EA036752B1 - Способ получения геля для ректального и наружного применения, включающего нифедипин и лидокаина гидрохлорид (варианты) - Google Patents
Способ получения геля для ректального и наружного применения, включающего нифедипин и лидокаина гидрохлорид (варианты) Download PDFInfo
- Publication number
- EA036752B1 EA036752B1 EA201991220A EA201991220A EA036752B1 EA 036752 B1 EA036752 B1 EA 036752B1 EA 201991220 A EA201991220 A EA 201991220A EA 201991220 A EA201991220 A EA 201991220A EA 036752 B1 EA036752 B1 EA 036752B1
- Authority
- EA
- Eurasian Patent Office
- Prior art keywords
- gel
- solution
- nifedipine
- poloxamer
- obtaining
- Prior art date
Links
- 229960001597 nifedipine Drugs 0.000 title claims abstract description 63
- HYIMSNHJOBLJNT-UHFFFAOYSA-N nifedipine Chemical compound COC(=O)C1=C(C)NC(C)=C(C(=O)OC)C1C1=CC=CC=C1[N+]([O-])=O HYIMSNHJOBLJNT-UHFFFAOYSA-N 0.000 title claims abstract description 62
- YECIFGHRMFEPJK-UHFFFAOYSA-N lidocaine hydrochloride monohydrate Chemical compound O.[Cl-].CC[NH+](CC)CC(=O)NC1=C(C)C=CC=C1C YECIFGHRMFEPJK-UHFFFAOYSA-N 0.000 title claims abstract description 38
- 229960004393 lidocaine hydrochloride Drugs 0.000 title claims abstract description 30
- 238000004519 manufacturing process Methods 0.000 title abstract description 6
- 238000011200 topical administration Methods 0.000 title 1
- 239000000203 mixture Substances 0.000 claims abstract description 86
- 238000000034 method Methods 0.000 claims abstract description 59
- NNJVILVZKWQKPM-UHFFFAOYSA-N Lidocaine Chemical compound CCN(CC)CC(=O)NC1=C(C)C=CC=C1C NNJVILVZKWQKPM-UHFFFAOYSA-N 0.000 claims abstract description 12
- 229960004194 lidocaine Drugs 0.000 claims abstract description 12
- 239000000243 solution Substances 0.000 claims description 106
- RVGRUAULSDPKGF-UHFFFAOYSA-N Poloxamer Chemical compound C1CO1.CC1CO1 RVGRUAULSDPKGF-UHFFFAOYSA-N 0.000 claims description 61
- 238000002156 mixing Methods 0.000 claims description 48
- 229920001992 poloxamer 407 Polymers 0.000 claims description 41
- 229940044476 poloxamer 407 Drugs 0.000 claims description 41
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical group [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 claims description 39
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 35
- 239000007864 aqueous solution Substances 0.000 claims description 34
- LXCFILQKKLGQFO-UHFFFAOYSA-N methylparaben Chemical compound COC(=O)C1=CC=C(O)C=C1 LXCFILQKKLGQFO-UHFFFAOYSA-N 0.000 claims description 33
- 238000003756 stirring Methods 0.000 claims description 33
- 239000012535 impurity Substances 0.000 claims description 25
- 229920001993 poloxamer 188 Polymers 0.000 claims description 19
- 229940044519 poloxamer 188 Drugs 0.000 claims description 19
- 229940068918 polyethylene glycol 400 Drugs 0.000 claims description 16
- 239000012456 homogeneous solution Substances 0.000 claims description 13
- 239000002202 Polyethylene glycol Substances 0.000 claims description 11
- 229920001223 polyethylene glycol Polymers 0.000 claims description 11
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 claims description 10
- 239000002245 particle Substances 0.000 claims description 8
- 229940057847 polyethylene glycol 600 Drugs 0.000 claims description 8
- 235000010270 methyl p-hydroxybenzoate Nutrition 0.000 claims description 6
- 239000004292 methyl p-hydroxybenzoate Substances 0.000 claims description 6
