CA2151409C - Formulation pour stabiliser les gammaglobulines humaines - Google Patents

Formulation pour stabiliser les gammaglobulines humaines Download PDF

Info

Publication number: CA2151409C
Authority: CA; Canada
Prior art keywords: formulation; rho; human; solution; immunoglobulins
Prior art date: 1995-05-05
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.): Expired - Fee Related

Application number

CA 2151409

Other languages

English (en)

Other versions

CA2151409A1 (fr

Inventor

Juan Carlos Rodriguez

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.)

PURISSIMUS SA

Original Assignee

PURISSIMUS S.A.

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.)

1995-05-05

Filing date

1995-06-09

Publication date

2000-08-15

1995-06-09 Application filed by PURISSIMUS S.A. filed Critical PURISSIMUS S.A.

1996-11-06 Publication of CA2151409A1 publication Critical patent/CA2151409A1/fr

2000-08-15 Application granted granted Critical

2000-08-15 Publication of CA2151409C publication Critical patent/CA2151409C/fr

2015-06-09 Anticipated expiration legal-status Critical

Status Expired - Fee Related legal-status Critical Current

Links

239000000203 mixture Substances 0.000 title claims abstract description 38
238000009472 formulation Methods 0.000 title claims abstract description 22
108060003951 Immunoglobulin Proteins 0.000 title claims abstract description 19
102000018358 immunoglobulin Human genes 0.000 title claims abstract description 19
229940072221 immunoglobulins Drugs 0.000 title claims abstract description 14
230000000087 stabilizing effect Effects 0.000 title claims abstract description 9
102000008100 Human Serum Albumin Human genes 0.000 claims abstract description 9
108091006905 Human Serum Albumin Proteins 0.000 claims abstract description 9
UFHFLCQGNIYNRP-UHFFFAOYSA-N Hydrogen Chemical compound [H][H] UFHFLCQGNIYNRP-UHFFFAOYSA-N 0.000 claims abstract description 9
229910000162 sodium phosphate Inorganic materials 0.000 claims abstract description 9
239000001488 sodium phosphate Substances 0.000 claims abstract description 8
150000001720 carbohydrates Chemical class 0.000 claims abstract description 7
229930006000 Sucrose Natural products 0.000 claims abstract description 5
CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 claims abstract description 5
235000013681 dietary sucrose Nutrition 0.000 claims abstract description 5
229960004793 sucrose Drugs 0.000 claims abstract description 5
RYFMWSXOAZQYPI-UHFFFAOYSA-K trisodium phosphate Chemical compound [Na+].[Na+].[Na+].[O-]P([O-])([O-])=O RYFMWSXOAZQYPI-UHFFFAOYSA-K 0.000 claims abstract description 5
OWEGMIWEEQEYGQ-UHFFFAOYSA-N 100676-05-9 Natural products OC1C(O)C(O)C(CO)OC1OCC1C(O)C(O)C(O)C(OC2C(OC(O)C(O)C2O)CO)O1 OWEGMIWEEQEYGQ-UHFFFAOYSA-N 0.000 claims abstract description 4
GUBGYTABKSRVRQ-XLOQQCSPSA-N Alpha-Lactose Chemical compound O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@H]1O[C@@H]1[C@@H](CO)O[C@H](O)[C@H](O)[C@H]1O GUBGYTABKSRVRQ-XLOQQCSPSA-N 0.000 claims abstract description 4
WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 claims abstract description 4
GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 claims abstract description 4
GUBGYTABKSRVRQ-PICCSMPSSA-N Maltose Natural products O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@@H](CO)OC(O)[C@H](O)[C@H]1O GUBGYTABKSRVRQ-PICCSMPSSA-N 0.000 claims abstract description 4
