HRP20170594T1 - Farmaceutski pripravci ko-kristala tramadola i koksiba - Google Patents
Farmaceutski pripravci ko-kristala tramadola i koksiba Download PDFInfo
- Publication number
- HRP20170594T1 HRP20170594T1 HRP20170594TT HRP20170594T HRP20170594T1 HR P20170594 T1 HRP20170594 T1 HR P20170594T1 HR P20170594T T HRP20170594T T HR P20170594TT HR P20170594 T HRP20170594 T HR P20170594T HR P20170594 T1 HRP20170594 T1 HR P20170594T1
- Authority
- HR
- Croatia
- Prior art keywords
- pharmaceutical preparation
- preparation according
- tramadol
- polymer
- celecoxib
- Prior art date
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- 239000013078 crystal Substances 0.000 title claims 8
- 229960004380 tramadol Drugs 0.000 title claims 8
- 239000008194 pharmaceutical composition Substances 0.000 title claims 2
- TVYLLZQTGLZFBW-ZBFHGGJFSA-N (R,R)-tramadol Chemical compound COC1=CC=CC([C@]2(O)[C@H](CCCC2)CN(C)C)=C1 TVYLLZQTGLZFBW-ZBFHGGJFSA-N 0.000 title 1
- 229940111134 coxibs Drugs 0.000 title 1
- 239000003255 cyclooxygenase 2 inhibitor Substances 0.000 title 1
- TVYLLZQTGLZFBW-GOEBONIOSA-N tramadol Natural products COC1=CC=CC([C@@]2(O)[C@@H](CCCC2)CN(C)C)=C1 TVYLLZQTGLZFBW-GOEBONIOSA-N 0.000 title 1
- 239000000825 pharmaceutical preparation Substances 0.000 claims 13
- 229920000642 polymer Polymers 0.000 claims 8
- 229960000590 celecoxib Drugs 0.000 claims 7
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims 6
- 208000002193 Pain Diseases 0.000 claims 6
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims 6
- 229920002554 vinyl polymer Polymers 0.000 claims 6
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 claims 5
- WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical compound C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 claims 4
- 239000002202 Polyethylene glycol Substances 0.000 claims 4
- RZEKVGVHFLEQIL-UHFFFAOYSA-N celecoxib Chemical compound C1=CC(C)=CC=C1C1=CC(C(F)(F)F)=NN1C1=CC=C(S(N)(=O)=O)C=C1 RZEKVGVHFLEQIL-UHFFFAOYSA-N 0.000 claims 4
- 239000000945 filler Substances 0.000 claims 4
- 229920001223 polyethylene glycol Polymers 0.000 claims 4
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 claims 3
- 229930195725 Mannitol Natural products 0.000 claims 3
- -1 acetate-polyethylene Chemical group 0.000 claims 3
- 229920001531 copovidone Polymers 0.000 claims 3
- 229920000578 graft copolymer Polymers 0.000 claims 3
- 239000000314 lubricant Substances 0.000 claims 3
- 239000000594 mannitol Substances 0.000 claims 3
- 235000010355 mannitol Nutrition 0.000 claims 3
- 239000008108 microcrystalline cellulose Substances 0.000 claims 3
- 229940016286 microcrystalline cellulose Drugs 0.000 claims 3
- 239000004094 surface-active agent Substances 0.000 claims 3
- SERLAGPUMNYUCK-DCUALPFSSA-N 1-O-alpha-D-glucopyranosyl-D-mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO[C@H]1O[C@H](CO)[C@@H](O)[C@H](O)[C@H]1O SERLAGPUMNYUCK-DCUALPFSSA-N 0.000 claims 2
- VTYYLEPIZMXCLO-UHFFFAOYSA-L Calcium carbonate Chemical compound [Ca+2].[O-]C([O-])=O VTYYLEPIZMXCLO-UHFFFAOYSA-L 0.000 claims 2
- FBPFZTCFMRRESA-FSIIMWSLSA-N D-Glucitol Natural products OC[C@H](O)[C@H](O)[C@@H](O)[C@H](O)CO FBPFZTCFMRRESA-FSIIMWSLSA-N 0.000 claims 2
- FBPFZTCFMRRESA-JGWLITMVSA-N D-glucitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-JGWLITMVSA-N 0.000 claims 2
- 208000032131 Diabetic Neuropathies Diseases 0.000 claims 2
- 239000004386 Erythritol Substances 0.000 claims 2
- UNXHWFMMPAWVPI-UHFFFAOYSA-N Erythritol Natural products OCC(O)C(O)CO UNXHWFMMPAWVPI-UHFFFAOYSA-N 0.000 claims 2
- 239000005715 Fructose Substances 0.000 claims 2
