HRP20191216T1 - Formulacije testosterona - Google Patents
Formulacije testosterona Download PDFInfo
- Publication number
- HRP20191216T1 HRP20191216T1 HRP20191216TT HRP20191216T HRP20191216T1 HR P20191216 T1 HRP20191216 T1 HR P20191216T1 HR P20191216T T HRP20191216T T HR P20191216TT HR P20191216 T HRP20191216 T HR P20191216T HR P20191216 T1 HRP20191216 T1 HR P20191216T1
- Authority
- HR
- Croatia
- Prior art keywords
- weight
- testosterone
- transdermal formulation
- transdermal
- formulation according
- Prior art date
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- MUMGGOZAMZWBJJ-DYKIIFRCSA-N Testostosterone Chemical compound O=C1CC[C@]2(C)[C@H]3CC[C@](C)([C@H](CC4)O)[C@@H]4[C@@H]3CCC2=C1 MUMGGOZAMZWBJJ-DYKIIFRCSA-N 0.000 title claims 10
- 238000009472 formulation Methods 0.000 title claims 10
- 239000000203 mixture Substances 0.000 title claims 10
- 229960003604 testosterone Drugs 0.000 title claims 5
- DNIAPMSPPWPWGF-UHFFFAOYSA-N Propylene glycol Chemical compound CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 claims 6
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims 4
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims 4
- MTHSVFCYNBDYFN-UHFFFAOYSA-N diethylene glycol Chemical compound OCCOCCO MTHSVFCYNBDYFN-UHFFFAOYSA-N 0.000 claims 3
- ZGTMUACCHSMWAC-UHFFFAOYSA-L EDTA disodium salt (anhydrous) Chemical compound [Na+].[Na+].OC(=O)CN(CC([O-])=O)CCN(CC(O)=O)CC([O-])=O ZGTMUACCHSMWAC-UHFFFAOYSA-L 0.000 claims 2
- GSEJCLTVZPLZKY-UHFFFAOYSA-N Triethanolamine Chemical compound OCCN(CCO)CCO GSEJCLTVZPLZKY-UHFFFAOYSA-N 0.000 claims 2
- 239000003795 chemical substances by application Substances 0.000 claims 2
- XXJWXESWEXIICW-UHFFFAOYSA-N diethylene glycol monoethyl ether Chemical compound CCOCCOCCO XXJWXESWEXIICW-UHFFFAOYSA-N 0.000 claims 2
- 229940075557 diethylene glycol monoethyl ether Drugs 0.000 claims 2
- 201000010099 disease Diseases 0.000 claims 2
- 208000035475 disorder Diseases 0.000 claims 2
- 229940124274 edetate disodium Drugs 0.000 claims 2
- 238000004519 manufacturing process Methods 0.000 claims 2
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims 2
- 206010058359 Hypogonadism Diseases 0.000 claims 1
- 239000002738 chelating agent Substances 0.000 claims 1
- 150000002191 fatty alcohols Chemical class 0.000 claims 1
- 150000002194 fatty esters Chemical class 0.000 claims 1
- 150000004668 long chain fatty acids Chemical class 0.000 claims 1
- 230000003472 neutralizing effect Effects 0.000 claims 1
- 239000002904 solvent Substances 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
- 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
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
- A61K31/565—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
- A61K31/568—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol substituted in positions 10 and 13 by a chain having at least one carbon atom, e.g. androstanes, e.g. testosterone
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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
- A61K31/58—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin
-
- 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
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- 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
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
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- 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
- A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
-
- 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
- A61K9/10—Dispersions; Emulsions
-
- 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
- A61K9/10—Dispersions; Emulsions
- A61K9/107—Emulsions ; Emulsion preconcentrates; Micelles
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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
- A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P15/00—Drugs for genital or sexual disorders; Contraceptives
