HRP20231207T1 - Pripravak koji sadrži ibrutinib - Google Patents
Pripravak koji sadrži ibrutinib Download PDFInfo
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- HRP20231207T1 HRP20231207T1 HRP20231207TT HRP20231207T HRP20231207T1 HR P20231207 T1 HRP20231207 T1 HR P20231207T1 HR P20231207T T HRP20231207T T HR P20231207TT HR P20231207 T HRP20231207 T HR P20231207T HR P20231207 T1 HRP20231207 T1 HR P20231207T1
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- Prior art keywords
- sodium
- pharmaceutical preparation
- mixing
- lymphoma
- preparation according
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- 239000002177 L01XE27 - Ibrutinib Substances 0.000 title claims 7
- XYFPWWZEPKGCCK-GOSISDBHSA-N ibrutinib Chemical compound C1=2C(N)=NC=NC=2N([C@H]2CN(CCC2)C(=O)C=C)N=C1C(C=C1)=CC=C1OC1=CC=CC=C1 XYFPWWZEPKGCCK-GOSISDBHSA-N 0.000 title claims 7
- 229960001507 ibrutinib Drugs 0.000 title claims 7
- 239000000203 mixture Substances 0.000 title 1
- 239000000825 pharmaceutical preparation Substances 0.000 claims 13
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims 6
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 claims 6
- DPXJVFZANSGRMM-UHFFFAOYSA-N acetic acid;2,3,4,5,6-pentahydroxyhexanal;sodium Chemical compound [Na].CC(O)=O.OCC(O)C(O)C(O)C(O)C=O DPXJVFZANSGRMM-UHFFFAOYSA-N 0.000 claims 6
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 claims 6
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 claims 6
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 claims 6
- UFVKGYZPFZQRLF-UHFFFAOYSA-N hydroxypropyl methyl cellulose Chemical compound OC1C(O)C(OC)OC(CO)C1OC1C(O)C(O)C(OC2C(C(O)C(OC3C(C(O)C(O)C(CO)O3)O)C(CO)O2)O)C(CO)O1 UFVKGYZPFZQRLF-UHFFFAOYSA-N 0.000 claims 6
- 239000008108 microcrystalline cellulose Substances 0.000 claims 6
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims 6
- 229940016286 microcrystalline cellulose Drugs 0.000 claims 6
- 238000000034 method Methods 0.000 claims 5
- YASYEJJMZJALEJ-UHFFFAOYSA-N Citric acid monohydrate Chemical compound O.OC(=O)CC(O)(C(O)=O)CC(O)=O YASYEJJMZJALEJ-UHFFFAOYSA-N 0.000 claims 4
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 claims 4
- 239000004376 Sucralose Substances 0.000 claims 4
- 229960002303 citric acid monohydrate Drugs 0.000 claims 4
- BNIILDVGGAEEIG-UHFFFAOYSA-L disodium hydrogen phosphate Chemical compound [Na+].[Na+].OP([O-])([O-])=O BNIILDVGGAEEIG-UHFFFAOYSA-L 0.000 claims 4
- 235000010226 sodium ethyl p-hydroxybenzoate Nutrition 0.000 claims 4
- 239000004402 sodium ethyl p-hydroxybenzoate Substances 0.000 claims 4
- 235000010268 sodium methyl p-hydroxybenzoate Nutrition 0.000 claims 4
- 239000004290 sodium methyl p-hydroxybenzoate Substances 0.000 claims 4
- QYNMSPKSYXPZHG-UHFFFAOYSA-M sodium;4-ethoxycarbonylphenolate Chemical compound [Na+].CCOC(=O)C1=CC=C([O-])C=C1 QYNMSPKSYXPZHG-UHFFFAOYSA-M 0.000 claims 4
- PESXGULMKCKJCC-UHFFFAOYSA-M sodium;4-methoxycarbonylphenolate Chemical compound [Na+].COC(=O)C1=CC=C([O-])C=C1 PESXGULMKCKJCC-UHFFFAOYSA-M 0.000 claims 4
- BAQAVOSOZGMPRM-QBMZZYIRSA-N sucralose Chemical compound O[C@@H]1[C@@H](O)[C@@H](Cl)[C@@H](CO)O[C@@H]1O[C@@]1(CCl)[C@@H](O)[C@H](O)[C@@H](CCl)O1 BAQAVOSOZGMPRM-QBMZZYIRSA-N 0.000 claims 4
- 235000019408 sucralose Nutrition 0.000 claims 4
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims 4
- 208000025205 Mantle-Cell Lymphoma Diseases 0.000 claims 3
- 229920003123 carboxymethyl cellulose sodium Polymers 0.000 claims 3
- 229940063834 carboxymethylcellulose sodium Drugs 0.000 claims 3
- 208000015914 Non-Hodgkin lymphomas Diseases 0.000 claims 2
- 210000003719 b-lymphocyte Anatomy 0.000 claims 2
- 239000001768 carboxy methyl cellulose Substances 0.000 claims 2
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims 2
- 239000008194 pharmaceutical composition Substances 0.000 claims 2
- 230000002062 proliferating effect Effects 0.000 claims 2
- 235000019812 sodium carboxymethyl cellulose Nutrition 0.000 claims 2
- 229920001027 sodium carboxymethylcellulose Polymers 0.000 claims 2
- 208000010839 B-cell chronic lymphocytic leukemia Diseases 0.000 claims 1
- 208000011691 Burkitt lymphomas Diseases 0.000 claims 1
- 229920002785 Croscarmellose sodium Polymers 0.000 claims 1
- 208000031671 Large B-Cell Diffuse Lymphoma Diseases 0.000 claims 1
- 208000031422 Lymphocytic Chronic B-Cell Leukemia Diseases 0.000 claims 1
- 206010025323 Lymphomas Diseases 0.000 claims 1
- 208000034578 Multiple myelomas Diseases 0.000 claims 1
- 206010035226 Plasma cell myeloma Diseases 0.000 claims 1
- 208000033559 Waldenström macroglobulinemia Diseases 0.000 claims 1
- 208000032852 chronic lymphocytic leukemia Diseases 0.000 claims 1
- 229960001681 croscarmellose sodium Drugs 0.000 claims 1
- 235000010947 crosslinked sodium carboxy methyl cellulose Nutrition 0.000 claims 1
- 206010012818 diffuse large B-cell lymphoma Diseases 0.000 claims 1
- 201000003444 follicular lymphoma Diseases 0.000 claims 1
- 235000013305 food Nutrition 0.000 claims 1
- 208000032839 leukemia Diseases 0.000 claims 1
- 239000006194 liquid suspension Substances 0.000 claims 1
- 238000004519 manufacturing process Methods 0.000 claims 1
- 238000002360 preparation method Methods 0.000 claims 1
- 235000021058 soft food Nutrition 0.000 claims 1
