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Optimization of propranolol hydrochloride sustained-release pellets using box-behnken design and desirability
1University of Medicine and Pharmacy luliu Hatieganu Cluj Napoca, Pharmaceutical Technology and Biopharmaceutics Department, 13, E. Isac, 3400 Cluj Napoca, Romania.
Drug Development and Industrial Pharmacy
|December 21, 2004
Summary
This study optimized ethylcellulose film coating for controlled propranolol hydrochloride delivery. The best formulation achieved predicted drug release, with the Higuchi model accurately describing the release mechanism.
Area of Science:
- Pharmaceutical Technology
- Materials Science
Background:
- Ethylcellulose films are used for controlled drug delivery.
- Optimizing coating processes is crucial for multi-particulate systems.
Purpose of the Study:
- To evaluate process parameters for ethylcellulose film coating of propranolol hydrochloride pellets.
- To optimize coating conditions for controlled drug release using a Box-Behnken design.
Main Methods:
- Coating process developed in a classical coating pan.
- Box-Behnken design to assess film thickness, lacquer concentration, and plasticizer concentration.
- Analysis of variables including t85, sticking, and process duration.
Main Results:
- Competitive responses required an overall desirability function for optimization.
- Optimized conditions yielded results close to predicted values.
- The Higuchi model best correlated with the drug release data.
Conclusions:
- Optimized ethylcellulose coating provides effective controlled release of propranolol hydrochloride.
- The Higuchi model is suitable for describing drug release from these optimized pellets.