CN104994847B - 美法仑氟灭酰胺的冻干制剂 - Google Patents
美法仑氟灭酰胺的冻干制剂 Download PDFInfo
- Publication number
- CN104994847B CN104994847B CN201380063592.5A CN201380063592A CN104994847B CN 104994847 B CN104994847 B CN 104994847B CN 201380063592 A CN201380063592 A CN 201380063592A CN 104994847 B CN104994847 B CN 104994847B
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- CN
- China
- Prior art keywords
- sucrose
- freeze
- pharmaceutical formulation
- melphalan flufenamide
- fluorine
- 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.)
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Classifications
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- 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
- A61J—CONTAINERS 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
- A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
- A61J3/02—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of powders
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/21—Esters, e.g. nitroglycerine, selenocyanates
- A61K31/215—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
- A61K31/22—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acyclic acids, e.g. pravastatin
- A61K31/223—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acyclic acids, e.g. pravastatin of alpha-aminoacids
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/21—Esters, e.g. nitroglycerine, selenocyanates
- A61K31/26—Cyanate or isocyanate esters; Thiocyanate or isothiocyanate esters
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
- A61K38/05—Dipeptides
-
- 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
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
-
- 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
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
- A61P35/02—Antineoplastic agents specific for leukemia
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2121/00—Preparations for use in therapy
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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Public Health (AREA)
- Medicinal Chemistry (AREA)
- Veterinary Medicine (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Biochemistry (AREA)
- Molecular Biology (AREA)
- Gastroenterology & Hepatology (AREA)
- Immunology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Emergency Medicine (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Oncology (AREA)
- Hematology (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Medicinal Preparation (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201810826176.0A CN108685860B (zh) | 2012-10-26 | 2013-10-24 | 美法仑氟灭酰胺的冻干制剂 |
Applications Claiming Priority (5)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201261719184P | 2012-10-26 | 2012-10-26 | |
| SE1251211 | 2012-10-26 | ||
| US61/719,184 | 2012-10-26 | ||
| SE1251211-7 | 2012-10-26 | ||
| PCT/SE2013/051246 WO2014065751A1 (en) | 2012-10-26 | 2013-10-24 | Lyophilized preparations of melphalan flufenamide |
Related Child Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201810826176.0A Division CN108685860B (zh) | 2012-10-26 | 2013-10-24 | 美法仑氟灭酰胺的冻干制剂 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN104994847A CN104994847A (zh) | 2015-10-21 |
| CN104994847B true CN104994847B (zh) | 2018-08-10 |
Family
ID=50544986
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201380063592.5A Active CN104994847B (zh) | 2012-10-26 | 2013-10-24 | 美法仑氟灭酰胺的冻干制剂 |
| CN201810826176.0A Active CN108685860B (zh) | 2012-10-26 | 2013-10-24 | 美法仑氟灭酰胺的冻干制剂 |
Family Applications After (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201810826176.0A Active CN108685860B (zh) | 2012-10-26 | 2013-10-24 | 美法仑氟灭酰胺的冻干制剂 |
Country Status (18)
| Country | Link |
|---|---|
| US (2) | US10285946B2 (enExample) |
| EP (2) | EP3628318A1 (enExample) |
| JP (1) | JP6284945B2 (enExample) |
| KR (1) | KR102205592B1 (enExample) |
| CN (2) | CN104994847B (enExample) |
| AU (1) | AU2013335359B2 (enExample) |
| BR (1) | BR112015009280B1 (enExample) |
| CA (1) | CA2889753C (enExample) |