- 238000002560 therapeutic procedure Methods 0.000 claims 1
Classifications
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- 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
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
- A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
- A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
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- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
- A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
- A23L33/16—Inorganic salts, minerals or trace elements
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- 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
- A61J3/07—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of capsules or similar small containers for oral use
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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- A61K47/02—Inorganic compounds
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- 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
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- 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
- A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
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- 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
- A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
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- 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
- A61K47/38—Cellulose; Derivatives thereof
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- 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
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
- A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
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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
- A61K9/10—Dispersions; Emulsions
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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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4841—Filling excipients; Inactive ingredients
- A61K9/4858—Organic compounds
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
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- A61K9/4866—Organic macromolecular compounds
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- 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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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01J—CHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOID CHEMISTRY; THEIR RELEVANT APPARATUS
- B01J2/00—Processes or devices for granulating materials, e.g. fertilisers in general; Rendering particulate materials free flowing in general, e.g. making them hydrophobic
- B01J2/10—Processes or devices for granulating materials, e.g. fertilisers in general; Rendering particulate materials free flowing in general, e.g. making them hydrophobic in stationary drums or troughs, provided with kneading or mixing appliances
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01J—CHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOID CHEMISTRY; THEIR RELEVANT APPARATUS
- B01J2/00—Processes or devices for granulating materials, e.g. fertilisers in general; Rendering particulate materials free flowing in general, e.g. making them hydrophobic
- B01J2/22—Processes or devices for granulating materials, e.g. fertilisers in general; Rendering particulate materials free flowing in general, e.g. making them hydrophobic by pressing in moulds or between rollers
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- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
- A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs
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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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4833—Encapsulating processes; Filling of capsules
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- Health & Medical Sciences (AREA)
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- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- General Health & Medical Sciences (AREA)
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- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
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- Polymers & Plastics (AREA)
- Food Science & Technology (AREA)
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- Dispersion Chemistry (AREA)
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- Hematology (AREA)
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- Biochemistry (AREA)
- Molecular Biology (AREA)
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- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Claims (14)
1. Farmaceutski pripravak, naznačen time, da sadrži:
(a) 30 do 80 mg/mL Ibrutiniba;
(b) 12 do 15 mg/mL mikrokristalne celuloze i karboksimetilceluloze natrij;
(c) 0,5 do 3 mg/mL hidroksipropilmetilceluloze;
(d) 1,4 do 1,7 mg/mL monohidrata limunske kiseline;
(e) 1,4 mg/mL dinatrij hidrogen fosfata;
(f) 0,5 do 1,5 mg/mL sukraloze;
(g) 1 do 1,5 mg/mL natrij metil parahidroksibenzoata;
(h) 0,5 do 0,7 mg/mL natrij etil parahidroksibenzoata;
(i) koncentriranu klorovodičnu kiselinu;
(j) natrijev hidroksid; i
(k) vodu.