- 229960002216 methylparaben Drugs 0.000 claims description 6
- 235000010232 propyl p-hydroxybenzoate Nutrition 0.000 claims description 6
- 239000004405 propyl p-hydroxybenzoate Substances 0.000 claims description 6
- QELSKZZBTMNZEB-UHFFFAOYSA-N propylparaben Chemical compound CCCOC(=O)C1=CC=C(O)C=C1 QELSKZZBTMNZEB-UHFFFAOYSA-N 0.000 claims description 6
- 239000000126 substance Substances 0.000 claims description 6
- 230000002906 microbiologic effect Effects 0.000 claims description 4
- 238000003908 quality control method Methods 0.000 claims description 4
- 238000012937 correction Methods 0.000 claims description 3
- 239000003795 chemical substances by application Substances 0.000 claims 2
- 229940126601 medicinal product Drugs 0.000 claims 2
- 239000000499 gel Substances 0.000 abstract description 114
- 206010002153 Anal fissure Diseases 0.000 abstract description 20
- 208000016583 Anus disease Diseases 0.000 abstract description 18
- 208000009531 Fissure in Ano Diseases 0.000 abstract description 18
- 208000014617 hemorrhoid Diseases 0.000 abstract description 16
- 208000002193 Pain Diseases 0.000 abstract description 14
- 208000024891 symptom Diseases 0.000 abstract description 8
- 239000008194 pharmaceutical composition Substances 0.000 abstract description 6
- 238000002360 preparation method Methods 0.000 abstract description 6
- 238000009472 formulation Methods 0.000 abstract description 5
- 238000009533 lab test Methods 0.000 abstract description 2
- 239000004615 ingredient Substances 0.000 description 17
- 238000011282 treatment Methods 0.000 description 12
- 239000003814 drug Substances 0.000 description 10
- 229940079593 drug Drugs 0.000 description 9
- 238000004128 high performance liquid chromatography Methods 0.000 description 8
- 239000008213 purified water Substances 0.000 description 8
- HPALAKNZSZLMCH-UHFFFAOYSA-M sodium;chloride;hydrate Chemical compound O.[Na+].[Cl-] HPALAKNZSZLMCH-UHFFFAOYSA-M 0.000 description 8
- 239000013543 active substance Substances 0.000 description 7
- 239000012736 aqueous medium Substances 0.000 description 7
- 238000005286 illumination Methods 0.000 description 7
- 241000700159 Rattus Species 0.000 description 6
- 238000010879 hemorrhoidectomy Methods 0.000 description 6
- 239000007788 liquid Substances 0.000 description 6
- 238000011002 quantification Methods 0.000 description 6
- 241001465754 Metazoa Species 0.000 description 5
- SNIOPGDIGTZGOP-UHFFFAOYSA-N Nitroglycerin Chemical compound [O-][N+](=O)OCC(O[N+]([O-])=O)CO[N+]([O-])=O SNIOPGDIGTZGOP-UHFFFAOYSA-N 0.000 description 5
- 208000005392 Spasm Diseases 0.000 description 5
- 239000002674 ointment Substances 0.000 description 5
- 210000005070 sphincter Anatomy 0.000 description 5
- 238000004090 dissolution Methods 0.000 description 4
- 230000035876 healing Effects 0.000 description 4
- 230000014759 maintenance of location Effects 0.000 description 4
- 238000004321 preservation Methods 0.000 description 4
- 239000004480 active ingredient Substances 0.000 description 3
- 238000011161 development Methods 0.000 description 3
- 201000010099 disease Diseases 0.000 description 3
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 3
- 239000002552 dosage form Substances 0.000 description 3
- 239000011521 glass Substances 0.000 description 3
- 210000003205 muscle Anatomy 0.000 description 3
- 239000000546 pharmaceutical excipient Substances 0.000 description 3
