JPWO2019207061A5 - - Google Patents
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- JPWO2019207061A5 JPWO2019207061A5 JP2020559465A JP2020559465A JPWO2019207061A5 JP WO2019207061 A5 JPWO2019207061 A5 JP WO2019207061A5 JP 2020559465 A JP2020559465 A JP 2020559465A JP 2020559465 A JP2020559465 A JP 2020559465A JP WO2019207061 A5 JPWO2019207061 A5 JP WO2019207061A5
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Description
考察および結論
この実施例に示されたデータでは、１，２－プロパンジオールが、ポリマーに基づく複
合体だけでなく、凝集を防ぎ、インビボでの活性を保持する脂質に基づく複合体の凍結も
可能にすることが示されている。
本発明の様々な実施形態を以下に示す。
１．（ｉ）液相に懸濁されている治療活性剤のナノまたはマイクロ粒子製剤、および
（ｉｉ）１つまたは２つのヒドロキシ基で置換されたＣ３～Ｃ５アルカンから選択される、少なくとも１つの凍結保護添加剤
を含む、組成物。
２．前記治療活性剤が、核酸である、上記１に記載の組成物。
３．前記治療活性剤が、ｍＲＮＡである、上記２に記載の組成物。
４．前記ナノまたはマイクロ粒子製剤が、１～４０００ｎｍ、より好ましくは２～２５００ｎｍ、最も好ましくは５～１０００ｎｍの範囲の平均粒径を示す、上記１から３のいずれかに記載の組成物。
５．前記治療活性剤が、核酸であり、前記ナノまたはマイクロ粒子製剤の粒子が、前記核酸およびカチオン性賦形剤を含む、上記２から４のいずれかに記載の組成物。
６．前記粒子製剤の粒子が、核酸と、カチオン性賦形剤としてのカチオン性オリゴマーまたはカチオン性ポリマーとで形成される複合体の形態で核酸を含む、上記５に記載の組成物。
７．前記粒子製剤の粒子が、核酸と、カチオン性賦形剤としてのカチオン性脂質またはカチオン性リピドイドとで形成される複合体の形態で核酸を含む、上記５に記載の組成物。
８．前記凍結保護添加剤が、少なくとも二級ヒドロキシ基を含む、上記１から７のいずれかに記載の組成物。
９．前記凍結保護添加剤が、１，２－プロパンジオール、２－プロパノール、１，２－ブタンジオール、および１，３－ブタンジオールから選択される、上記８に記載の組成物。
１０．前記凍結保護添加剤が、１，２－プロパンジオールである、上記９に記載の組成物。
１１．前記凍結保護添加剤が、液相の体積を基準として０．５～５０％ｗ／ｖの濃度で含有される、上記１から１０のいずれかに記載の組成物。
１２．（ｉ）治療活性剤のナノまたはマイクロ粒子製剤、および
（ｉｉ）１つまたは２つのヒドロキシ基で置換されたＣ３～Ｃ５アルカンから選択される、少なくとも１つの凍結保護添加剤
を含み、上記１から１１のいずれかに記載の組成物を凍結することにより得られる、固体組成物。
１３．上記１から１１のいずれかに記載の組成物を調製するための方法であって、
ａ）液相に懸濁されている治療活性剤のナノまたはマイクロ粒子製剤を生成すること、および
ｂ）１つまたは２つのヒドロキシ基で置換されたＣ３～Ｃ５アルカンから選択される、少なくとも１つの凍結保護添加剤を前記液相に添加すること
を含み、前記凍結保護添加剤の前記液相への添加が、前記液相に懸濁されている前記粒子製剤を生成する前、生成する間、または生成した後に達成することができる、
方法。
１４．上記１２に記載の固体組成物を調製するための方法であって、
ａ）液相に懸濁されている治療活性剤のナノまたはマイクロ粒子製剤を生成すること、および
ｂ）１つまたは２つのヒドロキシ基で置換されたＣ３～Ｃ５アルカンから選択される、少なくとも１つの凍結保護添加剤を前記液相に添加すること
を含み、前記凍結保護添加剤の前記液相への添加が、前記液相に懸濁されている前記粒子製剤を生成する前、生成する間、または生成した後に達成することができる、
方法により、上記の第一の態様による組成物を調製する、第一のステップ、
ならびに、第一のステップで得られる前記組成物を凍結する、第二のステップ
を含む、方法。
１５．治療活性剤のナノまたはマイクロ粒子製剤を保存する方法であって、上記１から１１のいずれかに記載の懸濁組成物を生成すること、および前記組成物を凍結することを含む、方法。
１６．治療活性剤のナノまたはマイクロ粒子製剤を含む組成物に対する凍結保護添加剤として、１つまたは２つのヒドロキシ基で置換されたＣ３～Ｃ５アルカンから選択される化合物の使用。
１７．液体に懸濁されている粒子状組成物からエアゾール剤を形成するための、または、このような組成物を噴霧するためのデバイスであって、上記１から１１のいずれかに記載の組成物を含む、デバイス。
１８．定量吸入器、ネブライザー、および鼻噴射デバイスから選択される吸入器である、上記１７に記載のデバイス。
１９．疾患の処置または予防での使用のための、上記１から１１のいずれかに記載の組成物であって、気道へ、または気道を介して投与される、組成物。
２０．経肺投与を介して、または経鼻投与を介して投与される、上記１９に記載の使用のための組成物。
Discussion and Conclusion In the data presented in this example, 1,2-propanediol can freeze not only polymer-based complexes, but also lipid-based complexes that prevent aggregation and retain in vivo activity. It is shown to be.
