HRP20201300T1 - Liofilizirani pripravak citotoksičnih dipeptida - Google Patents
Liofilizirani pripravak citotoksičnih dipeptida Download PDFInfo
- Publication number
- HRP20201300T1 HRP20201300T1 HRP20201300TT HRP20201300T HRP20201300T1 HR P20201300 T1 HRP20201300 T1 HR P20201300T1 HR P20201300T T HRP20201300T T HR P20201300TT HR P20201300 T HRP20201300 T HR P20201300T HR P20201300 T1 HRP20201300 T1 HR P20201300T1
- Authority
- HR
- Croatia
- Prior art keywords
- cyclodextrin
- pharmaceutical preparation
- lyophilized pharmaceutical
- melphalan flufenamide
- solution
- Prior art date
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- 238000002360 preparation method Methods 0.000 title claims 3
- 108010016626 Dipeptides Proteins 0.000 title 1
- 231100000433 cytotoxic Toxicity 0.000 title 1
- 230000001472 cytotoxic effect Effects 0.000 title 1
- YQZNKYXGZSVEHI-VXKWHMMOSA-N ethyl (2s)-2-[[(2s)-2-amino-3-[4-[bis(2-chloroethyl)amino]phenyl]propanoyl]amino]-3-(4-fluorophenyl)propanoate Chemical compound C([C@@H](C(=O)OCC)NC(=O)[C@@H](N)CC=1C=CC(=CC=1)N(CCCl)CCCl)C1=CC=C(F)C=C1 YQZNKYXGZSVEHI-VXKWHMMOSA-N 0.000 claims 13
- 229950009924 melphalan flufenamide Drugs 0.000 claims 13
- 239000000825 pharmaceutical preparation Substances 0.000 claims 13
- 239000000243 solution Substances 0.000 claims 11
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims 9
- DNIAPMSPPWPWGF-UHFFFAOYSA-N Propylene glycol Chemical compound CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 claims 6
- 206010028980 Neoplasm Diseases 0.000 claims 4
- DKGAVHZHDRPRBM-UHFFFAOYSA-N Tert-Butanol Chemical compound CC(C)(C)O DKGAVHZHDRPRBM-UHFFFAOYSA-N 0.000 claims 4
- 201000011510 cancer Diseases 0.000 claims 4
- 238000000034 method Methods 0.000 claims 4
- 239000003960 organic solvent Substances 0.000 claims 4
- 239000000546 pharmaceutical excipient Substances 0.000 claims 4
- 150000003839 salts Chemical class 0.000 claims 4
- QTBSBXVTEAMEQO-UHFFFAOYSA-N Acetic acid Chemical compound CC(O)=O QTBSBXVTEAMEQO-UHFFFAOYSA-N 0.000 claims 3
- CSCPPACGZOOCGX-UHFFFAOYSA-N Acetone Chemical compound CC(C)=O CSCPPACGZOOCGX-UHFFFAOYSA-N 0.000 claims 3
- WEVYAHXRMPXWCK-UHFFFAOYSA-N Acetonitrile Chemical compound CC#N WEVYAHXRMPXWCK-UHFFFAOYSA-N 0.000 claims 3
- 229920001450 Alpha-Cyclodextrin Polymers 0.000 claims 3
- WVDDGKGOMKODPV-UHFFFAOYSA-N Benzyl alcohol Chemical compound OCC1=CC=CC=C1 WVDDGKGOMKODPV-UHFFFAOYSA-N 0.000 claims 3
- 229920000858 Cyclodextrin Polymers 0.000 claims 3
- 239000001116 FEMA 4028 Substances 0.000 claims 3
- OKKJLVBELUTLKV-UHFFFAOYSA-N Methanol Chemical compound OC OKKJLVBELUTLKV-UHFFFAOYSA-N 0.000 claims 3
- ZMXDDKWLCZADIW-UHFFFAOYSA-N N,N-Dimethylformamide Chemical compound CN(C)C=O ZMXDDKWLCZADIW-UHFFFAOYSA-N 0.000 claims 3
- HFHDHCJBZVLPGP-RWMJIURBSA-N alpha-cyclodextrin Chemical compound OC[C@H]([C@H]([C@@H]([C@H]1O)O)O[C@H]2O[C@@H]([C@@H](O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O3)[C@H](O)[C@H]2O)CO)O[C@@H]1O[C@H]1[C@H](O)[C@@H](O)[C@@H]3O[C@@H]1CO HFHDHCJBZVLPGP-RWMJIURBSA-N 0.000 claims 3
- 229940043377 alpha-cyclodextrin Drugs 0.000 claims 3
- WHGYBXFWUBPSRW-FOUAGVGXSA-N beta-cyclodextrin Chemical compound OC[C@H]([C@H]([C@@H]([C@H]1O)O)O[C@H]2O[C@@H]([C@@H](O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O3)[C@H](O)[C@H]2O)CO)O[C@@H]1O[C@H]1[C@H](O)[C@@H](O)[C@@H]3O[C@@H]1CO WHGYBXFWUBPSRW-FOUAGVGXSA-N 0.000 claims 3
- 235000011175 beta-cyclodextrine Nutrition 0.000 claims 3
- 229960004853 betadex Drugs 0.000 claims 3
- 229940097346 sulfobutylether-beta-cyclodextrin Drugs 0.000 claims 3