- 229930091371 Fructose Natural products 0.000 claims 2
- RFSUNEUAIZKAJO-ARQDHWQXSA-N Fructose Chemical compound OC[C@H]1O[C@](O)(CO)[C@@H](O)[C@@H]1O RFSUNEUAIZKAJO-ARQDHWQXSA-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
- 208000004454 Hyperalgesia Diseases 0.000 claims 2
- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 claims 2
- MHQJUHSHQGQVTM-HNENSFHCSA-N Octadecyl fumarate Chemical group CCCCCCCCCCCCCCCCCCOC(=O)\C=C/C(O)=O MHQJUHSHQGQVTM-HNENSFHCSA-N 0.000 claims 2
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 claims 2
- 229930006000 Sucrose Natural products 0.000 claims 2
- TVXBFESIOXBWNM-UHFFFAOYSA-N Xylitol Natural products OCCC(O)C(O)C(O)CCO TVXBFESIOXBWNM-UHFFFAOYSA-N 0.000 claims 2
- WQZGKKKJIJFFOK-VFUOTHLCSA-N beta-D-glucose Chemical compound OC[C@H]1O[C@@H](O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-VFUOTHLCSA-N 0.000 claims 2
- 239000003795 chemical substances by application Substances 0.000 claims 2
- 229960000913 crospovidone Drugs 0.000 claims 2
- 239000008121 dextrose Substances 0.000 claims 2
- 238000007907 direct compression Methods 0.000 claims 2
- UNXHWFMMPAWVPI-ZXZARUISSA-N erythritol Chemical compound OC[C@H](O)[C@H](O)CO UNXHWFMMPAWVPI-ZXZARUISSA-N 0.000 claims 2
- 235000019414 erythritol Nutrition 0.000 claims 2
- 229940009714 erythritol Drugs 0.000 claims 2
- 239000000905 isomalt Substances 0.000 claims 2
- 235000010439 isomalt Nutrition 0.000 claims 2
- HPIGCVXMBGOWTF-UHFFFAOYSA-N isomaltol Natural products CC(=O)C=1OC=CC=1O HPIGCVXMBGOWTF-UHFFFAOYSA-N 0.000 claims 2
- 239000008101 lactose Substances 0.000 claims 2
- 229940031703 low substituted hydroxypropyl cellulose Drugs 0.000 claims 2
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims 2
- HEBKCHPVOIAQTA-UHFFFAOYSA-N meso ribitol Natural products OCC(O)C(O)C(O)CO HEBKCHPVOIAQTA-UHFFFAOYSA-N 0.000 claims 2
- 238000000034 method Methods 0.000 claims 2
- 239000000203 mixture Substances 0.000 claims 2
- 235000013809 polyvinylpolypyrrolidone Nutrition 0.000 claims 2
- 229920000523 polyvinylpolypyrrolidone Polymers 0.000 claims 2
- 229920000036 polyvinylpyrrolidone Polymers 0.000 claims 2
- 229940069328 povidone Drugs 0.000 claims 2
- 238000002360 preparation method Methods 0.000 claims 2
- 239000008109 sodium starch glycolate Substances 0.000 claims 2
- 229920003109 sodium starch glycolate Polymers 0.000 claims 2
- 229940079832 sodium starch glycolate Drugs 0.000 claims 2
- 235000010356 sorbitol Nutrition 0.000 claims 2
- 239000000600 sorbitol Substances 0.000 claims 2
- 229940071138 stearyl fumarate Drugs 0.000 claims 2
- 239000005720 sucrose Substances 0.000 claims 2
- 235000000346 sugar Nutrition 0.000 claims 2
- 150000008163 sugars Chemical group 0.000 claims 2
- 239000000454 talc Substances 0.000 claims 2
- 229910052623 talc Inorganic materials 0.000 claims 2
- 239000000811 xylitol Substances 0.000 claims 2
- 235000010447 xylitol Nutrition 0.000 claims 2
- HEBKCHPVOIAQTA-SCDXWVJYSA-N xylitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)CO HEBKCHPVOIAQTA-SCDXWVJYSA-N 0.000 claims 2
- 229960002675 xylitol Drugs 0.000 claims 2
- GUBGYTABKSRVRQ-UHFFFAOYSA-N 2-(hydroxymethyl)-6-[4,5,6-trihydroxy-2-(hydroxymethyl)oxan-3-yl]oxyoxane-3,4,5-triol Chemical compound OCC1OC(OC2C(O)C(O)C(O)OC2CO)C(O)C(O)C1O GUBGYTABKSRVRQ-UHFFFAOYSA-N 0.000 claims 1
- 206010002556 Ankylosing Spondylitis Diseases 0.000 claims 1
- OYPRJOBELJOOCE-UHFFFAOYSA-N Calcium Chemical compound [Ca] OYPRJOBELJOOCE-UHFFFAOYSA-N 0.000 claims 1
- 229920002134 Carboxymethyl cellulose Polymers 0.000 claims 1
- 206010064012 Central pain syndrome Diseases 0.000 claims 1
