HRP20171902T1 - Farmaceutski oblik za doziranje za oralnu primjenu inhibitora iz obitelji bcl-2 - Google Patents
Farmaceutski oblik za doziranje za oralnu primjenu inhibitora iz obitelji bcl-2 Download PDFInfo
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- HRP20171902T1 HRP20171902T1 HRP20171902TT HRP20171902T HRP20171902T1 HR P20171902 T1 HRP20171902 T1 HR P20171902T1 HR P20171902T T HRP20171902T T HR P20171902TT HR P20171902 T HRP20171902 T HR P20171902T HR P20171902 T1 HRP20171902 T1 HR P20171902T1
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- cancer
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- 239000002552 dosage form Substances 0.000 title claims 19
- 102000051485 Bcl-2 family Human genes 0.000 title 1
- 108700038897 Bcl-2 family Proteins 0.000 title 1
- 239000003112 inhibitor Substances 0.000 title 1
- 239000004480 active ingredient Substances 0.000 claims 13
- 206010028980 Neoplasm Diseases 0.000 claims 8
- 239000007962 solid dispersion Substances 0.000 claims 7
- 239000002904 solvent Substances 0.000 claims 7
- 201000011510 cancer Diseases 0.000 claims 5
- 229920000642 polymer Polymers 0.000 claims 4
- 150000003839 salts Chemical class 0.000 claims 4
- KHBQMWCZKVMBLN-UHFFFAOYSA-N Benzenesulfonamide Chemical compound NS(=O)(=O)C1=CC=CC=C1 KHBQMWCZKVMBLN-UHFFFAOYSA-N 0.000 claims 3
- WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical compound C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 claims 3
- DNIAPMSPPWPWGF-UHFFFAOYSA-N Propylene glycol Chemical group CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 claims 3
- 229920001577 copolymer Polymers 0.000 claims 3
- 238000000354 decomposition reaction Methods 0.000 claims 3
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims 3
- 208000035475 disorder Diseases 0.000 claims 3
- 239000002270 dispersing agent Substances 0.000 claims 3
- 239000000314 lubricant Substances 0.000 claims 3
- 125000002496 methyl group Chemical group [H]C([H])([H])* 0.000 claims 3
- 125000004194 piperazin-1-yl group Chemical group [H]N1C([H])([H])C([H])([H])N(*)C([H])([H])C1([H])[H] 0.000 claims 3
- 230000002062 proliferating effect Effects 0.000 claims 3
- 125000001436 propyl group Chemical group [H]C([*])([H])C([H])([H])C([H])([H])[H] 0.000 claims 3
- 150000003462 sulfoxides Chemical class 0.000 claims 3
- -1 tocopheryl compound Chemical class 0.000 claims 3
- 206010008342 Cervix carcinoma Diseases 0.000 claims 2
- 206010009944 Colon cancer Diseases 0.000 claims 2
- 208000031422 Lymphocytic Chronic B-Cell Leukemia Diseases 0.000 claims 2
- 206010033128 Ovarian cancer Diseases 0.000 claims 2
- 206010061535 Ovarian neoplasm Diseases 0.000 claims 2
- 208000006664 Precursor Cell Lymphoblastic Leukemia-Lymphoma Diseases 0.000 claims 2
- 208000005718 Stomach Neoplasms Diseases 0.000 claims 2
- 208000006105 Uterine Cervical Neoplasms Diseases 0.000 claims 2
- 239000000654 additive Substances 0.000 claims 2
- 201000010881 cervical cancer Diseases 0.000 claims 2
- 206010017758 gastric cancer Diseases 0.000 claims 2
- 125000003827 glycol group Chemical group 0.000 claims 2
- 208000014829 head and neck neoplasm Diseases 0.000 claims 2
- 229920001519 homopolymer Polymers 0.000 claims 2
- 238000000034 method Methods 0.000 claims 2
- 229920001515 polyalkylene glycol Polymers 0.000 claims 2
- 238000002360 preparation method Methods 0.000 claims 2
- 201000011549 stomach cancer Diseases 0.000 claims 2
- 206010000830 Acute leukaemia Diseases 0.000 claims 1
- 208000024893 Acute lymphoblastic leukemia Diseases 0.000 claims 1
