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Comparative dissolution studies for mefenamic acid-polyethylene glycol solid dispersion systems and tablets
G Owusu-Ababio1, N K Ebube, R Reams
1College of Pharmacy and Pharmaceutical Sciences, Florida A&M University, Tallahassee 32307, USA.
Pharmaceutical Development and Technology
|September 22, 1998
Summary
Solid dispersions of mefenamic acid (MFA) significantly enhance drug dissolution. Formulating these dispersions into tablets maintained the improved dissolution rates, potentially reducing doses for poorly soluble drugs.
Area of Science:
- Pharmaceutical Sciences
- Drug Delivery Systems
- Materials Science
Background:
- Mefenamic acid (MFA) is a practically water-insoluble non-steroidal anti-inflammatory drug.
- Enhancing the dissolution rate of poorly soluble drugs is crucial for improving their bioavailability and therapeutic efficacy.
- Solid dispersion technology offers a promising approach to overcome solubility challenges.
Purpose of the Study:
- To enhance the dissolution of mefenamic acid (MFA) via solid dispersion systems.
- To compare the dissolution profiles of unformulated solid dispersions versus formulated tablet dosage forms.
- To investigate the impact of formulation components and processing on MFA dissolution.
Main Methods:
- Preparation of binary (MFA/polyethylene glycol 3350) and ternary (MFA/polyethylene glycol 3350/Tween 20) solid dispersions using the melt method.
- Characterization techniques included dissolution studies, scanning electron microscopy (SEM), and powder X-ray diffraction (PXRD).
- Formulation of dispersions into tablets and comparison with uncompressed mixtures and pure MFA.
Main Results:
- Reduced MFA content in binary dispersions (down to 5% w/w) increased dissolution rate threefold compared to pure MFA.
- Ternary systems incorporating Tween 20 further enhanced MFA dissolution, achieving a sevenfold increase at MFA/PEG/TW 4.7:93:2.3 (% w/w).
- SEM indicated increased particle size, while PXRD showed decreased crystallinity of dispersions. Tablet compression did not negatively impact dissolution from dispersions.
Conclusions:
- Solid dispersions, particularly ternary systems with PEG and Tween 20, significantly improve mefenamic acid dissolution.
- Formulating these enhanced dispersions into tablets preserves the improved dissolution characteristics.
- This approach holds potential for reducing the dosage of poorly water-soluble drugs like MFA when formulated as tablets.