EP0179092A1 - Solutions de mitomycine - Google Patents

Solutions de mitomycine

Info

Publication number
EP0179092A1
EP0179092A1 EP85901884A EP85901884A EP0179092A1 EP 0179092 A1 EP0179092 A1 EP 0179092A1 EP 85901884 A EP85901884 A EP 85901884A EP 85901884 A EP85901884 A EP 85901884A EP 0179092 A1 EP0179092 A1 EP 0179092A1
Authority
EP
European Patent Office
Prior art keywords
mitomycin
solution
solutions
day
days
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Withdrawn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
EP85901884A
Other languages
German (de)
English (en)
Other versions
EP0179092A4 (fr
Inventor
Norman E. Hoffman
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 International Inc
Original Assignee
Baxter Travenol Laboratories Inc
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 Travenol Laboratories Inc filed Critical Baxter Travenol Laboratories Inc
Publication of EP0179092A1 publication Critical patent/EP0179092A1/fr
Publication of EP0179092A4 publication Critical patent/EP0179092A4/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • 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
    • A61K47/02—Inorganic compounds
    • 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
    • A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner

Definitions

  • Mitomycin is sold as a cancer chemotherapy agent which has antibiotic activity by Bristol Meyers under the trademark 5 MUTAMYCIN®. See the 38th edition of the Physician Desk Refer ⁇ ence®, page 750 (1984).
  • mitomycin is provided to patients intermit ⁇ tently at six to eight week intervals.
  • the patient may be ambulatory, making use of an adminis ⁇ tration pump of known design, for example, the pump as shown in Cromie U. S. Patent No. 4,416,595.
  • the patient may receive chemotherapy on a 24-hour a day basis, often with the highest • - • 5 concentration of chemotherapy agent being administered to the exact tumor site by means of a catheter.
  • cancer can often be controlled in a manner better than a therapeutic regime using a general ad ⁇ ministration of mitomycin or other antitumor agent.
  • solutions of mitomycin must be provided having better stability than currently available reconstituted mitomycin solutions.
  • the official package circular for Bristol Meyers MUTAMYCIN states that MUTAMYCIN, reconstituted with Sterile Water for Injection to s* . 25 a concentration of 0.5 mg. per ml, is stable for seven days at room temperature. The same product is stated to be stable at * room temperature for three hours when diluted to a concentration of 20 or 40 micrograms per ml with 5% dextrose injection, twelve hours with 0.9% sodium chloride injection, and 24 hours with sodium lactate injection.
  • mitomycin solutions are dis- closed which have long shelf life in solution form, to facilitate packaging and storage of mitomycin solution. This provides a great improvement in the flexibility and convenience of mitomycin therapy.
  • one may store, with ⁇ out freezing, a buffered aqu ⁇ ous solution of mitomycin having a pH of 7.5 to 8.0 for a period of at least 15 days.
  • the solution can retain a mitomycin activity on the 15th day which is at least 90 percent of such activ y on the first day.
  • the solution may contain from 10 micrograms to one mg. of mitomycin per ml. of solution.
  • the buffer mentioned above must be pharmacologically ac ⁇ ceptable so as to be suitable for administration, and should be present in its dosage form in a concentration to provide no more than a minor osmotic gradient with blood.
  • One highly suitable buffer for this purpose is a mixture of mo ⁇ osodium phosphate and disodium phosphate, which is a basically conventional and well-known pharmaceutical buffer.
  • Other suitable buffers may be used as well.
  • mitomycin solutions can be provided which are stable for at least 15 days storage at room temperature, and much longer if refrigerated.
  • stable the intended meaning is that the amount of active mitomycin present in the solution at the end of a given period is at least 90 percent of the amount of active mitomycin present at the beginning of the period over which stability is measured.
  • a solution was prepared by adding to 5 weight percent dextrose injection solution the following amounts of solutes per 100 ml. of solution: 0.134 gram of disodium phosphate; 0.0105 gram of monosodium phosphate; and 5 milligrams of lyophilized mitomycin.
  • the resulting solution has a pH between 7.7 and 7.8. Storage of the solution at room temperature (about 22°C) for 19 days resulted in less than a 10% loss of mitomycin concentration from the solution.
  • a solution suitable for IV administration may be prepared from the above formulation following appropriate sterilization if necessary, for example, by filtration through a 0.22 micron filter.

