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Coherent anti-Stokes Raman Scattering CARS Microscopy Visualizes Pharmaceutical Tablets During Dissolution
Published on: July 4, 2014
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In Vitro Dissolution Studies of Amiodarone Hydrochloride From Hydroxy-Propyl-β-Cyclodextrin/Amiodarone Inclusion
Summary
Modified-release matrix tablets using Kollidon® SR and Chitosan were developed. Complexing amiodarone hydrochloride with hydroxypropyl-β-cyclodextrin enhanced solubility and modified drug release profiles.
Area of Science:
- Pharmaceutical Sciences
- Drug Delivery Systems
- Materials Science
Background:
- Drug release from modified-release matrix tablets is influenced by drug solubility and polymer properties.
- Amiodarone hydrochloride solubility was significantly increased (>200%) by forming an inclusion complex with hydroxypropyl-β-cyclodextrin.
Purpose of the Study:
- To develop and evaluate modified-release matrix tablets incorporating an amiodarone hydrochloride-hydroxypropyl-β-cyclodextrin inclusion complex.
- To compare the drug release kinetics of tablets made with non-complexed amiodarone versus the inclusion complex using Kollidon® SR and Chitosan.
Main Methods:
- Modified-release matrix tablets (F1 and F10) were prepared via direct compression using non-complexed amiodarone and the inclusion complex, respectively.
- In vitro drug release studies were conducted for 12 hours using a paddle apparatus II in simulated gastrointestinal fluids (pH 1.2 for 2 hours, pH 6.8 for 10 hours).
- Amiodarone hydrochloride release was quantified using High-Performance Liquid Chromatography (HPLC), and release profiles were assessed using similarity (f1) and difference (f2) factors.
Main Results:
- Increased Kollidon® SR concentration led to a reduced amiodarone release rate at both pH 1.2 and pH 6.8.
- Chitosan incorporation decreased amiodarone release specifically at pH 6.8.
- The similarity factor (f1=43.697) and difference factor (f2=68.263) indicated similarities between the release profiles of the two formulations.
Conclusions:
- The hydroxypropyl-β-cyclodextrin complexation effectively enhanced amiodarone hydrochloride solubility.
- Modified-release matrix tablets formulated with Kollidon® SR and Chitosan demonstrated controlled amiodarone release profiles.
- The study confirmed the feasibility of using inclusion complexes to modulate drug release from matrix tablets.
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