DK3116498T3 - Formulering til bløde anticholinerge analoger - Google Patents
Formulering til bløde anticholinerge analoger Download PDFInfo
- Publication number
- DK3116498T3 DK3116498T3 DK15762178.0T DK15762178T DK3116498T3 DK 3116498 T3 DK3116498 T3 DK 3116498T3 DK 15762178 T DK15762178 T DK 15762178T DK 3116498 T3 DK3116498 T3 DK 3116498T3
- Authority
- DK
- Denmark
- Prior art keywords
- composition
- hydroxyacetoxy
- cyclopentyl
- phenyl
- compound
- Prior art date
Links
Classifications
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07D—HETEROCYCLIC COMPOUNDS
- C07D207/00—Heterocyclic compounds containing five-membered rings not condensed with other rings, with one nitrogen atom as the only ring hetero atom
- C07D207/02—Heterocyclic compounds containing five-membered rings not condensed with other rings, with one nitrogen atom as the only ring hetero atom with only hydrogen or carbon atoms directly attached to the ring nitrogen atom
- C07D207/04—Heterocyclic compounds containing five-membered rings not condensed with other rings, with one nitrogen atom as the only ring hetero atom with only hydrogen or carbon atoms directly attached to the ring nitrogen atom having no double bonds between ring members or between ring members and non-ring members
- C07D207/10—Heterocyclic compounds containing five-membered rings not condensed with other rings, with one nitrogen atom as the only ring hetero atom with only hydrogen or carbon atoms directly attached to the ring nitrogen atom having no double bonds between ring members or between ring members and non-ring members with hetero atoms or with carbon atoms having three bonds to hetero atoms with at the most one bond to halogen, e.g. ester or nitrile radicals, directly attached to ring carbon atoms
- C07D207/12—Oxygen or sulfur atoms
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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
- A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
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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
- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K33/00—Medicinal preparations containing inorganic active ingredients
- A61K33/06—Aluminium, calcium or magnesium; Compounds thereof, e.g. clay
-
- 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
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
-
- 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
- A61K47/24—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing atoms other than carbon, hydrogen, oxygen, halogen, nitrogen or sulfur, e.g. cyclomethicone or phospholipids
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/34—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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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K8/00—Cosmetics or similar toiletry preparations
- A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
- A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
- A61K8/49—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing heterocyclic compounds
- A61K8/4906—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing heterocyclic compounds with one nitrogen as the only hetero atom
- A61K8/4913—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing heterocyclic compounds with one nitrogen as the only hetero atom having five membered rings, e.g. pyrrolidone carboxylic acid
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0014—Skin, i.e. galenical aspects of topical compositions
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/06—Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
-
- 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
- A61K9/08—Solutions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P17/00—Drugs for dermatological disorders
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
- A61Q15/00—Anti-perspirants or body deodorants
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/38—Cellulose; Derivatives thereof
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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Medicinal Chemistry (AREA)
- Epidemiology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Engineering & Computer Science (AREA)
- Organic Chemistry (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Inorganic Chemistry (AREA)
- Dermatology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Birds (AREA)
- Molecular Biology (AREA)
- Biophysics (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Cosmetics (AREA)
Claims (15)
1. Topisk vandfri gelsammensætning, hvilken sammensætning omfatter følgende bestanddele: (a) en forbindelse med formlen:
(2) hvor R er methyl eller ethyl, hvor forbindelsen er den stereoisomeriske R-konfiguration ved position 2 og den stereoisomeriske R-, S- eller RS-konfiguration ved T- og 3'-positioneme eller er en blanding deraf; (b) ethanol som et ikke-vandigt opløsningsmiddel til forbindelsen med formlen (2), til stede i en mængde på 70-99,9 % vægt/vægt eller vægt/volumen af sammensætningen; (c) mindst én geleringsbestanddel eller viskositetsstyrende bestanddel og (d) eventuelt mindst én supplerende bærer eller excipiens; hvor den topiske vandfri gelsammensætning omfatter fra 0,1 % til 30 % vægt/vægt eller vægt/volumen af forbindelsen med formlen (2).
