Back to results
US 2010/0168011 A1Published application
Pharmaceutical Formulations and Methods for Making the Same
AssigneeAmylin Pharmaceuticals, Inc.
InventorsRobert N. Jennings, JR., Scott H. Coleman
Life of this patent
Estimating the term…
Abstract
In certain embodiments, the invention relates to pre-lyophilization formulations, lyophilized compositions, reconstituted formulations, kits comprising the same, and methods for preparing, storing and using the same.
Claims29
1-34. (canceled)
A pre-lyophilization solution comprising:
- a peptide;
- and
- a cyclic oligosaccharide;
- wherein the solution comprises a solids content of at least 20% w/w, and wherein the cyclic oligosaccharide provides for at least 80% of the solids content.
1 more element
A method for preparing a lyophilized peptide composition, comprising:
- providing a container comprising a pre-lyophilization solution comprising the peptide, wherein the pre-lyophilization solution comprises a solids content of at least 20% w/w;
- lyophilizing the pre-lyophilization solution comprising the peptide, thereby providing a lyophilized peptide composition;
- wherein the ratio of the fill height of the pre-lyophilization solution to the container internal diameter is greater than 0.5.
A method for preparing a lyophilized peptide composition, comprising:
- providing a pre-lyophilization solution comprising the peptide;
- wherein the pre-lyophilization solution comprises a solids content of at least 20% w/w and further comprises a cyclic oligosaccharide which provides at least 80% of the solids content and lyophilizing the pre-lyophilization solution, thereby obtaining the lyophilized peptide composition.
Dependencies are inferred from the claim text.