IL239355A - Gamma-hydroxybutyrate compositions and their use in the treatment of disorders - Google Patents
Gamma-hydroxybutyrate compositions and their use in the treatment of disordersInfo
- Publication number
- IL239355A IL239355A IL239355A IL23935515A IL239355A IL 239355 A IL239355 A IL 239355A IL 239355 A IL239355 A IL 239355A IL 23935515 A IL23935515 A IL 23935515A IL 239355 A IL239355 A IL 239355A
- Authority
- IL
- Israel
- Prior art keywords
- ghb
- salt
- certain embodiments
- present
- mixture
- Prior art date
Links
- SJZRECIVHVDYJC-UHFFFAOYSA-M 4-hydroxybutyrate Chemical compound OCCCC([O-])=O SJZRECIVHVDYJC-UHFFFAOYSA-M 0.000 title claims abstract description 61
- 239000000203 mixture Substances 0.000 title claims description 273
- 238000011282 treatment Methods 0.000 title abstract description 18
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 title description 5
- 208000035475 disorder Diseases 0.000 title description 4
- 239000008194 pharmaceutical composition Substances 0.000 claims abstract description 126
- 150000003839 salts Chemical class 0.000 claims abstract description 120
- 239000011575 calcium Substances 0.000 claims description 130
- 239000011777 magnesium Substances 0.000 claims description 123
- 239000011734 sodium Substances 0.000 claims description 113
- 239000007864 aqueous solution Substances 0.000 claims description 26
- 230000000813 microbial effect Effects 0.000 claims description 24
- 239000006172 buffering agent Substances 0.000 claims description 12
- 239000003002 pH adjusting agent Substances 0.000 claims description 12
- 239000003755 preservative agent Substances 0.000 claims description 10
- 159000000007 calcium salts Chemical class 0.000 claims description 4
- 159000000003 magnesium salts Chemical class 0.000 claims description 4
- XAEFZNCEHLXOMS-UHFFFAOYSA-M potassium benzoate Chemical compound [K+].[O-]C(=O)C1=CC=CC=C1 XAEFZNCEHLXOMS-UHFFFAOYSA-M 0.000 claims description 4
- 159000000000 sodium salts Chemical class 0.000 claims description 4
- 238000009472 formulation Methods 0.000 abstract description 73
- 238000000034 method Methods 0.000 abstract description 32
- 201000003631 narcolepsy Diseases 0.000 abstract description 26
- 230000007958 sleep Effects 0.000 abstract description 26
- 208000001573 Cataplexy Diseases 0.000 abstract description 10
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- 208000005439 Sleep paralysis Diseases 0.000 abstract description 7
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- 206010020927 Hypnagogic hallucination Diseases 0.000 abstract description 6
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- 208000023515 periodic limb movement disease Diseases 0.000 abstract description 6
- SJZRECIVHVDYJC-UHFFFAOYSA-N 4-hydroxybutyric acid Chemical compound OCCCC(O)=O SJZRECIVHVDYJC-UHFFFAOYSA-N 0.000 description 563
- 239000000243 solution Substances 0.000 description 42
- 239000012736 aqueous medium Substances 0.000 description 35
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 description 30
- KWYUFKZDYYNOTN-UHFFFAOYSA-M Potassium hydroxide Chemical compound [OH-].[K+] KWYUFKZDYYNOTN-UHFFFAOYSA-M 0.000 description 27
- 239000002585 base Substances 0.000 description 23
- 150000001875 compounds Chemical class 0.000 description 23
- 150000001768 cations Chemical class 0.000 description 22
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- 238000006243 chemical reaction Methods 0.000 description 20
- 238000007792 addition Methods 0.000 description 19