WQZGKKKJIJFFOK-VFUOTHLCSA-N beta-D-glucose Chemical compound OC[C@H]1O[C@@H](O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-VFUOTHLCSA-N 0.000 claims abstract description 4
GUBGYTABKSRVRQ-QUYVBRFLSA-N beta-maltose Chemical compound OC[C@H]1O[C@H](O[C@H]2[C@H](O)[C@@H](O)[C@H](O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@@H]1O GUBGYTABKSRVRQ-QUYVBRFLSA-N 0.000 claims abstract description 4
239000008103 glucose Substances 0.000 claims abstract description 4
239000008101 lactose Substances 0.000 claims abstract description 4
239000000243 solution Substances 0.000 claims description 12
239000007864 aqueous solution Substances 0.000 claims description 6
239000008135 aqueous vehicle Substances 0.000 claims description 4
238000001990 intravenous administration Methods 0.000 claims description 4
238000007918 intramuscular administration Methods 0.000 claims description 3
230000006641 stabilisation Effects 0.000 claims description 2
238000011105 stabilization Methods 0.000 claims description 2
229940102223 injectable solution Drugs 0.000 abstract description 2
230000003449 preventive effect Effects 0.000 description 6
238000012360 testing method Methods 0.000 description 6
230000000694 effects Effects 0.000 description 5
DHMQDGOQFOQNFH-UHFFFAOYSA-N Glycine Chemical compound NCC(O)=O DHMQDGOQFOQNFH-UHFFFAOYSA-N 0.000 description 4
102000007562 Serum Albumin Human genes 0.000 description 4
108010071390 Serum Albumin Proteins 0.000 description 4
238000007792 addition Methods 0.000 description 4
210000004369 blood Anatomy 0.000 description 4
239000008280 blood Substances 0.000 description 4
230000035935 pregnancy Effects 0.000 description 4
208000032023 Signs and Symptoms Diseases 0.000 description 3
239000000539 dimer Substances 0.000 description 3
102000009027 Albumins Human genes 0.000 description 2
108010088751 Albumins Proteins 0.000 description 2
BPYKTIZUTYGOLE-IFADSCNNSA-N Bilirubin Chemical compound N1C(=O)C(C)=C(C=C)\C1=C\C1=C(C)C(CCC(O)=O)=C(CC2=C(C(C)=C(\C=C/3C(=C(C=C)C(=O)N\3)C)N2)CCC(O)=O)N1 BPYKTIZUTYGOLE-IFADSCNNSA-N 0.000 description 2
239000004471 Glycine Substances 0.000 description 2
208000032843 Hemorrhage Diseases 0.000 description 2
NBIIXXVUZAFLBC-UHFFFAOYSA-N Phosphoric acid Chemical compound OP(O)(O)=O NBIIXXVUZAFLBC-UHFFFAOYSA-N 0.000 description 2
FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 2
241000700605 Viruses Species 0.000 description 2
230000000890 antigenic effect Effects 0.000 description 2
239000000306 component Substances 0.000 description 2
238000011161 development Methods 0.000 description 2
208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 2
230000002949 hemolytic effect Effects 0.000 description 2
239000008194 pharmaceutical composition Substances 0.000 description 2
230000002265 prevention Effects 0.000 description 2
230000002035 prolonged effect Effects 0.000 description 2
230000004044 response Effects 0.000 description 2
229940053819 winrho Drugs 0.000 description 2
JPPZWICGMJJBIH-JEDNCBNOSA-N 2-aminoacetic acid;(2s)-2-amino-3-(1h-imidazol-5-yl)propanoic acid Chemical compound NCC(O)=O.OC(=O)[C@@H](N)CC1=CNC=N1 JPPZWICGMJJBIH-JEDNCBNOSA-N 0.000 description 1
102000002572 Alpha-Globulins Human genes 0.000 description 1
