Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Carbohydrate doai
Reexamination Certificate
2006-02-28
2006-02-28
Peselev, Elli (Department: 1623)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Carbohydrate doai
C536S006400
Reexamination Certificate
active
07005421
ABSTRACT:
According to the invention there is provided a sterile, pyrogen-free, ready-to-use solution of an anthracycline glycoside, especially doxorubicin, which consists essentially of a physiologically acceptable salt of an anthracycline glycoside dissolved in a physiologically acceptable solvent therefor, which has not been reconstituted from a lyophilizate and which has a pH of from 2.5 to 6.5. The solution of the invention is particularly advantageous for the administration by injection of the anthracycline glycoside drugs. e.g. doxorubicin, in the treatment of both human and animal tumors.
REFERENCES:
patent: 3686163 (1972-08-01), Arcamone et al.
patent: 4035566 (1977-07-01), Israel et al.
patent: 4039633 (1977-08-01), Zelinski
patent: 4039663 (1977-08-01), Arcamone et al.
patent: 4039736 (1977-08-01), Nettleton, Jr. et al.
patent: 4109076 (1978-08-01), Henry et al.
patent: 4296105 (1981-10-01), Baurain et al.
patent: 4327087 (1982-04-01), Rosenkrantz et al.
patent: 4537593 (1985-08-01), Alchas
patent: 4564054 (1986-01-01), Gustavsson
patent: 4576211 (1986-03-01), Valentini et al.
patent: 4588403 (1986-05-01), Weiss et al.
patent: 4786281 (1988-11-01), Valentini et al.
patent: 1005760 (1977-02-01), None
patent: 1041488 (1978-10-01), None
patent: 1046507 (1979-01-01), None
patent: 1046508 (1979-01-01), None
patent: 1204738 (1980-05-01), None
patent: 1129344 (1982-08-01), None
patent: 1203482 (1986-04-01), None
patent: 2014244 (1990-10-01), None
patent: 401 896 (1990-12-01), None
patent: 2405957 (1979-05-01), None
patent: 2178311 (1987-02-01), None
patent: 985598 (1995-03-01), None
patent: 8602743 (1987-03-01), None
Kano et al.Electrochemical Properties of Adriamycin Adsorbed on a Mercury Electrode Surface, The Chemical Society of Japan, Bull. Chem. Soc. Jpn., 57, 2383-2390 (1984).
Kano et al.,The Effects of the pH and the Temperature on the Oxidation-reduction Properties of Adrimycin Adsorbed on a Mercury Electrode Surface, The Chemical Society of Japan, Bull. Chem. Soc. Jpn., 58, 424-428 (1985).
Beijnen et al. (1985), “Stability of Anthracycline Antitumor Agents in Infusion Fluids,”J. Parenteral Science and Technology, vol. 39, pp. 220-222.
Beijnen et al. (1986), “Aspects of Degradation Kinetics of Daunorubicin in Aqueous Solution,”International J. Pharmaceutics, vol. 31, pp. 75-82.
Beijnen et al. (1986), “Aspects of the Degradation Kinetics of Doxorubicin in Aqueous Solution,”International J. of Pharmaceutics, vol. 32, pp. 123-131.
Bosanquet, A.G. (1986), “Stability of Solutions of Antineoplastic Agents During Preparation and Storage for in Vitro Assays,”Cancer Chemother, Pharmacol., vol. 17, pp. 1-10.
Daugherty et al. (1981), “Photolytic Destruction of Adriamycin,”J. Pharm. Pharmacol., vol. 33, p. 556.
Dorr and Fritz (1980), “Doxorubicin,”Cancer Chemotherapy Handbook, Elsevier, New York, pp. 388-401.
Eksborg and Ehrsson (1984), “Liquid Chromatography in Anticancer Drug Research with Special Reference to Anthraquinone Glycosides,”J. Pharmaceutical&Biomedical Analysis, vol. 2, pp. 297-303.
Eksborg, S. (1978), “Extraction of Daunorubicin and Doxorubicin and their Hydroxyl Metabolities: Self-Association in Aqueous Solution,”J. Pharmaceutical Sciences, vol. 67, pp. 782-785.
Flora et al. (1980), “The Loss of Paraben Preservatives During Freeze Drying,”J. Pharm. Pharmacol., vol. 32, pp. 577-578.
Florence and Atwood (1981), “Physicochemial Principles of Pharmacy,” MacMillan Press, London, p. 475.
Garnick et al. (1983), “Clinical Evaluation of Long-Term, Continuous-Infusion Doxorubicin,”Cancer Treatment Reports, vol. 67, pp. 133-142.
Henry, D.W. (1976), “Adriamycin,”Cancer Chemotherapy, American Chemical Society Symposium Series, pp. 15-57.
Hoffman et al. (1979) “Stability of Refrigerated and Frozen Solutions of Doxorubicin Hydrochloride,”Am. J. Hosp. Pharm., vol. 36, 1536-1538.