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Inorganic Chemistry (AREA)
  • Dermatology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)

Abstract

Solution aqueuse tamponnée de mitomycine possédant un pH compris entre 7,5 et 8,0 et pouvant être stockée, sans la congeler, pendant au moins 15 jours sans réduction sensible de l'activité de la mitomycine.
EP19850901884 1984-04-10 1985-04-05 Solutions de mitomycine. Withdrawn EP0179092A4 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US59864584A 1984-04-10 1984-04-10
US598645 1984-04-10

Publications (2)

Publication Number Publication Date
EP0179092A1 true EP0179092A1 (fr) 1986-04-30
EP0179092A4 EP0179092A4 (fr) 1987-08-05

Family

ID=24396387

Family Applications (1)

Application Number Title Priority Date Filing Date
EP19850901884 Withdrawn EP0179092A4 (fr) 1984-04-10 1985-04-05 Solutions de mitomycine.

Country Status (3)

Country Link
EP (1) EP0179092A4 (fr)
JP (1) JPS61501848A (fr)
WO (1) WO1985004552A1 (fr)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5216011A (en) * 1989-09-01 1993-06-01 Bristol-Myers Squibb Co. Stable solutions of mitomycin c
DE19957371A1 (de) * 1999-11-29 2001-06-13 Medac Klinische Spezialpraep Mitomycin C-Lösung
ES2197817B2 (es) * 2002-06-10 2004-12-16 Laboratorios Casen-Fleet, S.A. Procedimiento para la obtencion de una solucion hipertonica tamponada y solucion obtenida.
WO2008063756A2 (fr) * 2006-10-03 2008-05-29 Accentia Biopharmaceuticals, Inc. Formulation d'amphotéricine b n'irritant pas les muqueuses, et procédés pour traiter une mucosite non-invasive induite par un champignon

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3660578A (en) * 1957-04-06 1972-05-02 Kyowa Hakko Kogyo Kk Mitomycin c
US3042582A (en) * 1958-12-11 1962-07-03 Bristol Myers Co Mitomycin recovery from fermentation broth
US3152954A (en) * 1962-02-06 1964-10-13 American Cyanamid Co Process of preparing mitomycin c
NL129868C (fr) * 1963-06-07
JPS5240B2 (fr) * 1973-12-17 1977-01-05
US4062964A (en) * 1975-12-03 1977-12-13 Ciba-Geigy Corporation Antifertility-combinations
US4260619A (en) * 1980-02-19 1981-04-07 Ciba-Geigy Corporation 2-Aminoalkyl-5-pyridinols

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
CHEMICAL AND PHARMACEUTICAL BULLETIN, vol. 34, no. 7, July 1986, pages 2900-2913, Pharmaceutical Society of Japan, Tokyo, JP; J.H. BEIJNEN et al.: "A systematic study on the chemical stability of mitomycin A and mitomycin B" *
See also references of WO8504552A1 *

Also Published As

Publication number Publication date
EP0179092A4 (fr) 1987-08-05
JPS61501848A (ja) 1986-08-28
WO1985004552A1 (fr) 1985-10-24

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Legal Events

Date Code Title Description
PUAI Public reference made under article 153(3) epc to a published international application that has entered the european phase

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17P Request for examination filed

Effective date: 19851213

AK Designated contracting states

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Designated state(s): AT BE CH DE FR GB IT LI LU NL SE

A4 Supplementary search report drawn up and despatched

Effective date: 19870805

STAA Information on the status of an ep patent application or granted ep patent

Free format text: STATUS: THE APPLICATION HAS BEEN WITHDRAWN

18W Application withdrawn

Withdrawal date: 19870915

RIN1 Information on inventor provided before grant (corrected)

Inventor name: HOFFMAN, NORMAN, E.