Method for coating pharmaceutical substrates
The present invention relates to the field of coating pharmaceutical substrates. In particular, the invention relates to methods of coating of pharmaceutical substances, pharmaceutical ingredients or a blend of them. The invention also provides a method of making a pharmaceutical formulation which may be processed into a pharmaceutical dosage form, which utilizes solid pharmaceutical particles and a pharmaceutical formulation obtained by the method. The methods of the invention utilize atomic layer deposition technology. The novel methods allow difficult, moisture sensitive and electrically charged pharmaceutical substrates to be easily processable.
1. A composition comprising individual nanoparticles or microparticles consisting of:
i) an active pharmaceutical substance and a coating layer; or
ii) an active pharmaceutical substance, one or more pharmaceutically acceptable excipients and a coating layer;
wherein the coating layer is conformal, pinhole-free and consists of an inorganic oxide selected from the group consisting of aluminum oxide, zinc oxide, silicon oxide and titanium oxide, wherein the coating layer is applied by atomic layer deposition and is 5 nm-15 nm thick.
2. The composition of claim 1 , wherein the individual nanoparticles or microparticles consist of an active pharmaceutical substance, at least one pharmaceutically acceptable excipient and a coating layer.
3. The composition of claim 1 , wherein the individual nanoparticles or microparticles consist of an active pharmaceutical substance and a coating layer.
4. A pharmaceutical dosage form comprising the composition of claim 1 and a pharmaceutically acceptable carrier or excipient.
5. The pharmaceutical dosage form of claim 4 which is a liquid dosage form.
6. The pharmaceutical dosage form of claim 4 which is a solid dosage form.
7. The pharmaceutical dosage form of claim 4 which is a semi-solid dosage form.
8. The pharmaceutical dosage form of claim 4 which is an oral dosage form.
9. The pharmaceutical dosage of claim 4 which is a parenteral dosage form.
10. The composition of claim 1 , wherein the active pharmaceutical substance is water soluble.
11. A composition comprising individual nanoparticles or microparticles consisting of:
i) a water soluble active pharmaceutical substance and a coating layer; or
ii) a water soluble active pharmaceutical substance, one or more pharmaceutically acceptable excipients and a coating layer;
wherein the coating layer is conformal, pinhole-free and consists of an inorganic oxide selected from the group consisting of aluminum oxide, zinc oxide, silicon oxide and titanium oxide, wherein the coating layer is applied by atomic layer deposition and the total thickness of the coating layer is 1 nm-100 nm.
12. The composition of claim 11 , wherein the individual nanoparticles or microparticles consist of an active pharmaceutical substance, at least one pharmaceutically acceptable excipient and a coating layer.
13. The composition of claim 11 , wherein the individual nanoparticles or microparticles consist of an active pharmaceutical substance and a coating layer.
14. The composition of claim 11 , wherein coating layer is 5 nm-15 nm thick.
15. A pharmaceutical dosage form comprising the composition of claim 11 and a pharmaceutically acceptable carrier or excipient.
16. A pharmaceutical dosage form comprising the composition of claim 2 and a pharmaceutically acceptable carrier or excipient.
17. The pharmaceutical dosage form of claim 16 , wherein the active pharmaceutical substance is water soluble.
18. A pharmaceutical dosage form comprising the composition of claim 3 and a pharmaceutically acceptable carrier or excipient.
19. The pharmaceutical dosage form of claim 18 , wherein the active pharmaceutical substance is water soluble.
20. A pharmaceutical dosage form comprising the composition of claim 12 and a pharmaceutically acceptable carrier or excipient.
21. The pharmaceutical dosage form of claim 20 , wherein the coating layer is 5 nm-15 nm thick.
22. A pharmaceutical dosage form comprising the composition of claim 13 and a pharmaceutically acceptable carrier or excipient.
23. The pharmaceutical dosage form of claim 22 , wherein the coating layer is 5 nm-15 nm thick.