2. Sammensætning ifølge krav 1, hvor mindst én supplerende bærer eller excipiens er til stede.
3. Sammensætning ifølge et hvilket som helst af kravene 1-2, hvor forbindelsen med formlen (2) er valgt fra gruppen bestående af: (a) (2R,3'R) 3-(2-cyclopentyl-2-phenyl-2-hydroxyacetoxy)- l-(ethoxycarbonylmethyl)-1- methylpyrrolidiniumbromid; (b) (2R,3'S) 3-(2-cyclopentyl-2-phenyl-2-hydroxyacetoxy)- l-(ethoxycarbonylmethyl)-1- methylpyrrolidiniumbromid; (c) (2R,l'R,3'S) 3-(2-cyclopentyl-2-phenyl-2-hydroxyacetoxy)-l-(ethoxycarbonylmethyl)-1 -methylpyrrolidinrumbromrd; (d) (2R,l'S,3'S) 3-(2-cyclopentyl-2-phenyl-2-hydroxyacetoxy)-l-(ethoxycarbonylmethyl)-1 -methylpyrrolidinrumbromrd;
(e) (2R,l'R,3'R) 3-(2-cyclopentyl-2-phenyl-2-hydroxyacetoxy)-l-(ethoxycarbonylmethyl)-1 -methylpyrrolidiniumbromid; (f) (2R,l'S,3'R) 3-(2-cyclopentyl-2-phenyl-2-hydroxyacetoxy)- l-(ethoxycarbonylmethyl)-1 -methylpyrrolidiniumbromid; (g) (2R,3'R) 3-(2-cyclopentyl-2-phenyl-2-hydroxyacetoxy)-l-methyl-l- methoxycarbonylmethylpyrrolidrnrumbromrd; (h) (2R,3'S) 3-(2-cyclopentyl-2-phenyl-2-hydroxyacetoxy)- 1-methyl-1- methoxycarbonylmethylpyrrolidrnrumbromrd; (r) (2R, l'R,3'R) 3-(2-cyclopentyl-2-phenyl-2-hydroxyacetoxy)- 1-methyl-1- methoxycarbonylmethylpyrrolidrnrumbromrd; (j) (2R, l'R,3 'S) 3 -(2-cyclopentyl-2-phenyl-2-hydroxyacetoxy) -1 -methyl-1 - methoxycarbonylmethylpyrrolrdrmumbromrd; (k) (2R,1'S,3'R) 3-(2-cyclopentyl-2-phenyl-2-hydroxyacetoxy)-l-methyl-l- methoxycarbonylmethylpyrrolidrnrumbromrd og (l) (2R, l'S,3'S) 3-(2-cyclopentyl-2-phenyl-2-hydroxyacetoxy)-1-methyl-1- methoxycarbonylmethylpyrrolidiniumbromid.
4. Sammensætning ifølge et hvilket som helst af kravene 1-3, hvor forbindelsen med formlen (2) er ved en koncentration på fra 1 % til 20 % vægt/vægt eller vægt/volumen af sammensætningen.
5. Sammensætning ifølge et hvilket som helst af kravene 1-3, hvor forbindelsen med formlen (2) er ved en koncentration på fra 2 % til 10 % vægt/vægt eller vægt/volumen af sammensætningen.
6. Sammensætning ifølge et hvilket som helst af de foregående krav, emballeret i den flerdosisbeholder, der afmåler en dosis på fra 0,5 ml til 1,0 ml af sammensætningen bestående af 3 % til 6 % vægt/vægt eller vægt/volumen af forbindelsen pr. behandlet område.
7. Sammensætning ifølge et hvilket som helst af kravene 1-5, emballeret i en enkelt- eller flerdosisbeholder, der udleverer en enkelt eller enhedsdosis på 0,5 ml til 1,0 ml af sammensætningen omfattende 3 % til 6 % vægt/vægt eller vægt/volumen af forbindelsen pr. behandlet område.
8. Sammensætning ifølge et hvilket som helst af de foregående krav, hvor forbindelsen med formlen (2) er (2R, 3'R) 3-(2-cyclopentyl-2-phenyl-2-hydroxyacetoxy)-l- (ethoxycarbonylmethyl)-1 -methylpyrrolidrnrumbromrd.
9. Sammensætning ifølge et hvilket som helst af kravene 1-8, hvor geleringsbestanddelen eller den viskositetsstyrende bestanddel er hydroxypropylcellulose.
10. Sammensætning ifølge et hvilket som helst af kravene 1-3, der endvidere omfatter citronsyre.
11. Sammensætning ifølge et hvilket som helst af kravene 1 -3, der omfatter én eller flere topiske exciprenser valgt fra gruppen bestående af alkoholer, aloe vera-gel, hexylenglycol, propylenglycol, dimethicon, prostaglandin E, allantoin, glycerin, vitamin A- og E-olier, mineralsk olie, PPG2, myristylpropionatlactose, dextrose, saccharose, sorbitol, mannitol, stivelser, gummi acacia, calciumphosphat, alginater, tragacanth, gelatine, calciumsilrcat, mikrokrystallinsk cellulose, polyvinylpyrrolidon, cellulose og methylcellulose.
12. Sammensætning ifølge et hvilket som helst af kravene 1-3, hvor sammensætningen består af: 10 % vægt/vægt (2R, 3'R) 3-(2-cyclopentyl-2-phenyl-2-hydroxyacetoxy)-l- (ethoxycarbonylmethyl)-1 -methylpyrrolidrnrumbromrd; 1,25 % vægt/vægt hydroxypropylcellulose; 10 % vægt/vægt hexylenglycol; 2,5 % vægt/vægt Dimethiconol Blend 20; 0,1 % vægt/vægt citronsyre og 76,15 % vægt/vægt ethanol som vandfri vehikel.
13. Sammensætning som defineret i et hvilket som helst af kravene 1-11 til anvendelse i behandlingen af hyperhidrose, hvor sammensætningen skal administreres topisk til et berørt hudområde på et individ.
