JPWO2021062061A5 - - Google Patents
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- JPWO2021062061A5 JPWO2021062061A5 JP2022518762A JP2022518762A JPWO2021062061A5 JP WO2021062061 A5 JPWO2021062061 A5 JP WO2021062061A5 JP 2022518762 A JP2022518762 A JP 2022518762A JP 2022518762 A JP2022518762 A JP 2022518762A JP WO2021062061 A5 JPWO2021062061 A5 JP WO2021062061A5
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- oral formulation
- oral
- denatonium
- acid
- formulation
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Description
５．梱包 - カプセル、50mg - 30個
33mmホワイトCRCキャップ付き50/60ccホワイトHDPE丸型Sライン容器の中に50mgカプセルを３０個入りで梱包した。容器を回転させ、インダクションシーラーを用いて密封した。
本発明はまた、以下の態様および実施態様を含む。
[1] 酢酸塩(DA)、クエン酸塩(DC)、酒石酸塩(CT)、マレイン酸塩(DM)およびそれらの組み合わせからなる群から選択される、デナトニウムカチオンと酸アニオンの塩（総称して「デナトニウム塩」）、並びにデナトニウム塩の胃での放出のための医薬賦形剤を含む、複数の疾患の治療用経口医薬組成物。
[2] 胃腸管製剤の胃領域でAPI（有効医薬成分）を実質的に遊離する経口速放出性医薬組成物であって、前記APIが有効量のデナトニウム塩を含む医薬組成物。
[3] ヒトの成人へ約20mgから約150mgのデナトニウム塩の1日用量を送達できる、約0.5gから約5gのデナトニウム塩を含む、[1]または[2]に記載の経口速放出性医薬製剤。
[4] 酢酸塩(DA)、クエン酸塩(DC)、酒石酸塩(CT)、マレイン酸塩(DM)およびそれらの組み合わせからなる群から選択される、デナトニウムカチオンと酸アニオンの塩（総称して「デナトニウム塩」）、並びにデナトニウム塩の胃での放出のための医薬賦形剤を含む顆粒を含有する、経口胃内速放出性医薬製剤(「経口製剤」)。
[5] 前記医薬賦形剤が、タルク、セルロース、およびサッカリドを含む、[4]に記載の経口製剤。
[6] 前記経口製剤が、酢酸、リンゴ酸、マレイン酸、クエン酸およびそれらの組み合わせからなる群から選択される有機酸をさらに含む、[4]または[5]に記載の経口製剤。
[7] 前記経口製剤が、約0.5gから約5gの酢酸をさらに含む、[4]～[6]のいずれかに記載の経口製剤。
[8] 前記成人のDAの1日用量が、約10mgから約600mgまたは約5mg/kgから約50mg/kgである、[4]～[6]のいずれかに記載の経口製剤。
[9] 前記成人のDAの1日用量が、約10mgから約200mgである、[4]～[6]のいずれかに記載の経口製剤。
[10] 前記成人のDAの1日用量が、約10mgから約100mg、または約10ppbから約10ppmの胃腸管内濃度を達成する用量である、[4]～[6]のいずれかに記載の経口製剤。
[11] 酢酸塩(DA)、クエン酸塩(DC)、酒石酸塩(CT)、マレイン酸塩(DM)およびそれらの組み合わせからなる群から選択される、デナトニウムカチオンと酸アニオンの塩（総称して「デナトニウム塩」）、並びにデナトニウム塩の胃での放出のための医薬賦形剤を含む顆粒を含有する、経口胃内速放出性医薬製剤(「経口製剤」)を投与することを特徴とする、体重減少をもたらす方法。
[12] 前記医薬賦形剤が、タルク、セルロース、およびサッカリドを含む、[11]に記載の方法。
[13] 前記経口製剤が、酢酸、リンゴ酸、マレイン酸、クエン酸およびそれらの組み合わせからなる群から選択される有機酸をさらに含む、[11]または[12]に記載の方法。
[14] 前記経口製剤が、約0.5gから約5gの酢酸をさらに含む、[11]～[13]のいずれかに記載の方法。
[15] 前記成人のDAの1日用量が、約10mgから約600mgまたは約5mg/kgから約50mg/kgである、[11]～[13]のいずれかに記載の方法。
[16] 前記成人のDAの1日用量が、約10mgから約200mgである、[11]～[13]のいずれかに記載の方法。
[17] 前記成人のDAの1日用量が、約10mgから約100mg、または約10ppbから約10ppmの胃腸管内濃度を達成する用量である、[11]～[13]のいずれかに記載の方法。
5. Packaging - Capsules, 50mg - 30 pieces
Packed in 30 pieces of 50mg capsules in a 50/60cc white HDPE round S-line container with a 33mm white CRC cap. The container was rotated and sealed using an induction sealer.