- 208000000094 Chronic Pain Diseases 0.000 claims 1
- RYGMFSIKBFXOCR-UHFFFAOYSA-N Copper Chemical compound [Cu] RYGMFSIKBFXOCR-UHFFFAOYSA-N 0.000 claims 1
- 229920002785 Croscarmellose sodium Polymers 0.000 claims 1
- 229920000858 Cyclodextrin Polymers 0.000 claims 1
- 208000001640 Fibromyalgia Diseases 0.000 claims 1
- 238000005033 Fourier transform infrared spectroscopy Methods 0.000 claims 1
- 208000035154 Hyperesthesia Diseases 0.000 claims 1
- 229920000881 Modified starch Polymers 0.000 claims 1
- 206010028980 Neoplasm Diseases 0.000 claims 1
- 208000001294 Nociceptive Pain Diseases 0.000 claims 1
- 206010034464 Periarthritis Diseases 0.000 claims 1
- 229920002690 Polyoxyl 40 HydrogenatedCastorOil Polymers 0.000 claims 1
- ZLMJMSJWJFRBEC-UHFFFAOYSA-N Potassium Chemical compound [K] ZLMJMSJWJFRBEC-UHFFFAOYSA-N 0.000 claims 1
- 208000008765 Sciatica Diseases 0.000 claims 1
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims 1
- DBMJMQXJHONAFJ-UHFFFAOYSA-M Sodium laurylsulphate Chemical compound [Na+].CCCCCCCCCCCCOS([O-])(=O)=O DBMJMQXJHONAFJ-UHFFFAOYSA-M 0.000 claims 1
- 229920002472 Starch Polymers 0.000 claims 1
- 238000010521 absorption reaction Methods 0.000 claims 1
- 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 1
- 208000005298 acute pain Diseases 0.000 claims 1
- 239000000783 alginic acid Substances 0.000 claims 1
- 235000010443 alginic acid Nutrition 0.000 claims 1
- 229920000615 alginic acid Polymers 0.000 claims 1
- 229960001126 alginic acid Drugs 0.000 claims 1
- 150000004781 alginic acids Chemical class 0.000 claims 1
- 206010053552 allodynia Diseases 0.000 claims 1
- 239000012752 auxiliary agent Substances 0.000 claims 1
- 239000011575 calcium Substances 0.000 claims 1
- 229910052791 calcium Inorganic materials 0.000 claims 1
- 229910000019 calcium carbonate Inorganic materials 0.000 claims 1
- 235000010216 calcium carbonate Nutrition 0.000 claims 1
- 239000001506 calcium phosphate Substances 0.000 claims 1
- 229910000389 calcium phosphate Inorganic materials 0.000 claims 1
- 235000011010 calcium phosphates Nutrition 0.000 claims 1
- 201000011510 cancer Diseases 0.000 claims 1
- 239000002775 capsule Substances 0.000 claims 1
- 239000001768 carboxy methyl cellulose Substances 0.000 claims 1
- 235000010948 carboxy methyl cellulose Nutrition 0.000 claims 1
- 239000008112 carboxymethyl-cellulose Substances 0.000 claims 1
- 229940075614 colloidal silicon dioxide Drugs 0.000 claims 1
- 150000001875 compounds Chemical class 0.000 claims 1
- 229910052802 copper Inorganic materials 0.000 claims 1
- 239000010949 copper Substances 0.000 claims 1
- 229960001681 croscarmellose sodium Drugs 0.000 claims 1
- 235000010947 crosslinked sodium carboxy methyl cellulose Nutrition 0.000 claims 1
- 239000007884 disintegrant Substances 0.000 claims 1
- 238000007908 dry granulation Methods 0.000 claims 1
- MVPICKVDHDWCJQ-UHFFFAOYSA-N ethyl 3-pyrrolidin-1-ylpropanoate Chemical compound CCOC(=O)CCN1CCCC1 MVPICKVDHDWCJQ-UHFFFAOYSA-N 0.000 claims 1
- 238000013467 fragmentation Methods 0.000 claims 1
- 238000006062 fragmentation reaction Methods 0.000 claims 1
- 201000010603 frozen shoulder Diseases 0.000 claims 1
- 125000005456 glyceride group Chemical group 0.000 claims 1
- 229910002011 hydrophilic fumed silica Inorganic materials 0.000 claims 1
- 229920001477 hydrophilic polymer Polymers 0.000 claims 1
- 125000000400 lauroyl group Chemical group O=C([*])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])[H] 0.000 claims 1
- 239000006194 liquid suspension Substances 0.000 claims 1
- 235000019359 magnesium stearate Nutrition 0.000 claims 1