108010068307 Alpha-Globulins Proteins 0.000 description 1
102000006395 Globulins Human genes 0.000 description 1
108010044091 Globulins Proteins 0.000 description 1
241000700721 Hepatitis B virus Species 0.000 description 1
208000005176 Hepatitis C Diseases 0.000 description 1
101100518359 Homo sapiens RHO gene Proteins 0.000 description 1
239000002202 Polyethylene glycol Substances 0.000 description 1
206010037549 Purpura Diseases 0.000 description 1
241001672981 Purpura Species 0.000 description 1
230000003187 abdominal effect Effects 0.000 description 1
206010000210 abortion Diseases 0.000 description 1
231100000176 abortion Toxicity 0.000 description 1
238000002669 amniocentesis Methods 0.000 description 1
125000000129 anionic group Chemical group 0.000 description 1
230000003171 anti-complementary effect Effects 0.000 description 1
239000000427 antigen Substances 0.000 description 1
102000036639 antigens Human genes 0.000 description 1
108091007433 antigens Proteins 0.000 description 1
230000006472 autoimmune response Effects 0.000 description 1
230000004071 biological effect Effects 0.000 description 1
230000015572 biosynthetic process Effects 0.000 description 1
230000000903 blocking effect Effects 0.000 description 1
239000012503 blood component Substances 0.000 description 1
210000001772 blood platelet Anatomy 0.000 description 1
150000001793 charged compounds Chemical class 0.000 description 1
239000003795 chemical substances by application Substances 0.000 description 1
230000001143 conditioned effect Effects 0.000 description 1
239000003599 detergent Substances 0.000 description 1
229910000397 disodium phosphate Inorganic materials 0.000 description 1
238000005194 fractionation Methods 0.000 description 1
230000028993 immune response Effects 0.000 description 1
238000011065 in-situ storage Methods 0.000 description 1
239000007972 injectable composition Substances 0.000 description 1
208000014674 injury Diseases 0.000 description 1
238000011835 investigation Methods 0.000 description 1
239000012528 membrane Substances 0.000 description 1
238000000034 method Methods 0.000 description 1
239000000178 monomer Substances 0.000 description 1
230000032696 parturition Effects 0.000 description 1
235000011007 phosphoric acid Nutrition 0.000 description 1
229920001223 polyethylene glycol Polymers 0.000 description 1
238000002360 preparation method Methods 0.000 description 1
102000004169 proteins and genes Human genes 0.000 description 1
108090000623 proteins and genes Proteins 0.000 description 1
239000011780 sodium chloride Substances 0.000 description 1
239000002904 solvent Substances 0.000 description 1
230000002269 spontaneous effect Effects 0.000 description 1
239000003381 stabilizer Substances 0.000 description 1
208000024891 symptom Diseases 0.000 description 1
206010043554 thrombocytopenia Diseases 0.000 description 1
230000008733 trauma Effects 0.000 description 1
239000013638 trimer Substances 0.000 description 1
229910000406 trisodium phosphate Inorganic materials 0.000 description 1
YNIRKEZIDLCCMC-UHFFFAOYSA-K trisodium;phosphate;hydrate Chemical compound [OH-].[Na+].[Na+].[Na+].OP([O-])([O-])=O YNIRKEZIDLCCMC-UHFFFAOYSA-K 0.000 description 1
238000012795 verification Methods 0.000 description 1
XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 1

