Solid dose delivery vehicle and methods of making same
AssigneeQuadrant Drug Delivery Limited
InventorsBruce J. Roser, Jaap Kampinga, Camilo Colaco, Julian Blair
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Abstract
The present invention encompasses a therapeutic composition in solid dose form that is suitable for pulmonary administration. The therapeutic composition may comprise therapeutic particles in a glassy state. The therapeutic composition preferably comprises a bioactive material such as insulin, and a sugar alcohol. The components are optionally in solid solution. The therapeutic composition can preferably remain in a glassy state when stored at elevated temperatures, and/or extended periods.
Claims34
A therapeutic composition in solid dose form comprising a bioactive material and a sugar alcohol, wherein
- a) the bioactive material is insulin,
- b) the therapeutic composition comprises therapeutic particles containing insulin homogeneously distributed in a solid solution with a sugar alcohol, wherein the therapeutic particles are in a glassy state,
- c) the therapeutic composition is a powder suitable for pulmonary administration,
- d) the therapeutic particles containing the insulin in the solid solution with the sugar alcohol remain in the glassy state when stored at elevated temperature for one month, wherein the elevated temperature is 60° C., and
- e) the therapeutic particles have a mean particle size of 0.5 to 5 μm.
Dependencies are inferred from the claim text.