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WO2006105399A1 - Methodes d'administration d'ixabepilone - Google Patents

Methodes d'administration d'ixabepilone Download PDF

Info

Publication number
WO2006105399A1
WO2006105399A1 PCT/US2006/011920 US2006011920W WO2006105399A1 WO 2006105399 A1 WO2006105399 A1 WO 2006105399A1 US 2006011920 W US2006011920 W US 2006011920W WO 2006105399 A1 WO2006105399 A1 WO 2006105399A1
Authority
WO
WIPO (PCT)
Prior art keywords
ixabepilone
solvent system
solvent
patient
diluent
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/US2006/011920
Other languages
English (en)
Inventor
Thomas A. Haby
Fahri T. Comezoglu
Vijay Naringrekar
Ismat Ullah
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Bristol Myers Squibb Co
Original Assignee
Bristol Myers Squibb Co
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Bristol Myers Squibb Co filed Critical Bristol Myers Squibb Co
Priority to EP06749025A priority Critical patent/EP1863481A1/fr
Priority to JP2008504420A priority patent/JP2008534610A/ja
Publication of WO2006105399A1 publication Critical patent/WO2006105399A1/fr
Anticipated expiration legal-status Critical
Priority to NO20075090A priority patent/NO20075090L/no
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/425—Thiazoles
    • A61K31/426—1,3-Thiazoles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents

Definitions

  • Co-solvent means any pharmaceutically-acceptable solvent (liquid) that may be used to dissolve ixabepilone to form an ixabepilone solution.
  • Preferred co- solvents according to the invention are water miscible co-solvents that may be used to dissolve ixabepilone in solution and which may be mixed with an aqueous medium such that the ixabepilone becomes solubilized in the aqueous medium.
  • a co-solvent is selected such that up to about 20 mg of ixabepilone may be dissolved in a 1 mL solution of co-solvent/water, wherein the 1 mL solution may contain from 10- 30% water by volume.
  • Co-solvents include but are not limited to ethanol, N 5 N dimethylacetamide, propylene glycol, glycerol and polyethylene glycols, e.g., polyethylene glycol 300 and/or polyethylene glycol 400,
  • this can be achieved via choice of solvents and/or use of one or more pH- adjusting ingredients such as one or more buffers, acid(s) and/or base(s).
  • One embodiment of the invention comprises using a buffer to adjust the pH of the solvent system, then further adjusting the pH to as close to the desired range as possible using small amounts of acid and/or base, the quantities being selected as needed to reach the desired range of pH.
  • the diluent is a saline or dextrose infusion fluid
  • the solvent system includes PEG 400 and dehydrated alcohol
  • a buffer of tromethamine is used together with trace quantities of IN HCl and/or IN NaOH to adjust the pH of the solvent system to a pH in the range of 8.3 ⁇ 1.0.
  • a lyophilized ixabepilone (see, e.g., US Pat. 6,670,384 incoiporated herein), is reconstituted with a pH- controlled solvent system having a minor percentage of water to provide an ixabepilone solution.
  • the ixabepilone solution may be prepared first, then placed in a first receptacle of an administration set, or it may be prepared directly within the administration set.
  • the first receptacle is in fluid communication with a central infusion line for delivery of the contents of the infusion line to a patient.
  • the diluent used for administration of the ixabepilone is placed in a second receptacle which also is in fluid communication with the central infusion line but is maintained separate from the first receptacle containing the ixabepilone solution.
  • a second receptacle which also is in fluid communication with the central infusion line but is maintained separate from the first receptacle containing the ixabepilone solution.
  • “maintained separate” or “in physical separation” it is meant that the ixabepilone is not exposed to the diluent whereby the degradation factors of the diluent (e.g., substantially aqueous and/or acidic conditions) may cause the ixabepilone to degrade.
  • the ixabepilone solution and diluent are combined in the central infusion line to form a pharmaceutical formulation for delivery of the formulation to the patient.
  • the pharmaceutical kit may be adapted for use in administering an IV infusion of ixabepilone to a patient over an extended period of time, for example, an infusion period lasting for more than 10 continuous or substantially-continuous hours, or for an infusion period lasting from 20 to 24 continuous or substantially-continuous hours.
  • the pH-controlled solvent system may further comprise pH adjusting ingredient and/or water.
  • Preferred co-solvents include propylene glycol, glycerol, polyethylene glycol 300, and/or polyethylene glycol 400.
  • a preferred viscosity-reducing agent is dehydrated alcohol.
  • the pH controlled solvent system does not comprise a non-ionic surfactant or is substantially free of a non-ionic surfactant.
  • Such other agents may be administered using a triparte source method, e.g., employing the concepts of the present invention, but also delivering another chemotherapeutic agent in combination with ixabepilone, using a third or further sources for the other agent(s).
  • the effective amount of ixabepilone may be determined by one of ordinary skill in the art. Exemplary dosage amounts may be found in US patent application Serial No. 10/055,653, filed January 23, 2002, incorporated herein by reference.
  • the syringe containing the constituted ixabepilone is placed into a syringe pump and an ixabepilone flow rate is started.
  • the rate of the constituted ixabepilone is set at a constant rate of 2.22 mL/hr.
  • the saline flow rate is varied from 6 to 96 mL/hr.
  • the infused ixabepilone solution is set at rates of 5 mL/hr and 17.8 mL/hr, and the saline infusion rate is varied from about 15 to 95 mL/hr.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Epidemiology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Nitrogen Condensed Heterocyclic Rings (AREA)

