Pharmaceutical formulations comprising paclitaxel,...

Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Having -c- – wherein x is chalcogen – bonded directly to...

Reexamination Certificate

Rate now

  [ 0.00 ] – not rated yet Voters 0   Comments 0

Details

Reexamination Certificate

active

06919370

ABSTRACT:
The invention concerns paclitaxel solubilizers and formulations thereof with a high propensity to dissolve paclitaxel. The formulations of the invention reduce or obviate the need for the disadvantageous excipient Cremophor® EL. The formulations of the invention are useful for administering paclitaxel, its derivatives, or pharmaceutically acceptable salts or such derivatives to patients in need thereof. The formulations of the invention are suitable for parenteral, oral, local, or transdermal administration to mammals including humans, particularly for intravenous delivery.

REFERENCES:
patent: 3070499 (1962-12-01), Mullins et al.
patent: 3220923 (1965-11-01), Scholtan
patent: 3824263 (1974-07-01), Umbach
patent: 3864370 (1975-02-01), Yamashita et al.
patent: 4366151 (1982-12-01), Oppenlaender et al.
patent: 4572915 (1986-02-01), Crooks
patent: 4814470 (1989-03-01), Colin et al.
patent: 4942184 (1990-07-01), Haugwitz et al.
patent: 4960790 (1990-10-01), Stella et al.
patent: 5156842 (1992-10-01), Mulligan
patent: 5157049 (1992-10-01), Haugwitz et al.
patent: 5254580 (1993-10-01), Chen et al.
patent: 5281727 (1994-01-01), Carver et al.
patent: 5364631 (1994-11-01), Janoff et al.
patent: 5387579 (1995-02-01), Meybeck et al.
patent: 5391385 (1995-02-01), Seybold
patent: 5403858 (1995-04-01), Bastard et al.
patent: 5438072 (1995-08-01), Bobee et al.
patent: 5504102 (1996-04-01), Agharkar et al.
patent: 5656618 (1997-08-01), Meybeck et al.
patent: 5681846 (1997-10-01), Trissel
patent: 5698582 (1997-12-01), Bastart et al.
patent: 5733888 (1998-03-01), Carver et al.
patent: 5877205 (1999-03-01), Andersson
patent: 5897876 (1999-04-01), Rudnic et al.
patent: 5925776 (1999-07-01), Nikolayev et al.
patent: 5952001 (1999-09-01), Meybeck et al.
patent: 5965603 (1999-10-01), Johnson et al.
patent: 5972992 (1999-10-01), Carver et al.
patent: 5977164 (1999-11-01), Carver et al.
patent: 6136846 (2000-10-01), Rubinfeld et al.
patent: 6140359 (2000-10-01), Carver et al.
patent: 6248363 (2001-06-01), Patel et al.
patent: 6267985 (2001-07-01), Chen et al.
patent: 6306894 (2001-10-01), Carver et al.
patent: 6660286 (2003-12-01), Lambert et al.
patent: 2001/0029264 (2001-10-01), McChesney-Harris
patent: 667142 (1994-06-01), None
patent: 694 178 (1940-06-01), None
patent: 1 235 452 (1971-06-01), None
patent: 1 440 275 (1976-06-01), None
patent: 0 295 941 (1988-12-01), None
patent: 0 428 376 (1991-05-01), None
patent: 0 505 047 (1992-09-01), None
patent: 0 522 936 (1993-01-01), None
patent: 0 522 937 (1993-01-01), None
patent: 0 674 510 (1994-06-01), None
patent: 90/08537 (1990-08-01), None
patent: 90/10443 (1990-09-01), None
patent: 94/12198 (1994-06-01), None
patent: 97 30695 (1997-08-01), None
patent: WO98/30205 (1998-07-01), None
patent: 99 45918 (1999-09-01), None
patent: WO 9945918 (1999-09-01), None
patent: 99 49848 (1999-10-01), None
patent: 00 03753 (2000-01-01), None
patent: 00 40238 (2000-07-01), None
patent: WO00/71163 (2000-11-01), None
patent: 00 71163 (2000-11-01), None
patent: 01 01960 (2001-01-01), None
patent: WO01/22937 (2001-04-01), None
patent: 01 30448 (2001-05-01), None
patent: 02 43765 (2002-06-01), None
Chen et al., “A High-Throughput Combinatorial Approach for the Discovery of a Cremophor EL-Free Paclitaxel Formulation”, Pharmaceutical Research, vol. 20, No. *, Aug. 2003.
Trissel, Lawrence A., “Handbook on Injectable Drugs”, American Society of Hospital Pharmacists, Inc. 1988.
Wauch, Wanda A., “Stability, Compatibility, and Plasticizer Extraction of (NSC-125973) Injection Diluted in Infusion Solutions and Stored in Various Containers”, AJHP, vol. 48, Jul. 1991.
“Cremophor EL” Technical Leaflet, BASF Ludwigshafen, Germany, (no date available).
