Stabilization of hot-melt extrusion formulations containing solid solutions using polymer blends |
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Authors: | Suneela Prodduturi Kevin L Urman Joshua U Otaigbe Michael A Repka |
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Institution: | (1) Division of Pharmaceutical Analysis, Food and Drug Administration, 63101 St Louis, MO;(2) School of Polymers and High Performance Materials, University of Southern Mississippi, Faser 104A, 39406 Hattiesburg, MS;(3) Department of Pharmaceutics and National Center for Natural Products Research, School of Pharmacy, University of Mississippi, Faser 104A, 38677 University, MS |
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Abstract: | This study was aimed at enhancing the physical stability of the drug clotrimazole (CT) and the polymer contained within hot-melt
extrusion (HME) films using polymer blends of hydroxypropyl cellulose (HPC) and poly(ethylene oxide) (PEO). The HME films
were investigated for solid-state characteristics, moisture sorption, bioadhesivity, mechanical properties, glass transition
temperature, release characteristics, and physical and chemical stability of the drug and the polymer within the HME films.
The solid-state characterization of the drug and the polymer was performed using differential scanning calorimetry, x-ray
diffractometry, and dynamic mechanical analysis. A texture analyzer was used to study the bioadhesive and mechanical properties
of the HME films. The physical and chemical stability of the films, stored at 25°C/60% relative humidity or in a desiccator,
was studied for up to 12 months. CT was found to be in solid solution within all of the formulations extruded. The physical
stability of the drug and PEO in the HME films increased with increasing HPC concentration, but the bioadhesivity and flexibility
of the PEO films decreased with increasing HPC concentration. Films containing HPC: PEO∶CT in the ratio of 55∶35∶10 demonstrated
optimum physical-mechanical, bioadhesive, and release properties. In conclusion, polymer blends of HPC and PEO were used successfully
to tailor the drug release, mechanical and bio-adhesive properties, and stability of the HME films.
Published: June 29, 2007 |
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Keywords: | Solid solution physical stability hot-melt extrusion polymers physicochemical characterization |
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