CA2473412A1 - Liquid pharmaceutical injectable formulation of octreotide - Google Patents
Liquid pharmaceutical injectable formulation of octreotide Download PDFInfo
- Publication number
- CA2473412A1 CA2473412A1 CA002473412A CA2473412A CA2473412A1 CA 2473412 A1 CA2473412 A1 CA 2473412A1 CA 002473412 A CA002473412 A CA 002473412A CA 2473412 A CA2473412 A CA 2473412A CA 2473412 A1 CA2473412 A1 CA 2473412A1
- Authority
- CA
- Canada
- Prior art keywords
- liquid pharmaceutical
- acid
- solution according
- pharmaceutical solution
- polymer
- 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.)
- Abandoned
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Classifications
-
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- A61K38/22—Hormones
- A61K38/31—Somatostatins
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS 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
- A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
- A61L2/0005—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts
- A61L2/0011—Methods 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
- A61L2/0017—Filtration
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Public Health (AREA)
- Epidemiology (AREA)
- Veterinary Medicine (AREA)
- Chemical & Material Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (AREA)
- Engineering & Computer Science (AREA)
- Pharmacology & Pharmacy (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Zoology (AREA)
- Immunology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Endocrinology (AREA)
- Gastroenterology & Hepatology (AREA)
- Biomedical Technology (AREA)
- Molecular Biology (AREA)
- Dermatology (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
Abstract
A liquid pharmaceutical composition of pH between about 3 and about 9 comprising (a) octreotide (salt or base) of concentration from about 0.001 to about 5 g/L (under free-peptide form); (b) a suitable inorganic or organic buffer system; (c) in water; (d) in an appropriate container. The packaging material could be treated glass container, or constituted of another appropriate material with or without an elastomeric stopper.
Description
TITLE OF THE INVENTION
[0001] LIQUID PHARMACEUTICAL INJECTABLE FORMULATION OF
OCTREOTIDE
FIELD OF THE INVENTION
[0001] LIQUID PHARMACEUTICAL INJECTABLE FORMULATION OF
OCTREOTIDE
FIELD OF THE INVENTION
[0002] This invention relates to a formulation sterilized by aseptic filtration containing octreotide in a buffer system other than lactate/lactic acid, in a container system with or without an elastomeric closure.
BACKGROUND OF THE INVENTION
BACKGROUND OF THE INVENTION
[0003] Patent CA1328402 described a pharmaceutical composition comprising a somatostatin analogue, and its use in the treatment of breast cancer. The pharmaceutical composition preferably contains lactic acid in addition to the somatostatin analogue without any other mention of different buffer systems.
SUMMARY OF THE INVENTION
SUMMARY OF THE INVENTION
[0004] The present invention relates to a liquid pharmaceutical injectable solution with a pH between 3 and 9 comprising (a) oc;treotide (salt or base) of concentration from 0.001 to 5 gIL (under free-peptide form); (b) a suitable inorganic or organic buffer system; {c) in water; (d) in an appropriate container.
The packaging material could be treated glass container, or constituted of another appropriate material with or without an elastomeric stopper.
The packaging material could be treated glass container, or constituted of another appropriate material with or without an elastomeric stopper.
[0005] The present invention provides at least 3 improvements to the product described in patent CA 1,328,402. The improvements relate to the following:
Use of different buffer systems Manufacturing process with sterilization method Preferred packaging OBJECT OF THE INVENTION
Use of different buffer systems Manufacturing process with sterilization method Preferred packaging OBJECT OF THE INVENTION
[0006] It is an object of the present invention to provide the manufacturing process for a stable sterile injectable solution containing octreotide and a pharmaceutically acceptable buffer system in a compatible container-closure system.
[0007] The present invention provides a method for preparing a pharmaceutical stable octreotide injectable solution with a pH between about 3 and about 9 comprising octreotide (salt or base) and acetic acid as a suitable inorganic or organic buffer system in a appropriate container system.
Preferable formulation Ingredient Amount Octreotide acetate 0.001 or 5 g Glacial acetic acid 2 g Sodium acetate trihydrate2 g Sodium chloride 7 g Phenol* 5 g Water for Injection q.s. to 1 L
* for multidose presentations
Preferable formulation Ingredient Amount Octreotide acetate 0.001 or 5 g Glacial acetic acid 2 g Sodium acetate trihydrate2 g Sodium chloride 7 g Phenol* 5 g Water for Injection q.s. to 1 L
* for multidose presentations
[0008] Preferable manufacturing process Gather water for injection into a clean stainless steel tank.
Add the sodium acetate trihydrate to the tank and mix.
Add sodium chloride far isotonicity to the tank and mix Add acetic acid to the tank and mix.
Add octreotide acetate to the tank and mix.
Measure pH of the solution and make sure that it is between 4.0 and 4.4 by adjusting with appropriate buffer system.
