Improving Stability and Dissolution of Amorphous Clofazimine by Polymer Nano-Coating View Full Text


Ontology type: schema:ScholarlyArticle     


Article Info

DATE

2019-05

AUTHORS

Yue Gui, Yinshan Chen, Zhenxuan Chen, Karen J. Jones, Lian Yu

ABSTRACT

PURPOSE: To inhibit the surface crystallization and enhance the dissolution of the basic amorphous drug clofazimine by polymer nano-coating. METHODS: The free surface of amorphous clofazimine was coated by dip coating in an alginate solution at pH 7. The stability of the coated amorphous drug against crystallization was evaluated by X-ray diffraction and light microscopy. The effect of coating on dissolution rate was measured in simulated gastric fluid in an USP-II apparatus at 37°C. RESULTS: At pH 7, the weak base clofazimine (pKa = 8.5) is positively charged, while the weak alginic acid (pKa = 3.5) is negatively charged, allowing coating by electrostatic deposition. Coated amorphous particles remain nearly amorphous after one year under the accelerated testing condition 40°C/75% R.H. and show faster dissolution than uncoated particles. In the first hour of dissolution, coated amorphous particles dissolve 50% faster than uncoated amorphous particles, and a factor of 3 faster than crystalline particles of the same size. CONCLUSIONS: A pharmaceutically acceptable polymer, alginate, is coated on amorphous clofazimine by electrostatic deposition and effectively inhibits its surface crystallization and enhances its dissolution rate. This is the first time the nano-coating technique is applied to a basic drug using the principle of electrostatic deposition, demonstrating the generality of the approach. More... »

PAGES

67

Identifiers

URI

http://scigraph.springernature.com/pub.10.1007/s11095-019-2584-9

DOI

http://dx.doi.org/10.1007/s11095-019-2584-9

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1112778466

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/30877389


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