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In vitro release of ketoprofen suppositories using the USP basket and the flow-through cell dissolution methods
José Raúl Medina1, Adrián Roberto Padilla1, Marcela Hurtado2
1Departamento Sistemas Biologicos, Universidad Autónoma Metropolitana-Xochimilco, Mexico.
Pakistan Journal of Pharmaceutical Sciences
|May 10, 2014
Summary
This study evaluated ketoprofen suppository release using USP Apparatus 1 and 4. USP Apparatus 4 with 1% sodium lauryl sulfate (SLS) showed better drug release than USP Apparatus 1.
Area of Science:
- Pharmaceutical Sciences
- Drug Delivery Systems
Background:
- Ketoprofen suppositories require appropriate dissolution testing for quality control.
- Understanding drug release under different hydrodynamic conditions is crucial.
Purpose of the Study:
- To investigate the release characteristics of ketoprofen suppositories.
- To compare dissolution profiles using USP Apparatus 1 (basket) and USP Apparatus 4 (flow-through cell).
- To identify an optimal dissolution method for ketoprofen suppositories.
Main Methods:
- Dissolution testing of a Mexican ketoprofen suppository reference product (100 mg).
- Utilized phosphate buffer pH 8 and 1% sodium lauryl sulfate (SLS) as dissolution media.
- Employed USP Apparatus 1 at 100 rpm and USP Apparatus 4 with flow rates of 16-32 mL/min.
- Quantified drug release via UV analysis and calculated Mean Dissolution Time (MDT) and Dissolution Efficiency (DE).
Main Results:
- USP Apparatus 1 showed poor ketoprofen release (<10%) in both media.
- USP Apparatus 4 with 1% SLS at 24 mL/min yielded improved results (43.6% dissolved, MDT 25.5 min, DE 25.0%).
- Kinetic analysis revealed variability with USP Apparatus 1; Gompertz model best fitted data from USP Apparatus 4 (R(2)(adjusted) > 0.99).
Conclusions:
- The choice of dissolution apparatus significantly impacts ketoprofen suppository release profiles.
- USP Apparatus 4, particularly with 1% SLS at 24 mL/min, appears more suitable for evaluating ketoprofen suppository release.
- An optimized dissolution method is necessary for accurate assessment of ketoprofen suppository release kinetics.
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