Claims
- 1. A powdered, dispersible composition having stable dispersibility over time, a characteristic glass transition temperature (Tg) and a recommended storage temperature (Ts), wherein the difference between Tg and Ts is at least about 10° C., which composition comprises a mixture of
a pharmaceutically-acceptable glassy matrix and at least one pharmacologically active material within the glassy matrix.
- 2. A powdered dispersible composition in unit dosage form having stable dispersibility over time and a characteristic glass transition temperature (Tg), in combination with labelling instructions for treating pulmonary or systemic disease in a mammalian subject that include a recommended storage temperature (Ts), wherein the difference between Tg and Ts is at least about 10° C., which composition comprises a pharmaceutically acceptable glassy matrix and at least one pharmaceutically active material within the amorphous glassy matrix.
- 3. The composition of claim 1 or 2, wherein the difference between Tg and Ts is at least about 20° C.
- 4. The composition of claim 1 or 2, wherein the difference between Tg and Ts is at least about 30° C.
- 5. The composition of claim 1 or 2, wherein the Tg is about 35° C. to about 200° C.
- 6. The composition of claim 1 or 2, wherein the Tg is greater than about 45° C.
- 7. The composition of claim 1 or 2, wherein the Tg is greater than about 55° C.
- 8. The composition of claim 1 or 2, wherein Ts is about 2° C. to about 30° C. and Tg is about 22° C. to about 200° C.
- 9. The composition of claim 1 or 2, wherein the glassy matrix comprises a glass former chosen from the group consisting of carbohydrates, carbohydrate derivatives, carbohydrate polymers, organic carboxylic salts, synthetic organic polymers, proteins, peptides, amino acids and mixtures thereof.
- 10. The composition of claim 1 or 2, wherein the glass former is sodium citrate, raffinose, lactose, trehalose, maltotriose, maltodextrin, maltose, glucopyranosyl-sorbitol, glucopyranosyl-mannitol, polydextrose, sucrose cyclodextrin, casein, HSA, hydroxyethyl starch, stachyose, magnesium gluconate, cellobiose, or a mixture of two or more of the foregoing.
- 11. A process for producing a powdered dispersible composition having stable dispersibility over time, a characteristic glass transition temperature (Tg) and a recommended storage temperature (Ts) wherein the difference between Tg and Ts is at least about 10° C., which process comprises removing the solvent from a solution comprising a solvent, a glass former and a pharmacologically active material under conditions sufficient to form a glassy matrix having the pharmacologically active material within the matrix.
- 12. The process of claim 11, wherein the solvent is removed by spray drying.
- 13. The process of claim 11, wherein the solvent is removed by evaporative drying.
- 14. The process of claim 11, wherein the solvent is removed by chemical precipitation.
- 15. The process of claim 11, wherein the solvent is water.
- 16. The process of claim 11, wherein the solvent is ethanol.
- 17. A powdered, dispersible composition having stable dispersibility over time, which composition comprises
(a) a first, respirable powdered component having a characteristic glass transition temperature (Tg) and a recommended storage temperature (Ts), wherein the difference between Tg and Ts is at least about 10° C., which composition comprises a mixture of
a pharmaceutically-acceptable glassy matrix and at least one pharmacologically active material within the glassy matrix, and (b) a second, nonrespirable powdered component comprising a powdered, pharmaceutically-acceptable carrier.
- 18. The composition of claim 17, wherein the largest particle size of the first component is about 10 microns, with the majority of the particles between about 1 micron to about 5 microns, and the particle size of the second component is between about 15 microns to about 100 microns.
- 19. The combination of claim 2, wherein the unit dosage form includes a moisture barrier.
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation-in-part of U.S. Ser. NO. 08/733,225 filed Oct. 17, 1996, which in turn is a continuation-in-part of PCT Application No. PCT 96/05070, filed 12 Apr. 1996, which is a continuation-in-part of U.S. Ser. No. 08/423,515, filed 14 Apr. 1995, which applications are incorporated herein by reference in their entirety.
Continuations (1)
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Number |
Date |
Country |
Parent |
08950385 |
Oct 1997 |
US |
Child |
09879853 |
Jun 2001 |
US |
Continuation in Parts (3)
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Number |
Date |
Country |
Parent |
08733225 |
Oct 1996 |
US |
Child |
08950385 |
Oct 1997 |
US |
Parent |
PCT/US96/05070 |
Apr 1996 |
US |
Child |
08733225 |
Oct 1996 |
US |
Parent |
08423515 |
Apr 1995 |
US |
Child |
PCT/US96/05070 |
Apr 1996 |
US |