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Crystal Transition and Drug-excipient Compatibility of Clarithromycin in Sustained Release Tablets
- Source :
- Current Pharmaceutical Analysis. 16:950-959
- Publication Year :
- 2020
- Publisher :
- Bentham Science Publishers Ltd., 2020.
-
Abstract
- Background: Clarithromycin is widely used for infections of helicobacter pylori. Clarithromycin belongs to polymorphic drug. Crystalline state changes of clarithromycin in sustained release tablets were found. Objective: The aim of this study was to find the influential factor of the crystal transition of clarithromycin in preparation process of sustained-release tablets and to investigate the possible interactions between the clarithromycin and pharmaceutical excipients. Methods and Results: The crystal transition of active pharmaceuticals ingredients from form II to form I in portion in clarithromycin sustained release tablets were confirmed by x-ray powder diffraction. The techniques including differential scanning calorimetry and infrared spectroscopy, x-ray powder diffraction were used for assessing the compatibility between clarithromycin and several excipients as magnesium stearate, lactose, sodium carboxymethyl cellulose, polyvinyl-pyrrolidone K-30 and microcrystalline cellulose. All of these methods showed compatibilities between clarithromycin and the selected excipients. Alcohol prescription simulation was also done, which showed incompatibility between clarithromycin and concentration alcohol. Conclusion: It was confirmed that the reason for the incompatibility of clarithromycin with high concentration of alcohol was crystal transition.
- Subjects :
- Chemistry
010401 analytical chemistry
Biophysics
Pharmaceutical Science
02 engineering and technology
bacterial infections and mycoses
021001 nanoscience & nanotechnology
01 natural sciences
Biochemistry
0104 chemical sciences
Crystal
Chemical engineering
Clarithromycin
medicine
Molecular Medicine
Drug excipient compatibility
0210 nano-technology
medicine.drug
Subjects
Details
- ISSN :
- 15734129
- Volume :
- 16
- Database :
- OpenAIRE
- Journal :
- Current Pharmaceutical Analysis
- Accession number :
- edsair.doi...........24732c43bbfa6c8a8f8d34c127acb48c