- ODLHGICHYURWBS-LKONHMLTSA-N trappsol cyclo Chemical compound CC(O)COC[C@H]([C@H]([C@@H]([C@H]1O)O)O[C@H]2O[C@@H]([C@@H](O[C@H]3O[C@H](COCC(C)O)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](COCC(C)O)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](COCC(C)O)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](COCC(C)O)[C@H]([C@@H]([C@H]3O)O)O3)[C@H](O)[C@H]2O)COCC(O)C)O[C@@H]1O[C@H]1[C@H](O)[C@@H](O)[C@@H]3O[C@@H]1COCC(C)O ODLHGICHYURWBS-LKONHMLTSA-N 0.000 claims 3
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims 3
- IAZDPXIOMUYVGZ-UHFFFAOYSA-N Dimethylsulphoxide Chemical compound CS(C)=O IAZDPXIOMUYVGZ-UHFFFAOYSA-N 0.000 claims 2
- 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 2
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims 2
- KFZMGEQAYNKOFK-UHFFFAOYSA-N Isopropanol Chemical compound CC(C)O KFZMGEQAYNKOFK-UHFFFAOYSA-N 0.000 claims 2
- BZLVMXJERCGZMT-UHFFFAOYSA-N Methyl tert-butyl ether Chemical compound COC(C)(C)C BZLVMXJERCGZMT-UHFFFAOYSA-N 0.000 claims 2
- FXHOOIRPVKKKFG-UHFFFAOYSA-N N,N-Dimethylacetamide Chemical compound CN(C)C(C)=O FXHOOIRPVKKKFG-UHFFFAOYSA-N 0.000 claims 2
- LRHPLDYGYMQRHN-UHFFFAOYSA-N N-Butanol Chemical compound CCCCO LRHPLDYGYMQRHN-UHFFFAOYSA-N 0.000 claims 2
- WYURNTSHIVDZCO-UHFFFAOYSA-N Tetrahydrofuran Chemical compound C1CCOC1 WYURNTSHIVDZCO-UHFFFAOYSA-N 0.000 claims 2
- 239000007864 aqueous solution Substances 0.000 claims 2
- BTANRVKWQNVYAZ-UHFFFAOYSA-N butan-2-ol Chemical compound CCC(C)O BTANRVKWQNVYAZ-UHFFFAOYSA-N 0.000 claims 2
- XBDQKXXYIPTUBI-UHFFFAOYSA-N dimethylselenoniopropionate Natural products CCC(O)=O XBDQKXXYIPTUBI-UHFFFAOYSA-N 0.000 claims 2
- 238000004108 freeze drying Methods 0.000 claims 2
- 239000008103 glucose Substances 0.000 claims 2
- JVTAAEKCZFNVCJ-UHFFFAOYSA-N lactic acid Chemical compound CC(O)C(O)=O JVTAAEKCZFNVCJ-UHFFFAOYSA-N 0.000 claims 2
- BDERNNFJNOPAEC-UHFFFAOYSA-N propan-1-ol Chemical compound CCCO BDERNNFJNOPAEC-UHFFFAOYSA-N 0.000 claims 2
- 239000000126 substance Substances 0.000 claims 2
- RYHBNJHYFVUHQT-UHFFFAOYSA-N 1,4-Dioxane Chemical compound C1COCCO1 RYHBNJHYFVUHQT-UHFFFAOYSA-N 0.000 claims 1
- JWUJQDFVADABEY-UHFFFAOYSA-N 2-methyltetrahydrofuran Chemical compound CC1CCCO1 JWUJQDFVADABEY-UHFFFAOYSA-N 0.000 claims 1
- 206010005003 Bladder cancer Diseases 0.000 claims 1
- 206010006187 Breast cancer Diseases 0.000 claims 1
- 208000026310 Breast neoplasm Diseases 0.000 claims 1
- 206010058467 Lung neoplasm malignant Diseases 0.000 claims 1
- 206010027406 Mesothelioma Diseases 0.000 claims 1
- 208000034578 Multiple myelomas Diseases 0.000 claims 1
- -1 N-methyl-2-pyrrolidone isopropanol n-butanol Chemical compound 0.000 claims 1
- 206010033128 Ovarian cancer Diseases 0.000 claims 1
- 206010061535 Ovarian neoplasm Diseases 0.000 claims 1
- 206010035226 Plasma cell myeloma Diseases 0.000 claims 1
- 208000007097 Urinary Bladder Neoplasms Diseases 0.000 claims 1
- 235000011054 acetic acid Nutrition 0.000 claims 1
- 239000002253 acid Substances 0.000 claims 1
- 235000019445 benzyl alcohol Nutrition 0.000 claims 1
- 201000010099 disease Diseases 0.000 claims 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims 1
- 239000003814 drug Substances 0.000 claims 1
- 235000011187 glycerol Nutrition 0.000 claims 1
- 230000002489 hematologic effect Effects 0.000 claims 1
- 239000004310 lactic acid Substances 0.000 claims 1
- 235000014655 lactic acid Nutrition 0.000 claims 1
- 201000005202 lung cancer Diseases 0.000 claims 1
- 208000020816 lung neoplasm Diseases 0.000 claims 1
- 239000000203 mixture Substances 0.000 claims 1
- 230000002265 prevention Effects 0.000 claims 1
