CA2507561A1 - A method for preparing a medical solution for the manufacture of a medicament for peritoneal dialysis - Google Patents

A method for preparing a medical solution for the manufacture of a medicament for peritoneal dialysis Download PDF

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Publication number
CA2507561A1
CA2507561A1 CA002507561A CA2507561A CA2507561A1 CA 2507561 A1 CA2507561 A1 CA 2507561A1 CA 002507561 A CA002507561 A CA 002507561A CA 2507561 A CA2507561 A CA 2507561A CA 2507561 A1 CA2507561 A1 CA 2507561A1
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CA
Canada
Prior art keywords
solution
acetylated
sugars
weight
compartment
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.)
Granted
Application number
CA002507561A
Other languages
French (fr)
Other versions
CA2507561C (en
Inventor
Ola Carlsson
Torbjoern Linden
Anders Wieslander
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.)
Gambro Lundia AB
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Individual
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
Priority claimed from SE0203671A external-priority patent/SE524530C2/en
Application filed by Individual filed Critical Individual
Publication of CA2507561A1 publication Critical patent/CA2507561A1/en
Application granted granted Critical
Publication of CA2507561C publication Critical patent/CA2507561C/en
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/70Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7008Compounds having an amino group directly attached to a carbon atom of the saccharide radical, e.g. D-galactosamine, ranimustine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/70Carbohydrates; Sugars; Derivatives thereof
    • A61K31/715Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
    • A61K31/716Glucans
    • A61K31/722Chitin, chitosan
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/70Carbohydrates; Sugars; Derivatives thereof
    • A61K31/715Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
    • A61K31/726Glycosaminoglycans, i.e. mucopolysaccharides
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0002Galenical forms characterised by the drug release technique; Application systems commanded by energy
    • A61K9/0004Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/0005Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts
    • A61L2/0011Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts using physical methods
    • A61L2/0023Heat
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/0005Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts
    • A61L2/0011Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts using physical methods
    • A61L2/0029Radiation
    • A61L2/0035Gamma radiation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/0005Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts
    • A61L2/0011Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts using physical methods
    • A61L2/0029Radiation
    • A61L2/007Particle radiation, e.g. electron-beam, alpha or beta radiation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/02Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using physical phenomena
    • A61L2/04Heat
    • A61L2/06Hot gas
    • A61L2/07Steam
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/02Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using physical phenomena
    • A61L2/08Radiation
    • A61L2/10Ultra-violet radiation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/28Peritoneal dialysis ; Other peritoneal treatment, e.g. oxygenation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Abstract

Method for preparing a medical solution, comprising the steps of a) providing a solution comprising one or more acetylated or deacetylated amino sugar/sugars in at least one compartment of a container at a pH from 2.5 to 5.0, and b) terminal sterilisation of said at least one compartment and the contents therein, is disclosed, as well as a solution used for preparing the medical solution, a container containing said solution, and use of said solution for the manufacture of a medicament for peritoneal dialysis.

Claims (16)

1. A method for preparing a medical solution, comprising the steps of:
a) providing a solution comprising one or more acetylated or deacetylated amino sugars in at least one compartment of a container, said solution having a pH of
2.0-5.0, and b) terminal sterilisation of said at least one compartment and the contents therein.

2. The method according to claim 1, wherein the pH
is 2.5-3.5, preferably 3Ø
3. The method according to claim 1, wherein said one or more acetylated or deacetylated amino sugar/sugars is/are chosen from N-acetylglucosamine (NAG), galactos-amine, N-acetylgalactosamine, mannosamine, and N-acetyl-mannosamine in the form of monomers, oligomers and/or polymers thereof including chitin, and human glucose-aminoglycans, as well as derivatives thereof.
4. Method according to any one of the previous claims, wherein said one or more acetylated or deacetyla-ted amino sugar/sugars is/are present in a concentration of 15-40% by weight, preferably 20-40% by weight, most preferably at least 30% by weight, with the basis of the solution in said at least one compartment.
5. The method according to any one of the previous claims, wherein said one or more acetylated or deacetyla-ted amino sugar/sugars is N-acetylglucosamine (NAG).
6. The method according to any one of the preceding claims, wherein the terminal sterilisation is heat sterilisation at a temperature of at least 100°C, prefer-ably at 121°C, and/or radiation sterilisation.
7. The method according to any one of the preceding claims, wherein each compartment of the container is de-limited from the other/others during the terminal sterilisation, and wherein the terminally sterilised solution containing one or more acetylated or deacetylat-ed amino sugars is/are mixed with a terminally sterilised pH adjusting and diluting solution in at least one other terminally sterilised compartment of the container, thereby finally preparing the medical solution.
8. The method according to claim 7, wherein the pH
in the finally prepared medical solution is 6.0-8.0, preferably 7.4.
9. The method according to claim 7 or 8, wherein the concentration of acetylated or deacetylated amino sugar/-sugars in the finally prepared solution is/are 0.2-l5.0%
by weight, preferably 0.5-6.0% by weight.
10. The method according to any one of the preceding claims, wherein physiologically compatible constituents in the form of carbohydrates, preferably glucose, pro-teins, peptides, and antioxidants are present in one or more of said compartments.
11. The method according to any one of the preceding claims, wherein the medical solution prepared is a peri-toneal dialysis solution.
12. A solution comprising one or more acetylated or deacetylated amino sugar/sugars and having a pH of 2.0-5.0, preferably 2.5-3.5, most preferably 3.0, wherein said solution is terminally sterilised and contains low levels of cytotoxic degradation products.
13. The solution according to claim 12, wherein said one or more acetylated or deacetylated amino sugar/sugars is/are present in a concentration of 15-40% by weight, preferably 20-40% by weight, most preferably at least 30%
by weight.
14. The solution according to any one of claims 12 and 13, wherein the acetylated or deacetylated amino sugar/sugars is/are as defined in claim 3, and preferably is N-acetylglucosamine.
15. A container comprising at least one compartment containing a solution according to any one of claims 12-14.
16. Use of a solution according to any one of claims 12-14 for the manufacture of a medicament for peritoneal dialysis, wherein it is mixed with a terminally sterilis-ed pH adjusting and diluting solution.
CA2507561A 2002-12-10 2003-12-10 A method for preparing a medical solution for the manufacture of a medicament for peritoneal dialysis Expired - Lifetime CA2507561C (en)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US43258002P 2002-12-10 2002-12-10
SE0203671-3 2002-12-10
SE0203671A SE524530C2 (en) 2002-12-10 2002-12-10 Solution useful in the manufacture of medicament for peritoneal dialysis e.g. continuous ambulatory peritoneal dialysis comprises acetylated or deacetylated amino sugar having specified pH
US60/432,580 2002-12-10
PCT/SE2003/001920 WO2004052268A1 (en) 2002-12-10 2003-12-10 A method for preparing a medical solution for the manufacture of a medicament for peritoneal dialysis