- 230000002265 prevention Effects 0.000 description 3
- 239000003381 stabilizer Substances 0.000 description 3
- 239000000725 suspension Substances 0.000 description 3
- 239000002562 thickening agent Substances 0.000 description 3
- UFFBMTHBGFGIHF-UHFFFAOYSA-N 2,6-dimethylaniline Chemical compound CC1=CC=CC(C)=C1N UFFBMTHBGFGIHF-UHFFFAOYSA-N 0.000 description 2
- 229940127291 Calcium channel antagonist Drugs 0.000 description 2
- LYCAIKOWRPUZTN-UHFFFAOYSA-N Ethylene glycol Chemical compound OCCO LYCAIKOWRPUZTN-UHFFFAOYSA-N 0.000 description 2
- 208000007101 Muscle Cramp Diseases 0.000 description 2
- 239000000006 Nitroglycerin Substances 0.000 description 2
- 241000218657 Picea Species 0.000 description 2
- 210000002255 anal canal Anatomy 0.000 description 2
- 238000004458 analytical method Methods 0.000 description 2
- 239000000480 calcium channel blocker Substances 0.000 description 2
- 230000008859 change Effects 0.000 description 2
- 230000000694 effects Effects 0.000 description 2
- 239000000839 emulsion Substances 0.000 description 2
- 238000005516 engineering process Methods 0.000 description 2
- 229940009493 gel-one Drugs 0.000 description 2
- 229960003711 glyceryl trinitrate Drugs 0.000 description 2
- 239000008240 homogeneous mixture Substances 0.000 description 2
- 238000000265 homogenisation Methods 0.000 description 2
- 238000001727 in vivo Methods 0.000 description 2
- 238000005259 measurement Methods 0.000 description 2
- 239000003002 pH adjusting agent Substances 0.000 description 2
- 230000000144 pharmacologic effect Effects 0.000 description 2
- 229920001983 poloxamer Polymers 0.000 description 2
- 229960000502 poloxamer Drugs 0.000 description 2
- -1 polyoxyethylene Polymers 0.000 description 2
- 230000008569 process Effects 0.000 description 2
- 210000002460 smooth muscle Anatomy 0.000 description 2
- 238000001356 surgical procedure Methods 0.000 description 2
- 208000011580 syndromic disease Diseases 0.000 description 2
- 238000010998 test method Methods 0.000 description 2
- BHPQYMZQTOCNFJ-UHFFFAOYSA-N Calcium cation Chemical compound [Ca+2] BHPQYMZQTOCNFJ-UHFFFAOYSA-N 0.000 description 1
- 206010010774 Constipation Diseases 0.000 description 1
- 229920005682 EO-PO block copolymer Polymers 0.000 description 1
- 206010019233 Headaches Diseases 0.000 description 1
- 206010061218 Inflammation Diseases 0.000 description 1
- 208000008238 Muscle Spasticity Diseases 0.000 description 1
- 229920003171 Poly (ethylene oxide) Polymers 0.000 description 1
- RTAQQCXQSZGOHL-UHFFFAOYSA-N Titanium Chemical compound [Ti] RTAQQCXQSZGOHL-UHFFFAOYSA-N 0.000 description 1
- 230000009471 action Effects 0.000 description 1
- 230000001154 acute effect Effects 0.000 description 1
- 208000037849 arterial hypertension Diseases 0.000 description 1
- QVGXLLKOCUKJST-UHFFFAOYSA-N atomic oxygen Chemical compound [O] QVGXLLKOCUKJST-UHFFFAOYSA-N 0.000 description 1
- 230000008901 benefit Effects 0.000 description 1
- 230000017531 blood circulation Effects 0.000 description 1
- 229910001424 calcium ion Inorganic materials 0.000 description 1
- 210000004027 cell Anatomy 0.000 description 1
- 230000007547 defect Effects 0.000 description 1
- 238000007872 degassing Methods 0.000 description 1
- 229960004166 diltiazem Drugs 0.000 description 1
- HSUGRBWQSSZJOP-RTWAWAEBSA-N diltiazem Chemical compound C1=CC(OC)=CC=C1[C@H]1[C@@H](OC(C)=O)C(=O)N(CCN(C)C)C2=CC=CC=C2S1 HSUGRBWQSSZJOP-RTWAWAEBSA-N 0.000 description 1