- 235000019260 propionic acid Nutrition 0.000 claims 1
- 235000013772 propylene glycol Nutrition 0.000 claims 1
- IUVKMZGDUIUOCP-BTNSXGMBSA-N quinbolone Chemical compound O([C@H]1CC[C@H]2[C@H]3[C@@H]([C@]4(C=CC(=O)C=C4CC3)C)CC[C@@]21C)C1=CCCC1 IUVKMZGDUIUOCP-BTNSXGMBSA-N 0.000 claims 1
- YLQBMQCUIZJEEH-UHFFFAOYSA-N tetrahydrofuran Natural products C=1C=COC=1 YLQBMQCUIZJEEH-UHFFFAOYSA-N 0.000 claims 1
- 201000005112 urinary bladder cancer Diseases 0.000 claims 1
Classifications
-
- 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
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
-
- 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
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
- A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid
- A61K31/198—Alpha-amino acids, e.g. alanine or edetic acid [EDTA]
-
- 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
- A61K31/222—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acyclic acids, e.g. pravastatin with compounds having aromatic groups, e.g. dipivefrine, ibopamine
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
-
- 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
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- 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
- A61K38/10—Peptides having 12 to 20 amino acids
- A61K38/105—Bombesin; Related peptides
-
- 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
- A61K47/02—Inorganic compounds
-
- 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
- A61K47/12—Carboxylic acids; Salts or anhydrides 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
- 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
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/40—Cyclodextrins; 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
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
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- 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
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- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
- F26—DRYING
- F26B—DRYING SOLID MATERIALS OR OBJECTS BY REMOVING LIQUID THEREFROM
- F26B5/00—Drying solid materials or objects by processes not involving the application of heat
- F26B5/04—Drying solid materials or objects by processes not involving the application of heat by evaporation or sublimation of moisture under reduced pressure, e.g. in a vacuum
- F26B5/06—Drying solid materials or objects by processes not involving the application of heat by evaporation or sublimation of moisture under reduced pressure, e.g. in a vacuum the process involving freezing
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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Immunology (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Inorganic Chemistry (AREA)
- Gastroenterology & Hepatology (AREA)
- Molecular Biology (AREA)
- Biochemistry (AREA)
- Emergency Medicine (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Oncology (AREA)
- Mechanical Engineering (AREA)
- Hematology (AREA)
- General Engineering & Computer Science (AREA)
- Medicinal Preparation (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Micro-Organisms Or Cultivation Processes Thereof (AREA)
- Peptides Or Proteins (AREA)
Claims (17)
1. Liofilizirani farmaceutski pripravak, naznačen time, da sadržava
i. melfalan flufenamid ili njegovu farmaceutski prihvatljivu sol; i
ii. barem jedan ekscipijens izabran iz skupine koju tvore β-ciklodekstrin; α-ciklodekstrin; hidroksipropil-β-ciklodekstrin; i sulfobutileter- β -ciklodekstrin.
