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Merck

Cinacalcet Hydrochloride.

Profiles of drug substances, excipients, and related methodology (2017-04-23)
Gamal A E Mostafa, Abdullah A Al-Badr
ABSTRACT

Cinacalcet hydrochloride is a calcimimetic agent that increases the sensitivity to the extracellular calcium of the calcium-sensing receptors of the parathyroid gland which regulates parathyroid hormone secretion. This comprehensive profile on cinacalcet hydrochloride starts with a description: nomenclature, formulae, chemical structure, elemental composition, and appearance. The uses and applications of the drug are included. The methods of preparation of cinacalcet hydrochloride are described and their respective schemes are outlined. The physical characterization of the drug is: ionization constant, solubility, X-ray powder diffraction (XRPD) pattern, crystal polymorphs, melting point, and differential scanning calorimetry. The spectral characteristics of the drug include: ultraviolet spectrum, vibrational spectrum, 1H and 13C nuclear magnetic resonance spectra, and the mass spectrum. The methods of analysis of the drug include: spectrophotometry, electrophoresis, fluorimetry, and high-performance liquid chromatography alone or with mass spectrometry. The stability of the drug in various media and storage conditions are reported. Biological studies on the drug include: the metabolism pharmacokinetics and pharmacodynamics. More than 100 references are listed at the end of the chapter.