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A nifedipine coground mixture with sodium deoxycholate. II. Dissolution characteristics and stability.
H Suzuki1, M Ogawa, K Hironaka
1Fuji Laboratory, Janssen-Kyowa Co., Ltd., Sunto-gun, Shizuoka, Japan.
Drug Development and Industrial Pharmacy
|January 5, 2002
Summary
Grinding nifedipine with sodium deoxycholate (DCNa) forms colloidal particles, enhancing drug dissolution. Factors like DCNa fraction, grinding time, and storage humidity significantly impact particle size and drug release.
Area of Science:
- Pharmaceutical Sciences
- Materials Science
Background:
- Nifedipine exhibits poor water solubility and low bioavailability.
- Previous work showed nifedipine-DCNa cogrinding forms colloidal particles in water.
Purpose of the Study:
- Investigate factors influencing colloidal particle formation of nifedipine-DCNa cogrounds.
- Characterize the impact of DCNa weight fraction, grinding time, dissolution media, and storage conditions.
Main Methods:
- Vibration rod mill used for cogrinding nifedipine and DCNa.
- Powder X-ray diffraction for solid-state characterization.
- Laser diffraction particle size analysis for particle size distribution in solution.
Main Results:
- Particle size decreased with increased DCNa fraction and grinding time.
- Colloidal particles formed in water and pH 6.8 buffer at 37°C.
- Storage at 40°C/75% RH for 1 month caused crystallization and increased particle size.
Conclusions:
- DCNa facilitates colloidal particle formation via micellar solubilization and crystal growth retardation.
- Weight fraction of DCNa, grinding time, dissolution media, and storage humidity are critical parameters affecting nifedipine dissolution.