2. Farmaceutski pripravak prema patentnom zahtjevu 1, naznačen time, da sadrži 30 do 50 mg/mL Ibrutiniba, ili poželjno 60 do 80 mg/mL Ibrutiniba.
3. Farmaceutski pripravak prema patentnom zahtjevu 1 ili 2, naznačen time, da sadrži 13 do 15 mg/mL mikrokristalne celuloze i karboksimetilceluloze natrij, ili poželjno 12 do 14 mg/mL mikrokristalne celuloze i karboksimetilceluloze natrij.
4. Farmaceutski pripravak prema bilo kojem od prethodnih patentnih zahtjeva, naznačen time, da sadrži 2 do 3 mg/mL hidroksipropilmetilceluloze, ili poželjno 0,5 do 1,5 mg/mL hidroksipropilmetilceluloze.
5. Farmaceutski pripravak prema bilo kojem od prethodnih patentnih zahtjeva, naznačen time, da sadrži dovoljnu količinu koncentrirane klorovodične kiseline ili natrijevog hidroksida za održavanje pH na oko 6.
6. Farmaceutski pripravak prema bilo kojem od prethodnih patentnih zahtjeva, naznačen time, da sadrži dovoljnu količinu vode kako bi se osigurao ukupni volumen od 1 mL.
7. Farmaceutski pripravak prema bilo kojem od prethodnih patentnih zahtjeva, naznačen time, da je tekuća suspenzija.
8. Farmaceutski pripravak prema patentnom zahtjevu 1, naznačen time, da sadrži:
(i) oko 70 mg/mL Ibrutiniba;
(ii) oko 13 mg/mL mikrokristalne celuloze i karboksimetilceluloze natrij;
(iii) oko 2,5 mg/mL hidroksipropilmetilceluloze;
(iv) oko 1,5 mg/mL monohidrata limunske kiseline;
(v) oko 1,4 mg/mL dinatrij hidrogen fosfata;
(vi) oko 1 mg/mL sukraloze;
(vii) oko 1 mg/mL natrij metil parahidroksibenzoata; i
(viii) oko 0,6 mg/mL natrij etil parahidroksibenzoata.
9. Farmaceutski pripravak prema patentnom zahtjevu 1, naznačen time, da sadrži:
(i) oko 40 mg/mL Ibrutiniba;
(ii) oko 14 mg/mL mikrokristalne celuloze i karboksimetilceluloze natrij;
(iii) oko 1 mg/mL hidroksipropilmetil celuloze;
(iv) oko 1,6 mg/mL monohidrata limunske kiseline;
(v) oko 1,4 mg/mL dinatrij hidrogen fosfata;
(vi) oko 0,5 mg/mL sukraloze;
(vii) oko 1,4 mg/mL natrij metil parahidroksibenzoata; i
(viii) oko 0,7 mg/mL natrij etil parahidroksibenzoata.
10. Farmaceutski pripravak prema bilo kojem od prethodnih patentnih zahtjeva, naznačen time, da je za uporabu u postupku za liječenje proliferativnog poremećaja B stanica.
11. Farmaceutski pripravak za uporabu prema patentnom zahtjevu 10, naznačen time, da navedeni proliferativni poremećaj B stanica je ne-Hodgkinov limfom, Waldenstromova makroglobulinemija, mijelom stanica plazme, ili kronična limfocitna leukemija, opcionalno gdje ne-Hodgkinov limfom je difuzni veliki limfom B stanica, folikularni limfom, limfom plaštenih stanica ili Burkittov limfom, istaknuto limfom, ili istaknuto leukemija.
12. Farmaceutski pripravak prema bilo kojem od patentnih zahtjeva 1 do 9, naznačen time, da je za uporabu u postupku za liječenje limfoma plaštenih stanica kod pojedinca koji je već primio najmanje jednu prethodnu terapiju za limfom plaštenih stanica, pri čemu postupak obuhvaća davanje farmaceutskog pripravka jednom na dan.