Abstract

L'invention concerne des méthodes d'administration d'ixabepilone à des patients, l'ixabepilone présentant la formule I. Un aspect de cette invention comprend l'utilisation d'une technique d'administration de source duale ou de site Y qui engendre une stabilité améliorée d'ixabepilone et permet une meilleure adaptabilité du temps de perfusion et/ou de la préparation du produit.
PCT/US2006/011920 2005-03-31 2006-03-30 Methodes d'administration d'ixabepilone Ceased WO2006105399A1 (fr)

Priority Applications (3)

Application Number Priority Date Filing Date Title
EP06749025A EP1863481A1 (fr) 2005-03-31 2006-03-30 Methodes d'administration d'ixabepilone
JP2008504420A JP2008534610A (ja) 2005-03-31 2006-03-30 イクサベピロンの投与方法
NO20075090A NO20075090L (no) 2005-03-31 2007-10-09 Fremgangsmate for administrering av ixabepilone

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US66690705P 2005-03-31 2005-03-31
US60/666,907 2005-03-31

Publications (1)

Publication Number Publication Date
WO2006105399A1 true WO2006105399A1 (fr) 2006-10-05

Family

ID=36763031

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2006/011920 Ceased WO2006105399A1 (fr) 2005-03-31 2006-03-30 Methodes d'administration d'ixabepilone

Country Status (5)

Country Link
EP (1) EP1863481A1 (fr)
JP (1) JP2008534610A (fr)
CN (1) CN101155584A (fr)
NO (1) NO20075090L (fr)
WO (1) WO2006105399A1 (fr)

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2009089138A1 (fr) * 2008-01-04 2009-07-16 Bristol-Myers Squibb Company Administration orale d'ixabépilone
WO2009089260A3 (fr) * 2008-01-08 2009-12-03 Bristol-Myers Squibb Company Combinaison d'anticorps anti-ctla4 avec des agents de modulation de la tubuline pour le traitement de maladies prolifératives
US10307418B2 (en) 2010-12-16 2019-06-04 Platform Brightworks Two, Ltd. Azole pharmaceutical formulations for parenteral administration and methods for preparing and using the same as treatment of diseases sensitive to azole compounds
US10548890B2 (en) 2011-04-28 2020-02-04 Platform Brightworks Two, Ltd. Parenteral formulations of lipophilic pharmaceutical agents and methods for preparing and using the same

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103908432B (zh) * 2013-01-02 2018-09-21 博瑞生物医药（苏州）股份有限公司 一种伊沙匹隆白蛋白的冻干组合物及其制备方法
JP6883428B2 (ja) * 2014-03-13 2021-06-09 ブードーリス，バシリオス ベンダムスチン固体分散体及び持続注入

Non-Patent Citations (8)

