STABLE GLASSY STATE POWDER FORMULATIONS

• Main Authors: FOSTER, LINDA C, KUO, MEIANG, BILLINGSLEY, SHEILA R
• Format: Patent
• Language: English; French
• Published: 29.09.2009
• Subjects: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROMTHE BODY; HUMAN NECESSITIES; HYGIENE; MEDICAL OR VETERINARY SCIENCE; PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES; SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS ORMEDICINAL PREPARATIONS

A powdered, dispersible composition having stable dispersibility over time i s provided. The composition exhibits a characteristic glass transition temperature (T g) and a recommended storage temperature (T s), wherein the difference between T g and T s is at least about .degree.C (i.e. T g-T s is greater than 10 .degree.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.