“Polyoxyl 35 Castor Oil”, “Polyoxyl 40 Hydrogenated Castor Oil”, The United States Pharmacopeia, United States Pharmacopeial Convention, Inc., Rockville, MD, Jan. 1, 1995.
Taxol Specification Sheet, Physicians Desk Reference, 1994.
Taxol Specification Sheet, Physicians Desk Reference, 1995.
Taxol Specification Sheet, Physicians Desk Reference, 1996.
Taxol Specification Sheet, Physicians Desk Reference, 1997.
Taxol Specification Sheet, Physicians Desk Reference, 1998.
Taxol Specification Sheet, Physicians Desk Reference, 2000.
Castor Oil Specification Sheet, The United States Pharmacopeia, United States Pharmacopeial Convention, Inc., Rockville, MD, Jan. 1, 2000.
Castor Oil, Merck Index, 12thEdition, pp. 311-312, (1999).
Kibbe, Arthur, “Polyoxethylene Castor Oil Derivatives”, Handbook of Pharmaceutical Excipients, Pennsylvania, pp. 412-415, (no date available).
Magri, Neal F., “Modified Taxols. Oxidation Products of Taxol”, Department of Chemistry, VA Polytechnic Institute and State University, VA, Sep. 26, 1985, pp. 797-802.
Mathew, Abraham E., “Synthesis and Evaluation of Some Water-Soluble Prodrugs and Derivatives of Taxol with Antitumor Activity”, Departments of Pharmaceutical Chemistry and Biochemistry, University of Kansas, Jan. 11, 1991.
Ringel, Israel, “Taxol is Converted to 7-Epitaxol, a Biologically Active Isomer, in Cell Culture Medium”, Department of Molecular Pharmacology and Cell Biology, Albert Einstein College of Medicine, NY, Apr. 13, 1987.
Richheimer, Steven L. et al., “High Performance Liquid Chromatographic Assay of Taxol” Analytical Chemistry, vol. 64, No. 20, Oct. 15, 1992.
Rowinsky, Eric K., “Taxol: A Novel Investigational Antimicrotubule Agent”, Journal of the National Cancer Institute, vol. 82, No. 15, Aug. 1, 1990.
Tarr, Bryan D. et al., “A New Parenteral Vehicle for the Administration of Some Poorly Water Soluble Anti-Cancer Drugs”, Journal of Parenteral Science and Technology, vol. 41, No. 1, Jan-Feb. 1987.
Drori, Stavit et al., “Potentiation of Anticancer Cytotoxicity by Multidrug-Resistance Chemosensitizers Involves Alterations in Membrane Fluidity Leading to Increased Membrane Permeability”, European Journal of Biochemistry, 228, pp. 1020-1029, (no date available).
Dordunoo, Stephen K. et al., “Solubility and Stability of Taxol: Effects of Buffers and Cyclodextrins”, International Journal of Pharmaceutics, 133, (1996) pp. 191-201.
Longnecker, Stephen M. et al., “High-Performance Liquid Chromatographic Assay for Taxol in Human Plasma and Urine and Pharmacokinetics in Phase I Trial”, Cancer Treatment Reports, vol. 71, No. 1, Jan. 1987.
Legha, Sewa S., “Phase I Study of Taxol Using a 5-Day Intermittent Schedule”, Journal of Clinical Oncology, vol. 4, No. 5, 1986, pp. 762-766.
Kingston, David G. I. Et al., “Synthesis and Structure-Activity Relationships of Taxol Derivatives as Anticancer Agents”, New Trends in Natural Products Chemistry 1986, Studies in Organic Chemistry, vol. 26.
Kingston, David G. I., “The Chemistry of Taxol”, Pharmaceutical Ther. vol. 52, pp. 1-34, 1991.
Kagel, J.R., et al., Taxol Stability in Aqueous Solutions or In Organic/Aqueous Cosolvents, Department of Pharmaceutical Chemistry, University of Kansas, APQ 1232., (no date available).

LandOfFree

Say what you really think

Search LandOfFree.com for the USA inventors and patents. Rate them and share your experience with other people.

Rating

Pharmaceutical formulations comprising paclitaxel,... does not yet have a rating. At this time, there are no reviews or comments for this patent.

If you have personal experience with Pharmaceutical formulations comprising paclitaxel,..., we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Pharmaceutical formulations comprising paclitaxel,... will most certainly appreciate the feedback.

Rate now

     

Profile ID: LFUS-PAI-O-3372795

  Search
All data on this website is collected from public sources. Our data reflects the most accurate information available at the time of publication.