View in EDS

Execution of Quality by Design Approach in the Formulation of Fluconazole Inclusion Complex Based Suppository for Vaginal Candidiasis.

Saved in:
Bibliographic Details
Title: Execution of Quality by Design Approach in the Formulation of Fluconazole Inclusion Complex Based Suppository for Vaginal Candidiasis.
Authors: Kanojiya, Pranita Sunil, Wadetwar, Rita Naresh, Godbole, Amita Prasanna
Source: Indian Journal of Pharmaceutical Education & Research; 2025 Supplement, Vol. 59, ps531-s551, 21p
Subject Terms: VULVOVAGINAL candidiasis, INCLUSION compounds, SUPPOSITORIES, X-ray diffraction, POLYETHYLENE glycol
Abstract: Aim: The present work was carried out to improve the aqueous solubility of Fluconazole by formulation of inclusion complex using ß-cyclodextrin and then loaded into the suppository for the treatment of vaginal candidiasis. Materials and Methods: Fluconazole (FOZ) Inclusion Complex (INC) with ß-Cyclodextrin (ßCD) was formulated first after optimization of the D-Optimal mixture design for the molar ratio. Then INC was prepared (1:1 molar ratio) with different methods (kneading, coprecipitation and microwave irradiation) and was studied for FTIR, DSC and XRD studies. Results: Microwave irradiation (MW) was the best method for the preparation of INC with the maximum % drug content (98.96±1.78%) and solubility (3.14±0.85 mg/mL). The QbD approach was employed to select the best ratio of the base and plasticizer for the suppository. The suppository was prepared using PEG 6000 (base) and PEG 400 (plasticizer) and an optimized inclusion complex was incorporated. The D-Optimal mixture design was applied to optimize a combination of PEG 6000 and PEG 400 by studying responses such as hardness, melting time and drug release from the suppository. The in vitro release study showed that higher drug release was achieved from the FOZ MW INC based suppository (99.40±1.43%) compared to the plain drug suppository (71.41±2.19%). Conclusion: The prepared FOZ suppository had higher drug release and enhanced antifungal activity. Therefore, it would be beneficial in the treatment of Vaginal Candidiasis. [ABSTRACT FROM AUTHOR]
Copyright of Indian Journal of Pharmaceutical Education & Research is the property of Association of Pharmaceutical Teachers of India and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
Database: Biomedical Index
Description
Abstract:Aim: The present work was carried out to improve the aqueous solubility of Fluconazole by formulation of inclusion complex using ß-cyclodextrin and then loaded into the suppository for the treatment of vaginal candidiasis. Materials and Methods: Fluconazole (FOZ) Inclusion Complex (INC) with ß-Cyclodextrin (ßCD) was formulated first after optimization of the D-Optimal mixture design for the molar ratio. Then INC was prepared (1:1 molar ratio) with different methods (kneading, coprecipitation and microwave irradiation) and was studied for FTIR, DSC and XRD studies. Results: Microwave irradiation (MW) was the best method for the preparation of INC with the maximum % drug content (98.96±1.78%) and solubility (3.14±0.85 mg/mL). The QbD approach was employed to select the best ratio of the base and plasticizer for the suppository. The suppository was prepared using PEG 6000 (base) and PEG 400 (plasticizer) and an optimized inclusion complex was incorporated. The D-Optimal mixture design was applied to optimize a combination of PEG 6000 and PEG 400 by studying responses such as hardness, melting time and drug release from the suppository. The in vitro release study showed that higher drug release was achieved from the FOZ MW INC based suppository (99.40±1.43%) compared to the plain drug suppository (71.41±2.19%). Conclusion: The prepared FOZ suppository had higher drug release and enhanced antifungal activity. Therefore, it would be beneficial in the treatment of Vaginal Candidiasis. [ABSTRACT FROM AUTHOR]
ISSN:00195464
DOI:10.5530/ijper.20256191