| CY (1) | CY1122483T1 (enExample) |
| IL (1) | IL238398B (enExample) |
| MX (1) | MX365205B (enExample) |
| NZ (1) | NZ708016A (enExample) |
| PL (1) | PL2928463T3 (enExample) |
| RS (1) | RS60068B1 (enExample) |
| RU (1) | RU2643762C2 (enExample) |
| SI (1) | SI2928463T1 (enExample) |
| SM (1) | SMT202000058T1 (enExample) |
| WO (1) | WO2014065751A1 (enExample) |
Families Citing this family (16)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| HUE037863T2 (hu) | 2011-04-28 | 2018-09-28 | Oncopeptides Ab | Citotoxikus dipeptidek liofilizált készítménye |
| BR112015009280B1 (pt) | 2012-10-26 | 2022-05-31 | Oncopeptides Ab | Preparação farmacêutica liofilizada de melfalana flufenamida, composição e kit de combinação de partes |
| GB201507903D0 (en) | 2015-05-08 | 2015-06-24 | Oncopeptides Ab | Process for preparation of nitrogen mustard derivatives |
| GB201521217D0 (en) * | 2015-12-01 | 2016-01-13 | Oncopeptides Ab | Dosage regimens |
| AU2019243707B2 (en) | 2018-03-29 | 2023-12-07 | Airway Therapeutics, Inc. | Methods and compositions comprising surfactant protein D (SP-D) |
| US12385894B2 (en) | 2018-03-29 | 2025-08-12 | Airway Therapeutics, Inc. | Systems and methods for characterizing surfactant protein D (SP-D) oligomers |
| MA53904A (fr) * | 2018-10-18 | 2021-08-25 | Oncopeptides Ab | Composés contenant du deutérium |
| JP2022527532A (ja) | 2019-04-03 | 2022-06-02 | オンコペプティデス エービー | メルフルフェンによるａｌアミロイドーシスの治療 |
| GB201905477D0 (en) | 2019-04-17 | 2019-05-29 | Oncopeptides Ab | Novel formulations |
| WO2021053185A1 (en) | 2019-09-20 | 2021-03-25 | Oncopeptides Ab | Melflufen formulations and their use in the treatment or prophylaxis of osteosarcoma |
| GB202109895D0 (en) | 2021-07-08 | 2021-08-25 | Oncopeptides Ab | Novel treatments |
| GB202109896D0 (en) | 2021-07-08 | 2021-08-25 | Oncopeptides Ab | Novel treatments |
| EP4366721A1 (en) | 2021-07-08 | 2024-05-15 | Oncopeptides Innovation AB | Melflufen for use in the treatment of multiple myeloma |
| GB202109894D0 (en) | 2021-07-08 | 2021-08-25 | Oncopeptides Ab | Novel treatments |
| KR102757193B1 (ko) * | 2021-10-19 | 2025-01-21 | 단국대학교 천안캠퍼스 산학협력단 | 피리미딘-2,4-다이온 유도체를 유효성분으로 포함하는 근감소증의 예방 또는 치료용 조성물 |
| GB202204171D0 (en) | 2022-03-24 | 2022-05-11 | Oncopeptides Ab | Novel formulations |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2001096367A1 (en) * | 2000-06-13 | 2001-12-20 | Oncopeptides Ab | Melphalan derivatives and their use as cancer chemotherapeutic drugs |
| CN101584669A (zh) * | 2009-06-19 | 2009-11-25 | 江苏奥赛康药业有限公司 | 美法仑冻干粉针剂 |
Family Cites Families (16)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| GB8727157D0 (en) | 1987-11-19 | 1987-12-23 | Wellcome Found | Pharmaceutical formulations |
| DE60141398D1 (de) * | 2000-06-13 | 2010-04-08 | Oncopeptides Ab | Melphalan-derivate und ihre verwendung als chemotherapeutika gegen krebs |
| EP1438019A1 (en) * | 2001-10-24 | 2004-07-21 | PARI GmbH Spezialisten für effektive Inhalation | Kit for the preparation of a pharmaceutical composition |
| US6780324B2 (en) | 2002-03-18 | 2004-08-24 | Labopharm, Inc. | Preparation of sterile stabilized nanodispersions |
| US7323479B2 (en) | 2002-05-17 | 2008-01-29 | Celgene Corporation | Methods for treatment and management of brain cancer using 1-oxo-2-(2,6-dioxopiperidin-3-yl)-4-methylisoindoline |
| US20040034099A1 (en) * | 2002-06-27 | 2004-02-19 | Ramsey Beverly J. | Pharmaceutical composition |
| US20050152979A1 (en) | 2003-09-05 | 2005-07-14 | Cell Therapeutics, Inc. | Hydrophobic drug compositions containing reconstitution enhancer |
| EP1674098A1 (en) | 2004-12-23 | 2006-06-28 | Schering Aktiengesellschaft | Stable and tolerable parental formulations of highly reactive organic drug substances with low or no solubility in water |
| GB0522082D0 (en) | 2005-10-31 | 2005-12-07 | Pharma Mar Sa | Formulations |
| AR061969A1 (es) * | 2006-07-07 | 2008-08-10 | Gilead Sciences Inc | Derivados halogenados de imidazo-piridino, metodo de preparacion, composiciones farmaceuticas que los contienen y usos como agentes anti vhc |
