Ingredients for inhalation and methods for making the same
A method of processing an active ingredient, the method comprising submitting a pharmaceutically active ingredient in the absence of excipients and/or additives to compression and shearing forces. The invention also relates to compositions comprising an active prepared by the method.
1. A method of processing an active ingredient, the method consisting of feeding a pharmaceutically active ingredient to a mechanofusion apparatus and subjecting the pharmaceutically active ingredient to compression and shearing forces, wherein the active ingredient is micronized prior to compression and shearing forces and wherein the active ingredient is glycopyrrolate.
2. The method of claim 1 , wherein the active is conditioned during compression and shearing.
3. The method of claim 2 , wherein the active is conditioned by an elevated level of relative humidity compared to ambient conditions.
4. The method of claim 3 , wherein the active is conditioned by increasing the relative humidity over time to 70%.
5. The method of claim 1 , wherein the active ingredient is conditioned at a minimum temperature.
6. The method of claim 2 , wherein the active ingredient is conditioned at a minimum temperature.
7. The method of claim 3 , wherein the active ingredient is conditioned at a minimum temperature.
8. The method of claim 4 , wherein the active ingredient is conditioned at a minimum temperature.
9. The method of claim 5 , wherein the minimum temperature is at least 50° C.
10. The method of claim 6 , wherein the minimum temperature is at least 50° C.
11. The method of claim 7 , wherein the minimum temperature is at least 50° C.
12. The method of claim 8 , wherein the minimum temperature is at least 50° C.
13. The method of claim 1 , wherein the micronization is impact milling or jet milling.
14. The method of claim 13 , wherein an amorphous content of the active is reduced with respect to the micronised active starting material, suitably as measured by DVS.
15. A method of processing an active ingredient according to claim 1 , wherein the active material is combined after compression and shearing with another material, wherein the another material is selected from a group consisting of another active, carrier and additive; or further processed.
16. A method according to claim 1 , wherein the active ingredient is packaged after processing into a receptacle or delivery device.