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P15/00—Drugs for genital or sexual disorders; Contraceptives
- A61P15/08—Drugs for genital or sexual disorders; Contraceptives for gonadal disorders or for enhancing fertility, e.g. inducers of ovulation or of spermatogenesis
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P15/00—Drugs for genital or sexual disorders; Contraceptives
- A61P15/10—Drugs for genital or sexual disorders; Contraceptives for impotence
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P19/00—Drugs for skeletal disorders
- A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
- A61P19/10—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease for osteoporosis
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P21/00—Drugs for disorders of the muscular or neuromuscular system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/24—Antidepressants
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/02—Nutrients, e.g. vitamins, minerals
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P5/00—Drugs for disorders of the endocrine system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P5/00—Drugs for disorders of the endocrine system
- A61P5/24—Drugs for disorders of the endocrine system of the sex hormones
- A61P5/26—Androgens
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P5/00—Drugs for disorders of the endocrine system
- A61P5/24—Drugs for disorders of the endocrine system of the sex hormones
- A61P5/30—Oestrogens
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Endocrinology (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Diabetes (AREA)
- Reproductive Health (AREA)
- Physical Education & Sports Medicine (AREA)
- Dermatology (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Inorganic Chemistry (AREA)
- Rheumatology (AREA)
- Neurology (AREA)
- Dispersion Chemistry (AREA)
- Gynecology & Obstetrics (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Neurosurgery (AREA)
- Biomedical Technology (AREA)
- Nutrition Science (AREA)
- Psychiatry (AREA)
- Pregnancy & Childbirth (AREA)
- Pain & Pain Management (AREA)
- Obesity (AREA)
- Hematology (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
Claims (8)
1. Transdermalna formulacija, koja sadrži:
- 2% tež. testosterona,
- C2 do C4 alkanol,
- 20.0% tež. propilen glikola i
- monoalkil eter od dietilen glikola,
naznačena time, da navedena formulacija sadrži masne alkohole s dugim lancem, masne kiseline s dugim lancem, i masne estere s dugim lancem u ukupnoj količini koja je manja od 0.1% tež.
2. Transdermalna formulacija prema zahtjevu 1, naznačena time, da sadrži:
- sredstvo za stvaranje gela,
- sredstvo za neutraliziranje,
- sredstvo za keliranje, i
- otapalo.
3. Transdermalna formulacija prema zahtjevu 1, naznačena time, da sadrži:
- 44% tež. etanola
- 5% tež. monoetil etera od dietilen glikola,
- 1.2% tež. karbomebra,
- 0.35% tež. trietanolamina,
- 0.06 % tež. edetat dinatrija i
- vodu (q.s.).
4. Transdermalna formulacija prema zahtjevu 3, naznačena time, da se sastoji od:
- 2% tež. testosterona,
- 44% tež. etanola,
- 20.0% tež. propilen glikola,
- 5% tež. monoetil etera od dietilen glikola,
- 1.2% tež. karbomebra,
- 0.35% tež. trietanolamina,
- 0.06 % tež. edetat dinatrija i
- vodu (q.s.).
5. Transdermalna formulacija prema bilo kojem od zahtjeva 1 do 4, naznačena time, da je za upotrebu u liječenju bolesti ili poremećaja povezanih sa smanjenom endogenom proizvodnjom testosterona kod muškarca putem transdermalne primjene.
6. Transdermalna formulacija za upotrebu prema zahtjevu 5, naznačena time, da bolest ili poremećaj povezan sa smanjenom endogenom proizvodnjom testosterona kod muškarca je hipogonadizam.
7. Oprema naznačena time, da sadrži najmanje jedan spremnik koji sadrži formulaciju prema bilo kojem od zahtjeva 1 do 4, i upute za njenu primjenu.
8. Oprema prema zahtjevu 7, naznačena time, da navedeni spremnik je prilagođen za doziranje predodređene izmjerene količine navedene formulacije.
