evaluation of Trans-Tympanic Reverse Gelatination Gel of Norfloxacin: Investigating Gene-Gene Interactions to Enhance Therapeutic Efficacy
title_full_unstemmed QbD Design, Formulation, Optimization and Evaluation of Trans-Tympanic Reverse Gelatination Gel of Norfloxacin: Investigating Gene-Gene Interactions to Enhance Therapeutic Efficacy
title_short QbD Design, Formulation, Optimization and Evaluation of Trans-Tympanic Reverse Gelatination Gel of Norfloxacin: Investigating Gene-Gene Interactions to Enhance Therapeutic Efficacy
title_sort qbd design, formulation, optimization and evaluation of trans-tympanic reverse gelatination gel of norfloxacin: investigating gene-gene interactions to enhance therapeutic efficacy
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10454480/
https://www.ncbi.nlm.nih.gov/pubmed/37623112
http://dx.doi.org/10.3390/gels9080657
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