Drug – bio-affecting and body treating compositions – Designated organic nonactive ingredient containing other... – Peptide containing
Reexamination Certificate
2006-10-10
2006-10-10
Carlson, Karen Cochrane (Department: 1653)
Drug, bio-affecting and body treating compositions
Designated organic nonactive ingredient containing other...
Peptide containing
C514S772000, C514S773000, C514S449000, C514S510000, C514S731000, C514S283000, C514S028000
Reexamination Certificate
active
07119124
ABSTRACT:
The invention is related to water-soluble products and pharmaceutical formulations in solid or liquid form mainly for parenteral use. They consist of or comprise a therapeutically active substance (having low aqueous solubility and a substantial binding affinity to plasma proteins) and a plasma protein fraction in controlled aggregation state, whereby the said active substance and the said protein fraction are bound to each other by way of non-covalent bonds. It also covers processes for the preparation of the product and pharmaceutical formulation by dissolving the water-insoluble active substance in a water-miscible, pharmaceutically acceptable solvent, combining said solution with the aqueous solution of a plasma protein fraction in controlled aggregation state whereby a true solution is obtained containing the said active substance and the said protein fraction bound together by way of non-covalent bonds. Optionally a further pharmaceutically acceptable auxiliary additive—such as a protein aggregation controller and/or a stabilizer—may be present. The organic solvent is eliminated by dialysing, ultrafiltrating, diafiltrating and/or lyophilising. The solid products consisting of the active substance and the protein are also protected. On optional dissolution in water clear, liquid compositions are obtained suitable for direct parenteral or other administration. Method of treatment is also covered. A series of water-insoluble substances is enlisted with appropriate protein fractions to be used.
REFERENCES:
patent: 4842856 (1989-06-01), Hoederath et al.
patent: 5560933 (1996-10-01), Soon-Shiong et al.
patent: 5621001 (1997-04-01), Canetta et al.
patent: 5665761 (1997-09-01), Canetta et al.
patent: 5670537 (1997-09-01), Canetta et al.
patent: 5916596 (1999-06-01), Desai et al.
patent: 37 02 105 (1988-08-01), None
patent: 0326 618 (1989-08-01), None
patent: 198381 (1987-01-01), None
patent: 58-216126 (1983-12-01), None
patent: WO 98/13173 (1998-04-01), None
patent: WO 98/14174 (1998-04-01), None
patent: WO 98/28011 (1998-07-01), None
Carter, Daniel C., et al., “Three-Dimensional Structure of Human Serum Albumin,” Science, vol. 244, p. 1195-1198, 1989.
Bridonneau, P., et al., “Liquid Pasteurization of an Immunoglobulin Preparation without Stabilizer: Effects on its Biological and Biochemical Properties,” vox Sang 1996; 70:203-209.
Paal, Krisztina et al., “High Affinity Binding of Paclitaxel to Human Serum Albumin,” Eur. J. Biochem., 268 2187-2191 (2001).
“Guidance for Industry, Extended Release Oral Dosage Forms: Development, Evaluation, and Application of In Vitro/In Vivo Correlations”,U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research(CDER) (Sep. 1997), 1-24.
Aarset et al., “A nurse with a rash on her neck”, Ansquer et al., “Survival in early-onset BRCA1 breast-cancer patients”, Shimomura et al., “Effects of Taxol on blood cells”, Ashok et al., “Termination of pregnancy at 9-13 weeks amenorrhoea with mifepristone and misoprostol”, The Lancet (Aug. 15, 1998), 352(9127):540-542.
Bejinen et al., “Bioanalysis, Pharmacokinetics, and Pharmacodynamics of the Novel Anticancer Drug Paclitaxel (Taxol)”,Seminars in Oncology(Oct. 1994), 21(5):53-62.
Eiseman et al., “Plasma pharmacokinetics and tissue distribution of paclitaxel in DC2F1mice”,Cancer Chemotherapy and Pharmacology(1994), 34: 465-471.
Guitton et al., “Quantitation of propofol in whole blood by gas chromatography-mass sepctrometry”,Journal of Chromatography B: Biomedical Applications(Jul. 21, 1995), 669:358-365.
Hallbach et al., “Determination of Lamotrigine, Carbamazepine and Carbamazepine Epoxide in Human Serum by Gas Chromatography Mass Sepctrometry”,European Journal of Clinical Chemistry and Clinical Biochemistry(Oct. 1997), 35(10):755-759.
Johansen et al., “Automated analysis of free and total concentrations of three antiepileptic drugs in plasma with on-line dialysis and high-performance liquid chromatography”,Journal of Chromatography B: Biomedical Applications(Jul. 21, 1995) 669: 281-288.
Olah et al., “Molecular Mechanisms in the Antiproliferative Action ofTaxol and Tiazofurin”,Anticancer Research—International Journal of Cancer Research and Treatment(Sep.-Oct. 1996), 16:2469-2477.
Pavan et al., “Monitoring Propofol Serum Levels by Rapid and Sensitive Reversed-Phase High-Performance Liquid Chromatography During Prolonged Sedation in ICU Patients”,Chromatographic Science(May 1992), 30(5):164-166.
Puls et al., “MicroTICAS—The Design of an Inexpensive Video-Based Microphotometer / Computer System for DNA Ploidy Studies”,Analytical and Quantitative Cytology Histology(1986), 8(1):1-7.
Rivory et al., “Identification and Properties of a Major Plasma Metabolite of Irinotecan (CPT-II) Isolated from the Plasma of Patients”,Cancer Research(Aug. 15, 1996), 56:3689-3694.
Rowinsky et al., “Taxol: A Novel Investigational Antimicrotubule Agent”,Journal of the National Cancer Institute(Aug. 1990), 82(15):1247-1259.
Royer et al., “Paclitaxel Metabolites in Human Plasma and Urine: Identifcation of 6α-Hydroxytaxol, 7-Epitaxol and Taxol Hydrolysis Products Using Liquid Chromatography/Atmospheric-pressure Chemical Ionization Mass Sepctrometry”,Rapid Communications in Mass Spectrometry(1995), 9:495-502.
Schäfer-Korting et al., “Influence of Serum Protein Binding on theIn VitroActivity of Antifugnal Agents”,Infection(1995), 23(5):292-297.
Sottani et al., “Structural Characterization of Mono-and Dihydroxylated Metabolites of Paclitaxel in Rat Bile Using Liquid Chromatography / Ion Spray Tandem Mass Spectrometry”,Rapid Communications in Mass Spectrometry(1997), 11:1025-1032.
Thomas et al., “15-Deoxyspergualin: A Novel Immunosuppressive Drug with Clinical Potential”,Annals of the New York Academy of Sciences(1993) 685:175-192.
Patent Abstracts of Japan, Inaba Mitsuhara, JP58-216126, Dec. 15, 1983.
Hegedus Lajos
Krempels Krisztina
Paal Krisztina
Petho Gabor
Carlson Karen Cochrane
Human Rt.
Kenyon & Kenyon LLP
Tsay Marsha
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