Multiple approaches to pharmaceutical polymorphism investigation-A case study

European Journal of Pharmaceutical Sciences

Volumn 38, Issue 5, 2009, Pages 426-432

  Li, Haitao ^a   Kiang, Y H ^a   Jona, Janan ^a  

^a AMGEN INC   (United States)

Author keywords

Enantiotropy; Monotropy; Polymorphism

Indexed keywords

ANTIASTHMATIC AGENT; TETRAHYDROFURAN DERIVATIVE;

ARTICLE; CONTROLLED STUDY; CRYSTALLIZATION; DRUG SCREENING; DRUG SOLUBILITY; DRUG STRUCTURE; MELTING POINT; PHYSICAL CHEMISTRY; PRIORITY JOURNAL; THERMAL ANALYSIS; THERMOSTABILITY; TRANSITION TEMPERATURE; X RAY DIFFRACTION;

ACETATES; CALORIMETRY, DIFFERENTIAL SCANNING; CHEMISTRY, PHARMACEUTICAL; CRYSTALLIZATION; FURANS; HUMANS; PHARMACEUTICAL PREPARATIONS; POWDERS; THERMODYNAMICS; X-RAY DIFFRACTION;

EID: 70449525227     PISSN: 09280987     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.ejps.2009.09.003     Document Type: Article

References (15)

1. Brittain H., and Grant D. Effects of polymorphism and solid-state solvation on solubility and dissolution rate. In: Brittain H. (Ed). Polymorphism in Pharmaceutical Solids (1999), Marcel Dekker, Inc., New York, NY, United States
2. Burger A., and Lettenbibichler A. Polymorphism and preformulation of Lifibrol. Eur. J. Pharm. Biopharm. 49 (2000) 65-72
3. Burger A., and Ramberger R. On the polymorphism of pharmaceuticals and other molecular crystals. I. Theory of thermodynamic rules. Mikrochim. Acta [Wien] II (1979) 259-271
4. FDA. Guideline for Submitting Supporting Documentation in Drug Applications for the Manufacture of Drug Substances (1987), Food and Drug Administration, Silver Spring, MD, United States
5. Grant D. Theory and origin of polymorphism. In: Brittain H. (Ed). Polymorphism in Pharmaceutical Solids (1999), Marcel Dekker, Inc., New York, NY, United States
6. Grant D., Mehdizadeh M., Chow A., and Fairbrother J. Non-linear van't Hoff solubility-temperature plots and their pharmaceutical interpretation. Int. J. Pharm. 18 (1984) 25-38
7. Haleblien J., and McCrone W. Pharmaceutical applications of polymorphism. J. Pharm. Sci. 58 (1969) 911-929
8. 2 selectively induces chemotaxis in T helper type 2 cells, eosinophils, and basophils via seven-transmembrane receptor CRTH 2. J. Exp. Med. 193 (2001) 255-261
9. Holgate S.T., Djukanovic R., Wilson J., Roche W., Britten K., and Howarth P.H. Allergic inflammation and its pharmacology modulation in asthma. Int. Arch. Allergy Appl. Immunol. 94 (1991) 210-217
10. Holgate S.T., Burns G.B., Robinson C., and Church M.K. Anaphylactic- and calcium-dependent generation of prostaglandin D2 (PGD2), thromboxane B2, and other cyclooxygenase products of arachidonic acid by dispersed human lung cells and relationship to histamine release. J. Immunol. 133 (1984) 2138-2144
11. ICH Harmonised Tripartite Guideline. Specifications: test procedures and acceptance criteria for new drug substances and new drug products: chemical substances. Q6A. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. Geneva, Switzerland (1999)
12. Narumiya S., Sugimoto Y., and Ushikubi F. Prostanoid receptors: structures, properties, and functions. Physiol. Rev. 79 (1999) 1193-1226
13. Noyes A., and Whitney W.R. The rate of solution of solid substances in their own solutions. J. Am. Chem. Soc. 19 (1897) 930-934
14. Singh D., Marshal P., Shields L., and York P. Solid state characterization of chlordiazepoxide polymorphs. J. Pharm. Sci. 87 (1998) 655-662
15. Yu L. Inferring thermodynamic stability relationship of polymorphs from melting data. J. Pharm. Sci. 84 (1995) 966-974