RU2015134142A - Композиции твердых растворов и их применение при сильной боли - Google Patents
Композиции твердых растворов и их применение при сильной боли Download PDFInfo
- Publication number
- RU2015134142A RU2015134142A RU2015134142A RU2015134142A RU2015134142A RU 2015134142 A RU2015134142 A RU 2015134142A RU 2015134142 A RU2015134142 A RU 2015134142A RU 2015134142 A RU2015134142 A RU 2015134142A RU 2015134142 A RU2015134142 A RU 2015134142A
- Authority
- RU
- Russia
- Prior art keywords
- pain
- headache
- pharmaceutical composition
- pharmaceutically acceptable
- glycerol
- Prior art date
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- 208000002193 Pain Diseases 0.000 title claims 35
- 239000006104 solid solution Substances 0.000 title claims 14
- 239000000203 mixture Substances 0.000 title claims 3
- 239000008194 pharmaceutical composition Substances 0.000 claims 32
- 206010019233 Headaches Diseases 0.000 claims 27
- 231100000869 headache Toxicity 0.000 claims 27
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims 20
- 208000004296 neuralgia Diseases 0.000 claims 18
- 208000021722 neuropathic pain Diseases 0.000 claims 15
- 229920001451 polypropylene glycol Polymers 0.000 claims 14
- 208000001294 Nociceptive Pain Diseases 0.000 claims 12
- 238000000034 method Methods 0.000 claims 10
- 229920000642 polymer Polymers 0.000 claims 10
- LYCAIKOWRPUZTN-UHFFFAOYSA-N Ethylene glycol Chemical compound OCCO LYCAIKOWRPUZTN-UHFFFAOYSA-N 0.000 claims 9
- 239000007788 liquid Substances 0.000 claims 9
- 239000002202 Polyethylene glycol Substances 0.000 claims 7
- 235000011187 glycerol Nutrition 0.000 claims 7
- 229920001223 polyethylene glycol Polymers 0.000 claims 7
- 206010036105 Polyneuropathy Diseases 0.000 claims 6
- 201000005518 mononeuropathy Diseases 0.000 claims 6
- 229940021182 non-steroidal anti-inflammatory drug Drugs 0.000 claims 6
- 230000001575 pathological effect Effects 0.000 claims 6
- 230000002093 peripheral effect Effects 0.000 claims 6
- 230000007824 polyneuropathy Effects 0.000 claims 6
- OGBUMNBNEWYMNJ-UHFFFAOYSA-N batilol Chemical class CCCCCCCCCCCCCCCCCCOCC(O)CO OGBUMNBNEWYMNJ-UHFFFAOYSA-N 0.000 claims 4
- 229940099371 diacetylated monoglycerides Drugs 0.000 claims 4
- WGCNASOHLSPBMP-UHFFFAOYSA-N hydroxyacetaldehyde Natural products OCC=O WGCNASOHLSPBMP-UHFFFAOYSA-N 0.000 claims 4
- 235000002316 solid fats Nutrition 0.000 claims 4
- 206010061666 Autonomic neuropathy Diseases 0.000 claims 3
- 208000000094 Chronic Pain Diseases 0.000 claims 3
- 206010009137 Chronic sinusitis Diseases 0.000 claims 3
- 208000023890 Complex Regional Pain Syndromes Diseases 0.000 claims 3
- 206010072720 Medication overuse headache Diseases 0.000 claims 3
- 208000019695 Migraine disease Diseases 0.000 claims 3
- 208000001407 Vascular Headaches Diseases 0.000 claims 3
- 208000005298 acute pain Diseases 0.000 claims 3
- 230000007845 axonopathy Effects 0.000 claims 3
- 208000027157 chronic rhinosinusitis Diseases 0.000 claims 3