- 238000004519 manufacturing process Methods 0.000 claims 1
- 238000002844 melting Methods 0.000 claims 1
- 230000008018 melting Effects 0.000 claims 1
- 208000004296 neuralgia Diseases 0.000 claims 1
- 208000021722 neuropathic pain Diseases 0.000 claims 1
- 239000008183 oral pharmaceutical preparation Substances 0.000 claims 1
- 201000008482 osteoarthritis Diseases 0.000 claims 1
- 239000000244 polyoxyethylene sorbitan monooleate Substances 0.000 claims 1
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 claims 1
- 229940068968 polysorbate 80 Drugs 0.000 claims 1
- 229920000053 polysorbate 80 Polymers 0.000 claims 1
- 239000011591 potassium Substances 0.000 claims 1
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- 229960003975 potassium Drugs 0.000 claims 1
- 235000007686 potassium Nutrition 0.000 claims 1
- 239000000843 powder Substances 0.000 claims 1
- 238000000634 powder X-ray diffraction Methods 0.000 claims 1
- 230000005855 radiation Effects 0.000 claims 1
- 206010039073 rheumatoid arthritis Diseases 0.000 claims 1
- 238000009490 roller compaction Methods 0.000 claims 1
- HFHDHCJBZVLPGP-UHFFFAOYSA-N schardinger α-dextrin Chemical compound O1C(C(C2O)O)C(CO)OC2OC(C(C2O)O)C(CO)OC2OC(C(C2O)O)C(CO)OC2OC(C(O)C2O)C(CO)OC2OC(C(C2O)O)C(CO)OC2OC2C(O)C(O)C1OC2CO HFHDHCJBZVLPGP-UHFFFAOYSA-N 0.000 claims 1
- 235000019333 sodium laurylsulphate Nutrition 0.000 claims 1
- 229940045902 sodium stearyl fumarate Drugs 0.000 claims 1
- 239000008107 starch Substances 0.000 claims 1
- 229940032147 starch Drugs 0.000 claims 1
- 235000019698 starch Nutrition 0.000 claims 1
- QORWJWZARLRLPR-UHFFFAOYSA-H tricalcium bis(phosphate) Chemical compound [Ca+2].[Ca+2].[Ca+2].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O QORWJWZARLRLPR-UHFFFAOYSA-H 0.000 claims 1
Classifications
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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
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
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- A61K31/13—Amines
- A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
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- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
- A61K31/415—1,2-Diazoles
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- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
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- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
- A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07C—ACYCLIC OR CARBOCYCLIC COMPOUNDS
- C07C59/00—Compounds having carboxyl groups bound to acyclic carbon atoms and containing any of the groups OH, O—metal, —CHO, keto, ether, groups, groups, or groups
- C07C59/40—Unsaturated compounds
- C07C59/58—Unsaturated compounds containing ether groups, groups, groups, or groups
- C07C59/64—Unsaturated compounds containing ether groups, groups, groups, or groups containing six-membered aromatic rings
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- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
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- A61K31/63—Compounds containing para-N-benzenesulfonyl-N-groups, e.g. sulfanilamide, p-nitrobenzenesulfonyl hydrazide
Claims (15)
1. Farmaceutski pripravak koji sadrži ko-kristal (rac)-tramadol·HCl - celekoksib (1:1) i barem a polimer za poboljšavanje topljivosti; pri čemu je polimer za poboljšavanje topljivosti odabran od polivinil kaprolaktam-polivinil acetat-polietilen glikol graft kopolimera ili od kopovidona, povidona, ciklodekstrina, polietilen glikola i lauroil makrogol-32 glicerida EP.