The invention also includes the following aspects and embodiments.
[1] Salts of denatonium cations and acid anions selected from the group consisting of acetate (DA), citrate (DC), tartrate (CT), maleate (DM) and combinations thereof (collectively An oral pharmaceutical composition for the treatment of multiple diseases, comprising a "denatonium salt") and a pharmaceutical excipient for gastric release of the denatonium salt.
[2] An oral immediate release pharmaceutical composition that substantially liberates an API (active pharmaceutical ingredient) in the gastric region of a gastrointestinal preparation, wherein the API comprises an effective amount of a denatonium salt.
[3] The oral immediate release medicament according to [1] or [2], comprising about 0.5 g to about 5 g of denatonium salt, capable of delivering a daily dose of about 20 mg to about 150 mg of denatonium salt to an adult human. formulation.
[4] Salts of denatonium cations and acid anions selected from the group consisting of acetate (DA), citrate (DC), tartrate (CT), maleate (DM) and combinations thereof (collectively An oral gastric immediate release pharmaceutical formulation (an ``oral formulation'') containing granules containing a denatonium salt (as a ``denatonium salt'') and a pharmaceutical excipient for gastric release of the denatonium salt.
[5] The oral formulation according to [4], wherein the pharmaceutical excipient includes talc, cellulose, and saccharide.
[6] The oral preparation according to [4] or [5], wherein the oral preparation further comprises an organic acid selected from the group consisting of acetic acid, malic acid, maleic acid, citric acid, and combinations thereof.
[7] The oral preparation according to any one of [4] to [6], wherein the oral preparation further contains about 0.5 g to about 5 g of acetic acid.
[8] The oral formulation according to any one of [4] to [6], wherein the daily dose of DA for adults is about 10 mg to about 600 mg or about 5 mg/kg to about 50 mg/kg.
[9] The oral preparation according to any one of [4] to [6], wherein the daily dose of DA for adults is about 10 mg to about 200 mg.
[10] The oral administration according to any one of [4] to [6], wherein the daily dose of DA for adults is a dose that achieves a concentration in the gastrointestinal tract of about 10 mg to about 100 mg, or about 10 ppb to about 10 ppm. formulation.
[11] Salts of denatonium cations and acid anions selected from the group consisting of acetate (DA), citrate (DC), tartrate (CT), maleate (DM) and combinations thereof (collectively and a granule containing a pharmaceutical excipient for gastric release of the denatonium salt (an "oral formulation"). A method that results in weight loss.
[12] The method according to [11], wherein the pharmaceutical excipient includes talc, cellulose, and saccharide.
[13] The method according to [11] or [12], wherein the oral formulation further comprises an organic acid selected from the group consisting of acetic acid, malic acid, maleic acid, citric acid, and combinations thereof.
[14] The method according to any one of [11] to [13], wherein the oral preparation further contains about 0.5 g to about 5 g of acetic acid.
[15] The method according to any one of [11] to [13], wherein the daily dose of DA for the adult is about 10 mg to about 600 mg or about 5 mg/kg to about 50 mg/kg.
[16] The method according to any one of [11] to [13], wherein the daily dose of DA for the adult is about 10 mg to about 200 mg.
[17] The method according to any one of [11] to [13], wherein the daily dose of DA for adults is a dose that achieves a concentration in the gastrointestinal tract of about 10 mg to about 100 mg, or about 10 ppb to about 10 ppm. .
