التفاصيل البيبلوغرافية
| العنوان: |
MICROPARTICLES, MICROPARTICLE DISPERSION AND METHOD AND APPARATUS FOR PRODUCING THE SAME |
| Document Number: |
20090142402 |
| تاريخ النشر: |
June 4, 2009 |
| Appl. No: |
12/295666 |
| Application Filed: |
March 19, 2007 |
| مستخلص: |
A method and an apparatus enabling manufacture of a microparticle dispersion liquid at high efficiency in a short time while suppressing drug degradation, etc., are provided. In a dissolving step, a poorly soluble drug and a dispersion stabilizer are dissolved in a volatile organic solvent in a container 13. In a fixing step following the dissolving step, the organic solvent, contained in a solution, is eliminated by evaporation, a pellet-form residue 1 is obtained by the organic solvent elimination, and the residue 1 is fixed on an inner wall of the container 13. In a water injecting step following the fixing step, water 2 is injected into an interior of the container 13. In an irradiating step following the water injecting step, laser light 1, emitted from a laser light source 11, is irradiated on the residue 1 fixed on the inner wall of the container 13, and the residue 1 is thereby pulverized and made into microparticles and a microparticle dispersion liquid, constituted of the microparticles being dispersed in the water 2, is manufactured. The microparticles contain the poorly soluble drug and the dispersion stabilizer. |
| Inventors: |
Takebe, Gen (Shizuoka, JP); Kawakami, Tomonori (Shizuoka, JP); Takagi, Tokio (Shizuoka, JP); Hiramatsu, Mitsuo (Shizuoka, JP) |
| Claim: |
1. A microparticle dispersion liquid manufacturing method comprising: a dissolving step of dissolving a poorly soluble drug and a dispersion stabilizer in a volatile organic solvent; a fixing step of performing elimination by evaporation of the organic solvent, contained in a solution obtained in the dissolving step, and fixing a residue, obtained by the organic solvent elimination, on an inner wall of a container; a water injecting step of injecting water into an interior of the container after the fixing step; and an irradiating step of irradiating light on the residue fixed on the inner wall of the container after the water injecting step to manufacture a liquid having microparticles, containing the poorly soluble drug and the dispersion stabilizer, dispersed in water. |
| Claim: |
2. The microparticle dispersion liquid manufacturing method according to claim 1, wherein in the irradiating step, light is irradiated from outside a region of the inner wall of the container on which the residue is fixed, and the irradiated light is made to propagate in an order of the container, the residue, and the water. |
| Claim: |
3. The microparticle dispersion liquid manufacturing method according to claim 1, wherein light of a wavelength of no less than 900 nm is irradiated on the residue in the irradiating step. |
| Claim: |
4. The microparticle dispersion liquid manufacturing method according to claim 3, wherein light of a wavelength of low absorbance with respect to the residue is irradiated in the irradiating step. |
| Claim: |
5. The microparticle dispersion liquid manufacturing method according to claim 1, wherein both or either of an intensity and a duration of light irradiation on the residue are or is adjusted in the irradiating step to control a particle diameter of the microparticles. |
| Claim: |
6. The microparticle dispersion liquid manufacturing method according to claim 1, wherein the irradiated region or the interior of the container is maintained at a fixed temperature during light irradiation on the residue in the irradiating step. |
| Claim: |
7. The microparticle dispersion liquid manufacturing method according to claim 1, wherein a sealed container is used as the container and the dissolving step, the fixing step, the water injecting step, and the irradiating step are performed in a sterilized state. |
| Claim: |
8. The microparticle dispersion liquid manufacturing method according to claim 1, wherein a container, having a function of a syringe, is used as the container. |
| Claim: |
9. The microparticle dispersion liquid manufacturing method according to claim 1, wherein the dispersion stabilizer is a high molecular weight polymer or a surfactant. |
| Claim: |
10. The microparticle dispersion liquid manufacturing method according to claim 1, wherein the organic solvent is a low toxicity alcohol. |
| Claim: |
11. A microparticle dispersion liquid manufacturing apparatus comprising: a container, in which a poorly soluble drug and a dispersion stabilizer are dissolved in a volatile organic solvent, a residue, obtained by elimination by evaporation of the organic solvent contained in the solution, is fixed on an inner wall, and water is injected into an interior; and a light source, irradiating light on the residue fixed on the inner wall of the container; and wherein a liquid, having microparticles, containing the poorly soluble drug and the dispersion stabilizer, dispersed in water, is manufactured by irradiation of the light on the residue by the light source. |
| Claim: |
12. The microparticle dispersion liquid manufacturing apparatus according to claim 11, wherein the light is irradiated by the light source from outside a region of the inner wall of the container on which the residue is fixed, and the irradiated light is made to propagate in an order of the container, the residue, and the water. |
| Claim: |
13. The microparticle dispersion liquid manufacturing apparatus according to claim 11, wherein the light source irradiates light of a wavelength of no less than 900 nm on the residue. |
| Claim: |
14. The microparticle dispersion liquid manufacturing apparatus according to claim 13, wherein the light source irradiates light of a wavelength of low absorbance with respect to the residue. |
| Claim: |
15. The microparticle dispersion liquid manufacturing apparatus according to claim 11, further comprising: an irradiation light controller, controlling both or either of an intensity and a duration of light irradiation on the residue by the light source. |
| Claim: |
16. The microparticle dispersion liquid manufacturing apparatus according to claim 11, further comprising: a temperature controller, maintaining the irradiated region or the interior of the container at a fixed temperature during the light irradiation on the residue by the light source. |
| Claim: |
17. The microparticle dispersion liquid manufacturing apparatus according to claim 11, wherein the container is a sealed container enabled to be maintained in a sterilized state. |
| Claim: |
18. The microparticle dispersion liquid manufacturing apparatus according to claim 11, wherein the container has a function of a syringe. |
| Claim: |
19. A microparticle dispersion liquid manufactured by the microparticle dispersion liquid manufacturing method according to claim 1 and having microparticles, containing a poorly soluble drug and a dispersion stabilizer, dispersed in water. |
| Claim: |
20. Microparticles manufactured from the microparticle dispersion liquid according to claim 19 and containing a poorly soluble drug and a dispersion stabilizer. |
| Claim: |
21. Lyophilized microparticles manufactured by lyophilizing the microparticle dispersion liquid according to claim 19 and a liquid containing the microparticles according to claim 20. |
| Claim: |
22. An orally administered formulation containing the microparticle dispersion liquid according to claim 19, the microparticles according to claim 20, and the lyophilized microparticles according to claim 21. |
| Claim: |
23. An injection formulation containing the microparticle dispersion liquid according to claim 19, and a dispersion liquid obtained by resuspending the microparticles according to claim 20 and the lyophilized microparticles according to claim 21 in water. |
| Claim: |
24. A microparticle dispersion liquid manufactured by the microparticle dispersion liquid manufacturing method according to claim 11 and having microparticles, containing a poorly soluble drug and a dispersion stabilizer, dispersed in water. |
| Current U.S. Class: |
424/489 |
| Current International Class: |
61; 01; 61 |
| رقم الانضمام: |
edspap.20090142402 |
| قاعدة البيانات: |
USPTO Patent Applications |