Polymorphism, its origin, its characteristics, its consequences in the pharmaceutical field;Le polymorphisme, son origine, ses caracteristiques ses consequences dans le domaine pharmaceutique

S.T.P. Pharma Pratiques

Volumn 9, Issue 5, 1999, Pages 354-362

  Bauer, M ^a  

^a SANOFI   (France)

Author keywords

Bioavailability; Burger rules; Desmotropy; Enantiotropy; Habitus; Monotropy; Polymorphism; Pseudopolymorphism; Regulatory aspects; Stability

Indexed keywords

DRUG;

CONFERENCE PAPER; CRYSTAL; DRUG BIOAVAILABILITY; DRUG CONFORMATION; DRUG FORMULATION; DRUG STABILITY; DRUG STRUCTURE; THERMODYNAMICS;

EID: 0032747953     PISSN: 11571497     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Conference Paper

References (28)

1. JACOB F. - La Logique du vivant. - Gallimard, Paris, 1970, p. 24.
2. GRUNENBERG A. - Polymorphie und Thermische Analyse Parmazeutischer Wirkstoffe. - Pharmazie in unserer Zeit. 26, 224-231, 1997
3. GIRON D. - Thermal analysis and calorimetric methods in the characterization of polymorphs and solvates. - Thermochim. Acta, 248, 1-59, 1995.
4. HALEBLIAN J., MCCRONE W. - Pharmaceutical applications of polymorphism. - J. Pharm. Sci., 58, 911-929, 1969.
5. BRANDSTÁTTER-KUHNERT M., AEPKERS M. - Moleküleverbindungen, Mischkristallbildung und neue Polymorphie fälle bei barbituraten. - Mikro Chim Acta, 6, 1040-1074, 1962.
6. HIGUCHI W. , LAU P., HIGUCHI T., SHELL J. - Polymorphism and drug availability, solubility in the methyl prednisolone system. - J. Pharm. Sci., 52, 150-153, 1963
7. THRELFALL T. - Analysis of organic polymorphs, a review. - Analyst, 120, 2453-2460, 1995.
8. GIRON D - Le polymorphisme. - Labo-Pharma., 307, 151-160, 1981.
9. MASSE J - Etude du polymorphisme et du pseudopolymorphisme à l'aide de méthodes thermo-analytiques. Rapport d'une commission SFSTP. - STP Pharma Prat., 7, 4, 235-246, 1997.
10. ROY R. - Classification of non-crystalline solids. - J of Non-Crystalline Solids, 3, 33-40, 1970.
11. BAUER M., HARRIS R., RAO R., APPERLEY D., RODGER C. - NMR study of desmotropy in Irbesartan, a tetrazole containing pharmaceutical compound. - J. Chem. Soc., Perkin Trans., 2, 475-481, 1998.
12. BERNSTEIN J. - Communication personnelle.
13. BYRN S., PFEIFFER R., GANEY M., HOIBERG C., POOCHIKIAN G. - Pharmaceutical solids: a strategic approach to regulatory considerations. - Pharm. Res., 12, 945-954, 1995.
14. VERWER P., LEUSEN J. - Computer simulation to predict possible crystal polymorphs. - Computational Chemistry, 12, 327-365, 1998.
15. HENCK J., KUHNERT-BRANDSTATTER M. - Demonstration of the terms enantiotropy and monotropy in polymorphism research exemplified by flurbiprofen. - J. Pharm. Sci., 88, 103-108, 1999.
16. BURGER A., RAMBERGER R. - On the polymorphism of pharmaceuticals and other molecular crystals I. Theory of thermodynamic rules - Mikrochim. Acta. I. 259-271, 1979
17. BENEDETTI G.P. - Analise del polimorfismo di un farmaco - Il Farmaco, 43, 71-99, 1998.
18. DUNITZ J.D , BERNSTEIN J. - Disappearing polymorphs - Acc. Chem. Res., 28, 193-200, 1995.
19. BRITTAIN H. - Spectral methods for the characterization of polymorphs and solvates. - J. Pharm. Sci., 86, 405-411, 1997.
20. CHAN H., DOELKER E - Polymorphism transformations of some drugs under compression. - Drug Dev. Ind. Pharm , 11, 315-332, 1985.
21. YORK P. - Solid-state properties of powders in formulation and processing of solid dosage forms. - Int. J. Pharm., 14, 1-28,1983.
22. BERNSTEIN J. - Polymorphism in drug design and delivery. - Prog. Clin. Biol. Res., 289, 203-215, 1989
23. GIRON D. - Influence de la qualité des matières premières sur la vitesse de dissolution et la biodisponibiliré. - STP Pharma Prat., 4, 330-340, 1988.
24. BYRN S.R - Solid-State Chemistry of Drugs. - Academic Press, New York, 1982, pp. 79-148.
25. ICH Q6A. - Specifications: Test procedures and acceptance criteria for new drugs substances and new drug products: chemical substances, July 1997. - Pharmeuropa, 9, 514-532, 1997.
26. BORKA L - Review on crystal polymorphism of substance in the European Pharmacopoeia, Part 1. - Pharmeuropa, 7, 574-585, 1995.
27. BAILLET A. - Communication personnelle.
28. LA COULONCHE F., CHAUVET A., MASSE J. - An investigation of flurbiprofen polymorphism by thermoanalytical and spectroscopic methods and a study of its interactions with poly-(ethylene glycol) 6000 by differential scanning calorimetry and modelling. - Int. J. Pharm., 153, 167-179, 1997