Q.S. with Water for Injection and mix thoroughly.
Verify pH and adjust if necessary.
Proceed to the filtration and protect the solution from light.
Proceed to the filling of chosen container.
[0009, The buffer system can be selected from the group consisting of benzoatelbenzoic acid, 4-ethylbenzoatel4-ethylbenzoic acid, malate/malic acid, maleate/maleic acid, fumaratelfumaric acid, succinatelsuccinic acid;
tartrateltartaric acid, citrate/citric acid, ascorbatelascorbic acid, acetatelacetic acid, gluconatelgluconic acid, bicarbonate/carbonic acid, bicarbonatelcarbonate, phosphates, and Tris.
[0010, According to a specific embodiment, the container consists of at least:
~ one (1) glass component having one (1) or more surface in contact with the solution wherein one (1 ) or more said surface having been pre-treated by application of a Si02 barrier by a plasma deposition process or by any other process.
The aluminium oxide content in glass component is less or equal to about 5%.
~ one (1 } packaging component manufactured from a non-glass material.
The said packaging component is manufactured from a material selected from the group consisting of polyethylene, polypropylene, polymethylpentene, polyolefin, cycloolefin, polycarbonate, polyvinylchloride, and ABS resin.
[0011] The closure system is constituted of an elastomeric stopper coated with a fluorinated resin selected from the group consisting of tetrafluoroethylene polymer, trifluorochloroethylene polymer, tetrafluoroethylene-hexafluoropropylene copolymer, fluorovinylidene polymer, vinylidene fluoride polymer, vinyl fluoride polymer, tetrafluoroethylene-ethylene copolymer, ethylene-tetrafluoroethylene copolymer, and perfluoroalkoxy polymer.
[0012] A liquid pharmaceutical solution wherein the solution contains a preservative agent at a concentration from 0.001 to 20 gIL.
[0013] In the process of the invention, final sterilization is achieved by passing the solution through a sterilizing filter with a membrane material selected from the group consisting of polyvinylidene difluoride, polycarbonate, polysulfone, and regenerated cellulose.
[0014] Although the present invention has been described hereinabove by way of preferred embodiments thereof, it can be modified, without departing from the spirit and nature of the subject invention as defined in the appended claims.
Add the sodium acetate trihydrate to the tank and mix.
Add sodium chloride far isotonicity to the tank and mix Add acetic acid to the tank and mix.
Add octreotide acetate to the tank and mix.
Measure pH of the solution and make sure that it is between 4.0 and 4.4 by adjusting with appropriate buffer system.
Q.S. with Water for Injection and mix thoroughly.
Verify pH and adjust if necessary.
Proceed to the filtration and protect the solution from light.
Proceed to the filling of chosen container.
[0009, The buffer system can be selected from the group consisting of benzoatelbenzoic acid, 4-ethylbenzoatel4-ethylbenzoic acid, malate/malic acid, maleate/maleic acid, fumaratelfumaric acid, succinatelsuccinic acid;
tartrateltartaric acid, citrate/citric acid, ascorbatelascorbic acid, acetatelacetic acid, gluconatelgluconic acid, bicarbonate/carbonic acid, bicarbonatelcarbonate, phosphates, and Tris.
[0010, According to a specific embodiment, the container consists of at least:
~ one (1) glass component having one (1) or more surface in contact with the solution wherein one (1 ) or more said surface having been pre-treated by application of a Si02 barrier by a plasma deposition process or by any other process.
The aluminium oxide content in glass component is less or equal to about 5%.
~ one (1 } packaging component manufactured from a non-glass material.
The said packaging component is manufactured from a material selected from the group consisting of polyethylene, polypropylene, polymethylpentene, polyolefin, cycloolefin, polycarbonate, polyvinylchloride, and ABS resin.
[0011] The closure system is constituted of an elastomeric stopper coated with a fluorinated resin selected from the group consisting of tetrafluoroethylene polymer, trifluorochloroethylene polymer, tetrafluoroethylene-hexafluoropropylene copolymer, fluorovinylidene polymer, vinylidene fluoride polymer, vinyl fluoride polymer, tetrafluoroethylene-ethylene copolymer, ethylene-tetrafluoroethylene copolymer, and perfluoroalkoxy polymer.
[0012] A liquid pharmaceutical solution wherein the solution contains a preservative agent at a concentration from 0.001 to 20 gIL.
[0013] In the process of the invention, final sterilization is achieved by passing the solution through a sterilizing filter with a membrane material selected from the group consisting of polyvinylidene difluoride, polycarbonate, polysulfone, and regenerated cellulose.
[0014] Although the present invention has been described hereinabove by way of preferred embodiments thereof, it can be modified, without departing from the spirit and nature of the subject invention as defined in the appended claims.