14. Sammensætning til anvendelse ifølge krav 13, hvor sammensætningen skal administreres i et én til fire ganges dagligt regimen.
15. Sammensætning til anvendelse ifølge krav 14, hvor sammensætningen skal administreres inden for 1-2 timer før individets søvnperiode.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201461952505P | 2014-03-13 | 2014-03-13 | |
| US14/285,488 US20150259283A1 (en) | 2014-03-13 | 2014-05-22 | Formulation for soft anticholinergic analogs |
| PCT/US2015/020253 WO2015138776A1 (en) | 2014-03-13 | 2015-03-12 | Formulation for soft anticholinergic analogs |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| DK3116498T3 true DK3116498T3 (da) | 2019-03-11 |
Family
ID=54068191
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK15762178.0T DK3116498T3 (da) | 2014-03-13 | 2015-03-12 | Formulering til bløde anticholinerge analoger |
| DK16828553.4T DK3325487T3 (da) | 2014-03-13 | 2016-07-21 | Formulering til bløde, anticholinerge analoger |
Family Applications After (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK16828553.4T DK3325487T3 (da) | 2014-03-13 | 2016-07-21 | Formulering til bløde, anticholinerge analoger |
Country Status (20)
| Country | Link |
|---|---|
| US (8) | US20150259283A1 (da) |
| EP (1) | EP3116498B1 (da) |
| JP (5) | JP6293919B2 (da) |
| KR (3) | KR102586868B1 (da) |
| CN (3) | CN106456603B (da) |
| AU (2) | AU2015229243B2 (da) |
| BR (1) | BR112016021011B1 (da) |
| CA (1) | CA2941649C (da) |
| DK (2) | DK3116498T3 (da) |
| ES (1) | ES2710292T3 (da) |
| HU (1) | HUE041868T2 (da) |
| IL (1) | IL247571B (da) |
| MX (1) | MX369129B (da) |
| MY (1) | MY183531A (da) |
| PH (1) | PH12016501732B1 (da) |
| PL (1) | PL3116498T3 (da) |
| PT (2) | PT3116498T (da) |
| SG (1) | SG11201607480SA (da) |
| WO (1) | WO2015138776A1 (da) |
| ZA (1) | ZA201607071B (da) |
Families Citing this family (15)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP1861112A4 (en) * | 2005-03-03 | 2009-07-22 | Revance Therapeutics Inc | COMPOSITIONS AND METHODS FOR TOPICAL APPLICATION AND TRANSDERMAL DELIVERY OF BOTULINUM TOXINES |
| ES2836132T3 (es) | 2013-08-08 | 2021-06-24 | Novan Inc | Composiciones tópicas y métodos de uso de las mismas |
| US20150259283A1 (en) | 2014-03-13 | 2015-09-17 | Brickell Biotech, Inc. | Formulation for soft anticholinergic analogs |
| US10322082B2 (en) | 2014-07-11 | 2019-06-18 | Novan, Inc. | Topical antiviral compositions and methods of using the same |
| AU2016297601B2 (en) | 2015-07-21 | 2021-08-19 | Bodor Laboratories, Inc. | Formulation for soft anticholinergic analogs |
| TWI719046B (zh) * | 2016-07-21 | 2021-02-21 | 美商波德實驗股份有限公司 | 軟性抗膽鹼類似物之製劑 |
| US11381304B2 (en) * | 2017-08-30 | 2022-07-05 | Iridium Satellite Llc | Satellite communications with multiple classes of terrestrial terminal devices |
| TWI838531B (zh) * | 2019-05-23 | 2024-04-11 | 日商科研製藥股份有限公司 | 索吡銨溴化物的結晶形態及其製造方法 |
| SG10201912063PA (en) * | 2019-12-12 | 2021-07-29 | Nat Skin Centre Singapore Pte Ltd | A pharmaceutical formulation |
| JPWO2021177257A1 (da) | 2020-03-03 | 2021-09-10 | ||
| TW202146009A (zh) | 2020-03-03 | 2021-12-16 | 日商科研製藥股份有限公司 | 含有溴化索非羅銨的醫藥 |
| KR102655121B1 (ko) | 2021-09-17 | 2024-04-08 | 한국식품연구원 | 락토바실러스 사케이 k040706 균주 검출용 프라이머 세트 및 이의 용도 |
| US11807604B1 (en) * | 2022-02-16 | 2023-11-07 | Miralogx Llc | Pharmaceutical compounds, pharmaceutical compositions, and methods of treating asthma and other disorders |
| WO2024026412A1 (en) * | 2022-07-28 | 2024-02-01 | Tff Pharmaceuticals, Inc. | Thin film freezing methods and compositions formulated from dispersed active agents |
| KR102611847B1 (ko) * | 2023-03-27 | 2023-12-12 | 주식회사 이플라스크 | 무스카린 수용체 길항 활성을 갖는 신규한 피롤리디늄 화합물 및 이의 용도 |
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| AU2016297601B2 (en) | 2015-07-21 | 2021-08-19 | Bodor Laboratories, Inc. | Formulation for soft anticholinergic analogs |
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