- 150000002313 glycerolipids Chemical class 0.000 claims 3
- 230000003054 hormonal effect Effects 0.000 claims 3
- 230000001709 ictal effect Effects 0.000 claims 3
- 230000002757 inflammatory effect Effects 0.000 claims 3
- 238000002844 melting Methods 0.000 claims 3
- 230000008018 melting Effects 0.000 claims 3
- 206010027599 migraine Diseases 0.000 claims 3
- 210000003205 muscle Anatomy 0.000 claims 3
- 230000001114 myogenic effect Effects 0.000 claims 3
- 230000007827 neuronopathy Effects 0.000 claims 3
- 150000005599 propionic acid derivatives Chemical class 0.000 claims 3
- 208000009935 visceral pain Diseases 0.000 claims 3
- HEFNNWSXXWATRW-UHFFFAOYSA-N Ibuprofen Chemical compound CC(C)CC1=CC=C(C(C)C(O)=O)C=C1 HEFNNWSXXWATRW-UHFFFAOYSA-N 0.000 claims 2
- MITFXPHMIHQXPI-UHFFFAOYSA-N Oraflex Chemical compound N=1C2=CC(C(C(O)=O)C)=CC=C2OC=1C1=CC=C(Cl)C=C1 MITFXPHMIHQXPI-UHFFFAOYSA-N 0.000 claims 2
- RZRNAYUHWVFMIP-HXUWFJFHSA-N glycerol monolinoleate Natural products CCCCCCCCC=CCCCCCCCC(=O)OC[C@H](O)CO RZRNAYUHWVFMIP-HXUWFJFHSA-N 0.000 claims 2
- 229960001680 ibuprofen Drugs 0.000 claims 2
- 229920006395 saturated elastomer Polymers 0.000 claims 2
- 150000003626 triacylglycerols Chemical class 0.000 claims 2
- RJMIEHBSYVWVIN-LLVKDONJSA-N (2r)-2-[4-(3-oxo-1h-isoindol-2-yl)phenyl]propanoic acid Chemical compound C1=CC([C@H](C(O)=O)C)=CC=C1N1C(=O)C2=CC=CC=C2C1 RJMIEHBSYVWVIN-LLVKDONJSA-N 0.000 claims 1
- MDKGKXOCJGEUJW-VIFPVBQESA-N (2s)-2-[4-(thiophene-2-carbonyl)phenyl]propanoic acid Chemical compound C1=CC([C@@H](C(O)=O)C)=CC=C1C(=O)C1=CC=CS1 MDKGKXOCJGEUJW-VIFPVBQESA-N 0.000 claims 1
- RZRNAYUHWVFMIP-MDZDMXLPSA-N 1-[(9E)-octadecenoyl]glycerol Chemical compound CCCCCCCC\C=C\CCCCCCCC(=O)OCC(O)CO RZRNAYUHWVFMIP-MDZDMXLPSA-N 0.000 claims 1
- KVYUBFKSKZWZSV-FPLPWBNLSA-N 1-[(9Z)-hexadecenoyl]glycerol Chemical compound CCCCCC\C=C/CCCCCCCC(=O)OCC(O)CO KVYUBFKSKZWZSV-FPLPWBNLSA-N 0.000 claims 1
- DCPCOKIYJYGMDN-DOFZRALJSA-N 1-arachidonoylglycerol Chemical compound CCCCC\C=C/C\C=C/C\C=C/C\C=C/CCCC(=O)OCC(O)CO DCPCOKIYJYGMDN-DOFZRALJSA-N 0.000 claims 1
- WECGLUPZRHILCT-GSNKCQISSA-N 1-linoleoyl-sn-glycerol Chemical compound CCCCC\C=C/C\C=C/CCCCCCCC(=O)OC[C@@H](O)CO WECGLUPZRHILCT-GSNKCQISSA-N 0.000 claims 1
- RZRNAYUHWVFMIP-KTKRTIGZSA-N 1-oleoylglycerol Chemical compound CCCCCCCC\C=C/CCCCCCCC(=O)OCC(O)CO RZRNAYUHWVFMIP-KTKRTIGZSA-N 0.000 claims 1
- ARCRKLOZHGPFFJ-WAYWQWQTSA-N 2,3-dihydroxypropyl (z)-tetradec-9-enoate Chemical compound CCCC\C=C/CCCCCCCC(=O)OCC(O)CO ARCRKLOZHGPFFJ-WAYWQWQTSA-N 0.000 claims 1
- PLIKAWJENQZMHA-UHFFFAOYSA-N 4-aminophenol Chemical class NC1=CC=C(O)C=C1 PLIKAWJENQZMHA-UHFFFAOYSA-N 0.000 claims 1
- 229940086562 Cyclooxygenase 1 inhibitor Drugs 0.000 claims 1
- 229940093444 Cyclooxygenase 2 inhibitor Drugs 0.000 claims 1
- 229940122204 Cyclooxygenase inhibitor Drugs 0.000 claims 1
- CMWTZPSULFXXJA-UHFFFAOYSA-N Naproxen Natural products C1=C(C(C)C(O)=O)C=CC2=CC(OC)=CC=C21 CMWTZPSULFXXJA-UHFFFAOYSA-N 0.000 claims 1