2. Liofilizirani farmaceutski pripravak u skladu s patentnim zahtjevom 1, naznačen time, da je količina pomoćne tvari oko 10 do 100 % težinskog udjela navedenog melfalan flufenamida.
3. Liofilizirani farmaceutski pripravak u skladu s patentnim zahtjevom 2, naznačen time, da je količina pomoćne tvari 10 do 50 % težinskog udjela navedenog melfalan flufenamida.
4. Liofilizirani farmaceutski pripravak u skladu s bilo kojim od patentnih zahtjeva 1 do 3, naznačen time, da je navedeni melfalan flufenamid melfalan flufenamid hidroklorid (J1).
5. Liofilizirani farmaceutski pripravak u skladu s bilo kojim od patentnih zahtjeva 1 do 4, naznačen time, da dodatno sadržava fiziološki prihvatljivu otopinu.
6. Liofilizirani farmaceutski pripravak u skladu s patentnim zahtjevom 5, naznačen time, da je navedena fiziološki prihvatljiva otopina otopina glukoze.
7. Liofilizirani farmaceutski pripravak u skladu s patentnim zahtjevom 6, naznačen time, da je količina glukoze 4,5 do 5,5 % težinskog udjela liofiliziranog pripravka.
8. Liofilizirani farmaceutski pripravak u skladu s bilo kojim od patentnih zahtjeva 1 do 7, naznačen time, da je slobodan ili u osnovi bez organskih otapala.
9. Komplet kombinacije dijelova, naznačen time, da sadržava
i. liofilizirani farmaceutski pripravak u skladu s bilo kojim od patentnih zahtjeva 1 do 4; i
ii. fiziološki prihvatljivu otopinu.
10. Liofilizirani farmaceutski pripravak u skladu s bilo kojim od patentnih zahtjeva 1 do 4, naznačen time, da se upotrebljava kao lijek.
11. Liofilizirani farmaceutski pripravak u skladu s bilo kojim od patentnih zahtjeva 1 do 4, naznačen time, da je namijenjen upotrebi u liječenju i / ili prevenciji karcinoma.
12. Liofilizirani farmaceutski pripravak za uporabu u skladu s patentnim zahtjevom 11, naznačen time, da je navedeni karcinom bilo koji od sljedećih bolesti: karcinom jajnika, rak pluća, rak mokraćnog mjehura, mezoteliom, multipli mijelom, karcinom dojke ili hematološki rak.
13. Komplet kombinacija dijelova u skladu s patentnim zahtjevom 9, naznačen time, da se upotrebljava za liječenje raka.
14. Postupak za pripremu liofiliziranog farmaceutskog pripravka u skladu s bilo kojim od patentnih zahtjeva 1 do 3, naznačen time, da:
a. melfalan flufenamid ili njegova farmaceutski prihvatljiva sol otopi se u organskom otapalu da se dobije otopina melfalan flufenamida;
b. u otopinu melfalan flufenamida dodaje se voda kako bi se dobila vodena otopina melfalan flufenamida, u koncentraciji od oko 0,2 do 3,0 mg/ml;
c. barem jedan ekscipijens izabran iz skupine koja sadržava β-ciklodekstrin; α-ciklodekstrin; hidroksipropil-β-ciklodekstrin; i sulfobutileter- β-ciklodekstrin dodan je otopini melfalan flufenamida; i
d. vodena otopina melafana flufenamida koja sadržava ekscipijens podvrgnuta je liofilizaciji.
15. Postupak u skladu s patentnim zahtjevom 14, naznačen time, da:
a. melfalan flufenamid, ili njegova farmaceutski prihvatljiva sol, otopljen je u organskom otapalu;
b. u otopinu dobivenu u koraku a) dodaje se voda kako bi se dobila otopina spomenutog melfalan flufenamida ili njegove farmaceutski prihvatljive soli u koncentraciji od oko 0,2 do 3,0 mg / ml;
c. barem jedan ekscipijens izabran iz skupine koja sadržava β-ciklodekstrin; α-ciklodekstrin; hidroksipropil-β-ciklodekstrin; i otopini dobivenoj u koraku b) doda se sulfobutileter- β -ciklodekstrin; i
d. otopina dobivena u koraku c) podvrgnuta je liofilizaciji.