13. Farmaceutski pripravak za uporabu prema bilo kojem od patentnih zahtjeva 10 do 12, naznačen time, da je farmaceutski pripravak raspršen u hrani kao blaga hrana.
14. Postupak za proizvodnju pripravka prema patentnom zahtjevu 1, naznačen time, da spomenuti postupak obuhvaća:
(a) miješanje vode, mikrokristalne celuloze kroskarmeloze natrij;
(b) miješanje vode i s hidroksipropilmetilcelulozom;
(c) miješanje proizvoda iz koraka (b) s Ibrutinibom;
(d) miješanje proizvoda iz koraka (a) i (c);
(e) miješanje proizvoda iz koraka (d) sa sukralozom;
(f) miješanje proizvoda iz koraka (e) s natrij metil parahidroksibenzoatom i natrij etil parahidroksibenzoatom;
(g) miješanje proizvoda iz koraka (f) s monohidratom limunske kiseline; i
(h) miješanje proizvoda iz koraka (g) s bezvodnim dinatrij hidrogen fosfatom.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US201562143659P | 2015-04-06 | 2015-04-06 | |
EP21161828.5A EP3892302B8 (en) | 2015-04-06 | 2016-04-06 | Compositions containing ibrutinib |
Publications (1)
Publication Number | Publication Date |
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HRP20231207T1 true HRP20231207T1 (hr) | 2024-01-19 |
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HRP20231207TT HRP20231207T1 (hr) | 2015-04-06 | 2016-04-06 | Pripravak koji sadrži ibrutinib |
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US (5) | US20160287594A1 (hr) |
EP (3) | EP4272835A3 (hr) |
JP (3) | JP2018513852A (hr) |
KR (2) | KR102632745B1 (hr) |
CN (2) | CN107530293A (hr) |
AU (3) | AU2016246669B2 (hr) |
CA (1) | CA2981601A1 (hr) |
CL (1) | CL2017002512A1 (hr) |
DK (1) | DK3892302T3 (hr) |
EA (1) | EA033992B1 (hr) |
ES (1) | ES2964472T3 (hr) |
FI (1) | FI3892302T3 (hr) |
HK (1) | HK1250925A1 (hr) |
HR (1) | HRP20231207T1 (hr) |
HU (1) | HUE063751T2 (hr) |
IL (2) | IL295941A (hr) |
LT (1) | LT3892302T (hr) |
MA (2) | MA54411B1 (hr) |
MD (1) | MD3892302T2 (hr) |
MX (2) | MX2017012822A (hr) |
PH (1) | PH12017501811A1 (hr) |
PL (1) | PL3892302T3 (hr) |
PT (1) | PT3892302T (hr) |
RS (1) | RS64653B1 (hr) |
SG (2) | SG10202103458QA (hr) |
SI (1) | SI3892302T1 (hr) |
UA (1) | UA125681C2 (hr) |
WO (1) | WO2016164404A1 (hr) |
Families Citing this family (19)
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CA3218491A1 (en) | 2012-06-04 | 2013-12-12 | Pharmacyclics Llc | Crystalline forms of a bruton's tyrosine kinase inhibitor |
MX2017001671A (es) | 2014-08-07 | 2017-07-04 | Pharmacyclics Llc | Formulaciones novedosas de un inhibidor de la tirosina cinasa de bruton. |
BR122023020985A2 (pt) | 2015-03-03 | 2023-12-26 | Pharmacyclics Llc | Formulação de comprimido sólido de um inibidor de tirosina quinase de bruton |
US11918684B2 (en) | 2017-03-13 | 2024-03-05 | Liqmeds Worldwide Limited | Pharmaceutical composition of oral suspension of immunosuppressive agents |
CN108653231A (zh) * | 2017-04-01 | 2018-10-16 | 北京赛林泰医药技术有限公司 | 含有布鲁顿酪氨酸激酶抑制剂的组合物及其制备方法 |
CN107014943B (zh) * | 2017-06-07 | 2018-08-21 | 福建省微生物研究所 | 一种依鲁替尼对映异构体的检测方法 |
EP3668508A1 (en) | 2017-08-19 | 2020-06-24 | FTF Pharma Private Limited | An oral pharmaceutical composition comprising zonisamide and process of preparation thereof |
