Parenteral paclitaxel in a stable non-toxic formulation

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

Patent

Rate now

  [ 0.00 ] – not rated yet Voters 0   Comments 0

Details

549510, A61K 31337, A61P 3300

Patent

active

061073334

ABSTRACT:
Disclosed is a stable and effective formulation of a taxane analog, preferably paclitaxel. The formulation comprises a dimethylacetamide and polyethylene glycol solution of the drug that is diluted into an aqueous lipid emulsion prior to use. The formulation is effective as a parenterel drug against taxane sensitive tumors.

REFERENCES:
patent: 5430057 (1995-07-01), Andersson et al.
patent: 5597820 (1997-01-01), Hausheer
Andersson et al., "KBM-7, A Human Myeloid Leukemia Cell Line with Double Philadelphia Chromosomes Lacking Normal c-ABL and BCR Transcripts," Leukemia, 9:2100-2108, 1995.
Andersson et al., "Nucleotide Excision Repair Genes as Determinants of Cellular Sensitivity to Cyclophosphamide Analogs," Cancer Chemother Pharmacol, 38:406-416, 1996.
Andersson et al., "The Role of DNA Damage in the Resistance of Human Chronic Myeloid Leukemia Cells to Cyclophosphamide Analogues," Cancer Research, 54:5394-5400, 1994.
Andersson et al., "Ph-Positive Chronic Myeloid Leukemia with Near-Haploid conversion In Vivo and Establishment of a Continuously Growing Cell Line wit Similar Cytogenetic Patter," Cancer Genet Cytogenet, 24:335-343, 1987.
Brown et al., "A Phase Trial of Taxol Given by a 6-Hour Intravenous Infusion," J Clincal Oncology, 9(7):1261-1267, 1991.
Chevallier et al., "Docetaxel is a Major Cytotoxic Drug for the Treatment of Advanced Breast Cancer: A Phase II Trial of the Clincal Screening Cooperative Group of the European Organization for Research and Treatment of Cancer," J Clinical Oncology, 13(2):314-322, 1995.
Eiseman et al., "Plasma Pharmacokinetics and Tissue Distribution of Paclitaxel in CD.sub.2 F.sub.1 Mice," Cancer Chemother Pharmacol, 34:465-471, 1994.
Fornter et al., "Fat Emulsion Vehicle for Intravenous Adminstration of an Aqueous Insoluble Drug," Amer J Hospital Pharm, 32:582-584, 1975.
Gallagher et al., "Characterization of the Continuous, Differentiating Myeloid Cell Line (HL-690) from a Patient with acute Promyelocytic Leukemia," Blood, 54(3):713-733, 1979.
Hansen et al., "Re-Examination and Further Development of a Precise and Rapid Dye Method for Measuring Cell Growth/Cell Kill," J Immunological Methods, 119:203-210, 1989.
Holmes et al., "Phase II Trial of Taxol, an Active Drug in the Treatment of Metastic Breast Cancer," J National Cancer Institute, 83(24):1797-1805, 1991.
Keating et al., "L-Asparaginase and PEG Asparaginase-Past, Present and Future," Leukemia and Lymphoma, 10:153-157, 1993.
Kim, "Preclinical Toxicology and Pharmacology of Dimethylacetamide, with Clincal Notes," Drug Metabolism Reviews, 19(3&4):345-368, 1988.
Lockard et al., "Efficacy and Toxicity of the Solvent Polyethylene Glycol 400 in Monkey Model," Epilepsia, 20:77-84, 1979.
Mann and Whitney, "On a Test of Whether One of Two Random Variables is Stochastically Larger than the Other," Ann Math Statist, 18(1):50-60, 1947.
Nicoletti et al., "Antitumor Activity of Taxol (NSC-125973) in Human Ovarian Carcinomas Growing in the Peritoneal Cavity of Nude Mice," Annals of Oncology, 4:151-155, 1993.
Parthasarathy et al., "Interaction of Lipsome-Associated All-Trans-Retinoic Acid with Squamous Carcinoma Cells," Cancer Chemother Pharmacol, 34:527-534, 1994.
Rizzo et al., "Analysis of Anticancer Drugs in Biological Fluids: Determination of Taxol with Application to Clinical Pharmacolkinetics," J Pharmaceut Biomed Anal, 8(2):159-164, 1990.
Rose, "Taxol-Based Combinational Chemotheraphy and Other In Vivo Preclincal Antitumor Studies," J National Cancer Institute, 15:47-53, 1993.
Rowinsky et al., "Taxol: A Novel Investigational Antimicrotubule Agent," J National Cancer Institute, 82(15):1247-1259, 1990.
Rowinsky et al., "The Current Status of Taxol," In: Principles and Practice of Gynecolgic Oncology Updates, Hoskins et al. (Eds.), 1(1):1-16, 1993.
Seidman et al., "Paclitaxel as Second and Subsequent Therapy for Metastatic Breast Cancer: Activity Independent of Prior Anthracycline Response," J Clinical Oncology, 13(5):1152-1159, 1995.
Sharma et al., "Reversed-Phase High-Performance Liquid Chromatographic Determination of Taxol in Mouse Plasma," J Chromatography B, 655:315-319, 1994.
Spiegel and Noseworthy, "Use of Nonaqueous Solvents in Parenteral Products," J Pharm. Sci., 52(10):917-927, 1963.
Verweij et al., "Paclitaxel (Taxol.TM.) and docetaxel (Taxotere.TM.): Not Simply Two of a Kind," Annals of Oncology, 5:495-505, 1994.
Weiss et al., "A Phase I Study of Dimethylacertamide," Cancer Chemotheraphy Reports, 16:477-485,1962.
Weiss et al., "Hypersensitivity Reactions from Taxol," J Clincal Onoclolgy, 8(7):1263-1268, 1990.
Willey et al., "High-Performance Liquide Chromatographic Procedure for the Quantative Determination of Paclitaxel (Taxol.RTM.) in Human Plasma," J Chromatography, 621:231-238, 1993.
Sparreboom et al., "Nonlinear Pharmacokinetics of Paxlitaxel in Mice Results from the Pharmaceutical vehicle Chremophor EL," Cnacer Research, 56:2112-2115, May 1996.

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

Parenteral paclitaxel in a stable non-toxic formulation does not yet have a rating. At this time, there are no reviews or comments for this patent.

If you have personal experience with Parenteral paclitaxel in a stable non-toxic formulation, we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Parenteral paclitaxel in a stable non-toxic formulation will most certainly appreciate the feedback.

Rate now

     

Profile ID: LFUS-PAI-O-581598

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