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US201161436207P | 2011-01-26 | 2011-01-26 | |
EP11152210 | 2011-01-26 | ||
EP16169138.1A EP3072505B1 (en) | 2011-01-26 | 2012-01-18 | Testosterone formulations |
Publications (1)
Publication Number | Publication Date |
---|---|
HRP20191216T1 true HRP20191216T1 (hr) | 2019-10-18 |
Family
ID=44146428
Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
HRP20160887TT HRP20160887T1 (hr) | 2011-01-26 | 2016-07-18 | Formulacije testosterona |
HRP20191216TT HRP20191216T1 (hr) | 2011-01-26 | 2019-07-04 | Formulacije testosterona |
Family Applications Before (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
HRP20160887TT HRP20160887T1 (hr) | 2011-01-26 | 2016-07-18 | Formulacije testosterona |
Country Status (28)
Country | Link |
---|---|
US (2) | US8895053B2 (hr) |
EP (2) | EP3072505B1 (hr) |
JP (2) | JP6012632B2 (hr) |
KR (1) | KR101877476B1 (hr) |
CN (1) | CN103327962B (hr) |
AR (1) | AR085090A1 (hr) |
AU (1) | AU2012210691B2 (hr) |
BR (1) | BR112013018951B1 (hr) |
CA (1) | CA2824941A1 (hr) |
DK (2) | DK3072505T3 (hr) |
ES (2) | ES2741744T3 (hr) |
HK (1) | HK1192719A1 (hr) |
HR (2) | HRP20160887T1 (hr) |
HU (3) | HUE027453T4 (hr) |
IL (1) | IL227454A (hr) |
JO (1) | JO3755B1 (hr) |
LT (2) | LT3072505T (hr) |
MX (1) | MX340259B (hr) |
PL (2) | PL2667851T3 (hr) |
PT (2) | PT2667851T (hr) |
RS (2) | RS54898B1 (hr) |
RU (1) | RU2613891C2 (hr) |
SA (1) | SA112330224B1 (hr) |
SI (2) | SI2667851T1 (hr) |
TR (1) | TR201909271T4 (hr) |
TW (1) | TWI564029B (hr) |
WO (1) | WO2012101016A1 (hr) |
ZA (1) | ZA201305665B (hr) |
Families Citing this family (15)
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GB0117057D0 (en) * | 2001-07-12 | 2001-09-05 | Ferring Bv | Pharmaceutical composition |
TWI442932B (zh) | 2008-02-11 | 2014-07-01 | Ferring Int Ct Sa | 以GnRH拮抗劑治療攝護腺癌的方法 |
CN105663059A (zh) * | 2009-05-01 | 2016-06-15 | 辉凌公司 | 用于治疗前列腺癌的组合物 |
US20110039787A1 (en) * | 2009-07-06 | 2011-02-17 | Ferring International Center S.A. | Compositions, kits and methods for treating benign prostate hyperplasia |
EP2447276A1 (en) | 2010-10-27 | 2012-05-02 | Ferring B.V. | Process for the manufacture of Degarelix and its intermediates |
RS55457B1 (sr) | 2010-10-27 | 2017-04-28 | Ferring Bv | Postupak za proizvodnju degareliksa i njegovih intermedijara |
US20180153904A1 (en) | 2010-11-30 | 2018-06-07 | Lipocine Inc. | High-strength testosterone undecanoate compositions |
US9034858B2 (en) | 2010-11-30 | 2015-05-19 | Lipocine Inc. | High-strength testosterone undecanoate compositions |
JO3755B1 (ar) | 2011-01-26 | 2021-01-31 | Ferring Bv | تركيبات تستوستيرون |
RU2657444C2 (ru) | 2012-06-01 | 2018-06-13 | Ферринг Б.В. | Получение дегареликса |
US8785426B1 (en) * | 2013-12-13 | 2014-07-22 | Upsher-Smith Laboratories, Inc. | Testosterone gel compositions and related methods |
CN107949389A (zh) * | 2015-09-30 | 2018-04-20 | 富士胶片株式会社 | 经皮吸收用组合物 |
US20200330371A1 (en) * | 2017-10-30 | 2020-10-22 | Teikoku Seiyaku Co., Ltd. | Transdermally administrable preparation |
WO2019140087A1 (en) | 2018-01-10 | 2019-07-18 | Celista Pharmaceuticals Llc | Testosterone transdermal spray with film |
CN109700764B (zh) * | 2019-02-20 | 2021-07-06 | 广东食品药品职业学院 | 双氢睾酮原位凝胶喷雾剂及其制备方法 |
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