Landscapes

Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
Medicinal Preparation (AREA)

CA 2151409 1995-05-05 1995-06-09 Formulation pour stabiliser les gammaglobulines humaines Expired - Fee Related CA2151409C (fr)

Applications Claiming Priority (2)

Application Number	Priority Date	Filing Date	Title
AR33196095		1995-05-05
AR331,960		1995-05-05

Publications (2)

Publication Number	Publication Date
CA2151409A1 CA2151409A1 (fr)	1996-11-06
CA2151409C true CA2151409C (fr)	2000-08-15

Family

ID=3478952

Family Applications (1)

Application Number	Title	Priority Date	Filing Date
CA 2151409 Expired - Fee Related CA2151409C (fr)	1995-05-05	1995-06-09	Formulation pour stabiliser les gammaglobulines humaines

Country Status (1)

Country	Link
CA (1)	CA2151409C (fr)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number	Priority date	Publication date	Assignee	Title
EP0973549A2 (fr) *	1997-04-07	2000-01-26	Cangene Corporation	Composition intraveineuse d'immunoglobuline contenant un tensioactif non ionique aux proprietes pharmacocinetiques ameliorees
US9309316B2 (en)	2005-12-20	2016-04-12	Bristol-Myers Squibb Company	Stable subcutaneous protein formulations and uses thereof

1995
- 1995-06-09 CA CA 2151409 patent/CA2151409C/fr not_active Expired - Fee Related

Also Published As

Publication number	Publication date
CA2151409A1 (fr)	1996-11-06

Legal Events

Date	Code	Title	Description
1997-03-07	EEER	Examination request
2007-06-11	MKLA	Lapsed

Publication	Publication Date	Title
US6281336B1 (en)	2001-08-28	Process for producing immunoglobulins for intravenous administration and other immunoglobulin products
EP1084147B1 (fr)	2004-09-29	Procede de production d'immunoglobulines destinees a une administration intraveineuse et d'autres produits d'immunoglobulines
EP0073371B1 (fr)	1985-11-21	Globuline de sérum immunisant injectable par voie intraveineuse et son procédé de préparation
US4499073A (en)	1985-02-12	Intravenously injectable immune serum globulin
US6485932B1 (en)	2002-11-26	Composition comprising immunoglobulin
US5122373A (en)	1992-06-16	Immunoglobulin-g-containing fraction
CA1331135C (fr)	1994-08-02	Solutions injectables de _-globuline
JPH0378373B2 (fr)	1991-12-13
JPS5822085B2 (ja)	1983-05-06	静注用ガンマ・グロブリン製剤
EP0085747B2 (fr)	1990-05-30	Immunoglobuline humaine pour administration intraveineuse et son procédé de préparation
AU709608B2 (en)	1999-09-02	Preparation of virally inactivated intravenously injectable immune serum globulin
Mollison et al.	1969	Suppression of primary Rh immunization by passively‐administered antibody. Experiments in volunteers
Delmer et al.	1992	Acquired von Willebrand disease: correction of hemostatic defect by high‐dose intravenous immunoglobulins
US4886758A (en)	1989-12-12	Method of determining incompatibility-reaction-causing substances in blood products as well as a method of inactivating said incompatibility-reaction-causing substances
WO1998044948A2 (fr)	1998-10-15	Composition intraveineuse d'immunoglobuline contenant un tensioactif non ionique aux proprietes pharmacocinetiques ameliorees
DE68926239T2 (de)	1996-12-05	Pharmazeutische Zubereitung und Verfahren zur Unterdrückung der Faktor VIII-Inhibitor-Produktion
Salama et al.	1992	Use of Rh antibodies in the treatment of autoimmune thrombocytopenia
JP2838166B2 (ja)	1998-12-16	第▲ｖｉｉｉ▼因子阻害剤産生の抑制のための医薬組成物および方法
Tomono et al.	1986	A new intact immunoglobulin for intravenous use stabilized by chemically modified gelatin derivatives
US5234685A (en)	1993-08-10	Method of determining incompatibility-reaction-causing substances in blood products as well as a method of inactivating said incompatibility-reaction-causing substances
HK1151045B (en)	2015-09-04	Liquid immunoglobulin g (lgg) product
JPH10504310A (ja)	1998-04-28	生物学的に活性な化合物で患者を治療する方法
HK1151044B (en)	2013-09-06	Process for manufacturing immunoglobulins for intravenous administration and other immunoglobulin-like products
Specht et al.	1994	Management of Chronic Idiopathic Thrombocytopenia (Werlhof’s Disease) by Partial Splenic Resection—An Alternative to Splenectomy in Childhood?
MXPA00012230A (en)	2002-07-25	Process for producing immunoglobulins for intravenous administration and other immunoglobulin products