WO2007022609B1 - Pharmaceutical composition of morphine in ready-to-use injectable solution form and single dosage form of morphine for epidural or intrathecal administration - Google Patents

Pharmaceutical composition of morphine in ready-to-use injectable solution form and single dosage form of morphine for epidural or intrathecal administration

Info

Publication number
WO2007022609B1
WO2007022609B1 PCT/BR2006/000168 BR2006000168W WO2007022609B1 WO 2007022609 B1 WO2007022609 B1 WO 2007022609B1 BR 2006000168 W BR2006000168 W BR 2006000168W WO 2007022609 B1 WO2007022609 B1 WO 2007022609B1
Authority
WO
Grant status
Application
Patent type
Prior art keywords
dosage form
characterized
single dosage
ready
use single
Prior art date
Application number
PCT/BR2006/000168
Other languages
French (fr)
Other versions
WO2007022609A1 (en )
Inventor
Ogari Pacheco
Roberto Moreira
Original Assignee
Cristalia Prod Quimicos Farm
Ogari Pacheco
Roberto Moreira
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

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine, rifamycins
    • A61K31/435Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine, rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/47Quinolines; Isoquinolines
    • A61K31/485Morphinan derivatives, e.g. morphine, codeine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0085Brain, e.g. brain implants; Spinal cord

Abstract

The present invention refers to an analgesic composition in the form of an injectable solution, sterile and apyrogenic, which is constituted by a pharmaceutically acceptable morphine salt dissolved in a pharmaceutically acceptable solvent (carrier), wherein the pH of the resulting solution is from 2.5 to 6.5 and the morphine concentration is from about 0.025 to 0.195 mg/mL (expressed as the hydrated salt thereof). Such composition, packed in a sealed container is ready-to-use and suitable for epidural and intrathecal administration in adults and intravenous in children.