- 208000014697 Acute lymphocytic leukaemia Diseases 0.000 claims 1
- 206010061424 Anal cancer Diseases 0.000 claims 1
- 208000007860 Anus Neoplasms Diseases 0.000 claims 1
- 208000010839 B-cell chronic lymphocytic leukemia Diseases 0.000 claims 1
- 208000032791 BCR-ABL1 positive chronic myelogenous leukemia Diseases 0.000 claims 1
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- 208000018084 Bone neoplasm Diseases 0.000 claims 1
- 208000003174 Brain Neoplasms Diseases 0.000 claims 1
- 206010006143 Brain stem glioma Diseases 0.000 claims 1
- 206010006187 Breast cancer Diseases 0.000 claims 1
- 208000026310 Breast neoplasm Diseases 0.000 claims 1
- 241001164374 Calyx Species 0.000 claims 1
- 201000009030 Carcinoma Diseases 0.000 claims 1
- 208000017897 Carcinoma of esophagus Diseases 0.000 claims 1
- 206010007953 Central nervous system lymphoma Diseases 0.000 claims 1
- 208000010833 Chronic myeloid leukaemia Diseases 0.000 claims 1
- 208000001333 Colorectal Neoplasms Diseases 0.000 claims 1
- 229920002785 Croscarmellose sodium Polymers 0.000 claims 1
- 206010061825 Duodenal neoplasm Diseases 0.000 claims 1
- 206010014733 Endometrial cancer Diseases 0.000 claims 1
- 206010014759 Endometrial neoplasm Diseases 0.000 claims 1
- 208000000461 Esophageal Neoplasms Diseases 0.000 claims 1
- 201000001342 Fallopian tube cancer Diseases 0.000 claims 1
- 208000013452 Fallopian tube neoplasm Diseases 0.000 claims 1
- 201000008808 Fibrosarcoma Diseases 0.000 claims 1
- 208000022072 Gallbladder Neoplasms Diseases 0.000 claims 1
- 206010017993 Gastrointestinal neoplasms Diseases 0.000 claims 1
- 208000017604 Hodgkin disease Diseases 0.000 claims 1
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- 206010061252 Intraocular melanoma Diseases 0.000 claims 1
- 208000008839 Kidney Neoplasms Diseases 0.000 claims 1
- 206010052178 Lymphocytic lymphoma Diseases 0.000 claims 1
- 206010027406 Mesothelioma Diseases 0.000 claims 1
- 208000034578 Multiple myelomas Diseases 0.000 claims 1
- 208000033761 Myelogenous Chronic BCR-ABL Positive Leukemia Diseases 0.000 claims 1
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- 201000005746 Pituitary adenoma Diseases 0.000 claims 1
- 206010061538 Pituitary tumour benign Diseases 0.000 claims 1
- 206010035226 Plasma cell myeloma Diseases 0.000 claims 1
- 239000002202 Polyethylene glycol Substances 0.000 claims 1
- 206010060862 Prostate cancer Diseases 0.000 claims 1
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- 208000015634 Rectal Neoplasms Diseases 0.000 claims 1
- 206010038389 Renal cancer Diseases 0.000 claims 1
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- 201000000582 Retinoblastoma Diseases 0.000 claims 1
- 206010039491 Sarcoma Diseases 0.000 claims 1
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims 1
- 208000000453 Skin Neoplasms Diseases 0.000 claims 1
- 206010041067 Small cell lung cancer Diseases 0.000 claims 1
- 206010054184 Small intestine carcinoma Diseases 0.000 claims 1
- 208000021712 Soft tissue sarcoma Diseases 0.000 claims 1
- 210000001744 T-lymphocyte Anatomy 0.000 claims 1
- 208000024770 Thyroid neoplasm Diseases 0.000 claims 1
- 208000023915 Ureteral Neoplasms Diseases 0.000 claims 1
- 206010046392 Ureteric cancer Diseases 0.000 claims 1
- 206010046458 Urethral neoplasms Diseases 0.000 claims 1
- 208000007097 Urinary Bladder Neoplasms Diseases 0.000 claims 1
- 208000002495 Uterine Neoplasms Diseases 0.000 claims 1
- 201000005969 Uveal melanoma Diseases 0.000 claims 1
- XTXRWKRVRITETP-UHFFFAOYSA-N Vinyl acetate Chemical compound CC(=O)OC=C XTXRWKRVRITETP-UHFFFAOYSA-N 0.000 claims 1
