Stable glassy state powder formulations
OwnerLinda C. Foster, Mei-chang Kuo +1inventors
InventorsLinda C. Foster, Mei-chang Kuo, Shelia R. Billingsley
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OwnerLinda C. Foster, Mei-chang Kuo +1inventors
InventorsLinda C. Foster, Mei-chang Kuo, Shelia R. Billingsley
Estimating the term…
A powdered, dispersible composition having stable dispersibility over time is provided. The composition exhibits 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. (i.e. Tg−Ts is greater than 10° C.). The composition comprises a mixture of a pharmaceutically-acceptable glassy matrix and at least one pharmacologically active material within the glassy matrix. It may be further mixed with a powdered, pharmaceutically-acceptable carrier. It is particularly valuable in unit dosage form having a moisture barrier, in combination with appropriate labelling instructions. A process for producing a powdered dispersible composition is also provided, wherein the 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.
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 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.
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.
A powdered, dispersible composition having stable dispersibility over time, which composition comprises
Dependencies are inferred from the claim text.