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Accelerated dissolution testing for controlled release microspheres using the flow-through dissolution apparatus
Jarrod W Collier1, Mohan Thakare, Solomon T Garner
1School of Pharmacy, Howard University, College of Pharmacy, Nursing, & AHS, Washington, DC, USA.
Pharmaceutical Development and Technology
|September 12, 2008
Summary
Accelerated dissolution testing of theophylline controlled release capsules (THEO-24 CR) identified increased temperature as the key variable for quality control. Microsphere integrity was maintained across tested conditions, indicating robustness.
Area of Science:
- Pharmaceutical Sciences
- Drug Delivery Systems
- Materials Science
Background:
- Controlled release formulations require robust quality control methods.
- Accelerated dissolution testing is crucial for process and formulation development.
- Theophylline controlled release capsules (THEO-24 CR) serve as a model for evaluating such tests.
Purpose of the Study:
- To evaluate accelerated dissolution tests for controlled release formulations.
- To identify optimal conditions for process and quality control.
- To assess the impact of various stress factors on theophylline microspheres.
Main Methods:
- Utilized theophylline controlled release capsules (THEO-24 CR) as a model system.
- Employed accelerated dissolution testing by manipulating temperature, pH, flow rate, and surfactant concentration.
- Conducted electron microscopy to assess the integrity of theophylline microspheres post-experiment.
Main Results:
- Increased temperature (37-57°C) did not affect microsphere integrity.
- Microsphere integrity was maintained at pH 6.6 and 7.6, but deteriorated at pH 8.6.
- Increased flow rate showed no detrimental effect on microsphere integrity.
- Increased temperature was identified as the statistically significant variable for acceleration.
Conclusions:
- Accelerated dissolution testing, particularly temperature elevation, is a viable method for quality control of controlled release formulations.
- Theophylline microspheres exhibit stability within a specific pH range and temperature range.
- The study highlights temperature as a critical factor for developing robust accelerated dissolution protocols.
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