- 208000004354 Vulvar Neoplasms Diseases 0.000 claims 1
- ZAKOWWREFLAJOT-ADUHFSDSSA-N [2,5,7,8-tetramethyl-2-[(4R,8R)-4,8,12-trimethyltridecyl]-3,4-dihydrochromen-6-yl] acetate Chemical group CC(=O)OC1=C(C)C(C)=C2OC(CCC[C@H](C)CCC[C@H](C)CCCC(C)C)(C)CCC2=C1C ZAKOWWREFLAJOT-ADUHFSDSSA-N 0.000 claims 1
- 230000000996 additive effect Effects 0.000 claims 1
- 208000024447 adrenal gland neoplasm Diseases 0.000 claims 1
- 201000010425 adrenal medulla cancer Diseases 0.000 claims 1
- 201000011165 anus cancer Diseases 0.000 claims 1
- 210000003719 b-lymphocyte Anatomy 0.000 claims 1
- 210000000013 bile duct Anatomy 0.000 claims 1
- 239000002775 capsule Substances 0.000 claims 1
- 210000003169 central nervous system Anatomy 0.000 claims 1
- 208000025997 central nervous system neoplasm Diseases 0.000 claims 1
- 208000006990 cholangiocarcinoma Diseases 0.000 claims 1
- 230000001684 chronic effect Effects 0.000 claims 1
- 208000024207 chronic leukemia Diseases 0.000 claims 1
- 208000032852 chronic lymphocytic leukemia Diseases 0.000 claims 1
- 229940075614 colloidal silicon dioxide Drugs 0.000 claims 1
- 208000029742 colonic neoplasm Diseases 0.000 claims 1
- 239000001767 crosslinked sodium carboxy methyl cellulose Substances 0.000 claims 1
- 235000010947 crosslinked sodium carboxy methyl cellulose Nutrition 0.000 claims 1
- 208000030381 cutaneous melanoma Diseases 0.000 claims 1
- 201000000312 duodenum cancer Diseases 0.000 claims 1
- 210000000750 endocrine system Anatomy 0.000 claims 1
- MVPICKVDHDWCJQ-UHFFFAOYSA-N ethyl 3-pyrrolidin-1-ylpropanoate Chemical compound CCOC(=O)CCN1CCCC1 MVPICKVDHDWCJQ-UHFFFAOYSA-N 0.000 claims 1
- 239000000945 filler Substances 0.000 claims 1
- 201000003444 follicular lymphoma Diseases 0.000 claims 1
- 239000012458 free base Substances 0.000 claims 1
- 201000010175 gallbladder cancer Diseases 0.000 claims 1
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- 210000003128 head Anatomy 0.000 claims 1
- 206010073071 hepatocellular carcinoma Diseases 0.000 claims 1
- 239000004615 ingredient Substances 0.000 claims 1
- 210000003734 kidney Anatomy 0.000 claims 1
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- 239000007788 liquid Substances 0.000 claims 1
- 210000004185 liver Anatomy 0.000 claims 1
- 208000014018 liver neoplasm Diseases 0.000 claims 1
- 208000003747 lymphoid leukemia Diseases 0.000 claims 1
- 230000036210 malignancy Effects 0.000 claims 1
- 208000015486 malignant pancreatic neoplasm Diseases 0.000 claims 1
- 208000026037 malignant tumor of neck Diseases 0.000 claims 1
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- 239000000155 melt Substances 0.000 claims 1
- 230000008018 melting Effects 0.000 claims 1
- 238000002844 melting Methods 0.000 claims 1
- 239000000203 mixture Substances 0.000 claims 1
- 208000002154 non-small cell lung carcinoma Diseases 0.000 claims 1
- 201000002575 ocular melanoma Diseases 0.000 claims 1
- 201000005443 oral cavity cancer Diseases 0.000 claims 1
- 201000002528 pancreatic cancer Diseases 0.000 claims 1
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- 210000002990 parathyroid gland Anatomy 0.000 claims 1
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- 229920001223 polyethylene glycol Polymers 0.000 claims 1
- 208000016800 primary central nervous system lymphoma Diseases 0.000 claims 1
- 206010038038 rectal cancer Diseases 0.000 claims 1
- 201000001275 rectum cancer Diseases 0.000 claims 1
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- 201000000849 skin cancer Diseases 0.000 claims 1
- 201000003708 skin melanoma Diseases 0.000 claims 1