16. Postupak u skladu sa zahtjevom 14 ili 15, naznačen time, da je organsko otapalo odabrano između jednog od sljedećeg: etanola, etanola koji sadržava kiselinu, glicerina, propilen glikola, benzil alkohola dimetilacetamida (DMA), N-metil-2-pirolidona izopropanola n-butanola, terc-butanola, metil terc-butil etera, propilen glikola, dimetilsulfoksida, tetrahidrofurana, 2-metil tetrahidrofurana, acetona, dimetilformamida, acetonitrila, dioksana, octene kiseline, mliječne kiseline, propionske kiseline, n-butanola, izopropanola, n-propanola, terc-butanola, sec-butanola, metanol i mješavine etanola i vode.
17. Postupak u skladu s bilo kojim od patentnih zahtjeva 14 do 16, naznačen time, da je navedeni melafanal flufenamid melfalan flufenamid hidroklorid (J1).
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| SE1150371 | 2011-04-28 | ||
| US201161535126P | 2011-09-15 | 2011-09-15 | |
| EP17173249.8A EP3228319B1 (en) | 2011-04-28 | 2012-04-25 | Lyophilized preparation of cytotoxic dipeptides |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20201300T1 true HRP20201300T1 (hr) | 2020-11-27 |
Family
ID=69569109
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20201300TT HRP20201300T1 (hr) | 2011-04-28 | 2020-08-20 | Liofilizirani pripravak citotoksičnih dipeptida |
Country Status (8)
| Country | Link |
|---|---|
| KR (2) | KR102122429B1 (hr) |
| ES (1) | ES2813979T3 (hr) |
| HK (1) | HK1250492A1 (hr) |
| HR (1) | HRP20201300T1 (hr) |
| HU (1) | HUE051690T4 (hr) |
| IL (1) | IL280812B2 (hr) |
| LT (1) | LT3228319T (hr) |
| PT (1) | PT3228319T (hr) |
Families Citing this family (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2023539154A (ja) * | 2020-08-19 | 2023-09-13 | セラクト ファーマ ジーエムビーエイチ | エトポシドトニリベート製剤 |
| US20240215568A1 (en) * | 2021-04-28 | 2024-07-04 | S&E Bio Co., Ltd. | Freeze-dry protective agent for extracellular vesicles |
| EP4233837A1 (en) * | 2022-02-24 | 2023-08-30 | CellAct Pharma GmbH | Solid and oral etoposide toniribate compositions |
Family Cites Families (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE60141398D1 (de) | 2000-06-13 | 2010-04-08 | Oncopeptides Ab | Melphalan-derivate und ihre verwendung als chemotherapeutika gegen krebs |
| SE0002202D0 (sv) * | 2000-06-13 | 2000-06-13 | Karolinska Innovations Ab | New peptides |
| US6780324B2 (en) * | 2002-03-18 | 2004-08-24 | Labopharm, Inc. | Preparation of sterile stabilized nanodispersions |
| US20040034099A1 (en) * | 2002-06-27 | 2004-02-19 | Ramsey Beverly J. | Pharmaceutical composition |
-
2012
- 2012-04-25 LT LTEP17173249.8T patent/LT3228319T/lt unknown
- 2012-04-25 ES ES17173249T patent/ES2813979T3/es active Active
- 2012-04-25 HU HUE17173249A patent/HUE051690T4/hu unknown
- 2012-04-25 IL IL280812A patent/IL280812B2/en unknown
- 2012-04-25 KR KR1020207003073A patent/KR102122429B1/ko active IP Right Grant
- 2012-04-25 KR KR1020207016300A patent/KR102194376B1/ko active IP Right Grant
- 2012-04-25 PT PT171732498T patent/PT3228319T/pt unknown
-
2018
- 2018-08-01 HK HK18109930.4A patent/HK1250492A1/zh unknown
-
2020
- 2020-08-20 HR HRP20201300TT patent/HRP20201300T1/hr unknown
Also Published As
| Publication number | Publication date |
|---|---|
| IL280812B (en) | 2022-12-01 |
| ES2813979T3 (es) | 2021-03-25 |
| KR20200084890A (ko) | 2020-07-13 |
| PT3228319T (pt) | 2020-08-27 |
| KR102194376B1 (ko) | 2020-12-23 |
| HK1250492A1 (zh) | 2018-12-21 |
| IL280812B2 (en) | 2023-04-01 |
| HUE051690T2 (hu) | 2021-03-29 |
| IL280812A (en) | 2021-04-29 |
| HUE051690T4 (hu) | 2023-09-28 |
| KR20200014947A (ko) | 2020-02-11 |
| KR102122429B1 (ko) | 2020-06-12 |
| LT3228319T (lt) | 2020-09-25 |
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