THE IMPORTANCE OF CHROMATOGRAPHICALLY PURIFIED EXCIPIENTS
Abstract
In the present work critical importance and benefits of Super Refined excipients for drug stability, integrity and safety are described. It was shown, that impurities can disrupt API and cause cell irritation. It was proved, that chromatographically purified excipients are fundamental to develop efficient, stable and reliable pharmaceutical formulations.
References
1. M. Bergh, L. Shao, E. Gaefvert, J. Nilsson, E. Karlberg. Contact Allergens from Surfactants. Atmospheric Oxidation of Polyoxyethylene Alcohols. Formation of Ethoxylated Aldehydes, and Their Allergenic Activity // J. Pharm. Sci. 1998. № 87(3). Р. 276-282.
2. M. Bergh, K. Magnusson, J. Nilsson and А-T. Karlberg. Formation of Formaldehyde and Peroxides by Air Oxidation of High Purity Polyoxyethylene Surfactants // Contact Derm. 1998. № 39(1). Р. 14-20.
3. R. Tchao. Trans-Epithelial Permeability of Fluroescein in vitro as an Assay to Determine Eye Irritants // Alternate Methods in Toxicology. 1987. V. 6. Progess in in vitro Toxicology (ed. by A.M. Goldberg). P. 271-282.
4. Purity of PEG 400 affects the stability of gelatin capsule / AAPS Poster Abstract, R6012, AAPS, Nashville, November 6-10, 2005.
5. Purity of Dimethyl Isosorbide Affects API Stability / AAPS Poster Abstract, AAPS, Atlanta, November 16-20, 2008.
Review
For citations:
Rizzo G.J., Chen K.H. THE IMPORTANCE OF CHROMATOGRAPHICALLY PURIFIED EXCIPIENTS. Drug development & registration. 2017;(4):84-87. (In Russ.)
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