Claims (13)
1. A liquid pharmaceutical solution comprising octreotide (salt or base) and the following:
a pH of between 3 and 9;
a suitable inorganic or organic buffer system.
a pH of between 3 and 9;
a suitable inorganic or organic buffer system.
2. A liquid pharmaceutical solution according to claim 1, wherein the buffer system is selected from the group consisting of benzoate/benzoic acid, 4-ethylbenzoate/4-ethylbenzoic acid, malate/malic acid, maleate/maleic acid, fumarate/fumaric acid, succinate/succinic acid, tartrate/tartaric acid, citrate/citric acid, ascorbate/ascorbic acid, acetate/acetic acid, gluconate/gluconic acid, bicarbonate/carbonic acid, bicarbonate/carbonate, phosphates, and Tris.
3. A liquid pharmaceutical solution according to claim 1 to 2, wherein the container consists of at least one (1) glass component having one (1) or more surface in contact with the solution.
4. A liquid pharmaceutical solution according to claim 1 to 3, wherein one (1) or more said surface having been pre-treated.
5. A liquid pharmaceutical solution according to claim 1 to 4, wherein the said surface has been pre-treated by application of a SiO2 barrier by a plasma deposition process or by any other process.
6. A liquid pharmaceutical solution according to claim 1 to 5, wherein the aluminium oxide content in glass component is less or equal to 5%.
7. A liquid pharmaceutical solution according to claim 1 to 6, wherein the container consists of at least one (1) packaging component manufactured from a non-glass material.
8. A liquid pharmaceutical solution according to claim 1 to 7, wherein the said packaging component is manufactured from a material selected from the group consisting of polyethylene, polypropylene, polymethylpentene, polyolefin, cycloolefin, polycarbonate, polyvinylchloride, and ABS resin.
9. A liquid pharmaceutical solution according to claim 1 to 8, wherein the closure system is constituted of an elastomeric stopper.
10. A liquid pharmaceutical solution according to claim 9, wherein the stopper is coated with a fluorinated resin.
11. A liquid pharmaceutical solution according to claim 10, wherein the fluorinated resin is selected from the group consisting of tetrafluoroethylene polymer, trifluorochloroethylene polymer, tetrafluoroethylene-hexafluoropropylene copolymer, fluorovinylidene polymer, vinylidene fluoride polymer, vinyl fluoride polymer, tetrafluoroethylene-ethylene copolymer, ethylene-tetrafluoroethylene copolymer, and perfluoroalkoxy polymer.
12. A liquid pharmaceutical solution according to claim 1 to 9, wherein the solution contains a preservative agent at a concentration from 0.001 to 20 g/L.
13. A liquid pharmaceutical solution according to any of the above claims, wherein the sterilization process comprises passing the solution through a sterilizing filter with a membrane material selected from the group consisting of polyvinylidene difluoride, polycarbonate, polysulfone, and regenerated cellulose.
Priority Applications (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CA002473412A CA2473412A1 (en) | 2004-07-08 | 2004-07-08 | Liquid pharmaceutical injectable formulation of octreotide |
| CA 2511711 CA2511711A1 (en) | 2004-07-08 | 2005-07-08 | Liquid pharmaceutical formulations of octreotide, manufacturing process and container for the same |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CA002473412A CA2473412A1 (en) | 2004-07-08 | 2004-07-08 | Liquid pharmaceutical injectable formulation of octreotide |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA2473412A1 true CA2473412A1 (en) | 2006-01-08 |
Family
ID=35610386
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA002473412A Abandoned CA2473412A1 (en) | 2004-07-08 | 2004-07-08 | Liquid pharmaceutical injectable formulation of octreotide |
Country Status (1)
| Country | Link |
|---|---|
| CA (1) | CA2473412A1 (en) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2014003199A1 (en) * | 2012-06-27 | 2014-01-03 | Takeda Pharmaceutical Company Limited | Liquid preparations of amines and organic acids stabilized by salts |
| WO2018211526A1 (en) * | 2017-05-15 | 2018-11-22 | Sun Pharmaceutical Industries Limited | Octreotide injection |
-
2004
- 2004-07-08 CA CA002473412A patent/CA2473412A1/en not_active Abandoned
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2014003199A1 (en) * | 2012-06-27 | 2014-01-03 | Takeda Pharmaceutical Company Limited | Liquid preparations of amines and organic acids stabilized by salts |
| CN104582687A (en) * | 2012-06-27 | 2015-04-29 | 武田药品工业株式会社 | Liquid preparations of amines and organic acids stabilized by salts |
| WO2018211526A1 (en) * | 2017-05-15 | 2018-11-22 | Sun Pharmaceutical Industries Limited | Octreotide injection |
| US10342850B2 (en) | 2017-05-15 | 2019-07-09 | Sun Pharmaceutical Industries Limited | Octreotide injection |
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| FZDE | Dead |