JP2019501199A5 - - Google Patents
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- Publication number
- JP2019501199A5 JP2019501199A5 JP2018535385A JP2018535385A JP2019501199A5 JP 2019501199 A5 JP2019501199 A5 JP 2019501199A5 JP 2018535385 A JP2018535385 A JP 2018535385A JP 2018535385 A JP2018535385 A JP 2018535385A JP 2019501199 A5 JP2019501199 A5 JP 2019501199A5
- Authority
- JP
- Japan
- Prior art keywords
- dosage form
- oral dosage
- form according
- ratio
- powder dispersion
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
- 239000006186 oral dosage form Substances 0.000 claims description 18
- 239000006185 dispersion Substances 0.000 claims description 11
- 239000000843 powder Substances 0.000 claims description 10
- 229940079832 sodium starch glycolate Drugs 0.000 claims description 7
- 229920003109 sodium starch glycolate Polymers 0.000 claims description 7
- 239000008109 sodium starch glycolate Substances 0.000 claims description 7
- NRJAVPSFFCBXDT-HUESYALOSA-N 1,2-distearoyl-sn-glycero-3-phosphocholine Chemical compound CCCCCCCCCCCCCCCCCC(=O)OC[C@H](COP([O-])(=O)OCC[N+](C)(C)C)OC(=O)CCCCCCCCCCCCCCCCC NRJAVPSFFCBXDT-HUESYALOSA-N 0.000 claims description 4
- 239000000546 pharmaceutical excipient Substances 0.000 claims description 3
- 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 claims 6
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims 5
- 229940016286 microcrystalline cellulose Drugs 0.000 claims 5
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims 5
- 239000008108 microcrystalline cellulose Substances 0.000 claims 5
- 229960003604 testosterone Drugs 0.000 claims 3
- 229960000746 testosterone undecanoate Drugs 0.000 claims 3
- UDSFVOAUHKGBEK-CNQKSJKFSA-N testosterone undecanoate Chemical compound C1CC2=CC(=O)CC[C@]2(C)[C@@H]2[C@@H]1[C@@H]1CC[C@H](OC(=O)CCCCCCCCCC)[C@@]1(C)CC2 UDSFVOAUHKGBEK-CNQKSJKFSA-N 0.000 claims 3
- 239000002775 capsule Substances 0.000 claims 2
- 239000002552 dosage form Substances 0.000 claims 2
- 208000007848 Alcoholism Diseases 0.000 claims 1
- 206010002261 Androgen deficiency Diseases 0.000 claims 1
- 208000030453 Drug-Related Side Effects and Adverse reaction Diseases 0.000 claims 1
- 206010016654 Fibrosis Diseases 0.000 claims 1
- 208000018565 Hemochromatosis Diseases 0.000 claims 1
- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 claims 1
- 201000007493 Kallmann syndrome Diseases 0.000 claims 1
- 208000008589 Obesity Diseases 0.000 claims 1
- 206010053142 Olfacto genital dysplasia Diseases 0.000 claims 1
- 230000005856 abnormality Effects 0.000 claims 1
- 201000007930 alcohol dependence Diseases 0.000 claims 1
- 238000009165 androgen replacement therapy Methods 0.000 claims 1
- 230000003796 beauty Effects 0.000 claims 1
- 238000002512 chemotherapy Methods 0.000 claims 1
- 208000020832 chronic kidney disease Diseases 0.000 claims 1
- 208000022831 chronic renal failure syndrome Diseases 0.000 claims 1
- 230000007882 cirrhosis Effects 0.000 claims 1
- 208000019425 cirrhosis of liver Diseases 0.000 claims 1
- 239000008199 coating composition Substances 0.000 claims 1
- 239000002702 enteric coating Substances 0.000 claims 1
- 238000009505 enteric coating Methods 0.000 claims 1
- 201000003585 eunuchism Diseases 0.000 claims 1
- 230000009246 food effect Effects 0.000 claims 1
- 230000002068 genetic effect Effects 0.000 claims 1
- 208000015181 infectious disease Diseases 0.000 claims 1
- 208000027866 inflammatory disease Diseases 0.000 claims 1
- 208000037106 male hypogonadism Diseases 0.000 claims 1
- 229940117841 methacrylic acid copolymer Drugs 0.000 claims 1
- 229920003145 methacrylic acid copolymer Polymers 0.000 claims 1
- 239000000203 mixture Substances 0.000 claims 1
- 235000020824 obesity Nutrition 0.000 claims 1