2. Farmaceutski pripravak u skladu s patentnim zahtjevom 1, naznačen time da je polimer za poboljšavanje topljivosti odabran od polivinil kaprolaktam-polivinil acetat-polietilen glikol graft kopolimera ili drugih hidrofilnih polimera koji su odabrani od kopovidona, ili povidona.
3. Farmaceutski pripravak u skladu s bilo kojim od patentnih zahtjeva 1 ili 2, naznačen time da polimer za poboljšavanje topljivosti je polivinil kaprolaktam-polivinil acetat-polietilen glikol graft kopolimer.
4. Farmaceutski pripravak u skladu s bilo kojim od patentnih zahtjeva 1 ili 2, naznačen time da polimer za poboljšavanje topljivosti je kopolimer kopovidon.
5. Farmaceutski pripravak u skladu s bilo kojim od patentnih zahtjeva 1 do 4, naznačen time da se udio polimera za poboljšavanje topljivosti koji je korišten u pripravku nalazi u rasponu između 2-50 težinskih %, poželjno između 8-12 težinskih % ili približno 8 težinskih %.
6. Farmaceutski pripravak u skladu s bilo kojim od patentnih zahtjeva 1 do 5, naznačen time da je u obliku koji je odabran od tablete, praškastih kapsula, ili je formuliran sa suhom granulacijom, tekućom suspenzijom i suhim sabijanjem valjkom, te je poželjno u obliku tablete, najpoželjnije je u obliku tablete koja se može proizvesti postupkom izravne kompresije.
7. Farmaceutski pripravak prema zahtjevu 1, naznačen time da je u obliku tablete koja sadrži ko-kristal (rac)-tramadol·HCl - celekoksib (1:1) i barem polimer za poboljšavanje topljivosti koja se dobiva postupkom izravne kompresije.
8. Farmaceutski pripravak u skladu s bilo kojim od patentnih zahtjeva 1 do 7, naznačen time da dodatno sadrži barem polimerni surfaktant.
9. Farmaceutski pripravak u skladu s patentnim zahtjevom ,8 naznačen time da je polimerni surfaktant odabran od mikroenkapsuliranog polisorbata 80, mikroenkapsuliranog polioksila 40 - hidrogeniziranog ricinusovog ulja i natrijevog lauril sulfata.
10. Farmaceutski pripravak u skladu s bilo kojim od patentnih zahtjeva 1 do 9, naznačen time da sadrži barem jedno dodatno farmaceutski prihvatljivo pomoćno sredstvo kao što su punila, sredstva za poboljšanje usitnjavanja i/ili sredstvo za podmazivanje.
11. Farmaceutski pripravak u skladu s patentnim zahtjevom 10 naznačen time da je punilo odabrano od šećera kao što su ksilitol, sorbitol, izomalt, eritritol, sukroza, fruktoza, dekstroza najpoželjnije raspršivanjem osušen manitol i obitelj laktoza ili od netopivih punila kao što je kalcijev fosfat, kalcijev karbonat ili mikrokristalne celuloze kao što je MCC 102 (90 µm) i MCC 200 (200 µm) ili drugi spojevi kao što su silicificirana mikrokristalna celuloza ili pripravci koji sadrže mikrokristalnu celulozu, koloidni silicijev dioksid, natrijev škrobni glikolat i natrijev stearil fumarat, poželjno su odabrani od šećera kao što su ksilitol, sorbitol, izomalt, eritritol, sukroza, fruktoza, dekstroza najpoželjnije su raspršivanjem osušeni manitola i obitelj laktoza ili mikrokristalna celuloza, te su najpoželjnije odabrani od raspršivanjem osušenog manitola i mikrokristalne celuloze.
12. Farmaceutski pripravak u skladu s patentnim zahtjevom 10 ili 11, naznačen time da je sredstvo za podmazivanje odabrano od stearil fumarata, magnezijevog stearata, talka, hidrofilnog pirogenog silicijevog dioksida, poželjno je odabran od stearil fumarata i talka i/ili pri čemu je sredstvo za raspadanje odabrano od krospovidona, kroskarmeloze natrija, natrijevog škrobnog glikolata, predželatiniziranog škroba, škroba, kalijevog polakrilina, nisko supstituirane hidroksipropil celuloze (L-HPC), kalcijeve karboksimetilceluloze, alginske kiseline, te je poželjno krospovidon.
