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Controlled-release cellulose esters matrices for water-soluble diclofenac sodium: compression and dissolution studies
Die Pharmazie
|March 20, 2014
Summary
This study developed matrix tablets using cellulose acetate butyrate (CAB) or propionate (CAP) to control diclofenac sodium release. Formulation F7D with 40% CAB35-39 showed optimal release, compressibility, and compactability.
Area of Science:
- Pharmaceutical Sciences
- Materials Science
Background:
- Controlled drug release systems are crucial for optimizing therapeutic efficacy.
- Cellulose derivatives like CAB and CAP offer tunable properties for drug delivery matrices.
- Diclofenac sodium is a widely used non-steroidal anti-inflammatory drug requiring effective delivery formulations.
Purpose of the Study:
- To investigate the influence of cellulose acetate butyrate (CAB) and cellulose acetate propionate (CAP) blends with alpha-lactose monohydrate on diclofenac sodium release.
- To evaluate the mechanical properties (compressibility and compactability) of these matrix tablets.
- To identify the optimal formulation for controlled diclofenac sodium release.
Main Methods:
- Matrix tablets were prepared using direct compression of CAB/CAP and alpha-lactose monohydrate blends.
- Diclofenac sodium release kinetics were studied in a buffer medium.
- Mechanical properties were assessed using Heckel and Kawakita plots to determine plastic deformation and compressibility.
- Compression pressure, crushing strength, and T50% (time for 50% drug release) were analyzed.
Main Results:
- Formulations with CAP75000 or CAB50-54 showed high plastic deformation extent but low release rates.
- Formulations with CAP15000 or CAB35-39 exhibited low plastic deformation extent but high release rates.
- Heckel (DA) and Kawakita (DI) plot analyses indicated similar trends in mechanical behavior.
- A curvilinear relationship was observed between compression pressure/crushing strength and T50% for all formulations.
- Formulation F7D, containing 40% CAB35-39, demonstrated the best performance regarding T50%, compressibility, and compactability.
Conclusions:
- The choice of cellulose ester (CAB or CAP) and its specific grade significantly impacts the mechanical properties and drug release profiles of matrix tablets.
- Formulation F7D (40% CAB35-39) is identified as a promising candidate for controlled diclofenac sodium delivery due to its favorable release and mechanical characteristics.
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