CA3076907A1 (en) | 2017-09-26 | 2019-04-04 | Tesaro, Inc. | Niraparib formulations |
CA3089537A1 (en) | 2018-01-20 | 2019-07-25 | Natco Pharma Limited | Pharmaceutical compositions comprising ibrutinib |
KR20190122561A (ko) * | 2018-04-21 | 2019-10-30 | 류형준 | 림프 순환 장애의 치료 또는 경감을 위한 약학적 조성물과 식품 조성물 |
WO2019238904A1 (en) | 2018-06-15 | 2019-12-19 | Janssen Pharmaceutica Nv | Formulations/compositions comprising ibrutinib |
EP3836899A2 (en) * | 2018-08-18 | 2021-06-23 | FTF Pharma Private Limited | Chemotherapeutic pharmaceutical suspension for oral dosage |
GB2591396B (en) * | 2018-08-18 | 2023-06-07 | Ftf Pharma Private Ltd | Pharmaceutical suspension for oral dosage |
KR102198502B1 (ko) * | 2018-09-16 | 2021-01-05 | 류형준 | 인체의 림프순환 개선을 위한 식품 조성물 |
CN113164782A (zh) * | 2018-11-30 | 2021-07-23 | 詹森生物科技公司 | 治疗滤泡型淋巴瘤的方法 |
US10688050B1 (en) | 2018-12-21 | 2020-06-23 | Synthon B.V. | Pharmaceutical composition comprising ibrutinib |
KR102251435B1 (ko) * | 2020-11-09 | 2021-05-11 | 류형준 | 림프순환 촉진에 의한 부종 개선을 위한 식품 조성물 |
WO2022260667A1 (en) * | 2021-06-10 | 2022-12-15 | Hikma Pharmaceuticals Usa Inc. | Oral dosage forms of ibrutinib |
US11433072B1 (en) * | 2021-06-10 | 2022-09-06 | Hikma Pharmaceuticals USA, Inc. | Oral dosage forms of ibrutinib |
Family Cites Families (15)
Publication number | Priority date | Publication date | Assignee | Title |
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BRPI0610431A2 (pt) * | 2005-04-28 | 2012-10-23 | Wyeth Corp | composição farmacêutica, processo para preparar uma composição, cápsula, e, kit farmacêutico |
DK2081435T3 (en) | 2006-09-22 | 2016-08-15 | Pharmacyclics Llc | INHIBITORS OF BRUTON'S TYROSINKINASE |
US8003309B2 (en) | 2008-01-16 | 2011-08-23 | International Business Machines Corporation | Photoresist compositions and methods of use in high index immersion lithography |
KR101580714B1 (ko) | 2010-06-03 | 2016-01-04 | 파마싸이클릭스 엘엘씨 | 브루톤 티로신 인산화효소(btk)의 억제제의 용도 |
CN110801454A (zh) * | 2011-10-19 | 2020-02-18 | 药品循环有限责任公司 | 布鲁顿酪氨酸激酶(btk)抑制剂的用途 |
CA3218491A1 (en) * | 2012-06-04 | 2013-12-12 | Pharmacyclics Llc | Crystalline forms of a bruton's tyrosine kinase inhibitor |
WO2014004707A1 (en) * | 2012-06-29 | 2014-01-03 | Principia Biopharma Inc. | Formulations comprising ibrutinib |
EP3603715B1 (en) | 2013-03-14 | 2021-03-03 | Fisher & Paykel Healthcare Limited | Catheter mount with suction port |
ES2709509T3 (es) * | 2013-08-12 | 2019-04-16 | Pharmacyclics Llc | Procedimientos para el tratamiento de cáncer amplificado por HER2 |
US9617432B2 (en) * | 2013-08-12 | 2017-04-11 | The Yokohama Rubber Co., Ltd. | Primer composition |
WO2015071432A1 (en) * | 2013-11-14 | 2015-05-21 | Sandoz Ag | Pharmaceutical compositions of ibrutinib |
MX2017001671A (es) | 2014-08-07 | 2017-07-04 | Pharmacyclics Llc | Formulaciones novedosas de un inhibidor de la tirosina cinasa de bruton. |
CN104523695A (zh) * | 2014-11-12 | 2015-04-22 | 广东东阳光药业有限公司 | 一种治疗过度增生性疾病的药物组合物 |
CN104407067B (zh) * | 2014-11-17 | 2016-01-20 | 广东东阳光药业有限公司 | 依鲁替尼及其异构体的检测方法 |
BR122023020985A2 (pt) * | 2015-03-03 | 2023-12-26 | Pharmacyclics Llc | Formulação de comprimido sólido de um inibidor de tirosina quinase de bruton |
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