Claims (17)
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201962905943P | 2019-09-25 | 2019-09-25 | |
| US62/905,943 | 2019-09-25 | ||
| PCT/US2020/052588 WO2021062061A1 (en) | 2019-09-25 | 2020-09-24 | Oral pharmaceutical immediate release composition and method of treatment for weight loss |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JP2022549833A JP2022549833A (en) | 2022-11-29 |
| JPWO2021062061A5 true JPWO2021062061A5 (en) | 2023-10-02 |
Family
ID=75167128
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2022518762A Pending JP2022549833A (en) | 2019-09-25 | 2020-09-24 | Oral immediate release pharmaceutical composition and method of weight loss treatment |
Country Status (8)
| Country | Link |
|---|---|
| US (1) | US20220280457A1 (en) |
| EP (1) | EP4034082A4 (en) |
| JP (1) | JP2022549833A (en) |
| KR (1) | KR20220106960A (en) |
| CN (1) | CN114786647A (en) |
| AU (1) | AU2020354634A1 (en) |
| CA (1) | CA3151431A1 (en) |
| WO (1) | WO2021062061A1 (en) |
Families Citing this family (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CA3215858A1 (en) * | 2021-04-27 | 2022-11-03 | Zhenhuan ZHENG | Combination of bitter receptor agonist and gut-signaling compound |
| AU2022364821A1 (en) * | 2021-10-14 | 2024-04-11 | Aardvark Therapeutics Inc. | Monohydrate salt of denatonium acetate |
Family Cites Families (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20030068276A1 (en) * | 2001-09-17 | 2003-04-10 | Lyn Hughes | Dosage forms |
| US20030198666A1 (en) * | 2002-01-07 | 2003-10-23 | Richat Abbas | Oral insulin therapy |
| KR20040063616A (en) * | 2003-01-08 | 2004-07-14 | 김원호 | Agent for diet Food |
| CA2629142A1 (en) * | 2005-11-10 | 2007-05-24 | Regents Of The University Of Minnesota | Systemic plant conditioning composition |
| US8357398B2 (en) * | 2009-10-21 | 2013-01-22 | Alitair Pharmaceuticals Inc. | Benzonatate compositions and methods of use |
| JP2013528661A (en) * | 2010-06-17 | 2013-07-11 | カリフォルニア インスティチュート オブ テクノロジー | Hormone regulation methods and systems and related methods, agents and compositions |
| BR112013017411B1 (en) * | 2011-01-07 | 2022-03-22 | Anji Pharma (Us) Llc | Use of a composition comprising metformin or a salt thereof |
| EP3138898A1 (en) * | 2015-09-04 | 2017-03-08 | The Procter and Gamble Company | Water-soluble detergent articles wrapped in a film with an aversive agent mainly in the flanges or skirt thereof |
| EP3138900A1 (en) * | 2015-09-04 | 2017-03-08 | The Procter and Gamble Company | Detergent compositions and wrapping films therefor having at least two different aversive agents and methods related thereto |
| US20210260013A1 (en) * | 2018-07-11 | 2021-08-26 | Aardvark Therapeutics lnc. | Oral Pharmaceutical Formulations of Bitter Compounds for Pulmonary Hypertension |
-
2020
- 2020-09-24 EP EP20868217.9A patent/EP4034082A4/en active Pending
- 2020-09-24 KR KR1020227013390A patent/KR20220106960A/en unknown
- 2020-09-24 CA CA3151431A patent/CA3151431A1/en active Pending
- 2020-09-24 WO PCT/US2020/052588 patent/WO2021062061A1/en unknown
- 2020-09-24 CN CN202080066539.0A patent/CN114786647A/en active Pending
- 2020-09-24 AU AU2020354634A patent/AU2020354634A1/en active Pending
- 2020-09-24 JP JP2022518762A patent/JP2022549833A/en active Pending
-
2022
- 2022-03-23 US US17/702,452 patent/US20220280457A1/en active Pending
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