Various embodiments of the present invention are shown below.
1. 1. (I) Nano or microparticle preparation of the therapeutically active agent suspended in the liquid phase, and
(Ii) At least one cryoprotective additive selected from C3 to C5 alkanes substituted with one or two hydroxy groups.
A composition comprising.
2. 2. The composition according to 1 above, wherein the therapeutically active agent is nucleic acid.
3. 3. 2. The composition according to 2 above, wherein the therapeutically active agent is mRNA.
4. The composition according to any one of 1 to 3 above, wherein the nano- or micro-particle preparation exhibits an average particle size in the range of 1 to 4000 nm, more preferably 2 to 2500 nm, and most preferably 5 to 1000 nm.
5. The composition according to any one of 2 to 4 above, wherein the therapeutically active agent is a nucleic acid, and the particles of the nano- or microparticle preparation contain the nucleic acid and a cationic excipient.
6. 5. The composition according to 5 above, wherein the particles of the particle preparation contain the nucleic acid in the form of a complex formed of the nucleic acid and a cationic oligomer or a cationic polymer as a cationic excipient.
7. 5. The composition according to 5 above, wherein the particles of the particle preparation contain the nucleic acid in the form of a complex formed of the nucleic acid and a cationic lipid as a cationic excipient or a cationic lipidoid.
8. The composition according to any one of 1 to 7 above, wherein the cryoprotective additive contains at least a secondary hydroxy group.
9. 8. The composition according to 8 above, wherein the cryoprotective additive is selected from 1,2-propanediol, 2-propanol, 1,2-butanediol, and 1,3-butanediol.
10. 9. The composition according to 9 above, wherein the cryoprotective additive is 1,2-propanediol.
11. The composition according to any one of 1 to 10 above, wherein the freeze-protection additive is contained at a concentration of 0.5 to 50% w / v based on the volume of the liquid phase.
12. (I) Nano or microparticle preparation of therapeutically active agent, and
(Ii) At least one cryoprotective additive selected from C3 to C5 alkanes substituted with one or two hydroxy groups.
A solid composition obtained by freezing the composition according to any one of 1 to 11 above.
13. A method for preparing the composition according to any one of 1 to 11 above.
a) Producing nano or microparticulate formulations of therapeutically active agents suspended in the liquid phase, and
b) Add at least one cryoprotectant additive to the liquid phase, selected from C3 to C5 alkanes substituted with one or two hydroxy groups.
The addition of the cryoprotective additive to the liquid phase can be achieved before, during, or after the production of the particle formulation suspended in the liquid phase.
Method.
14. A method for preparing the solid composition according to 12 above, wherein the solid composition is prepared.
a) Producing nano or microparticulate formulations of therapeutically active agents suspended in the liquid phase, and
b) Add at least one cryoprotectant additive to the liquid phase, selected from C3 to C5 alkanes substituted with one or two hydroxy groups.
The addition of the cryoprotective additive to the liquid phase can be achieved before, during, or after the production of the particle formulation suspended in the liquid phase.
The first step, by method, to prepare the composition according to the first aspect described above.
In addition, the second step of freezing the composition obtained in the first step.
Including, how.
15. A method for storing a nano- or micro-particle formulation of a therapeutically active agent, comprising producing the suspension composition according to any one of 1 to 11 above, and freezing the composition.
16. Use of a compound selected from C3-C5 alkanes substituted with one or two hydroxy groups as a cryoprotective additive for compositions containing nano or microparticle formulations of therapeutically active agents.
