Author: I. Vitez 1
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  • 1 Bristol-Myers Squibb Pharmaceutical Research Institute New Brunswick Materials Science Group New Jersey 08903-0191 USA E-mail
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Abstract  

The existence of multiple crystal forms in a drug substance poses interesting development challenges as the material is taken from discovery through formulation, manufacture and market. There are a number of factors why drug substances under development are screened for presence of multiple crystal forms. Different crystal forms may exhibit varied performance properties including bioavailability and solubility, as well as, differences in physical properties such as morphology and melting point. These properties can affect the design of the manufacturing processes for the bulk drug substance, the formulation and the performance of the drug product. This paper will focus on the application of differential scanning calorimetry (DSC) for the quantitation of pharmaceutical crystal forms. Feasibility studies were conducted on several pharmaceutical drug substances which were known to have multiple crystal forms, to determine if quantitative, semi-quantitative or limit of detection tests could be developed. The conclusion from these studies is that polymorphic crystal systems comprised of either close, or melting with decomposing, endotherms, competing transitions, or that contain sample contaminants, may not be optimum candidates for quantitation by DSC. Conversely, crystal systems that contain polymorphs that exhibit well-resolved endothermic or exothermic transitions, for either solvated vs. unsolvated species or both unsolvated, may be excellent candidates for crystal form quantitation by DSC.

Manuscript Submission: HERE

  • Impact Factor (2019): 2.731
  • Scimago Journal Rank (2019): 0.415
  • SJR Hirsch-Index (2019): 87
  • SJR Quartile Score (2019): Q3 Condensed Matter Physics
  • SJR Quartile Score (2019): Q3 Physical and Theoretical Chemistry
  • Impact Factor (2018): 2.471
  • Scimago Journal Rank (2018): 0.634
  • SJR Hirsch-Index (2018): 78
  • SJR Quartile Score (2018): Q2 Condensed Matter Physics
  • SJR Quartile Score (2018): Q2 Physical and Theoretical Chemistry

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Journal of Thermal Analysis and Calorimetry
Language English
Size A4
Year of
Foundation
1969
Volumes
per Year
4
Issues
per Year
24
Founder Akadémiai Kiadó
Founder's
Address
H-1117 Budapest, Hungary 1516 Budapest, PO Box 245.
Publisher Akadémiai Kiadó
Springer Nature Switzerland AG
Publisher's
Address
H-1117 Budapest, Hungary 1516 Budapest, PO Box 245.
CH-6330 Cham, Switzerland Gewerbestrasse 11.
Responsible
Publisher
Chief Executive Officer, Akadémiai Kiadó
ISSN 1388-6150 (Print)
ISSN 1588-2926 (Online)