13. Farmaceutski pripravak u skladu s bilo kojim od patentnih zahtjeva 1 do 12, pri čemu je ko-kristal (rac)-tramadol·HCl i celekoksib (1:1) naznačen time da pokazuje uzorak difrakcije X-zraka na prahu s vršcima [2θ] kod 7.1, 9.3, 10.2, 10.7, 13.6, 13.9, 14.1, 15.5, 16.1, 16.2, 16.8, 17.5, 18.0, 19.0, 19.5, 19.9, 20.5, 21.2, 21.3, 21.4, 21.8, 22.1, 22.6, 22.7, 23.6, 24.1, 24.4, 25.2, 26.1, 26.6, 26.8, 27.4, 27.9, 28.1, 29.1, 29.9, 30.1, 31.1, 31.3, 31.7, 32.5, 32.8, 34.4, 35.0, 35.8, 36.2 i 37.2[°], s vrijednostima 2θ dobivenim koristeći zračenje bakra (CuKα1 1.54060A); i/ili
pri čemu je ko-kristal (rac)-tramadol·HCl i celekoksib (1:1) naznačen time da pokazuje infracrveni uzorak Fourierove transformacije s apsorpcijskim pojasevima kod 3481.6 (m), 3133.5 (m), 2923.0 (m), 2667.7 (m), 1596.0 (m), 1472.4 (m), 1458.0 (m), 1335.1 (m), 1288.7 (m), 1271.8 (m), 1168.7 (s), 1237.3 (m), 1168.7 (s), 1122.6 (s), 1100.9 (m), 1042.2 (m), 976.8 (m), 844.6 (m), 820.1 (m), 786.5 (m) 625.9 (m) cm-1; i/ili naznačen time da ko-kristal (rac)-tramadol·HCl i celekoksib (1:1) ima ortorompsku jediničnu ćeliju sa sljedećim dimenzijama:
a = 11.0323(7) A
b = 18.1095(12) Å
c = 17.3206(12) A; i/ili
naznačen time da endotermni oštar vrh koji odgovara talištu ko-kristala (rac)-tramadol·HCl i celekoksib (1:1) nastupa na 164°C.
14. Postupak za proizvodnju oralnog farmaceutskog pripravka prema bilo kojem od zahtjeva 1 do 13, naznačen time da sadrži korake:
(a) miješanje ko-kristala (rac)-tramadol·HCl - celekoksib (1:1) s najmanje polimerom za poboljšavanje topljivosti i proizvoljno jednim ili više punila, sredstvom za raspadanje ili polimernim surfaktantom ili bilo kojom njihovom kombinacijom;
(b) proizvoljno dodavanje barem sredstva za podmazivanje;
(c) izravno komprimiranje smjese iz koraka (a) ili podmazane smjese iz koraka (b) u tabletu.
15. Farmaceutski pripravak u skladu s bilo kojim od patentnih zahtjeva 1 do 13, naznačen time da je za uporabu za liječenje boli, poželjno akutne boli, kronične boli, neuropatske boli, nociceptivne boli, blage i teške do umjerene boli, hiperalgezije, boli povezane sa središnjom senzibilizacijom, alodinije ili boli zbog raka, uključujući dijabetičku neuropatiju ili dijabetičku perifernu neuropatiju i osteoartritis, fibromijalgiju; reumatoidnog artritisa, ankilozirajućeg spondilitisa, smrznutog ramena ili išijasa.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP10384002A EP2392319A1 (en) | 2010-06-04 | 2010-06-04 | Pharmaceutical compositions of co-crystals of tramadol and coxibs |
| EP11723885.7A EP2575778B1 (en) | 2010-06-04 | 2011-06-03 | Pharmaceutical compositions of co-crystals of tramadol and coxibs |
| PCT/EP2011/002749 WO2011151080A1 (en) | 2010-06-04 | 2011-06-03 | Pharmaceutical compositions of co-crystals of tramadol and coxibs |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20170594T1 true HRP20170594T1 (hr) | 2017-06-16 |
Family
ID=42358396
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20170594TT HRP20170594T1 (hr) | 2010-06-04 | 2017-04-13 | Farmaceutski pripravci ko-kristala tramadola i koksiba |
Country Status (32)
| Country | Link |
|---|---|
| US (1) | US8846744B2 (hr) |
| EP (3) | EP2392319A1 (hr) |
| JP (1) | JP5800016B2 (hr) |
| KR (1) | KR101556700B1 (hr) |
| CN (1) | CN102946871B (hr) |
| AR (1) | AR081774A1 (hr) |
| AU (1) | AU2011260608B2 (hr) |