- 230000006584 pituitary dysfunction Effects 0.000 claims 1
- 238000001959 radiotherapy Methods 0.000 claims 1
- 239000011734 sodium Substances 0.000 claims 1
- 229910052708 sodium Inorganic materials 0.000 claims 1
- 229940071117 starch glycolate Drugs 0.000 claims 1
- 230000002381 testicular Effects 0.000 claims 1
Applications Claiming Priority (5)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201662276452P | 2016-01-08 | 2016-01-08 | |
| US62/276,452 | 2016-01-08 | ||
| US201662394576P | 2016-09-14 | 2016-09-14 | |
| US62/394,576 | 2016-09-14 | ||
| PCT/US2017/012739 WO2017120592A1 (en) | 2016-01-08 | 2017-01-09 | Proliposomal testosterone undecanoate formulations |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JP2019501199A JP2019501199A (ja) | 2019-01-17 |
| JP2019501199A5 true JP2019501199A5 (https=) | 2020-02-13 |
Family
ID=59274044
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2018535385A Pending JP2019501199A (ja) | 2016-01-08 | 2017-01-09 | プロリポソームテストステロンウンデカノエート製剤 |
Country Status (6)
| Country | Link |
|---|---|
| US (1) | US20190248830A1 (https=) |
| EP (1) | EP3399965A4 (https=) |
| JP (1) | JP2019501199A (https=) |
| KR (1) | KR20180101452A (https=) |
| CN (1) | CN108601736A (https=) |
| WO (1) | WO2017120592A1 (https=) |
Families Citing this family (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US8492369B2 (en) | 2010-04-12 | 2013-07-23 | Clarus Therapeutics Inc | Oral testosterone ester formulations and methods of treating testosterone deficiency comprising same |
| CA2604943C (en) | 2005-04-15 | 2013-09-17 | Clarus Therapeutics, Inc. | Pharmaceutical delivery systems for hydrophobic drugs and compositions comprising same |
| SI3709979T1 (sl) | 2017-11-17 | 2025-03-31 | Evonik Operations Gmbh | Postopek za pripravo obložene kapsule s trdo ovojnico |
| AU2019308326B2 (en) * | 2018-07-20 | 2025-07-31 | Lipocine Inc. | Liver disease |
| US20200197412A1 (en) * | 2018-12-20 | 2020-06-25 | Clarus Therapeutics, Inc. | Methods of treating testosterone deficiency |
| US11564933B2 (en) | 2019-04-12 | 2023-01-31 | Tolmar, Inc. | Methods of treating testosterone deficiency |
| US20220265679A1 (en) * | 2019-08-09 | 2022-08-25 | Tesorx Pharma, Llc | Proliposomal testosterone undecanoate formulations |
| GB202307501D0 (en) * | 2023-05-19 | 2023-07-05 | Lawley Pharmaceuticals Pty Ltd | Process for preparing dispensable testosterone cream |
Family Cites Families (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US6759058B1 (en) * | 2001-04-25 | 2004-07-06 | Western Center For Drug Development College Of Pharmacy Western University Of Health Sciences | Enteric-coated proliposomal formulations for poorly water soluble drugs |
| EP2034961A1 (de) * | 2006-06-30 | 2009-03-18 | Gertrud Langhoff | Solubilisatformulierungen |
| EP2146692A1 (en) * | 2007-03-19 | 2010-01-27 | Fresenius Kabi Oncology Limited | Proliposomal and liposomal compositions |
| EP2229936B1 (en) * | 2009-03-09 | 2015-05-06 | PharmaSol GmbH | Nanonized testosterone formulations for improved bioavailability |
| US20140309202A1 (en) * | 2010-11-30 | 2014-10-16 | Lipocine Inc. | High-strength testosterone undecanoate compositions |
| CN104780914B (zh) * | 2012-05-09 | 2018-02-09 | 健康科学西部大学 | 前体脂质体睾酮制剂 |
-
2017
- 2017-01-09 EP EP17736520.2A patent/EP3399965A4/en not_active Withdrawn
- 2017-01-09 KR KR1020187022494A patent/KR20180101452A/ko not_active Withdrawn
- 2017-01-09 US US16/068,190 patent/US20190248830A1/en not_active Abandoned
- 2017-01-09 CN CN201780010451.5A patent/CN108601736A/zh active Pending
- 2017-01-09 JP JP2018535385A patent/JP2019501199A/ja active Pending
- 2017-01-09 WO PCT/US2017/012739 patent/WO2017120592A1/en not_active Ceased
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