- 208000000587 small cell lung carcinoma Diseases 0.000 claims 1
- 210000000813 small intestine Anatomy 0.000 claims 1
- 159000000000 sodium salts Chemical class 0.000 claims 1
- 229940045902 sodium stearyl fumarate Drugs 0.000 claims 1
- 238000007711 solidification Methods 0.000 claims 1
- 230000008023 solidification Effects 0.000 claims 1
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- KDYFGRWQOYBRFD-UHFFFAOYSA-L succinate(2-) Chemical compound [O-]C(=O)CCC([O-])=O KDYFGRWQOYBRFD-UHFFFAOYSA-L 0.000 claims 1
- 210000001550 testis Anatomy 0.000 claims 1
- 210000001685 thyroid gland Anatomy 0.000 claims 1
- 208000029729 tumor suppressor gene on chromosome 11 Diseases 0.000 claims 1
- 201000011294 ureter cancer Diseases 0.000 claims 1
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- 206010046766 uterine cancer Diseases 0.000 claims 1
- 206010046885 vaginal cancer Diseases 0.000 claims 1
- 208000013139 vaginal neoplasm Diseases 0.000 claims 1
- 201000005102 vulva cancer Diseases 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
- A61K31/535—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one oxygen as the ring hetero atoms, e.g. 1,2-oxazines
- A61K31/5375—1,4-Oxazines, e.g. morpholine
- A61K31/5377—1,4-Oxazines, e.g. morpholine not condensed and containing further heterocyclic rings, e.g. timolol
-
- 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
- A61K31/63—Compounds containing para-N-benzenesulfonyl-N-groups, e.g. sulfanilamide, p-nitrobenzenesulfonyl hydrazide
- A61K31/635—Compounds containing para-N-benzenesulfonyl-N-groups, e.g. sulfanilamide, p-nitrobenzenesulfonyl hydrazide having a heterocyclic ring, e.g. sulfadiazine
-
- 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
-
- 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
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
-
- 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
-
- 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
- A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
- A61K9/146—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic macromolecular compounds
-
- 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
- A61K9/20—Pills, tablets, discs, rods
-
- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
-
- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
-
- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
-
- 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
-
- 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)
- Life Sciences & Earth Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Medicinal Chemistry (AREA)
- Chemical & Material Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Physiology (AREA)
- Nutrition Science (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Biophysics (AREA)
- Molecular Biology (AREA)
- Oncology (AREA)
- Hematology (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Claims (18)
1. Farmaceutski oblik za doziranje koji sadržava proizvod u obliku čvrste disperzije koji sadržava farmaceutski aktivni sastojak, najmanje jedan farmaceutski prihvatljiv polimer koji sadržava homopolimer ili kopolimer N-vinil pirolidona i najmanje jedan farmaceutski prihvatljiv solubilizator koji sadržava tokoferilni spoj s polialkilen glikolnom skupinom, naznačen time, da je navedeni farmaceutski aktivni sastojak N-(4-(4-((2-(4-klorfenil) -5,5-dimetil-l-cikloheks-l-en-l-il)metil)piperazin-l-il)benzoil)-4-(((lR)-3-(morfolin-4-il)-l-((fenilsulfanil)metil)propil)amino)-3-((trifluorometil)sulfonil)benzensulfonamid ili njegova sol ili hidrat.