| PT2101731T (pt) * | 2006-11-21 | 2018-04-18 | Jina Pharmaceuticals Inc | Endoxifeno para utilização no tratamento de cancro |
| WO2011078782A1 (en) | 2009-12-22 | 2011-06-30 | Oncopeptides Ab | A composition comprising of melphalan derivatives and gemcitabine or etoposide useful in the treatment of cancer |
| AR077384A1 (es) | 2010-07-05 | 2011-08-24 | Eriochem Sa | Una formulacion farmaceutica inyectable de melfalano. |
| CA2832410C (en) | 2011-04-15 | 2019-07-23 | Janssen Pharmaceutica Nv | Freeze dried drug nanosuspensions |
| HUE037863T2 (hu) | 2011-04-28 | 2018-09-28 | Oncopeptides Ab | Citotoxikus dipeptidek liofilizált készítménye |
| BR112015009280B1 (pt) | 2012-10-26 | 2022-05-31 | Oncopeptides Ab | Preparação farmacêutica liofilizada de melfalana flufenamida, composição e kit de combinação de partes |
-
2013
- 2013-10-24 BR BR112015009280-2A patent/BR112015009280B1/pt active IP Right Grant
- 2013-10-24 AU AU2013335359A patent/AU2013335359B2/en active Active
- 2013-10-24 RS RS20200116A patent/RS60068B1/sr unknown
- 2013-10-24 SM SM20200058T patent/SMT202000058T1/it unknown
- 2013-10-24 CN CN201380063592.5A patent/CN104994847B/zh active Active
- 2013-10-24 CA CA2889753A patent/CA2889753C/en active Active
- 2013-10-24 JP JP2015539556A patent/JP6284945B2/ja active Active
- 2013-10-24 SI SI201331667T patent/SI2928463T1/sl unknown
- 2013-10-24 NZ NZ708016A patent/NZ708016A/en unknown
- 2013-10-24 MX MX2015005217A patent/MX365205B/es active IP Right Grant
- 2013-10-24 CN CN201810826176.0A patent/CN108685860B/zh active Active
- 2013-10-24 EP EP19207842.6A patent/EP3628318A1/en active Pending
- 2013-10-24 WO PCT/SE2013/051246 patent/WO2014065751A1/en not_active Ceased
- 2013-10-24 RU RU2015118581A patent/RU2643762C2/ru active
- 2013-10-24 EP EP13849763.1A patent/EP2928463B1/en active Active
- 2013-10-24 US US14/438,473 patent/US10285946B2/en active Active
- 2013-10-24 PL PL13849763T patent/PL2928463T3/pl unknown
- 2013-10-24 KR KR1020157013026A patent/KR102205592B1/ko active Active
-
2015
- 2015-04-21 IL IL238398A patent/IL238398B/en active IP Right Grant
-
2016
- 2016-05-09 US US15/149,975 patent/US10285947B2/en active Active
-
2020
- 2020-01-13 CY CY20201100028T patent/CY1122483T1/el unknown
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2001096367A1 (en) * | 2000-06-13 | 2001-12-20 | Oncopeptides Ab | Melphalan derivatives and their use as cancer chemotherapeutic drugs |
| CN101584669A (zh) * | 2009-06-19 | 2009-11-25 | 江苏奥赛康药业有限公司 | 美法仑冻干粉针剂 |
Non-Patent Citations (2)
| Title |
|---|
| Excipients and their use in injectable products;NEMA, S, ET AL;《Journal of Pharmaceutical Science and Technology》;19971231;第51卷(第4期);166-171 * |
| Excipients used in lyophilization of small molecules;BAHETI，A. ET AL;《Journal of Excipients and Food Chemicals》;20101231;第1卷(第1期);41-54 * |
Also Published As
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Legal Events
| Date | Code | Title | Description |
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| C06 | Publication | ||
| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| REG | Reference to a national code |
Ref country code: HK Ref legal event code: DE Ref document number: 1216501 Country of ref document: HK |
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| CB02 | Change of applicant information |
Address after: Stockholm Applicant after: ONCOPEPTIDES AB Address before: Solna, Sweden Applicant before: ONCOPEPTIDES AB |
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| CB02 | Change of applicant information | ||
| GR01 | Patent grant | ||
| GR01 | Patent grant | ||
| TR01 | Transfer of patent right |
Effective date of registration: 20241126 Address after: Stockholm, Sweden Patentee after: Tumor Peptide Innovation Co.,Ltd. Country or region after: Sweden Address before: Stockholm, Sweden Patentee before: ONCOPEPTIDES AB Country or region before: Sweden |
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| TR01 | Transfer of patent right |