WO2016122722A1 - Process for manufacturing glatiramer acetate product - Google Patents

Process for manufacturing glatiramer acetate product Download PDF

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Publication number
WO2016122722A1
WO2016122722A1 PCT/US2015/051203 US2015051203W WO2016122722A1 WO 2016122722 A1 WO2016122722 A1 WO 2016122722A1 US 2015051203 W US2015051203 W US 2015051203W WO 2016122722 A1 WO2016122722 A1 WO 2016122722A1
Authority
WO
WIPO (PCT)
Prior art keywords
aqueous pharmaceutical
pharmaceutical solution
temperature
filter
solution
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.)
Ceased
Application number
PCT/US2015/051203
Other languages
English (en)
French (fr)
Inventor
Rakefet Cohen
Sasson Habbah
Muhammad Safadi
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.)
Teva Pharmaceutical Industries Ltd
Teva Pharmaceuticals USA Inc
Original Assignee
Teva Pharmaceutical Industries Ltd
Teva Pharmaceuticals USA 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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=54199060&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=WO2016122722(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Priority to UAA201610444A priority Critical patent/UA116060C2/uk
Priority to CN201580071551.XA priority patent/CN107530394B/zh
Priority to AU2015380381A priority patent/AU2015380381B2/en
Priority to MX2016011219A priority patent/MX352734B/es
Priority to KR1020177012458A priority patent/KR102268210B1/ko
Priority to KR1020167028604A priority patent/KR101737295B1/ko
Priority to BR112016023736A priority patent/BR112016023736A2/pt
Priority to EP15880609.1A priority patent/EP3113785A4/en
Priority to US15/510,156 priority patent/US20170312331A1/en
Priority to EA201691790A priority patent/EA028484B1/ru
Priority to NZ724875A priority patent/NZ724875B2/en
Priority to CA2945537A priority patent/CA2945537C/en
Application filed by Teva Pharmaceutical Industries Ltd, Teva Pharmaceuticals USA Inc filed Critical Teva Pharmaceutical Industries Ltd
Priority to RU2017104222A priority patent/RU2669769C2/ru
Priority to JP2017534813A priority patent/JP2018503627A/ja
Publication of WO2016122722A1 publication Critical patent/WO2016122722A1/en
Priority to IL247851A priority patent/IL247851A0/en
Priority to ZA2016/06903A priority patent/ZA201606903B/en
Anticipated expiration legal-status Critical
Priority to IL267152A priority patent/IL267152A/en
Priority to IL277601A priority patent/IL277601B/en
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/02—Peptides of undefined number of amino acids; Derivatives thereof
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/03—Peptides having up to 20 amino acids in an undefined or only partially defined sequence; Derivatives thereof
    • 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
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/08—Solutions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm rests
    • A61M5/178—Syringes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P21/00—Drugs for disorders of the muscular or neuromuscular system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/14—Drugs for disorders of the nervous system for treating abnormal movements, e.g. chorea, dyskinesia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders

Definitions

  • Copaxone® is a clear, colorless to slightly yellow, sterile, nonpyrogenic solution for subcutaneous injection.
  • Each 1 mL of Copaxone® solution contains 20mg or 40mg of GA, the active ingredient, and 40mg of mannitol.
  • the pH of the solutions is approximately 5.5 to 7.0.
  • Copaxone® 20mg/mL in a prefilled syringe (PFS) is an approved product, the safety and efficacy of which are supported by over two decades of clinical research and over a decade of post-marketing experience.
  • Copaxone® 40mg/mL in a PFS was developed as a new formulation of the active ingredient GA.
  • This patent also provides a prefilled syringe containing 40mg of glatiramer acetate and 40mg mannitol, which syringe is prepared by a process of the invention.
  • the aqueous pharmaceutical solution is passed through the second filter at a rate of 3-25 liters/hour.
  • the pressure during the filtering step (ii) and the pressure during the filling step (iii) is maintained below 2.0 bar.
  • the temperature of the aqueous pharmaceutical solution is between 0°C and 14°C, or the temperature of the aqueous pharmaceutical solution is reduced to a temperature between 0°C and 14°C.
  • the process further comprises a step of lyophilizing the filtrate after it has been filled into the suitable container so as to form a lyophilized powder of glatiramer acetate and mannitol in the suitable container.
  • the aqueous pharmaceutical solution comprises glatiramer acetate having a viscosity in the range of 2.3-3.2 cPa.
  • the obtaining step (i) comprises compounding the aqueous pharmaceutical solution in a compounding vessel.
  • the process further comprises the step of reducing the temperature of the first filter to a temperature from above 0°C up to 17.5 °C.
  • compositions of Copaxone® 20mg/mL and Copaxone® 40mg/mL are detailed in Table 1.
  • Water for injection is the most widely used solvent and inert vehicle in parenteral formulations. Water is chemically stable in all physical states. It is the base for many biological life forms, and its safety in pharmaceutical formulations is unquestioned.
  • the first objective of Experiment No. 2 was to evaluate whether local cooling of GA 40mg/mL solution using a Heat Exchanger (HE) could improve the filterability through cooled Filter B compared to filterability of the same bulk solution at controlled room temperature.
  • HE Heat Exchanger
  • Reducing the temperature of the GA 40mg/mL bulk solution in the receiving vessel significantly reduces impairment of filterability caused by the total duration of the process (holding time) as well as by filtering larger volume, compared to the same bulk solution held under controlled room temperature.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Immunology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Dermatology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Anesthesiology (AREA)
  • Hematology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Psychology (AREA)
  • Hospice & Palliative Care (AREA)
  • Psychiatry (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
PCT/US2015/051203 2015-01-28 2015-09-21 Process for manufacturing glatiramer acetate product Ceased WO2016122722A1 (en)