Publications (2)

Publication Number Publication Date
CA2507561A1 true CA2507561A1 (en) 2004-06-24
CA2507561C CA2507561C (en) 2011-09-20

Family

ID=32510744

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2507561A Expired - Lifetime CA2507561C (en) 2002-12-10 2003-12-10 A method for preparing a medical solution for the manufacture of a medicament for peritoneal dialysis

Country Status (10)

Country Link
US (3) US7790102B2 (en)
EP (1) EP1569596B1 (en)
JP (1) JP4361492B2 (en)
KR (1) KR101142863B1 (en)
AT (1) ATE403412T1 (en)
AU (1) AU2003302889B2 (en)
CA (1) CA2507561C (en)
DE (1) DE60322738D1 (en)
ES (1) ES2311754T3 (en)
WO (1) WO2004052268A1 (en)

Families Citing this family (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE60321213D1 (en) * 2002-12-10 2008-07-03 Gambro Lundia Ab METHOD FOR PREPARING A MEDICAL SOLUTION FOR PREPARING A MEDICAMENT FOR DIEPERITONEAL DIALYSIS
US8367731B2 (en) 2005-05-30 2013-02-05 Fresenius Medical Care Deutschland Gmbh Peritoneal dialysis fluid
US7736328B2 (en) 2007-07-05 2010-06-15 Baxter International Inc. Dialysis system having supply container autoconnection
AU2017261342A1 (en) 2016-05-06 2018-12-13 Gambro Lundia Ab Systems and methods for peritoneal dialysis having point of use dialysis fluid preparation using water accumulator and disposable set
DE102019103222B3 (en) 2019-02-08 2020-06-25 Elmos Semiconductor Aktiengesellschaft Device for auto-configuration of automotive ultrasonic sensors on different data buses in different applications and corresponding method
CN112505175B (en) * 2020-11-20 2023-01-31 西安乐析医疗科技有限公司 Method for determining content of impurities in peritoneal dialysis solution

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE1792346C3 (en) * 1968-08-22 1980-10-23 Rotta Research Laboratorium S.P.A., San Fruttuoso Di Monza, Mailand (Italien) Pharmaceutical preparation for the treatment of degenerative joint diseases
SE9103395D0 (en) * 1991-11-18 1991-11-18 Gambro Ab SYSTEM USING ENSTERIL MEDICAL SOLUTION CONTAINING GLUCOSE OR GLUCOSE-LIKE SUBSTANCES AND A SOLUTION INTENDED FOR THIS SYSTEM
CA2155910C (en) 1995-08-11 1999-12-14 George Wu Biocompatible aqueous solution for use in continuous ambulatory peritoneal dialysis
SE512349C2 (en) * 1997-11-28 2000-03-06 Gambro Lundia Ab Multi-chamber container for medical solution, procedure for preparation of medical solution for peritoneal dialysis and use of such container for preparation of medical solution
DE60321213D1 (en) * 2002-12-10 2008-07-03 Gambro Lundia Ab METHOD FOR PREPARING A MEDICAL SOLUTION FOR PREPARING A MEDICAMENT FOR DIEPERITONEAL DIALYSIS

Also Published As

Publication number Publication date
KR20050085489A (en) 2005-08-29
ES2311754T3 (en) 2009-02-16
US20120083468A1 (en) 2012-04-05
EP1569596B1 (en) 2008-08-06
JP2006509555A (en) 2006-03-23
CA2507561C (en) 2011-09-20
US20160038522A1 (en) 2016-02-11
KR101142863B1 (en) 2012-05-21
US7790102B2 (en) 2010-09-07
JP4361492B2 (en) 2009-11-11
ATE403412T1 (en) 2008-08-15
US20060045794A1 (en) 2006-03-02
AU2003302889B2 (en) 2008-09-11
WO2004052268A1 (en) 2004-06-24
DE60322738D1 (en) 2008-09-18
EP1569596A1 (en) 2005-09-07
US9918999B2 (en) 2018-03-20
AU2003302889A1 (en) 2004-06-30

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Effective date: 20231211