DOP2015000026A - Formulas de testosterona proliposomal - Google Patents
Formulas de testosterona proliposomalInfo
- Publication number
- DOP2015000026A DOP2015000026A DO2015000026A DO2015000026A DOP2015000026A DO P2015000026 A DOP2015000026 A DO P2015000026A DO 2015000026 A DO2015000026 A DO 2015000026A DO 2015000026 A DO2015000026 A DO 2015000026A DO P2015000026 A DOP2015000026 A DO P2015000026A
- Authority
- DO
- Dominican Republic
- Prior art keywords
- dispersion
- testosterone
- ranging
- dosage forms
- formulas
- Prior art date
Links
- 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 abstract 8
- 229960003604 testosterone Drugs 0.000 title abstract 4
- 239000006185 dispersion Substances 0.000 abstract 6
- 229920000168 Microcrystalline cellulose Polymers 0.000 abstract 4
- 235000019813 microcrystalline cellulose Nutrition 0.000 abstract 4
- 239000008108 microcrystalline cellulose Substances 0.000 abstract 4
- 229940016286 microcrystalline cellulose Drugs 0.000 abstract 4
- HVYWMOMLDIMFJA-DPAQBDIFSA-N cholesterol Chemical compound C1C=C2C[C@@H](O)CC[C@]2(C)[C@@H]2[C@@H]1[C@@H]1CC[C@H]([C@H](C)CCCC(C)C)[C@@]1(C)CC2 HVYWMOMLDIMFJA-DPAQBDIFSA-N 0.000 abstract 2
- 239000002552 dosage form Substances 0.000 abstract 2
- 238000009165 androgen replacement therapy Methods 0.000 abstract 1
- 235000012000 cholesterol Nutrition 0.000 abstract 1
- 239000011248 coating agent Substances 0.000 abstract 1
- 238000000576 coating method Methods 0.000 abstract 1
- 230000003111 delayed effect Effects 0.000 abstract 1
- 230000037406 food intake Effects 0.000 abstract 1
- 238000000034 method Methods 0.000 abstract 1
- 239000000203 mixture Substances 0.000 abstract 1
- 239000006186 oral dosage form Substances 0.000 abstract 1
- 239000008194 pharmaceutical composition Substances 0.000 abstract 1
- 150000003904 phospholipids Chemical class 0.000 abstract 1
- 230000036470 plasma concentration Effects 0.000 abstract 1
- 239000000843 powder Substances 0.000 abstract 1
Classifications
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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
- A61K31/565—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
- A61K31/575—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of three or more carbon atoms, e.g. cholane, cholestane, ergosterol, sitosterol
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
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- A61K9/10—Dispersions; Emulsions
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- A61K9/127—Synthetic bilayered vehicles, e.g. liposomes or liposomes with cholesterol as the only non-phosphatidyl surfactant
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- A61K9/127—Synthetic bilayered vehicles, e.g. liposomes or liposomes with cholesterol as the only non-phosphatidyl surfactant
- A61K9/1277—Preparation processes; Proliposomes
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- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
- A61K9/145—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic compounds
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- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
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- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
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- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
- A61K9/2846—Poly(meth)acrylates
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- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4841—Filling excipients; Inactive ingredients
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- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4891—Coated capsules; Multilayered drug free capsule shells
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- A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
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- A—HUMAN NECESSITIES
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- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4841—Filling excipients; Inactive ingredients
- A61K9/4866—Organic macromolecular compounds
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Medicinal Chemistry (AREA)
- Epidemiology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- General Chemical & Material Sciences (AREA)
- Dispersion Chemistry (AREA)
- Endocrinology (AREA)
- Diabetes (AREA)
- Physical Education & Sports Medicine (AREA)
- Molecular Biology (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Reproductive Health (AREA)
- Biophysics (AREA)
- Virology (AREA)
- Cardiology (AREA)
- Rheumatology (AREA)
- Physiology (AREA)
- Nutrition Science (AREA)
- Urology & Nephrology (AREA)
- Pulmonology (AREA)
- Obesity (AREA)
- Oncology (AREA)
- Gynecology & Obstetrics (AREA)
- Pregnancy & Childbirth (AREA)
- Hematology (AREA)
- Gastroenterology & Hepatology (AREA)
- Emergency Medicine (AREA)
- Neurology (AREA)
- Tropical Medicine & Parasitology (AREA)
Abstract
La invención se refiere a dispersiones de polvo proliposomal que comprenden (a) la testosterona, (b) colesterol, y (c) fosfolípidos en relaciones de peso especificadas de (a) :( b), que van desde 1: 0,05 a 1: 0,30, y (a ): ((b) + (c)), que van desde 1: 1 y 1: 2,5, y en varias realizaciones, dicha dispersión se puede mezclar con celulosa microcristalina (MC) en una proporción de peso que varía de 1: 0,5 a 1 : 2 (dispersión: MC). Las formas de dosificación oral que comprende la mezcla de dispersión o dispersión/MC pueden estar recubiertas con un recubrimiento de liberación retardada, y pueden tener perfiles farmacocinéticos de ayuno caracterizadas por concentraciones plasmáticas medias de testosterona que van desde aproximadamente 350 a aproximadamente 950 ng / dL de testosterona cinco horas después de la ingestión de las formas de dosificación. Los métodos de la terapia de reemplazo de testosterona, que comprende administrar una dispersión liposomal en polvo, una composición farmacéutica, o una forma de dosificación descrita en el presente documento a un individuo en necesidad del mismo se describen también en el presente documento.