| BR (1) | BR112012030704A2 (hr) |
| CA (1) | CA2798090C (hr) |
| CO (1) | CO6660469A2 (hr) |
| CY (1) | CY1118813T1 (hr) |
| DK (1) | DK2575778T3 (hr) |
| EC (1) | ECSP13012368A (hr) |
| ES (1) | ES2622192T3 (hr) |
| HR (1) | HRP20170594T1 (hr) |
| HU (1) | HUE033999T2 (hr) |
| IL (1) | IL222731A (hr) |
| LT (1) | LT2575778T (hr) |
| MX (1) | MX351507B (hr) |
| MY (1) | MY156859A (hr) |
| NZ (1) | NZ603457A (hr) |
| PL (1) | PL2575778T3 (hr) |
| PT (1) | PT2575778T (hr) |
| RS (1) | RS55878B1 (hr) |
| RU (1) | RU2567843C2 (hr) |
| SG (1) | SG185385A1 (hr) |
| SI (1) | SI2575778T1 (hr) |
| TN (1) | TN2012000515A1 (hr) |
| TW (1) | TWI508722B (hr) |
| UA (1) | UA109661C2 (hr) |
| WO (1) | WO2011151080A1 (hr) |
| ZA (1) | ZA201208767B (hr) |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP2177215A1 (en) | 2008-10-17 | 2010-04-21 | Laboratorios Del. Dr. Esteve, S.A. | Co-crystals of tramadol and NSAIDs |
| EP2311446A1 (en) * | 2009-10-16 | 2011-04-20 | Laboratorios Del. Dr. Esteve, S.A. | Compositions comprising Tramadol and Celecoxib in the treatment of pain |
| US9138425B2 (en) | 2013-03-12 | 2015-09-22 | Patheon Inc. | Drug delivery system to increase bioavailability |
| US10258583B2 (en) | 2014-05-01 | 2019-04-16 | Sun Pharmaceutical Industries Limited | Extended release liquid compositions of guanfacine |
| US20180104197A9 (en) | 2014-05-01 | 2018-04-19 | Sun Pharmaceutical Industries Limited | Extended release liquid compositions of metformin |
| WO2015166472A1 (en) * | 2014-05-01 | 2015-11-05 | Sun Pharmaceutical Industries Limited | Extended release liquid compositions of metformin |
| US9962336B2 (en) | 2014-05-01 | 2018-05-08 | Sun Pharmaceutical Industries Limited | Extended release suspension compositions |
| PL3137060T5 (pl) | 2014-05-01 | 2024-04-08 | Sun Pharmaceutical Industries Ltd | Kompozycje zawiesinowe o przedłużonym uwalnianiu |
| RU2017106010A (ru) | 2014-07-30 | 2018-08-28 | Сан Фармасьютикал Индастриз Лимитед | Двухкамерная упаковка |
| WO2016046693A1 (en) * | 2014-09-25 | 2016-03-31 | Nathwani Sandeep Vinodkumar | A co-processed pharmaceutical excipient |
| CN104276960B (zh) * | 2014-09-26 | 2016-09-28 | 安徽省逸欣铭医药科技有限公司 | 盐酸他喷他多和塞来昔布共晶及其组合物和制备方法 |
| US10369078B2 (en) | 2016-05-02 | 2019-08-06 | Sun Pharmaceutical Industries Limited | Dual-chamber pack for pharmaceutical compositions |
| US10238803B2 (en) | 2016-05-02 | 2019-03-26 | Sun Pharmaceutical Industries Limited | Drug delivery device for pharmaceutical compositions |
| WO2018031577A1 (en) * | 2016-08-09 | 2018-02-15 | Autotelic Llc | Fixed dose combination for pain relief without edema |
| DE102016012746A1 (de) | 2016-10-25 | 2018-04-26 | WindplusSonne GmbH | Vorprodukte zur Herstellung von porösen, mineralischen Leichtbaumaterialien, Verfahren zur Herstellung von porösen, mineralischen Leichtbaumaterialien und ihre Verwendung |
| JP2020510625A (ja) | 2016-12-14 | 2020-04-09 | ナンジェネックス ナノテクノロジー インコーポレーテッドＮａｎｇｅｎｅｘ Ｎａｎｏｔｅｃｈｎｏｌｏｇｙ Ｉｎｃｏｒｐｏｒａｔｅｄ | セレコキシブを含有する医薬組成物 |
| CN107595792A (zh) * | 2017-11-06 | 2018-01-19 | 刘丽 | 一种盐酸他喷他多塞来昔布片剂及其制备方法 |
| CN110101673A (zh) * | 2019-05-07 | 2019-08-09 | 安徽金太阳生化药业有限公司 | 一种盐酸曲马多分散片的制备方法 |
| CA3137381A1 (en) * | 2019-05-14 | 2020-11-19 | Esteve Pharmaceuticals, S.A. | Use of co-crystals of tramadol and celecoxib for treating pain while reducing the abuse liability of tramadol |