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- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 description 15
- 238000007865 diluting Methods 0.000 description 14
- -1 for example Chemical class 0.000 description 14
- VTHJTEIRLNZDEV-UHFFFAOYSA-L magnesium dihydroxide Chemical compound [OH-].[OH-].[Mg+2] VTHJTEIRLNZDEV-UHFFFAOYSA-L 0.000 description 13
- 239000000347 magnesium hydroxide Substances 0.000 description 13
- 229910001862 magnesium hydroxide Inorganic materials 0.000 description 13
- 235000012254 magnesium hydroxide Nutrition 0.000 description 13
- VWYANPOOORUCFJ-UHFFFAOYSA-N alpha-Fernenol Chemical compound CC1(C)C(O)CCC2(C)C3=CCC4(C)C5CCC(C(C)C)C5(C)CCC4(C)C3CCC21 VWYANPOOORUCFJ-UHFFFAOYSA-N 0.000 description 12
- 239000000047 product Substances 0.000 description 12
- 229960003928 sodium oxybate Drugs 0.000 description 12
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- 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 description 11
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- 239000004480 active ingredient Substances 0.000 description 6
- BJEPYKJPYRNKOW-UHFFFAOYSA-N alpha-hydroxysuccinic acid Natural products OC(=O)C(O)CC(O)=O BJEPYKJPYRNKOW-UHFFFAOYSA-N 0.000 description 6
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- A61K31/554—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole having at least one nitrogen and one sulfur as ring hetero atoms, e.g. clothiapine, diltiazem
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- A—HUMAN NECESSITIES
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Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
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| US201261737695P | 2012-12-14 | 2012-12-14 | |
| PCT/US2013/074954 WO2014093791A1 (en) | 2012-12-14 | 2013-12-13 | Gamma-hydroxybutyrate compositions and their use for the treatment of disorders |
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| IL239355A0 IL239355A0 (en) | 2015-07-30 |
| IL239355A true IL239355A (en) | 2017-05-29 |
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| IL239355A IL239355A (en) | 2012-12-14 | 2015-06-11 | Gamma-hydroxybutyrate compositions and their use in the treatment of disorders |
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| EP (3) | EP2931268B1 (enExample) |
| JP (1) | JP6215347B2 (enExample) |
| KR (1) | KR102180343B1 (enExample) |
| CN (1) | CN105025892B (enExample) |
| AU (1) | AU2013359114B2 (enExample) |
| CA (1) | CA2894876C (enExample) |
| CY (2) | CY1119918T1 (enExample) |
| DK (2) | DK2931268T3 (enExample) |
| ES (2) | ES2827005T3 (enExample) |
| HR (1) | HRP20201685T1 (enExample) |
| HU (1) | HUE051060T2 (enExample) |
| IL (1) | IL239355A (enExample) |
| IN (1) | IN342829B (enExample) |
| LT (1) | LT3335709T (enExample) |
| MX (1) | MX366681B (enExample) |
| NO (1) | NO3027826T3 (enExample) |
| PL (1) | PL2931268T3 (enExample) |
| PT (2) | PT3335709T (enExample) |
| SG (1) | SG11201504637TA (enExample) |
| SI (1) | SI3335709T1 (enExample) |
| TR (1) | TR201802271T4 (enExample) |
| TW (2) | TWI681770B (enExample) |
| WO (1) | WO2014093791A1 (enExample) |
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| US11504347B1 (en) | 2016-07-22 | 2022-11-22 | Flamel Ireland Limited | Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics |
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| US11839597B2 (en) | 2016-07-22 | 2023-12-12 | Flamel Ireland Limited | Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics |
