Solid dose delivery vehicle and methods of making same
First Claim
1. A therapeutic composition in solid dose form comprising a bioactive material and a carbohydrate, whereina) the bioactive material is a protein,b) the carbohydrate stabilizes the bioactive material in the presence of an organic solvent,c) the therapeutic composition comprises therapeutic particles which contain said protein homogeneously distributed in solid solution in said carbohydrate in a glassy state,d) the therapeutic composition is a powder having a particle size distribution suitable for pulmonary administration,e) the therapeutic particles containing said protein and said carbohydrate in the solid solution remain in the glassy state when stored at 60°
- C. for one month,f) the carbohydrate is selected from the group consisting of monosaccharides, disaccharides and sugar alcohols, andg) the therapeutic particles have a mean particle size of 0.5 to 5 μ
m.
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Abstract
The present invention encompasses a solid dose delivery vehicle for ballistic administration of a bioactive material to subcutaneous and intradermal tissue, the delivery vehicle being sized and shaped for penetrating the epidermis. The delivery vehicle further comprises a stabilizing polyol glass loaded with the bioactive material and capable of releasing the bioactive material in situ. The present invention further includes methods of making and using the solid dose delivery vehicle of the invention.
383 Citations
39 Claims
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1. A therapeutic composition in solid dose form comprising a bioactive material and a carbohydrate, wherein
a) the bioactive material is a protein, b) the carbohydrate stabilizes the bioactive material in the presence of an organic solvent, c) the therapeutic composition comprises therapeutic particles which contain said protein homogeneously distributed in solid solution in said carbohydrate in a glassy state, d) the therapeutic composition is a powder having a particle size distribution suitable for pulmonary administration, e) the therapeutic particles containing said protein and said carbohydrate in the solid solution remain in the glassy state when stored at 60° - C. for one month,
f) the carbohydrate is selected from the group consisting of monosaccharides, disaccharides and sugar alcohols, and g) the therapeutic particles have a mean particle size of 0.5 to 5 μ
m. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 28, 29, 30, 31, 32, 33, 34, 35, 36)
- C. for one month,
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14. A therapeutic composition in solid dose form comprising a bioactive material and a carbohydrate, wherein
a) the bioactive material is a protein, b) the bioactive material of the therapeutic composition is stabilized in the presence of an organic solvent, c) the therapeutic composition comprises therapeutic particles which contain said protein homogeneously distributed in solid solution in said carbohydrate in a glassy state, d) the therapeutic composition is a powder having a particle size distribution suitable for pulmonary administration, e) the therapeutic composition further comprises a glass modifier, wherein the glass modifier is not the bioactive material, f) the therapeutic particles containing the protein and the carbohydrate in the solid solution remain in the glassy state when stored at 60° - C. for one month,
g) the carbohydrate is selected from the group consisting of monosaccharides, disaccharides and sugar alcohols, and h) the therapeutic particles have a mean particle size of 0.5 to 5 μ
m. - View Dependent Claims (15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 37, 38, 39)
- C. for one month,
Specification