- 208000002173 dizziness Diseases 0.000 description 1
- 238000011067 equilibration Methods 0.000 description 1
- 238000002474 experimental method Methods 0.000 description 1
- 231100000869 headache Toxicity 0.000 description 1
- 208000019622 heart disease Diseases 0.000 description 1
- 239000001307 helium Substances 0.000 description 1
- 229910052734 helium Inorganic materials 0.000 description 1
- SWQJXJOGLNCZEY-UHFFFAOYSA-N helium atom Chemical compound [He] SWQJXJOGLNCZEY-UHFFFAOYSA-N 0.000 description 1
- 230000004054 inflammatory process Effects 0.000 description 1
- 208000028867 ischemia Diseases 0.000 description 1
- 239000008141 laxative Substances 0.000 description 1
- 229940125722 laxative agent Drugs 0.000 description 1
- 230000010534 mechanism of action Effects 0.000 description 1
- 230000004089 microcirculation Effects 0.000 description 1
- 230000003020 moisturizing effect Effects 0.000 description 1
- 230000004660 morphological change Effects 0.000 description 1
- 210000004400 mucous membrane Anatomy 0.000 description 1
- 238000006386 neutralization reaction Methods 0.000 description 1
- 239000001301 oxygen Substances 0.000 description 1
- 229910052760 oxygen Inorganic materials 0.000 description 1
- 238000010979 pH adjustment Methods 0.000 description 1
- 230000001717 pathogenic effect Effects 0.000 description 1
- 230000002035 prolonged effect Effects 0.000 description 1
- 238000011084 recovery Methods 0.000 description 1
- 238000006479 redox reaction Methods 0.000 description 1
- 230000009467 reduction Effects 0.000 description 1
- 238000011160 research Methods 0.000 description 1
- 210000003491 skin Anatomy 0.000 description 1
- 208000018198 spasticity Diseases 0.000 description 1
- 230000001839 systemic circulation Effects 0.000 description 1
- 230000001225 therapeutic effect Effects 0.000 description 1
- 229910052719 titanium Inorganic materials 0.000 description 1
- 239000010936 titanium Substances 0.000 description 1
- 230000000699 topical effect Effects 0.000 description 1
- 230000007704 transition Effects 0.000 description 1
- 230000000304 vasodilatating effect Effects 0.000 description 1
Classifications
-
- 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
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/16—Amides, e.g. hydroxamic acids
- A61K31/165—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
- A61K31/167—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- 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
-
- 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
- A61K9/0014—Skin, i.e. galenical aspects of topical compositions
-
- 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
- A61K9/0031—Rectum, anus
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P23/00—Anaesthetics
- A61P23/02—Local anaesthetics
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Epidemiology (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Engineering & Computer Science (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Anesthesiology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Dermatology (AREA)
- Pain & Pain Management (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| PCT/RU2019/000120 WO2020176004A1 (ru) | 2019-02-25 | 2019-02-25 | Гель для ректального и наружного применения |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| EA201991220A1 EA201991220A1 (ru) | 2020-08-31 |