| CN112007024A (zh) * | 2019-05-28 | 2020-12-01 | 江苏恒瑞医药股份有限公司 | 艾瑞昔布与曲马多联合在制备治疗疼痛的药物中的用途 |
| CN115251264B (zh) * | 2022-08-05 | 2023-11-21 | 齐鲁工业大学 | 含桑叶提取物的共结晶粉末功能性饮料及其制备方法 |
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|---|---|---|---|---|
| CA2364127A1 (en) * | 1999-03-01 | 2000-09-08 | Ortho-Mcneil Pharmaceutical, Inc. | Composition comprising a tramadol material and a selective cox-2 inhibitor drug |
| DE10014588A1 (de) * | 2000-03-27 | 2001-10-04 | Basf Ag | Wirkstoffhaltige Schwimmformen enthaltend Polyvinylacetat und Polyvinylpyrrolidon, deren Verwendung und Herstellung |
| US20030105141A1 (en) * | 2001-04-17 | 2003-06-05 | Ping Gao | Finely self-emulsifiable pharmaceutical composition |
| US20050090517A1 (en) * | 2002-02-19 | 2005-04-28 | Norris Michael C. | Pharmaceutical combinations of cox-2 inhibitors and opiates |
| JP2005154334A (ja) * | 2003-11-25 | 2005-06-16 | Toa Yakuhin Kk | アズレンスルホン酸塩水溶液剤 |
| DE102006044694A1 (de) * | 2006-09-22 | 2008-03-27 | Krewel Meuselbach Gmbh | Perorale feste Schmerzmittelzubereitung |
| WO2008085674A1 (en) * | 2007-01-04 | 2008-07-17 | Transform Pharmaceuticals, Inc. | Pharmaceutical compositions comprising celecoxib co-crystals |
| CN101254180B (zh) * | 2008-03-28 | 2010-11-10 | 辽宁正鑫药物研究有限公司 | 一种内容物为半固体组合物的尼莫地平胶囊剂及制备方法 |
| EP2177215A1 (en) | 2008-10-17 | 2010-04-21 | Laboratorios Del. Dr. Esteve, S.A. | Co-crystals of tramadol and NSAIDs |
-
2010
- 2010-06-04 EP EP10384002A patent/EP2392319A1/en not_active Withdrawn
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2011
- 2011-06-03 AU AU2011260608A patent/AU2011260608B2/en active Active
- 2011-06-03 DK DK11723885.7T patent/DK2575778T3/en active
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- 2011-06-03 NZ NZ603457A patent/NZ603457A/en unknown
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- 2011-06-03 LT LTEP11723885.7T patent/LT2575778T/lt unknown
- 2011-06-03 JP JP2013512793A patent/JP5800016B2/ja active Active
- 2011-06-03 HU HUE11723885A patent/HUE033999T2/en unknown
- 2011-06-03 PL PL11723885T patent/PL2575778T3/pl unknown
- 2011-06-03 BR BR112012030704A patent/BR112012030704A2/pt not_active Application Discontinuation
- 2011-06-03 WO PCT/EP2011/002749 patent/WO2011151080A1/en active Application Filing
- 2011-06-03 AR ARP110101933A patent/AR081774A1/es not_active Application Discontinuation
- 2011-06-03 SG SG2012080545A patent/SG185385A1/en unknown
- 2011-06-03 RS RS20170378A patent/RS55878B1/sr unknown
- 2011-06-03 CA CA2798090A patent/CA2798090C/en active Active
- 2011-06-03 MX MX2012014087A patent/MX351507B/es active IP Right Grant
- 2011-06-03 EP EP11723885.7A patent/EP2575778B1/en active Active
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- 2011-06-03 UA UAA201300099A patent/UA109661C2/uk unknown
- 2011-06-03 EP EP16203254.4A patent/EP3158994A1/en not_active Withdrawn
- 2011-06-03 KR KR1020127033847A patent/KR101556700B1/ko active IP Right Grant
- 2011-06-03 RU RU2012157256/15A patent/RU2567843C2/ru active
- 2011-06-03 CN CN201180026578.9A patent/CN102946871B/zh active Active
- 2011-06-03 TW TW100119536A patent/TWI508722B/zh active
- 2011-06-03 US US13/701,192 patent/US8846744B2/en active Active
- 2011-06-03 ES ES11723885.7T patent/ES2622192T3/es active Active
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2012
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