17. The composition according to any one of 1 to 11 above, which is a device for forming an aerosol agent from a particulate composition suspended in a liquid or for spraying such a composition. Including devices.
18. 17. The device according to 17 above, which is an inhaler selected from a metered dose inhaler, a nebulizer, and a nasal injection device.
19. The composition according to any one of 1 to 11 above, for use in the treatment or prevention of a disease, which is administered to or through the respiratory tract.
20. 19. The composition for use according to 19 above, which is administered via pulmonary administration or via nasal administration.
Claims (14)
（ｉ）液相に懸濁されている治療活性剤のナノまたはマイクロ粒子製剤、および
（ｉｉ）１つまたは２つのヒドロキシ基で置換されたＣ３～Ｃ５アルカンから選択される、少なくとも１つの凍結保護添加剤
を含む、組成物を含み、
前記治療活性剤が、核酸である、デバイス。 A device for forming an aerosol agent from a particulate composition suspended in a liquid, or for spraying such a composition, wherein the device is:
At least one cryoprotection selected from (i) a nano- or microparticle formulation of the therapeutically active agent suspended in the liquid phase, and (ii) C3-C5 alkanes substituted with one or two hydroxy groups. Contains the composition, including the additive ,
A device in which the therapeutically active agent is a nucleic acid .
（ｉ）液相に懸濁されている治療活性剤のナノまたはマイクロ粒子製剤、および
（ｉｉ）１つまたは２つのヒドロキシ基で置換されたＣ３～Ｃ５アルカンから選択される、少なくとも１つの凍結保護添加剤
を含み、
前記治療活性剤が、核酸である、
気道へ、または気道を介して投与される、組成物。 A composition for use in the treatment or prevention of a disease , wherein the composition is:
(I) Nano or microparticle preparation of the therapeutically active agent suspended in the liquid phase, and
(Ii) At least one cryoprotective additive selected from C3 to C5 alkanes substituted with one or two hydroxy groups.
Including
The therapeutically active agent is a nucleic acid.
A composition that is administered to or through the airways.
13. The composition for use according to claim 13 , which is administered via pulmonary administration or via nasal administration.
Applications Claiming Priority (5)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP18169325.0 | 2018-04-25 | ||
| EP18169325 | 2018-04-25 | ||
| EP18189010 | 2018-08-14 | ||
| EP18189010.4 | 2018-08-14 | ||
| PCT/EP2019/060646 WO2019207061A1 (en) | 2018-04-25 | 2019-04-25 | Cryoprotective agents for particulate formulations |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| JP2021522248A JP2021522248A (en) | 2021-08-30 |
| JPWO2019207061A5 true JPWO2019207061A5 (en) | 2022-04-28 |
| JP7256824B2 JP7256824B2 (en) | 2023-04-12 |
Family
ID=66240151
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2020558887A Pending JP2021522228A (en) | 2018-04-25 | 2019-04-25 | Lipid-based formulations for RNA delivery |
| JP2020559465A Active JP7256824B2 (en) | 2018-04-25 | 2019-04-25 | Cryoprotectant for particulate formulations |
Family Applications Before (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2020558887A Pending JP2021522228A (en) | 2018-04-25 | 2019-04-25 | Lipid-based formulations for RNA delivery |
Country Status (13)
| Country | Link |
|---|---|
| US (2) | US20210137840A1 (en) |
| EP (3) | EP4311541A3 (en) |
| JP (2) | JP2021522228A (en) |
| KR (2) | KR20210021943A (en) |
| CN (2) | CN112153986B (en) |
| AU (2) | AU2019258679A1 (en) |
| BR (2) | BR112020021054A2 (en) |
| CA (2) | CA3098262A1 (en) |
| ES (2) | ES2960939T3 (en) |
| MX (2) | MX2020011166A (en) |
| PL (1) | PL3784285T3 (en) |
| WO (2) | WO2019207060A1 (en) |
| ZA (1) | ZA202006026B (en) |
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2019
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- 2019-04-25 ES ES19718760T patent/ES2960939T3/en active Active
- 2019-04-25 ES ES19718759T patent/ES2960936T3/en active Active
- 2019-04-25 AU AU2019258678A patent/AU2019258678A1/en active Pending
- 2019-04-25 EP EP23187109.6A patent/EP4311541A3/en active Pending
- 2019-04-25 CN CN201980034487.6A patent/CN112153986B/en active Active
- 2019-04-25 KR KR1020207030471A patent/KR20210021943A/en unknown
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