Using DOE to achieve reliable drug administration: A case study

Organic Process Research and Development

Volumn 8, Issue 5, 2004, Pages 802-807

  Sjövall, Sven ^a   Hansen, Lars ^a   Granquist, Bo ^a  

^a DUPONT COMPANY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ROQUINIMEX;

ARTICLE; DRUG BIOAVAILABILITY; DRUG CONFORMATION; DRUG DISTRIBUTION; DRUG DOSE REGIMEN; DRUG FORMULATION; DRUG INDUSTRY; DRUG MANUFACTURE; DRUG SOLUBILITY; EXPERIMENTAL DESIGN; PARTICLE SIZE; TEMPERATURE DEPENDENCE;

EID: 5144234472     PISSN: 10836160     EISSN: None     Source Type: Journal    
DOI: 10.1021/op049904l     Document Type: Article

References (12)

1. (a) Brittain, H. G. Polymorphism in Pharmaceutical Solids; Marcel Dekker: New York, 1999.
2. (b) Anderson N. G. Practical Process Research & Development; Academic Press: New York, 2000.
3. Sandell, E. Industrial Aspects of Pharmaceutics; Swedish Pharmaceutical Press: Stockholm, 1993.
4. Carlson, R. Design and Optimization in Organic Synthesis; Elsevier: Amsterdam, 1992.
5. Later, it was realized that the FDA would not accept a limit higher than 100 ppm for the N-methyl aniline content. Consequently, future production would have to take this 10-fold decrease of N-methyl aniline into account.
6. United States Pharmacopeia, paddle method. Rotation speed: 100 rpm. Volume: 500 mL. Medium: 0.1 M HCl. Sample: 2.5, 5, or 10 mg Roquinimex tablet. Temp: 37°C.
7. United States Pharmacopeia, paddle method. Rotation speed: 50 rpm. Volume: 900 mL. Medium: 0.005 M Phosphate buffer pH 6.8 with 0.01% Brij 35. Sample: ca. 100 mg Roquinimex. Temp: 377°C.
8. a; Pharmacia Document 21554F: Helsingborg, 1994.
9. Hansen, B.; Wadsten, T. Roquinimex, Some Solid State Properties and Possible Polymorphism; Pharmacia Document 21541F: Helsingborg, 1994.
10. Hansen, B.; Ranklev, H. Roquinimex, Particle Size Measurements; Pharmacia Document 9520027: Helsingborg, 1995.
11. j.
12. Modde 7.0, Umemetri AB, Umeå, Sweden.