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Design of Experiments-Driven Optimization of Spray Drying for Amorphous Clotrimazole Nanosuspension.
- Source :
-
AAPS PharmSciTech [AAPS PharmSciTech] 2024 Jul 13; Vol. 25 (6), pp. 164. Date of Electronic Publication: 2024 Jul 13. - Publication Year :
- 2024
-
Abstract
- This study employed a Quality by Design (QbD) approach to spray dry amorphousclotrimazole nanosuspension (CLT-NS) consisting of Soluplus <superscript>®</superscript> and microcrystallinecellulose. Using the Box-Behnken Design, a systematic evaluation was conducted toanalyze the impact of inlet temperature, % aspiration, and feed rate on the criticalquality attributes (CQAs) of the clotrimazole spray-dried nanosuspension (CLT-SDNS). In this study, regression analysis and ANOVA were employed to detect significantfactors and interactions, enabling the development of a predictive model for the spraydrying process. Following optimization, the CLT-SD-NS underwent analysis using Xraypowder diffraction (XRPD), Fourier transform infrared spectroscopy (FTIR), Dynamic Scanning Calorimetry (DSC), and in vitro dissolution studies. The resultsshowed significant variables, including inlet temperature, feed rate, and aspiration rate,affecting yield, redispersibility index (RDI), and moisture content of the final product. The models created for critical quality attributes (CQAs) showed statistical significanceat a p-value of 0.05. XRPD and DSC confirmed the amorphous state of CLT in theCLT-SD-NS, and FTIR indicated no interactions between CLT and excipients. In vitrodissolution studies showed improved dissolution rates for the CLT-SD-NS (3.12-foldincrease in DI water and 5.88-fold increase at pH 7.2 dissolution media), attributed torapidly redispersing nanosized amorphous CLT particles. The well-designed studyutilizing the Design of Experiments (DoE) methodology.<br /> (© 2024. The Author(s), under exclusive licence to American Association of Pharmaceutical Scientists.)
- Subjects :
- Spray Drying
Chemistry, Pharmaceutical methods
Solubility
Spectroscopy, Fourier Transform Infrared methods
Particle Size
Calorimetry, Differential Scanning methods
Temperature
Drug Compounding methods
Polyvinyls chemistry
X-Ray Diffraction methods
Polyethylene Glycols
Clotrimazole chemistry
Clotrimazole administration & dosage
Nanoparticles chemistry
Suspensions chemistry
Subjects
Details
- Language :
- English
- ISSN :
- 1530-9932
- Volume :
- 25
- Issue :
- 6
- Database :
- MEDLINE
- Journal :
- AAPS PharmSciTech
- Publication Type :
- Academic Journal
- Accession number :
- 38997569
- Full Text :
- https://doi.org/10.1208/s12249-024-02871-1