- 229920000604 Polyethylene Glycol 200 Polymers 0.000 claims 1
- 229920002556 Polyethylene Glycol 300 Polymers 0.000 claims 1
- 229920002565 Polyethylene Glycol 400 Polymers 0.000 claims 1
- 229920002582 Polyethylene Glycol 600 Polymers 0.000 claims 1
- 229920002593 Polyethylene Glycol 800 Polymers 0.000 claims 1
- 229920002596 Polyethylene Glycol 900 Polymers 0.000 claims 1
- TVQZAMVBTVNYLA-UHFFFAOYSA-N Pranoprofen Chemical compound C1=CC=C2CC3=CC(C(C(O)=O)C)=CC=C3OC2=N1 TVQZAMVBTVNYLA-UHFFFAOYSA-N 0.000 claims 1
- 150000001242 acetic acid derivatives Chemical class 0.000 claims 1
- 239000002253 acid Substances 0.000 claims 1
- 229960004663 alminoprofen Drugs 0.000 claims 1
- FPHLBGOJWPEVME-UHFFFAOYSA-N alminoprofen Chemical compound OC(=O)C(C)C1=CC=C(NCC(C)=C)C=C1 FPHLBGOJWPEVME-UHFFFAOYSA-N 0.000 claims 1
- 229960005430 benoxaprofen Drugs 0.000 claims 1
- 239000003260 cyclooxygenase 1 inhibitor Substances 0.000 claims 1
- 239000003255 cyclooxygenase 2 inhibitor Substances 0.000 claims 1
- 229960002783 dexketoprofen Drugs 0.000 claims 1
- DKYWVDODHFEZIM-NSHDSACASA-N dexketoprofen Chemical compound OC(=O)[C@@H](C)C1=CC=CC(C(=O)C=2C=CC=CC=2)=C1 DKYWVDODHFEZIM-NSHDSACASA-N 0.000 claims 1
- 239000003814 drug Substances 0.000 claims 1
- 150000002148 esters Chemical class 0.000 claims 1
- 229960002390 flurbiprofen Drugs 0.000 claims 1
- SYTBZMRGLBWNTM-UHFFFAOYSA-N flurbiprofen Chemical compound FC1=CC(C(C(O)=O)C)=CC=C1C1=CC=CC=C1 SYTBZMRGLBWNTM-UHFFFAOYSA-N 0.000 claims 1
- -1 glycerol glycerol glycerol monostearidonate Chemical compound 0.000 claims 1
- 229960004187 indoprofen Drugs 0.000 claims 1
- DKYWVDODHFEZIM-UHFFFAOYSA-N ketoprofen Chemical compound OC(=O)C(C)C1=CC=CC(C(=O)C=2C=CC=CC=2)=C1 DKYWVDODHFEZIM-UHFFFAOYSA-N 0.000 claims 1
- 229960000991 ketoprofen Drugs 0.000 claims 1
- YMBXTVYHTMGZDW-UHFFFAOYSA-N loxoprofen Chemical compound C1=CC(C(C(O)=O)C)=CC=C1CC1C(=O)CCC1 YMBXTVYHTMGZDW-UHFFFAOYSA-N 0.000 claims 1
- 229960002373 loxoprofen Drugs 0.000 claims 1
- 238000004519 manufacturing process Methods 0.000 claims 1
- 230000003278 mimic effect Effects 0.000 claims 1
- 229960002009 naproxen Drugs 0.000 claims 1
- CMWTZPSULFXXJA-VIFPVBQESA-N naproxen Chemical compound C1=C([C@H](C)C(O)=O)C=CC2=CC(OC)=CC=C21 CMWTZPSULFXXJA-VIFPVBQESA-N 0.000 claims 1
- 239000000041 non-steroidal anti-inflammatory agent Substances 0.000 claims 1
- 229960002739 oxaprozin Drugs 0.000 claims 1
- OFPXSFXSNFPTHF-UHFFFAOYSA-N oxaprozin Chemical compound O1C(CCC(=O)O)=NC(C=2C=CC=CC=2)=C1C1=CC=CC=C1 OFPXSFXSNFPTHF-UHFFFAOYSA-N 0.000 claims 1
- 229920002523 polyethylene Glycol 1000 Polymers 0.000 claims 1
- 229960003101 pranoprofen Drugs 0.000 claims 1
- WSRQNKKUPGBCOT-KVVVOXFISA-N propane-1,2,3-triol (Z)-tetracos-15-enoic acid Chemical compound OCC(O)CO.CCCCCCCC\C=C/CCCCCCCCCCCCCC(O)=O WSRQNKKUPGBCOT-KVVVOXFISA-N 0.000 claims 1
- 239000002599 prostaglandin synthase inhibitor Substances 0.000 claims 1