2. Oblik za doziranje u skladu s patentnim zahtjevom 1, naznačen time, da farmaceutski prihvatljivo otapalo sadržava alfa tokoferil polietilen glikol sukcinat.
3. Oblik za doziranje u skladu s patentnim zahtjevom 1, naznačen time, da sadržava nehlapljivo otapalo za farmaceutski aktivni sastojak, a navedeno otapalo je tekućina pri sobnoj temperaturi.
4. Oblik za doziranje u skladu s patentnim zahtjevom 3, naznačen time, da je navedeno nehlapljivo otapalo propilen glikol.
5. Oblik za doziranje u skladu s patentnim zahtjevom 1, naznačen time, da je navedeni farmaceutski prihvatljiv polimer kopolimer N-vinilpirolidona i vinil acetata.
6. Oblik za doziranje u skladu s patentnim zahtjevom 1, naznačen time, da je navedeni farmaceutski aktivni sastojak odabran iz skupine koju čine slobodna baza, natrijeva sol i dihidrokloridna sol N-(4-(4- ((2-(4- klorfenil) -5,5-dimetil-l-cikloheks-l-en- 1-il) metil )piperazin-l-il )benzoil)-4-((( lR)-3-( morfolin-4-il)-1- ((fenil sulfanil) metil)propil)amino)-3-((trifluorometil)sulfonil)benzensulfonamida i njihove kombinacije.
7. Oblik za doziranje u skladu s patentnim zahtjevom 1, naznačen time, da sadržava najmanje jedan aditiv odabran između regulatora protoka, sredstava za raspršivanje, punila i maziva.
8. Oblik za doziranje u skladu s patentnim zahtjevom 7, naznačen time, da sadržava regulator protoka, a regulator protoka sadržava koloidni silicijev dioksid.
9. Oblik za doziranje u skladu s patentnim zahtjevom 7, naznačen time, da sadržava sredstvo za raspršivanje, a sredstvo za raspršivanje sadržava umreženu natrijevu karboksimetil celulozu.
10. Oblik za doziranje u skladu s patentnim zahtjevom 7, naznačen time, da sadržava lubrikant, a lubrikant sadržava natrij stearil fumarat.
11. Oblik za doziranje u skladu s patentnim zahtjevom 1, naznačen time, da kruti disperzijski proizvod sadržava od oko 0,5 do 40 % težinskih udjela farmaceutski aktivnog sastojka, 40 do 97,5 % težinskih udjela navedenog barem jednog farmaceutski prihvatljivog polimera, 2 do 20 % težinskih udjela navedenog najmanje jednog solubilizatora i 0 do 15 % težinskih udjela aditiva.
12. Oblik za doziranje u skladu s patentnim zahtjevom 1, naznačen time, da sadržava manje od 1,5 % težinskih udjela sulfoksidnih produkata raspadanja aktivnog sastojka, u odnosu na težinu aktivnog sastojka ili manje od 1,2 % težinskih udjela sulfoksidnih produkata raspadanja aktivnog sastojka, u odnosu na težinu aktivnog sastojka ili manje od 0,9 % težinskih udjela sulfoksidnih proizvoda raspadanja aktivnog sastojka, u odnosu na težinu aktivnog sastojka.
