Article

Application of Terahertz Absorption Spectroscopy to Evaluation of Aging Variation of Medicine

Nagahama Institute of Bio-science and Technology, 1266 Tamura, Nagahama, Shiga 526-0829, Japan.
Analytical Sciences (Impact Factor: 1.4). 02/2011; 27(2):209-12. DOI: 10.2116/analsci.27.209
Source: PubMed

ABSTRACT The absorption spectra of three kinds of medicines both before and after the expiration date: Amlodin OD(®) (5 mg), Basen OD(®) (0.2 mg) and Gaster D(®) (10 mg) have been measured by terahertz time domain spectroscopy (THz-TDS). All the medicines show some differences in the THz absorption spectra between medicines before and after the expiration dates. X-Ray powder diffraction (XRD) studies of all medicines suggest that the polymorph of the main effective compound is not changed before and after the expiration date. Therefore, the differences in the THz spectra between medicines before and after the expiration dates arise from aging variation of diluting agents and/or from modifications of intermolecular interaction between the effective compounds and diluting agents.

Full-text

Available from: Kenji Ikeda, Feb 20, 2015
0 Followers
 · 
96 Views
  • [Show abstract] [Hide abstract]
    ABSTRACT: Crystal polymorphism of pharmaceuticals has well-known profound effects on the physical, chemical, and pharmaceutical properties of drugs, which can result in changes in the solubility, stability, dissolution, bioavailability, and efficacy of drugs. In this review article, famotidine (FAM), which has a well-known trade name of Pepcid®, was selected as a model drug. Although FAM has three polymorphs (forms A, B and C), forms A and B have been commonly discussed. The active pharmaceutical ingredient (API) in the commercial version of FAM is the metastable form B. FAM has been a concern of FDA because of the physical properties, solubilities, bioavailabilities, or bioequivalencies of the different polymorphic forms. In addition, a patent infringement suit of FAM polymorph had been made sound legal arguments in the pharmaceutical market. We review the solid-state characteristics, thermodynamics, polymorphic transformation, and quality control of FAM in drug products. In particular, pharmaceutical processes, such as grinding, compression, and heating temperature have a significant effect on the polymorphic transformation of FAM. Moreover, environmental humidity and residual water content should be well controlled to prevent polymorphic transformation of FAM during pharmaceutical processing. Several thermal and spectroscopic analytical techniques used for qualitative and quantitative determinations of polymorphic transformation of FAM after different treatments or quality control of FAM in the commercial tablets before and after the expiration dates have been discussed.
    Pharmaceutical Research 03/2014; 31(7). DOI:10.1007/s11095-014-1323-5 · 3.95 Impact Factor
  • [Show abstract] [Hide abstract]
    ABSTRACT: The temperature dependent vibrational spectra of,three biological and pharmaceutical sets, genistein and biochanin A, clenbuterol hydrochloride and salbutamol, as well as ginseng R2 and R3, in the range of 0.2-4.5 THz (6.6-150.0 cm(-)) are presented over the temperature range from 295 to 77 K Although there are only some minor difference in their molecular structures, the spectra of two samples in every group are quite differences in both absorption band positions and their relative intensities, and display strong linewidth narrowing and frequency blue-shift with cooling. Au 77 K, 13 highly resolved spectral features for biochanin A were obtained and the sensitivity of the experiment allows detection of amounts as small as 1.9 x 10(-5) mol of ginseng R3. Such high-resolution THz fingerprint spectra provide a rapid, nondestructive and reliable method for the identification of these pharmaceutical settings molecules.
    Guang pu xue yu guang pu fen xi = Guang pu 11/2012; 32(11):3035-9. DOI:10.3964/j.issn.1000-0593(2012)11-3035-05 · 0.27 Impact Factor
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: The paper deals with recognition of typical components used in the pharmaceutical sciences and pharmaceutical industry. It is shown usefulness in the field of terahertz spectroscopy to research pseudo-polymorphisms - hydration.
    Infrared, Millimeter, and Terahertz Waves (IRMMW-THz), 2012 37th International Conference on; 01/2012