- 150000003873 salicylate salts Chemical class 0.000 claims 1
- 239000007787 solid Substances 0.000 claims 1
- 229960004492 suprofen Drugs 0.000 claims 1
- 208000024891 symptom Diseases 0.000 claims 1
Classifications
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- Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
- Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
Claims (52)
1. Фармацевтическая композиция твердого раствора, включающая:
a) одно или более нестероидных противовоспалительных средств (NSAID) в количестве от приблизительно 20% до приблизительно 40% по массе от массы фармацевтической композиции;
b) один или более фармацевтически приемлемых твердых жиров в количестве, по меньшей мере, 30% по массе от массы фармацевтической композиции, где один или более фармацевтически приемлемых твердых жиров включают один или более глицеролипидов;
c) один или более фармацевтически приемлемых моноглицеридов или ацетилированных моноглицеридов, которые являются жидкими при комнатной температуре, в количестве менее чем 30% по массе от массы фармацевтической композиции, и
d) жидкий полимер гликоля в количестве от приблизительно 5% до приблизительно 15% по массе от массы фармацевтической композиции;
где фармацевтическая композиция твердого раствора приготовлена так, что она является твердой при температуре приблизительно 15°C или ниже.
2. Фармацевтическая композиция твердого раствора по п. 1, где количество одного или более NSAID составляет от приблизительно 25% до приблизительно 35% по массе от массы фармацевтической композиции.
3. Фармацевтическая композиция по п. 1, где одно или более NSAID включают неселективный ингибитор циклооксигеназы, селективный ингибитор циклооксигеназы 1, селективный ингибитор циклооксигеназы 2 или любую их комбинацию.
4. Фармацевтическая композиция по п. 3, где одно или более NSAID включают фармацевтически приемлемую форму салицилатного производного, фармацевтически приемлемую форму п-аминофенольного производного, фармацевтически приемлемую форму производного пропионовой кислоты, фармацевтически приемлемую форму производного уксусной кислоты, фармацевтически приемлемую форму производного эноловой кислоты, фармацевтически приемлемую форму производного фенамовой кислоты, эфира NSAID, или любую их комбинацию.
5. Фармацевтическая композиция по п. 4, где производное пропионовой кислоты включает фармацевтически приемлемую форму альминопрофена, фармацевтически приемлемую форму беноксапрофена, фармацевтически приемлемую форму декскетопрофена, фармацевтически приемлемую форму фенопрофена, фармацевтически приемлемую форму флурбипрофена, фармацевтически приемлемую форму ибупрофена, фармацевтически приемлемую форму индопрофена, фармацевтически приемлемую форму кетопрофена, фармацевтически приемлемую форму локсопрофена, фармацевтически приемлемую форму напроксена, фармацевтически приемлемую форму оксапрозина, фармацевтически приемлемую форму пранопрофена или фармацевтически приемлемую форму супрофена.