* Cited by examiner, † Cited by third party
Title
A. AWADA ET AL: "Final results of the phase I study of the novel epothilone BMS-247550 administered weekly in patients (pts) with advanced solid tumors", EUROPEAN JOURNAL OF CANCER, PERGAMON PRESS, OXFORD, GB, vol. 38, November 2002 (2002-11-01), pages S41, XP004403563, ISSN: 0959-8049 *
ABRAHAM JAME ET AL: "Phase I trial and pharmacokinetic study of BMS-247550, an epothilone B analog, administered intravenously on a daily schedule for five days.", JOURNAL OF CLINICAL ONCOLOGY : OFFICIAL JOURNAL OF THE AMERICAN SOCIETY OF CLINICAL ONCOLOGY. 1 MAY 2003, vol. 21, no. 9, 1 May 2003 (2003-05-01), pages 1866 - 1873, XP002394536, ISSN: 0732-183X *
ENG C ET AL: "A PHASE II TRIAL OF THE EPOTHILONE B ANALOG, BMS-247550, IN PATIENTS WITH PREVIOUSLY TREATED ADVANCED COLORECTAL CANCER", ANNALS OF ONCOLOGY, KLUWER, DORDRECHT, NL, vol. 15, no. 6, 2004, pages 928 - 932, XP008060117, ISSN: 0923-7534 *
GOLDSPIEL B R: "PHARMACEUTICAL ISSUES: PREPARATION, ADMINISTRATION, STABILITY, AND COMPATIBILITY WITH OTHER MEDICATIONS", ANNALS OF PHARMACOTHERAPY, vol. 28, no. 5, 1994, pages S23 - S26, XP000874384, ISSN: 1060-0280 *
LEE F Y F ET AL: "BMS-247550: a novel epothilone analog with a mode of action similar to paclitaxel but possessing superior antitumor efficacy", CLINICAL CANCER RESEARCH, THE AMERICAN ASSOCIATION FOR CANCER RESEARCH, US, vol. 7, no. 5, May 2001 (2001-05-01), pages 1429 - 1437, XP002254263, ISSN: 1078-0432 *
O'CONNOR O A ET AL: "CLINICAL DEVELOPMENT OF THE NOVEL EPOTHILONE BMS-247550: FIRST OF A NEW CLASS OF TUBULIN POLYMERIZATION AGENTS WITH PROMISING ACTIVITY AGAINST CHEMOTHERAPY-REFRACTORY AGGRESSIVE AND MANTLE CELL LYMPHOMA", BLOOD, W.B.SAUNDERS COMPANY, ORLANDO, FL, US, vol. 98, no. 11, PART 1, 16 November 2001 (2001-11-16), pages 347A - 348A, XP001120000, ISSN: 0006-4971 *
SMALETZ O ET AL: "PILOT STUDY OF EPOTHILONE B ANALOG (BMS-247550) AND ESTRAMUSTINE PHOSPHATE IN PATIENTS WITH PROGRESSIVE METASTATIC PROSTATE CANCER FOLLOWING CASTRATION", ANNALS OF ONCOLOGY, KLUWER, DORDRECHT, NL, vol. 14, no. 10, October 2003 (2003-10-01), pages 1518 - 1524, XP008042341, ISSN: 0923-7534 *
SULLIVAN D ET AL: "536 A phase 1 study of Epothilone B analog BMS-247550 in combination with carboplatin in recurrent and/or refractory solid tumors", EUROPEAN JOURNAL OF CANCER. SUPPLEMENT, PERGAMON, OXFORD, GB, vol. 2, no. 8, September 2004 (2004-09-01), pages 163, XP004639980, ISSN: 1359-6349 *

Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2009089138A1 (fr) * 2008-01-04 2009-07-16 Bristol-Myers Squibb Company Administration orale d'ixabépilone
WO2009089260A3 (fr) * 2008-01-08 2009-12-03 Bristol-Myers Squibb Company Combinaison d'anticorps anti-ctla4 avec des agents de modulation de la tubuline pour le traitement de maladies prolifératives
CN101909693A (zh) * 2008-01-08 2010-12-08 百时美施贵宝公司 用于治疗增殖性疾病的抗-ctla4抗体与微管蛋白调节剂的组合
US8449886B2 (en) 2008-01-08 2013-05-28 Bristol-Myers Squibb Company Combination of anti-CTLA4 antibody with tubulin modulating agents for the treatment of proliferative diseases
US10307418B2 (en) 2010-12-16 2019-06-04 Platform Brightworks Two, Ltd. Azole pharmaceutical formulations for parenteral administration and methods for preparing and using the same as treatment of diseases sensitive to azole compounds
US10548890B2 (en) 2011-04-28 2020-02-04 Platform Brightworks Two, Ltd. Parenteral formulations of lipophilic pharmaceutical agents and methods for preparing and using the same
US11045466B2 (en) 2011-04-28 2021-06-29 Platform Brightworks Two, Ltd. Parenteral formulations of lipophilic pharmaceutical agents and methods for preparing and using the same

Also Published As

Publication number Publication date
CN101155584A (zh) 2008-04-02
JP2008534610A (ja) 2008-08-28
NO20075090L (no) 2007-12-04
EP1863481A1 (fr) 2007-12-12

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