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Development and optimization of a novel sustained-release dextran tablet formulation for propranolol hydrochloride
Eddy Castellanos Gil1, Antonio Iraizoz Colarte, Bernard Bataille
1Center of Pharmaceutical Chemistry, Calle 200 esq 21, Atabey, Playa, Havana, Cuba. eddy02cu@yahoo.es
International Journal of Pharmaceutics
|April 6, 2006
Summary
A new oral controlled delivery system for propranolol hydrochloride (PPL) was developed. Optimized matrix tablets showed similar dissolution profiles to commercial capsules, indicating effective sustained release.
Area of Science:
- Pharmaceutical Technology
- Drug Delivery Systems
Background:
- Propranolol hydrochloride (PPL) is a widely used beta-blocker.
- Developing effective oral controlled delivery systems is crucial for improving patient compliance and therapeutic outcomes.
Purpose of the Study:
- To develop and optimize a novel oral controlled delivery system for propranolol hydrochloride (PPL).
- To investigate the influence of various matrix-forming agents on PPL release.
- To compare the in vitro dissolution profile with established pharmacopeial standards and commercial products.
Main Methods:
- Formulation of sustained-release matrix tablets using dextran, hydroxypropyl methylcellulose (HPMC), and cetyl alcohol.
- Optimization using a central composite design.
- In vitro dissolution studies and kinetic analysis (Higuchi and Hixon-Crowell models).
- Comparison with United States Pharmacopeia (USP) specifications and a commercial product (SUMIAL RETARD).
Main Results:
- Optimized tablets achieved desired physical, mechanical, and technological properties.
- Optimal formulation involved a 60:40 excipient:PPL ratio, a 4:1 dextran:HPMC ratio, and 15% cetyl alcohol.
- Dissolution profile similarity factor (f(2)=69.6) indicated similarity to commercial extended-release capsules.
- Drug release followed a codependent mechanism of diffusion (Higuchi) and erosion (Hixon-Crowell).
Conclusions:
- A novel, optimized sustained-release oral delivery system for propranolol hydrochloride was successfully developed.
- The developed formulation demonstrates comparable in vitro drug release to commercial products.
- The study establishes a codependent diffusion-erosion mechanism governing drug release from the matrix tablets.
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