Priority Applications (18)

Application Number Priority Date Filing Date Title
JP2017534813A JP2018503627A (ja) 2015-01-28 2015-09-21 酢酸グラチラマーの製造方法
NZ724875A NZ724875B2 (en) 2015-09-21 Process for manufacturing glatiramer acetate product
AU2015380381A AU2015380381B2 (en) 2015-01-28 2015-09-21 Process for manufacturing glatiramer acetate product
MX2016011219A MX352734B (es) 2015-01-28 2015-09-21 Procedimiento para fabricar un producto de acetato de glatiramer.
KR1020177012458A KR102268210B1 (ko) 2015-01-28 2015-09-21 글라티라머 아세테이트 제품의 제조 방법
KR1020167028604A KR101737295B1 (ko) 2015-01-28 2015-09-21 글라티라머 아세테이트 제품의 제조 방법
BR112016023736A BR112016023736A2 (pt) 2015-01-28 2015-09-21 processo para a fabricação de produto de acetato de glatiramer
EP15880609.1A EP3113785A4 (en) 2015-01-28 2015-09-21 Process for manufacturing glatiramer acetate product
US15/510,156 US20170312331A1 (en) 2015-01-28 2015-09-21 Process for manufacturing glatiramer acetate product
UAA201610444A UA116060C2 (uk) 2015-01-28 2015-09-21 Спосіб одержання продукту на основі глатирамеру ацетату
CA2945537A CA2945537C (en) 2015-01-28 2015-09-21 Process for manufacturing glatiramer acetate product
CN201580071551.XA CN107530394B (zh) 2015-01-28 2015-09-21 制备醋酸格拉替雷产品的方法
EA201691790A EA028484B1 (ru) 2015-01-28 2015-09-21 Способ получения предварительно заполненного шприца, содержащего глатирамера ацетата
RU2017104222A RU2669769C2 (ru) 2015-01-28 2015-09-21 Способ получения продукта глатирамера ацетата
IL247851A IL247851A0 (en) 2015-01-28 2016-09-15 A process for producing a preparation containing glatiramer acetate
ZA2016/06903A ZA201606903B (en) 2015-01-28 2016-10-07 Process for manufacturing glatiramer acetate product
IL267152A IL267152A (en) 2015-01-28 2019-06-06 A process for producing a preparation containing glatiramer acetate
IL277601A IL277601B (en) 2015-01-28 2020-09-24 A process for producing a preparation containing glatiramer acetate

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US14/608,126 US9155775B1 (en) 2015-01-28 2015-01-28 Process for manufacturing glatiramer acetate product
US14/608,126 2015-01-28

Publications (1)

Publication Number Publication Date
WO2016122722A1 true WO2016122722A1 (en) 2016-08-04

Family

ID=54199060

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2015/051203 Ceased WO2016122722A1 (en) 2015-01-28 2015-09-21 Process for manufacturing glatiramer acetate product

Country Status (31)