6. Фармацевтическая композиция по п. 5, где производное пропионовой кислоты представляет собой фармацевтически приемлемую форму ибупрофена.
7. Фармацевтическая композиция твердого раствора по п. 1, где количество одного или более фармацевтически приемлемых твердых жиров составляет от приблизительно 35% до приблизительно 45% по массе от массы фармацевтической композиции.
8. Фармацевтическая композиция твердого раствора по п. 1, где один или более фармацевтически приемлемых твердых жиров имеют температуру плавления от приблизительно 40°C до приблизительно 50°C.
9. Фармацевтическая композиция твердого раствора по п. 1, где один или более глицеролипидов включают смесь насыщенных C10-C18 триглицеридов, имеющих температуру плавления в диапазоне от приблизительно 41°C до приблизительно 45°C.
10. Фармацевтическая композиция твердого раствора по п. 9, где один или более глицеролипидов включают смесь насыщенных C10-C18 триглицеридов, имеющих температуру плавления в диапазоне приблизительно 43°C.
11. Фармацевтическая композиция твердого раствора по п. 1, где количество одного или более фармацевтически приемлемых моноглицеридов или ацетилированных моноглицеридов составляет от приблизительно 8% до приблизительно 30% по массе от массы фармацевтической композиции.
12. Фармацевтическая композиция твердого раствора по п. 11, где один или более фармацевтически приемлемых моноглицеридов или ацетилированных моноглицеридов включают глицерина мономиристолеат, глицерина монопальмитолеат, глицерина моносапиенат, глицерина моноолеат, глицерина моноэлаидат, глицерина моновакценат, глицерина монолинолеат, глицерина монолиноэлаидат, глицерина монолиноленат, глицерина моностеаридонат, глицерина моноэйкозеноат, глицерина мономеадат, глицерина моноарахидонат, глицерина моноэйкозапентаеноат, глицерина моноэрукат, глицерина монодокозагексаеноат, глицерина мононервонат.
13. Фармацевтическая композиция твердого раствора по п. 12, где один или более фармацевтически приемлемых моноглицеридов или ацетилированных моноглицеридов включают глицерина монолинолеат.
14. Фармацевтическая композиция твердого раствора по п. 1, где жидкий полимер гликоля составляет количество от приблизительно 9% до приблизительно 12% по массе от массы фармацевтической композиции.
15. Фармацевтическая композиция твердого раствора по п. 14, где жидкий полимер гликоля составляет количество от приблизительно 10% до приблизительно 12% по массе от массы фармацевтической композиции.
16. Фармацевтическая композиция твердого раствора по п. 1, где жидкий полимер гликоля представляет собой жидкий полимер полиэтиленгликоля (ПЭГ) и/или жидкий полимер полипропиленгликоля (ППГ).
17. Фармацевтическая композиция по п. 16, где молекулярная масса жидкого полимера ПЭГ и/или жидкого полимера ППГ составляет не более чем 1000 г/моль.
18. Фармацевтическая композиция по п. 17, где полимер ПЭГ включает ПЭГ 100, ПЭГ 200, ПЭГ 300, ПЭГ 400, ПЭГ 500, ПЭГ 600,
ПЭГ 700, ПЭГ 800, ПЭГ 900, ПЭГ 1000 или любую их комбинацию.
19. Фармацевтическая композиция по п. 17, где полимер ППГ включает ППГ 100, ППГ 200, ППГ 300, ППГ 400, ППГ 500, ППГ 600, ППГ 700, ППГ 800, ППГ 900, ППГ 1000 или любую их комбинацию.
20. Применение фармацевтической композиции по одному из пп. 1-19 в производстве лекарственного препарата для лечения состояния сильной боли.
21. Применение по п. 20, где состояние сильной боли представляет собой острую боль, подострую боль или хроническую боль.
22. Применение по п. 20, где состояние сильной боли представляет собой ноцицептивную боль, патологическую боль, отраженную боль, головную боль или мигрень.
23. Применение по п. 22, где ноцицептивная боль представляет собой висцеральную боль, глубокую соматическую боль, поверхностную соматическую боль или любую их комбинацию.
