DE10346134A1 - Storage-stable, concentrated or supersaturated aqueous preparations containing the cytostatic agent ifosfamide, obtained using mercatoethanesulfonate-sodium as solubilizer - Google Patents

Storage-stable, concentrated or supersaturated aqueous preparations containing the cytostatic agent ifosfamide, obtained using mercatoethanesulfonate-sodium as solubilizer Download PDF

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Publication number
DE10346134A1
DE10346134A1 DE10346134A DE10346134A DE10346134A1 DE 10346134 A1 DE10346134 A1 DE 10346134A1 DE 10346134 A DE10346134 A DE 10346134A DE 10346134 A DE10346134 A DE 10346134A DE 10346134 A1 DE10346134 A1 DE 10346134A1
Authority
DE
Germany
Prior art keywords
production
concentrated
mercatoethanesulfonate
sodium
stable
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.)
Withdrawn
Application number
DE10346134A
Other languages
German (de)
Inventor
Berthold Roessler
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.)
Baxter Healthcare SA
Original Assignee
Baxter Healthcare SA
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 Baxter Healthcare SA filed Critical Baxter Healthcare SA
Priority to DE10346134A priority Critical patent/DE10346134A1/en
Publication of DE10346134A1 publication Critical patent/DE10346134A1/en
Withdrawn legal-status Critical Current

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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
    • A61K31/66—Phosphorus compounds
    • A61K31/665—Phosphorus compounds having oxygen as a ring hetero atom, e.g. fosfomycin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents

Abstract

The use of mesna (i.e. mercatoethanesulfonate-sodium) is claimed for improving the solubility of ifosfamide (I) in aqueous pharmaceutical preparations (A) containing more than 10 % w/v (I) and optionally one or more auxiliaries. Independent claims are included for: (a) storage-stable, concentrated or highly concentrated (supersaturated) preparations (A') for parenteral administration, as for (A) except that the weight ratio of (I) to mesna is restricted to 1:1-4; (b) lyophilizates (B) for reconstitution to (A'); (c) the production of (A'), by (a) combining (I) with part (preferably 90 %) of the total amount of water for injection, (b) adding (I) and (c) adding the remainder of the water; (d) the production of (B), by steps (a)-(c) as for the production of (A'), followed by (d) lyophilization; (e) the production of reconstituted (A'), by steps (a) - (d) as for the production of (B), followed by (e) adding the appropriate amount of water; and (f) (A'), (B) and reconstituted (A') obtained by the above methods. ACTIVITY : Cytostatic. MECHANISM OF ACTION : Alkylating agent.
DE10346134A 2003-10-01 2003-10-01 Storage-stable, concentrated or supersaturated aqueous preparations containing the cytostatic agent ifosfamide, obtained using mercatoethanesulfonate-sodium as solubilizer Withdrawn DE10346134A1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
DE10346134A DE10346134A1 (en) 2003-10-01 2003-10-01 Storage-stable, concentrated or supersaturated aqueous preparations containing the cytostatic agent ifosfamide, obtained using mercatoethanesulfonate-sodium as solubilizer

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
DE10346134A DE10346134A1 (en) 2003-10-01 2003-10-01 Storage-stable, concentrated or supersaturated aqueous preparations containing the cytostatic agent ifosfamide, obtained using mercatoethanesulfonate-sodium as solubilizer

Publications (1)

Publication Number Publication Date
DE10346134A1 true DE10346134A1 (en) 2005-04-21

Family

ID=34353311

Family Applications (1)

Application Number Title Priority Date Filing Date
DE10346134A Withdrawn DE10346134A1 (en) 2003-10-01 2003-10-01 Storage-stable, concentrated or supersaturated aqueous preparations containing the cytostatic agent ifosfamide, obtained using mercatoethanesulfonate-sodium as solubilizer

Country Status (1)

Country Link
DE (1) DE10346134A1 (en)

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE3907079A1 (en) * 1988-03-19 1989-09-28 Asta Pharma Ag Ifosfamide/mesna lyophilisate and process for its production
WO1999018973A2 (en) * 1997-10-13 1999-04-22 Stada Arzneimittel Ag Liquid presentations of oxazaphosphorine-containing pharmaceutical products
WO2004022699A2 (en) * 2002-09-05 2004-03-18 Bharat Serums And Vaccines Ltd. Liquid stable composition of oxazaphosphorine with mesna

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE3907079A1 (en) * 1988-03-19 1989-09-28 Asta Pharma Ag Ifosfamide/mesna lyophilisate and process for its production
WO1999018973A2 (en) * 1997-10-13 1999-04-22 Stada Arzneimittel Ag Liquid presentations of oxazaphosphorine-containing pharmaceutical products
WO2004022699A2 (en) * 2002-09-05 2004-03-18 Bharat Serums And Vaccines Ltd. Liquid stable composition of oxazaphosphorine with mesna

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Legal Events

Date Code Title Description
OM8 Search report available as to paragraph 43 lit. 1 sentence 1 patent law
8110 Request for examination paragraph 44
8128 New person/name/address of the agent

Representative=s name: MUELLER-BORE & PARTNER, PATENTANWAELTE, EUROPEAN P

R119 Application deemed withdrawn, or ip right lapsed, due to non-payment of renewal fee

Effective date: 20130501