Low temperature process for preparing silicon oxide coated pharmaceuticals

Patent metadata

Field	Value
Publication number	US-12064522-B2
Application number	US-202117492363-A
Country	US
Kind code	B2
Filing date	Oct 1, 2021
Priority date	Oct 2, 2020
Publication date	Aug 20, 2024
Grant date	Aug 20, 2024

Abstract

A method of preparing a pharmaceutical composition having a drug-containing core enclosed by one or more silicon oxide materials is provided. The method entails alternating exposing the particles to gaseous or vaporous SiCl4 and gaseous or vaporous H2O at a reduced temperature and in the absence of a catalyst.

First claim

What is claimed is:

1. A method of preparing coated particles comprising an active pharmaceutical ingredient (API)-containing core enclosed by one or more silicon oxide layers, the method comprising:
(a1) loading particles comprising a hydrophobic API into a reactor;
(a2) applying gaseous SiCl 4 to the particles in the reactor;
(a3) performing one or more pump-purge cycles using inert gas;
(a4) applying gaseous H 2 O to the particles in the reactor; and
(a5) lowering the gaseous H 2 O pressure in the reactor to below 0.5 Torr,
(b) performing two or more reaction cycles, each reaction cycle consisting of steps (a2)-(a5), to increase the total thickness of the silicon oxide layer, thereby creating coated particles comprising an API-containing core, wherein reaction cycles take place between 25° C. and 50° C. in the absence of a catalyst, and there is no pump-purge cycle between the first and second reaction cycles.

2. The method of claim 1 , wherein there is no pump-purge cycle between the second and the third reaction cycles.

3. The method of claim 1 , wherein there is no pump-purge cycle between any of the first 10 reaction cycles.

4. The method of claim 1 , wherein there is no pump-purge cycle between any of the first 100 reaction cycles.

5. The method of claim 1 , wherein the particles are agitated prior to and/or during one or more of steps (a2) to (a5).

6. The method of claim 1 , wherein the particles are agitated prior to and/or during step (a1), step (a3), and/or step (a5).

7. The method of claim 1 , wherein a subset of gaseous SiCl 4 is pumped out prior to step (a3).

8. The method of claim 1 , wherein the silicon oxide layer has a thickness in a range of 0.1 nm to 50 nm.

9. The method of claim 1 , wherein the particles are not removed from the reactor between the reaction cycles.

10. The method of claim 1 , wherein the particles are not removed from the reactor during step until the silicon oxide layer is complete.

11. The method of claim 1 , wherein the API-containing core comprises one or more pharmaceutically acceptable excipients.

12. The method of claim 1 , wherein the particles in step (a1) have a median particle size, on a volume average basis between 0.1 μm and 20 μm.

13. The method of claim 1 , wherein the particles in step (a1) have a median particle size, on a volume average basis between 0.1 μm and 5 μm.

14. The method of claim 1 , wherein the particles in step (a1) have a median particle size, on a volume average basis between 0.1 μm and 1000 μm.

15. The method of claim 1 , wherein the API-containing core comprises the hydrophobic API and a second API.

16. The method of claim 1 , wherein the API-containing core consists of the hydrophobic API.

17. The method of claim 1 , wherein the API-containing core consists of the hydrophobic API and a second API.

18. The method of claim 1 , wherein the API-containing core comprises the hydrophobic API, a second API and one or more pharmaceutically acceptable excipients.

19. The method of claim 1 , wherein the API-containing core consists of the hydrophobic API and one or more pharmaceutically acceptable excipients.

20. The method of claim 1 , wherein the API-containing core consists of the hydrophobic API, a second API and one or more pharmaceutically acceptable excipients.

21. The method of claim 1 , wherein the API-containing core comprises the hydrophobic API and step (a1) further comprises one or both of (1) loading particles comprising a second API into the reactor (second particles) and (2) loading particles comprising one more excipients into the reactor (excipient particles).

22. The method of claim 1 , further comprising admixing the coated particles with a pharmaceutically acceptable diluent or carrier.

23. The method of claim 1 , further comprising processing the coated particles to form a tablet or capsule.

24. The method of claim 1 , further comprising admixing the coated particles with a pharmaceutically acceptable diluent or carrier to form a mixture and processing the mixture to form a table or capsule.

25. The method of claim 1 , wherein each pump-purge cycle comprises flowing an inert gas into the reactor to reach a pressure of at least 1 Torr and after a delay time evacuating the reactor to reduce the pressure of the inert gas to below 1 Torr.

26. The method of claim 1 , wherein the gaseous SiCl 4 is pumped into the reactor to reach a pressure of 2 to 200 Torr during step (a2).

27. The method of claim 1 , wherein step (a3) is the only pump-purge step.

28. The method of claim 1 , wherein the gaseous H 2 O is pumped into the reactor to reach a pressure of 2 to 20 Torr and is allowed to react with SiCl 4 in the reactor for 1-30 minutes during step (a4).

29. The method of claim 1 , wherein there is one or more pump-purge cycles between the second and each subsequent cycles.

30. The method of claim 1 , wherein there is one or more pump-purge cycles between the third and each subsequent cycles.

31. The method of claim 1 , wherein there is one or more pump-purge cycles between the 10th and each subsequent cycles.

32. The method of claim 1 , wherein there is one or more pump-purge cycles between the 100th and each subsequent cycles.

Assignees

• Applied Materials Inc

Inventors

• Wang Fei
• Wang Miaojun
• Neikirk Colin C
• Frankel Jonathan
• Narwankar Pravin K

Classifications

• A61K9/501 Primary

  Inorganic compounds · CPC title

• A61K9/5089 Primary

  Processes · CPC title