| US11986451B1 (en) | 2016-07-22 | 2024-05-21 | Flamel Ireland Limited | Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics |
| US12186296B1 (en) | 2016-07-22 | 2025-01-07 | Flamel Ireland Limited | Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics |
| US12478604B1 (en) | 2016-07-22 | 2025-11-25 | Flamel Ireland Limited | Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics |
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| US8591922B1 (en) | 2012-12-14 | 2013-11-26 | Jazz Pharmacuticals, Inc. | Gamma-hydroxybutyrate compositions and their use for the treatment of disorders |
| US9050302B2 (en) | 2013-03-01 | 2015-06-09 | Jazz Pharmaceuticals Ireland Limited | Method of administration of gamma hydroxybutyrate with monocarboxylate transporters |
| US10398662B1 (en) | 2015-02-18 | 2019-09-03 | Jazz Pharma Ireland Limited | GHB formulation and method for its manufacture |
| CA3207643A1 (en) | 2015-09-23 | 2017-03-30 | XWPharma Ltd. | Prodrugs of gamma-hydroxybutyric acid, compositions and uses thereof |
| FR3049463B1 (fr) | 2016-04-01 | 2019-07-05 | Debregeas Et Associes Pharma | Doses unitaires a liberation immediate de ghb ou de l'un de ses sels therapeutiquement acceptables administrees par voie orale et leur utilisation pour maintenir l'abstinence alcoolique |
| US11000498B2 (en) | 2016-07-22 | 2021-05-11 | Flamel Ireland Limited | Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics |
| US20180263936A1 (en) | 2017-03-17 | 2018-09-20 | Jazz Pharmaceuticals Ireland Limited | Gamma-hydroxybutyrate compositions and their use for the treatment of disorders |
| IL275312B2 (en) * | 2017-12-18 | 2024-09-01 | Tris Pharma Inc | Ghb pharmaceutical compositions comprising a floating interpenetrating polymer network forming system |
| US11337920B2 (en) | 2017-12-18 | 2022-05-24 | Tris Pharma, Inc. | Pharmaceutical composition comprising GHB gastro-retentive raft forming systems having trigger pulse drug release |
| JP2021506984A (ja) | 2017-12-18 | 2021-02-22 | トリス・フアルマ・インコーポレーテツド | トリガーパルス薬物放出を有する胃内滞留型raft形成システムを含む放出調節薬物粉末組成物 |
| BR112021006027A2 (pt) | 2018-11-19 | 2021-06-29 | Jazz Pharmaceuticals Ireland Limited | formulações de fármaco resistente a álcool |
| AU2020414694A1 (en) * | 2019-12-24 | 2022-08-18 | Jazz Pharmaceuticals Ireland Limited | Gamma-hydroxybutyrate (GHB) dosing |
| TW202139986A (zh) | 2020-02-21 | 2021-11-01 | 愛爾蘭商爵士製藥愛爾蘭有限責任公司 | 治療原發性嗜睡症之方法 |
| KR102436227B1 (ko) * | 2020-05-29 | 2022-08-24 | 주식회사 케이티앤지 | 기능성 물질이 코팅된 흡연물품용 팁페이퍼 및 상기 팁페이퍼의 코팅 방법 |
| AU2021292406B2 (en) | 2020-06-18 | 2024-03-14 | XWPharma Ltd. | Controlled release granulations of water-soluble active pharmaceutical ingredients |
| CN116261451A (zh) * | 2020-07-24 | 2023-06-13 | 凯瑞康宁生物工程有限公司 | γ-羟基丁酸衍生物的药物组合物和药物动力学 |
| CN115666527B (zh) | 2020-10-05 | 2025-03-07 | 凯瑞康宁生物工程有限公司 | γ-羟基丁酸衍生物的修饰释放组合物 |
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| US20180263936A1 (en) | 2017-03-17 | 2018-09-20 | Jazz Pharmaceuticals Ireland Limited | Gamma-hydroxybutyrate compositions and their use for the treatment of disorders |
-
2013
- 2013-01-11 US US13/739,886 patent/US8591922B1/en active Active
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- 2013-12-13 SI SI201331802T patent/SI3335709T1/sl unknown
- 2013-12-13 DK DK13863231.0T patent/DK2931268T3/en active
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- 2013-12-13 TR TR2018/02271T patent/TR201802271T4/tr unknown
- 2013-12-13 EP EP20190343.2A patent/EP3799867A1/en not_active Withdrawn
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