Inhalable dry powders
The invention related to dry powders that contain a therapeutic agent. The dry powders have characteristics, e.g., they are processable and/or dense in therapeutic agent that provide advantages for formulating and delivering therapeutic agents to patients.
1. A process for producing one or more receptacles with a respirable dry powder disposed therein, comprising
disposing the respirable dry powder into a plurality of said receptacles at a target fill weight and at a rate of about one receptacle every 4 seconds or less to produce filled receptacles, wherein at least 80% of said filled receptacles contain said respirable dry powder within 85% to 115% of the target fill weight; and
wherein the respirable dry powder consists of respirable dry particles that have a volume median geometric diameter (VMGD) of about 10 micrometers or less, and a tap density of at least about 0.45 g/cubic centimeters, and wherein the respirable dry particles comprise a sodium salt and an anti-fungal agent that provides at least about 25% of the total mass of the contents disposed within the one or more receptacles, with the proviso that the respirable dry particles do not contain a divalent metal cation salt.
2. The process of claim 1 , wherein the respirable dry powder is filled into a plurality of said receptacles at a target fill weight and at a rate of about one receptacle every 1 second or less to produce filled receptacles, wherein at least 80% of said filled receptacles contain said respirable dry powder within 85% to 115% of the target fill weight.
3. The process of claim 1 , further comprising sealing the one or more receptacles.
4. The process of claim 1 , wherein the sodium salt is at least about 3% by weight of the respirable dry particles.
5. The process of claim 1 , wherein the sodium salt is selected from the group consisting of sodium chloride, sodium citrate, sodium sulfate, sodium lactate, sodium acetate, sodium bicarbonate, sodium carbonate, sodium stearate, sodium ascorbate, sodium benzoate, sodium biphosphate, dibasic sodium phosphate, sodium bisulfate, sodium borate, sodium gluconate, sodium metasilicate, and sodium propionate.
6. The process of claim 1 , wherein said disposing the respirable dry powder into a plurality of said receptacles is performed with a vacuum dosator.
7. The process of claim 1 , wherein said vacuum dosator is a rotating drum vacuum dosator.
8. A process for producing one or more receptacles with a respirable dry powder disposed therein, comprising
disposing the respirable dry powder into a plurality of said receptacles at a target fill weight and at a rate of about one receptacle every 4 seconds or less to produce filled receptacles, wherein at least 80% of said filled receptacles contain said respirable dry powder within 85% to 115% of the target fill weight; and
wherein the respirable dry powder consists of respirable dry particles that have a volume median geometric diameter (VMGD) of about 10 micrometers or less, and a tap density of at least about 0.45 g/cubic centimeters, and wherein the respirable dry particles comprise a sodium salt and itraconazole that provides at least about 25% of the total mass of the contents disposed within the one or more receptacles, with the proviso that the respirable dry particles do not contain a divalent metal cation salt.
9. The process of claim 8 , wherein the respirable dry powder is filled into a plurality of said receptacles at a target fill weight and at a rate of about one receptacle every 1 second or less to produce filled receptacles, wherein at least 80% of said filled receptacles contain said respirable dry powder within 85% to 115% of the target fill weight.
10. The process of claim 8 , further comprising sealing the one or more receptacles.
11. The process of claim 8 , wherein the sodium salt is at least about 3% by weight of the respirable dry particles.
12. The process of claim 8 , wherein the sodium salt is selected from the group consisting of sodium chloride, sodium citrate, sodium sulfate, sodium lactate, sodium acetate, sodium bicarbonate, sodium carbonate, sodium stearate, sodium ascorbate, sodium benzoate, sodium biphosphate, dibasic sodium phosphate, sodium bisulfate, sodium borate, sodium gluconate, sodium metasilicate, and sodium propionate.
13. The process of claim 8 , wherein said disposing the respirable dry powder into a plurality of said receptacles is performed with a vacuum dosator.
14. The process of claim 13 , wherein said vacuum dosator is a rotating drum vacuum dosator.