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201261644996P | 2012-05-09 | 2012-05-09 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| DOP2015000026A true DOP2015000026A (es) | 2015-06-15 |
Family
ID=49551459
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DO2015000026A DOP2015000026A (es) | 2012-05-09 | 2015-02-12 | Formulas de testosterona proliposomal |
Country Status (32)
| Country | Link |
|---|---|
| US (5) | US8957053B2 (es) |
| EP (1) | EP2846781B1 (es) |
| JP (3) | JP6055088B2 (es) |
| KR (1) | KR20150032939A (es) |
| CN (2) | CN104780914B (es) |
| AP (1) | AP2014008099A0 (es) |
| AR (1) | AR091006A1 (es) |
| AU (2) | AU2013259509B2 (es) |
| BR (1) | BR112014027942A2 (es) |
| CA (1) | CA2872779A1 (es) |
| CL (1) | CL2014003034A1 (es) |
| CO (1) | CO7240373A2 (es) |
| CR (1) | CR20140561A (es) |
| DO (1) | DOP2015000026A (es) |
| EA (2) | EA201791738A1 (es) |
| EC (1) | ECSP14030572A (es) |
| GE (1) | GEP201706754B (es) |
| HK (2) | HK1210409A1 (es) |
| IL (1) | IL235464B (es) |
| IN (1) | IN2014DN10383A (es) |
| MA (1) | MA37610B1 (es) |
| MX (1) | MX367123B (es) |
| MY (1) | MY175305A (es) |
| NZ (2) | NZ721900A (es) |
| PE (1) | PE20150203A1 (es) |
| PH (1) | PH12014502498A1 (es) |
| SG (2) | SG11201407349UA (es) |
| TN (1) | TN2014000467A1 (es) |
| TW (2) | TWI664982B (es) |
| UA (1) | UA115058C2 (es) |
| WO (1) | WO2013170012A2 (es) |
| ZA (2) | ZA201408996B (es) |
Families Citing this family (21)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US10213440B2 (en) | 2014-08-20 | 2019-02-26 | Professional Compounding Centers Of America (Pcca) | Oral transmucosal pharmaceutical compositions including testosterone and an aromatase inhibitor |
| KR101682821B1 (ko) | 2015-07-21 | 2016-12-06 | 서울대학교산학협력단 | 프로리포솜 제조방법 |
| MY198105A (en) * | 2016-01-07 | 2023-08-02 | Univ Western Health Sciences | Formulations for treating bladder cancer |
| WO2017120592A1 (en) * | 2016-01-08 | 2017-07-13 | Western University Of Health Sciences | Proliposomal testosterone undecanoate formulations |
| KR102574139B1 (ko) | 2016-07-07 | 2023-09-05 | 삼성전자주식회사 | 무선 충전 모드를 변경하는 장치 및 방법 |
| US20190343763A1 (en) * | 2016-11-11 | 2019-11-14 | Western University Of Health Sciences | Methods of treating upper tract urothelial carcinomas |
| US11980692B2 (en) | 2017-11-17 | 2024-05-14 | Evonik Operations Gmbh | Process for preparing a coated hard shell capsule |
| US10716774B1 (en) | 2018-01-05 | 2020-07-21 | Yale Pharmaceuticals LLC | Pharmaceutical compositions containing isotretinoin with improved dissolution profile and enhanced stability |
| US12150945B2 (en) | 2018-07-20 | 2024-11-26 | Lipocine Inc. | Liver disease |
| WO2020069450A1 (en) * | 2018-09-28 | 2020-04-02 | Joel Studin | Transpore delivery of drugs and uses thereof |
| KR102938078B1 (ko) * | 2019-05-15 | 2026-03-11 | 에보닉 오퍼레이션스 게엠베하 | 캡슐 충전 기계를 사용한 셀룰로오스 또는 전분을 기반으로 하는 코팅을 갖는 충전된 경질 쉘 캡슐의 제조 방법 |
| IL288005B2 (en) * | 2019-05-15 | 2026-03-01 | Evonik Operations Gmbh | Process for preparing hard-shelled, filled capsules with (meth)acrylate copolymer-based coatings using a capsule filling machine |
| JP2022544197A (ja) * | 2019-08-09 | 2022-10-17 | テソリックス ファーマ， エルエルシー | プロリポソームウンデカン酸テストステロン製剤 |
| CN110747271B (zh) * | 2019-12-02 | 2023-07-18 | 延边大学 | 关于pci术后血管损伤-再狭窄程度的标记物 |
| JP6945874B2 (ja) * | 2019-12-24 | 2021-10-06 | 一般財団法人バイオダイナミックス研究所 | 経口投与用医薬組成物 |
| CN111840240A (zh) * | 2020-05-29 | 2020-10-30 | 仁和堂药业有限公司 | 一种非那雄胺制剂及其应用 |
| CN112121003B (zh) * | 2020-09-29 | 2022-02-01 | 江苏集萃新型药物制剂技术研究所有限公司 | 缓释制剂载药材料及其组合物、缓释制剂及其制备方法 |
| EP4340838A4 (en) * | 2021-05-19 | 2025-04-16 | Alberto Paz | ORALLY ADMINISTERED COMPOSITIONS FOR CANCER TREATMENT |
| CN114668719B (zh) * | 2022-02-21 | 2023-06-16 | 广东食品药品职业学院 | 双氢睾酮混悬剂与双氢睾酮冻干粉及其制备方法 |
| WO2024056062A1 (zh) * | 2022-09-16 | 2024-03-21 | 长春金赛药业有限责任公司 | 一种甾体类激素磷脂组合物及其制备方法 |
| CN117018211B (zh) * | 2023-07-31 | 2025-09-09 | 沈阳药科大学 | 一种睾酮-胆固醇前药及制备方法和应用 |
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