Claims

24AMENDED CLAIMS received by the International Bureau on 27 February 2007 (27.02.07)
1. Ready-to-use single dosage form characterized by comprising a container filled with an analgesic composition comprising a pharmaceutically acceptable morphine salt, selected from the group consisting of morphine sulfate and morphine hydrochloride, in its anhydrous or hydrated forms, dissolved in a pharmaceutically acceptable solvent wherein the amount of morphine expressed as the hydrated salt thereof is from 0.025 to 0.195 mg and the volume capacity of the container is of 1 or 2 mL.
2. The ready-to-use single dosage form according to claim 1, characterized by the fact that the solvent is selected from the group consisting of water for injection, physiological saline solution, glucose solution, dextrose solution, local anesthetics solution and artificial spinal fluid.
3. The ready-to-use single dosage form according to claim 1, characterized by the fact that the solvent is 0.9% sodium chloride solution.
4. The ready-to-use single dosage form according to claim 1, characterized by the fact that the analgesic composition comprises morphine sulfate pentahydrate, in an amount ranging from 0.05 to 0.1 mg.
5. The ready-to-use single dosage form according to claim 1, characterized by the fact that the analgesic composition comprises morphine hydrochloride trihydrate, employed in an amount ranging from 0.05 to 0.1 mg.
6. The ready-to-use single dosage form according to claim 1, characterized by the fact that the analgesic composition is preservative and/or conservative free.
7. The ready-to-use single dosage form according to claim 1, characterized by being administered via intrathecal or epidural routes in adults and children or intravenous route in children.
8. The ready-to-use single dosage form according to claim 1, characterized by the fact that the container is selected from the group consisting of ampoule and syringe coupled to an epidural anesthesia needle.
9. The ready-to-use single dosage form according to claim 8, characterized by the fact that the ampoule is made of amber glass.
10. The ready-to-use single dosage form according to claim 8, characterized by the fact that the syringe coupled to an epidural anesthesia needle is made of amber glass.
11. Ready-to-use single dosage form, characterized by comprising an ampoule containing 0.1 mg of morphine sulfate pentahydrate dissolved in 1 iriL of 0.9% sodium chloride solution being preservative and/or conservative free.
12. Ready-to-use single dosage form, characterized by comprising an ampoule containing 0.05 mg of morphine sulfate pentahydrate dissolved in 1 mL 0.9% sodium chloride solution being preservative and/or conservative free. 26
13. Readγ-to-use single dosage form, characterized by comprising an ampoule containing 0.1 mg of morphine sulfate pentahydrate dissolved in 2 mL of 0.9% sodium chloride solution being preservative and/or conservative free.
14. Ready-to-use single dosage form, characterized by comprising an ampoule containing 0.05 mg of morphine sulfate pentahydrate dissolved in 2 mL of 0.9% sodium chloride solution being preservative and/or conservative free.
15. Ready-to-use single dosage form, characterized by comprising an ampoule containing 0.1 mg of morphine hydrochloride trihydrate dissolved in 1 mL of 0.9% sodium chloride solution being preservative and/or conservative free.
16. Readγ-to-use single dosage form, characterized by comprising an ampoule containing 0.05 mg of morphine hydrochloride trihydrate dissolved in 1 mL of 0.9% sodium chloride solution being preservative and/or conservative free.
17. Readγ-to-use single dosage form, characterized by comprising an ampoule containing 0.1 mg of morphine hydrochloride trihydrate dissolved in 2 mL of 0.9% sodium chloride solution being preservative and/or conservative free.
18. Readγ-to~use single dosage form, characterized by comprising an ampoule containing 0.05 mg of morphine hydrochloride trihydrate dissolved in 2 mL of 0.9% 27
sodium chloride solution being preservative and/or conservative free.
19. Ready-to-use single dosage form, characterized by comprising a syringe coupled to an epidural anesthesia needle containing 0.1 mg of morphine sulfate pentahydrate dissolved in 1 mL of 0.9% sodium chloride solution being preservative and/or conservative free.
20. Ready-to-use single dosage form, characterized by comprising a syringe coupled to an epidural anesthesia needle containing 0.05 mg of morphine sulfate pentahydrate dissolved in 1 mL of 0.9% sodium chloride solution being preservative and/or conservative free.
21. Ready-to-use single dosage form, characterized by comprising a syringe coupled to an epidural anesthesia needle containing 0.1 mg of morphine sulfate pentahydrate dissolved in 2 mL of 0.9% sodium chloride solution being preservative and/or conservative free.
22. Ready-to-use single dosage form, characterized by comprising a syringe coupled to an epidural anesthesia needle containing 0.05 mg of morphine sulfate pentahydrate dissolved in 2 mL of 0.9% sodium chloride solution being preservative and/or conservative free.
23. Ready-to-use single dosage form, characterized by comprising a syringe coupled to an epidural anesthesia needle containing 0.1 mg of morphine hydrochloride trihydrate dissolved in 1 mL of 0.9% sodium chloride solution being preservative and/or conservative free. 28
24. Ready-to-use single dosage form, characterized by comprising a syringe coupled to an epidural anesthesia needle containing 0.05 mg of morphine hydrochloride trihydrate dissolved in 1 mL of 0.9% sodium chloride solution being preservative and/or conservative free.
25. Ready-to-use single dosage form, characterized by comprising a syringe coupled to an epidural anesthesia needle containing 0.1 mg of morphine hydrochloride trihydrate dissolved in 2 mL of 0.9% sodium chloride solution being preservative and/or conservative free.
26. Ready-to-use single dosage form, characterized by comprising a syringe coupled to an epidural anesthesia needle containing 0.05 mg of morphine hydrochloride trihydrate dissolved in 2 mL of 0.9% sodium chloride solution being preservative and/or conservative free.
PCT/BR2006/000168 2005-08-23 2006-08-18 Pharmaceutical composition of morphine in ready-to-use injectable solution form and single dosage form of morphine for epidural or intrathecal administration WO2007022609B1 (en)

Priority Applications (2)

Application Number Priority Date Filing Date Title
BRPI0503734-4 2005-08-23
BRPI0503734 2005-08-23

Publications (2)

Publication Number Publication Date
WO2007022609A1 true WO2007022609A1 (en) 2007-03-01
WO2007022609B1 true true WO2007022609B1 (en) 2007-04-12

Family

ID=37771186

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/BR2006/000168 WO2007022609B1 (en) 2005-08-23 2006-08-18 Pharmaceutical composition of morphine in ready-to-use injectable solution form and single dosage form of morphine for epidural or intrathecal administration

Country Status (1)

Country Link
WO (1) WO2007022609B1 (en)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2968729A1 (en) 2013-03-14 2016-01-20 Becton Dickinson France S.A.S Packaging system for oxygen-sensitive drugs
US9072781B2 (en) 2013-03-14 2015-07-07 Becton, Dickinson France S.A.S. Morphine formulations
WO2014140899A3 (en) * 2013-03-15 2015-01-29 Johnson Matthey Public Limited Company Morphine sulfate methanolic solvate, processes for making same and related compositions and methods for treating pain

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4367738A (en) * 1981-10-28 1983-01-11 Janssen Pharmaceutica Inc. Pre-filled syringe for abusable drugs
WO1998000159A1 (en) * 1996-06-28 1998-01-08 Oxigene, Inc. Useful formulations of acid addition salt drugs

Also Published As

Publication number Publication date Type
WO2007022609A1 (en) 2007-03-01 application

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