Country Link
US (6) US9155775B1 (cg-RX-API-DMAC10.html)
EP (3) EP3113785A4 (cg-RX-API-DMAC10.html)
JP (2) JP2018503627A (cg-RX-API-DMAC10.html)
KR (2) KR101737295B1 (cg-RX-API-DMAC10.html)
CN (1) CN107530394B (cg-RX-API-DMAC10.html)
AR (1) AR102096A1 (cg-RX-API-DMAC10.html)
AU (4) AU2015380381B2 (cg-RX-API-DMAC10.html)
BR (1) BR112016023736A2 (cg-RX-API-DMAC10.html)
CA (2) CA2965890A1 (cg-RX-API-DMAC10.html)
CL (1) CL2016002607A1 (cg-RX-API-DMAC10.html)
CY (1) CY1118826T1 (cg-RX-API-DMAC10.html)
DK (1) DK3050556T3 (cg-RX-API-DMAC10.html)
EA (3) EA028484B1 (cg-RX-API-DMAC10.html)
ES (1) ES2584190T3 (cg-RX-API-DMAC10.html)
HK (1) HK1225309B (cg-RX-API-DMAC10.html)
HR (1) HRP20170625T1 (cg-RX-API-DMAC10.html)
HU (1) HUE034059T2 (cg-RX-API-DMAC10.html)
IL (3) IL247851A0 (cg-RX-API-DMAC10.html)
LT (1) LT3050556T (cg-RX-API-DMAC10.html)
ME (1) ME02721B (cg-RX-API-DMAC10.html)
MX (1) MX352734B (cg-RX-API-DMAC10.html)
PE (1) PE20170296A1 (cg-RX-API-DMAC10.html)
PL (1) PL3050556T3 (cg-RX-API-DMAC10.html)
PT (1) PT3050556T (cg-RX-API-DMAC10.html)
RS (1) RS55959B1 (cg-RX-API-DMAC10.html)
RU (1) RU2669769C2 (cg-RX-API-DMAC10.html)
SI (1) SI3050556T1 (cg-RX-API-DMAC10.html)
SM (1) SMT201700227T1 (cg-RX-API-DMAC10.html)
UA (1) UA116060C2 (cg-RX-API-DMAC10.html)
WO (1) WO2016122722A1 (cg-RX-API-DMAC10.html)
ZA (1) ZA201606903B (cg-RX-API-DMAC10.html)

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USRE49251E1 (en) 2010-01-04 2022-10-18 Mapi Pharma Ltd. Depot systems comprising glatiramer or pharmacologically acceptable salt thereof
EA025780B1 (ru) 2010-10-11 2017-01-30 Тева Фармасьютикал Индастриз Лтд. Цитокиновые биомаркеры в качестве биомаркеров, прогнозирующих клинический ответ на глатирамер ацетат
MX2014004309A (es) 2011-10-10 2015-07-06 Teva Pharma Polimorfismos de nucleotidos individuales utiles para predecir una respuesta clinica para el acetato de glatiramer.
WO2014058976A2 (en) 2012-10-10 2014-04-17 Teva Pharmaceutical Industries Ltd. Biomarkers predictive for clinical response for glatiramer acetate
UY35790A (es) 2013-10-21 2015-05-29 Teva Pharma Marcadores genéticos que predicen la respuesta al acetato de glatiramer
US9155775B1 (en) 2015-01-28 2015-10-13 Teva Pharmaceutical Industries, Ltd. Process for manufacturing glatiramer acetate product
CN107550853B (zh) * 2016-06-30 2020-06-12 深圳翰宇药业股份有限公司 一种醋酸格拉替雷注射液的制备方法
US12097292B2 (en) 2016-08-28 2024-09-24 Mapi Pharma Ltd. Process for preparing microparticles containing glatiramer acetate
AU2017319728B2 (en) 2016-08-31 2024-09-05 Mapi Pharma Ltd Depot systems comprising glatiramer acetate
CA3045944A1 (en) 2016-12-07 2018-06-14 Progenity, Inc. Gastrointestinal tract detection methods, devices and systems
IL316573A (en) 2017-03-26 2024-12-01 Mapi Pharma Ltd Storage systems containing glatiramer acetate for the treatment of multiple sclerosis
AU2017420758A1 (en) 2017-06-29 2020-01-02 Regeneron Pharmaceuticals Inc. Devices and methods for overfilling drug containers
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CN112933210A (zh) * 2019-12-11 2021-06-11 深圳翰宇药业股份有限公司 一种西曲瑞克冻干药物组合物的制备方法

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