Janssen et al. (1985), “Doxorubicin Decomposition on Storage. Effect of pH, Type of Buffer and liposome Encapsulation,”International J. Pharmaceutics, vol. 23, pp. 1-11.
Jonkman-de Vries et al. (1994), “Pharmaceutical Development of a Parenteral Lyophilized Formulation of the Novel Indoloquinone Antitumor Agent EO9,”Cancer Chemother. Pharmacol., 34, pp. 416-422.
Kaniewska, T. (1978), “Study of the Decomposition of Adrimycin,”Chemical Abstracts, vol. 88, No. 197526x, p. 396.
Kaniewska, T. (1977), “A Study of Decomposition of Adriamycin,”Pharmacia Polska, vol. 9, 539-542 (English translation attachced).
Ketchum et al. (1981), “Cost Benefit and Stability Study of Doxorubicin Following Reconstitution,”Am. J. Intravenous Therapy&Clinical Nutrition, vol. 8, pp. 15-18.
Kristensen and Moller (1983), “Alman Farmaci II,”Dansk Farmaceutiforeings Forlag Kobenhavn, pp. 408, 442, 447 (English translation attached).
Martindale (1982), “Doxorubicin Hydrochloride,” The Extra Pharmacopeia,Antineoplastic Agents and Immunosuppressants, 28thEdition, The Pharmaceutical Press, London, J.E.F. Reynolds, Ed., pp. 205-208.
Masuike et al. (1984), “Determination of Adriamycin and its Metabolities in Biological Samples Using High Performance Liquid Chromotography. I. Analysis of Serum and Plasma by Direct Injection Method,”Yakugaku Zasshi, vol. 104, 614-619 (English abstract).
Masuike et al. (1984), “Determination of Adriamycin and its Metabolities in Biological Samples Using High Performance Liquid Chromatography. II. Analysis of Tissues by Extraction Method,”Yakugaku Zasshi, vol. 104, 620-623 (English abstract).
Menozzi et al. (1984), “Self-Association of Doxorubicin and Related Compounds in Aqueous Solution,”J. Pharmaceutical Sciences, vol. 73, pp. 766-770.
Poochikian et al. (1981), “Stability of Anthracycline Antitumor Agents in Four Infusion Fluids,”Am. J. Hospital Pharmacy, vol. 38, pp. 483-486.
Savlov et al. (1981), “Comparision of Doxoorubicin with Cycloleucine in the Treatment of Sarcomas,”Cancer Treatment Reports, vol. 65, pp. 21-27.
Trissell (1980), “Doxorubicin HCI,”Handbook of Injectable Drugs, 3rdEdition. (American Society of Hospital Pharmacists, Bethesda, MD), pp. 131-132.
Vigevani and Williams (1980), “Doxorubicin,” in Analytical Profiles of Drug Substances, Academic Press, New York, vol. 9, pp. 245-263.
Vigevani and Williamson (1980), “Doxorubicin,” In Analytical Profiles of Drug Substances, Academic Press, New York, vol. 9, pp. 246-274.
Williamson et al. (1983), “Doxorubicin Hydrochloride-Aluminum Interaction,”Am. J. Hospital Pharmacy, vol. 40, p. 214.
Yu-Chang et al. (1980), “Review of Excipients and pH's for Parenteral Products Usedin the United States,”J. Parenteral Drug Assoc., vol. 14, pp. 452-462.
Chemistry Industry, “Union Warms of Cancer Drug Dangers,” Issue Jul. 4, 1983, p. 488.
Drug Topics, “Cancer Drug Danger,” Feb. 7, 1983, p. 99.
Gutteridge and Wilkins (1983), “Doxorubicin Degradation: Changes in Activity Compared by Bacterial Growth Inhibitation and Free Radical-Dependent Damage to Deoxyribose,”J. Biological Standardization, vol. 11, pp. 359-364.
Akbiyik et al. (1979), “Total Lung Irradiation and Chemotherapy in Pulmonary Metastases from Carcinoma of the Uterine Cervix and Endometrium,”J. Nat'l Medical Assn., vol. 71, pp. 1061-1063.
The Pharmaceutical Codex, (1979), “Injections,” The Pharmaceutical Press, London, 11thEdition, pp. 446-447.
Swinyard, E.A. (1980), “Introduction of New Drugs,”Pharmaceutical Sciences, Mack Publishing Co., Easton, Pennsylvania, pp. 1365-1376.
The Merck Index (1983), “Doxorubicin,”10thEdition, Entry 3435, p. 3436.
Nikula et al. (1984), “Chromosome Aberrations in Lymphocytes of Nurses Handling Cytostatic Agents,”Scand. J. Work Environ. Health, vol. 10
Bottoni Giuseppe
Confalonieri Carlo
De Ponti Roberto
Gambini Luciano
Gatti Gaetano
McDonnell Boehnen & Hulbert & Berghoff LLP
Peselev Elli
Pharmacia & Upjohn Company
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