24. Применение по п. 22, где патологическая боль представляет собой нейропатическую боль, дисфункциональную боль или любую их комбинацию.
25. Применение по п. 24, где нейропатическая боль представляет собой центральную нейропатическую боль, периферическую нейропатическую боль, деафферентационную боль или любую их комбинацию.
26. Применение по п. 25, где периферическая нейропатическая боль представляет собой мононевропатию, множественную мононевропатию, полинейропатию, вегетативную нейропатию, невралгию или комплексный региональный болевой синдром.
27. Применение по п. 26, где полинейропатия представляет собой дистальную аксонопатию, миелинопатию или нейронопатию.
28. Применение по п. 22, где головная боль представляет собой мышечную/миогенную головную боль, сосудистую головную боль, тракционную головную боль, воспалительную головную боль, головную боль при хроническом синусите, головную боль при гормональных нарушениях, рикошетную головную боль, органическую головную боль или иктальную головную боль.
29. Применение фармацевтической композиции по любому одному из пп. 1-19 для лечения состояния сильной боли.
30. Применение по п. 29, где состояние сильной боли представляет собой острую боль, подострую боль или хроническую боль.
31. Применение по п. 29, где состояние сильной боли представляет собой ноцицептивную боль, патологическую боль, отраженную боль, головную боль или мигрень.
32. Применение по п. 31, где ноцицептивная боль представляет собой висцеральную боль, глубокую соматическую боль, поверхностную соматическую боль или любую их комбинацию.
33. Применение по п. 31, где патологическая боль представляет собой нейропатическую боль, дисфункциональную боль или любую их комбинацию.
34. Применение по п. 33, где нейропатическая боль представляет собой центральную нейропатическую боль, периферическую нейропатическую боль, деафферентационную боль или любую их комбинацию.
35. Применение по п. 34, где периферическая нейропатическая боль представляет собой мононевропатию, множественную мононевропатию, полинейропатию, вегетативную нейропатию, невралгию или комплексный региональный болевой синдром.
36. Применение по п. 35, где полинейропатия представляет собой дистальную аксонопатию, миелинопатию или нейронопатию.
37. Применение по п. 31, где головная боль представляет собой мышечную/миогенную головную боль, сосудистую головную боль, тракционную головную боль, воспалительную головную боль, головную боль при хроническом синусите, головную боль при гормональных нарушениях, рикошетную головную боль, органическую головную боль или иктальную головную боль.
38. Способ лечения индивидуума, страдающего состоянием сильной боли, где способ включает стадии: введения индивидууму, если это ему необходимо, фармацевтической композиции по пп. 1-19, где введение приводит в результате к уменьшению интенсивности симптома, связанного с состоянием сильной боли, вследствие чего происходит лечение индивидуума.
39. Способ по п. 38, где состояние сильной боли представляет собой острую боль, подострую боль или хроническую боль.
40. Способ по п. 38, где состояние сильной боли представляет собой ноцицептивную боль, патологическую боль, отраженную боль, головную боль или мигрень.
41. Способ по п. 40, где ноцицептивная боль представляет собой висцеральную боль, глубокую соматическую боль, поверхностную соматическую боль или любую их комбинацию.
42. Способ по п. 40, где патологическая боль представляет собой нейропатическую боль, дисфункциональную боль или любую их комбинацию.
43. Способ по п. 42, где нейропатическая боль представляет собой центральную нейропатическую боль, периферическую нейропатическую боль, деафферентационную боль или любую их комбинацию.
44. Способ по п. 43, где периферическая нейропатическая боль представляет собой мононевропатию, множественную мононевропатию, полинейропатию, вегетативную нейропатию, невралгию или комплексный региональный болевой синдром.
45. Способ по п. 44, где полинейропатия представляет собой дистальную аксонопатию, миелинопатию или нейронопатию.
46. Способ по п. 40, где головная боль представляет собой мышечную/миогенную головную боль, сосудистую головную боль, тракционную головную боль, воспалительную головную боль, головную боль при хроническом синусите, головную боль при гормональных нарушениях, рикошетную головную боль, органическую головную боль или иктальную головную боль.
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