Method for dissolution testing of pharmaceutical products

Chemistry: analytical and immunological testing – Involving immune complex formed in liquid phase

Reexamination Certificate

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C436S008000

Reexamination Certificate

active

07968351

ABSTRACT:
The present invention relates to the field of dissolution measurement and, more particularly to methods for reproducible dissolution testing of pharmaceutical products such as allergen vaccines.

REFERENCES:
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patent: 6132759 (2000-10-01), Schacht et al.
patent: WO-2004047794 (2004-06-01), None
patent: WO-2004051263 (2004-06-01), None
patent: WO-2004079338 (2004-09-01), None
patent: WO-2005/114214 (2005-12-01), None
Bayomi et al. Pharmaceutica Acta Helvetiae 1998 vol. 73, p. 187-192.
Heya et al. (J. Pharmaceutical Sciences 1994 vol. 83, p. 636-640).
Blanco-Prieto M J et al., “Importance of the test medium for the release kinetics of a somatostatin analogue from poly(D,L-lactide-co-glycolide) microspheres.” International Journal of Pharmaceutics (1999), vol. 184, No. 2, pp. 243-250.
European Pharmacopeia 5.0, 2.9.3. Dissolution Test for Solid Dosage Forms, pp. 228-230 (2005).
US Pharmacopeia, (711) Dissolution/Physical Tests, pp. 2412-2414 (2005).
Guidance for Industry, Dissolution Test of Immediate Release Solid Oral Dosage Forms, U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Aug. 1997.
Tacha et al., “Casein Reduces Nonspecific Background Staining in Immunolabeling Techniques”, The Journal of Histotechnology; vol. 15, No. 2; (1992).

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