| EA036752B1 true EA036752B1 (ru) | 2020-12-16 |
Family
ID=72235046
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| EA201991220A EA036752B1 (ru) | 2019-02-25 | 2019-02-25 | Способ получения геля для ректального и наружного применения, включающего нифедипин и лидокаина гидрохлорид (варианты) |
Country Status (3)
| Country | Link |
|---|---|
| JP (1) | JP7331149B2 (enrdf_load_stackoverflow) |
| EA (1) | EA036752B1 (enrdf_load_stackoverflow) |
| WO (1) | WO2020176004A1 (enrdf_load_stackoverflow) |
Families Citing this family (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN117377461A (zh) * | 2021-04-01 | 2024-01-09 | 钢铁疗法公司 | 含有硝苯地平和利多卡因的局部擦拭物 |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2016118040A1 (ru) * | 2015-01-21 | 2016-07-28 | ОБЩЕСТВО С ОГРАНИЧЕННОЙ ОТВЕТСТВЕННОСТЬЮ "НоваМедика" | Гель, содержащий нифедипин и лидокаина гидрохлорид, его применение и способ приготовления с использованием нанотехнологий |
| RU2641570C2 (ru) * | 2015-01-21 | 2018-01-18 | ОБЩЕСТВО С ОГРАНИЧЕННОЙ ОТВЕТСТВЕННОСТЬЮ "НоваМедика" | Гель, включающий нифедипин и лидокаина гидрохлорид (варианты), применение геля, включающего нифедипин и лидокаина гидрохлорид (варианты), способ приготовления геля, включающего нифедипин и лидокаина гидрохлорид, с использованием нанотехнологии |
Family Cites Families (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| IT1297886B1 (it) * | 1997-02-28 | 1999-12-20 | Carmine Antropoli | Nifedipina per uso topico |
| CN1813766A (zh) * | 2005-12-19 | 2006-08-09 | 杨树强 | 一种痔疮软膏及其制备方法 |
| RU2538079C1 (ru) * | 2013-12-30 | 2015-01-10 | Светлана Николаевна Суслина | Композиция для лечения анальных трещин |
| RU2606858C2 (ru) * | 2014-09-30 | 2017-01-10 | ОБЩЕСТВО С ОГРАНИЧЕННОЙ ОТВЕТСТВЕННОСТЬЮ "НоваМедика" | Способ растворения нифедипина в водной среде с использованием нанотехнологии. фармацевтическая композиция, содержащая раствор нифедипина в водной среде. способ количественного определения нифедипина в растворе |
-
2019
- 2019-02-25 WO PCT/RU2019/000120 patent/WO2020176004A1/ru active Application Filing
- 2019-02-25 EA EA201991220A patent/EA036752B1/ru unknown
- 2019-02-25 JP JP2021572255A patent/JP7331149B2/ja active Active
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2016118040A1 (ru) * | 2015-01-21 | 2016-07-28 | ОБЩЕСТВО С ОГРАНИЧЕННОЙ ОТВЕТСТВЕННОСТЬЮ "НоваМедика" | Гель, содержащий нифедипин и лидокаина гидрохлорид, его применение и способ приготовления с использованием нанотехнологий |
| RU2641570C2 (ru) * | 2015-01-21 | 2018-01-18 | ОБЩЕСТВО С ОГРАНИЧЕННОЙ ОТВЕТСТВЕННОСТЬЮ "НоваМедика" | Гель, включающий нифедипин и лидокаина гидрохлорид (варианты), применение геля, включающего нифедипин и лидокаина гидрохлорид (варианты), способ приготовления геля, включающего нифедипин и лидокаина гидрохлорид, с использованием нанотехнологии |
Non-Patent Citations (1)
| Title |
|---|
| Инструкция по медицинскому применению лекарственного препарата Фиссарио. Номер ЛП-004782, дата регистрации 03.04.2018, [ГРЛС] [онлайн] найдено в <http://grls.rosminzdrav.ru/Grls_View_v2.aspx?routingGuid=60371fbb-b77e-4abe-9c12-24a18838b2eb&t=> * |
Also Published As
| Publication number | Publication date |
|---|---|
| WO2020176004A1 (ru) | 2020-09-03 |
| EA201991220A1 (ru) | 2020-08-31 |
| JP2022521444A (ja) | 2022-04-07 |
| JP7331149B2 (ja) | 2023-08-22 |
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