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In Vitro Dissolution Studies of Amiodarone Hydrochloride From Hydroxy-Propyl-β-Cyclodextrin/Amiodarone Inclusion

Andreea Creţeanu, Lăcrămioara Ochiuz, Mădălina Vieriu

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    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.

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    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.