13. Oblik za doziranje u skladu s patentnim zahtjevom 1, naznačen time, da je smjesa dobivena taljenjem i skrućivanjem.
14. Oblik za doziranje u skladu s patentnim zahtjevom 1, za uporabu u postupku liječenja proliferacijskog poremećaja, naznačen time, da uključuje oblik za doziranje u skladu s patentnim zahtjevom 1 subjektu kojem je to potrebno.
15. Oblik za doziranje za uporabu u skladu s patentnim zahtjevom 14, naznačen time, da je proliferativni poremećaj odabran između tumora i karcinoma.
16. Oblik za doziranje za uporabu u skladu s patentnim zahtjevom 15, naznačen time, da je proliferativni poremećaj odabran iz skupine koju čine mezoteliom, rak mjehura, rak gušterače, rak kože, rak glave ili vrata, kožni ili intraokularni melanom, rak jajnika, rak dojke, rak maternice, rak jajovoda, rak endometrija, rak grlića maternice, rak vagine, rak vulve, rak kostiju, rak grlića maternice, rak debelog crijeva, rak rektuma, rak analnog područja, rak želuca, gastrointestinalni rak (rak želuca, kolorektalni rak i rak dvanaesnika), kronična limfocitna leukemija, akutna limfocitna leukemija, rak jednjaka, rak tankog crijeva, rak endokrinog sustava, rak tiroidne žlijezde, rak paratiroidne žlijezde, rak nadbubrežne žlijezde, sarkom mekog tkiva, rak uretre, rak penisa, rak testisa, hepatocelularni rak (jetre i žučnih kanala), primarni ili sekundarni tumor centralnog živčanog sustava, primarni ili sekundarni tumor mozga, Hodgkinova bolest, kronična ili akutna leukemija, kronična mijeloična leukemija, limfocitni limfom, limfoblastična leukemija, folikularni limfom, limfoidne maligne bolesti uzrokovane T-stanicama ili B-stanicama, melanom, višestruki mijelom, rak usne šupljine, rak jajnika, rak ne-malih stanica pluća, rak prostate, rak malih stanica pluća, rak bubrega i mokraćovoda, rak bubrežnih stanica, rak bubrežne čašice, neoplazam središnjeg živčanog sustava, primarni limfom centralnog živčanog sustava, ne-Hodgkinov limfom, tumori spinalne osi, gliom moždanog stabla, adenom hipofize, rak ovojnice nadbubrežne žlijezde, rak žučnog mjehura, rak slezene, kolangiokarcinom, fibrosarkom, neuroblastom, retinoblastom i njihove kombinacije.
17. Postupak za pripravu farmaceutskog oblika doziranja koji sadržava proizvod u obliku čvrste disperzije u skladu s patentnim zahtjevom 1, naznačen time, da obuhvaća: (a) pripremu homogene taline farmaceutski aktivnog sastojka ili njegove soli ili hidrata, najmanje jednog farmaceutski prihvatljivog polimera koji sadržava homopolimer ili kopolimer N-vinil pirolidona i najmanje jedan solubilizator koji sadržava tokoferilni spoj s polialkilen glikolnom skupinom, navedeni farmaceutski aktivni sastojak je N-(4-(4-((2-(4-klorfenil)-5,5- dimetil-l-cikloheks-l-en-l-il)metil)piperazin-l-il)benzoil)-4-(((lR)-3-(morfolin-4-il)-l-((fenilsulfanil)metil)propil)amino)-3-((trifluorometil)sulfonil)benzensulfonamid ili njegova sol ili hidrat i (b) ostavljanje taline da se skrutne kako bi se dobio kruti disperzijski produkt.
18. Postupak u skladu s patentnim zahtjevom 17, naznačen time, da nadalje obuhvaća mljevenje navedenog proizvoda u obliku čvrste disperzije i komprimiranje navedenog proizvoda u obliku čvrste disperzije u tabletu ili punjenje navedenog krutog disperzijskog produkta u čahuru kapsule.
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