United States Patent:  6,066,619

Assignee:  Alza Corporation (Mt. View, CA)

Filed:  April 16, 1999

This invention relates to stable non-aqueous protic formulations of peptide compounds. These stable formulations comprise peptide in non-aqueous protic solvent. They may be stored at elevated temperatures for long periods of time and are especially useful in implantable delivery devices for long term delivery of drug.

SUMMARY OF THE INVENTION

The present invention provides stable non-aqueous formulations which are solutions of peptide compounds in non-aqueous protic solvents. In particular, formulations with concentrations of at least about 10% peptide are provided. These stable formulations may be stored at elevated temperatures (e.g., 37^oC.) for long periods of time and are especially useful in implantable delivery devices for long term delivery (e.g., 1-12 month or longer) of drug.

In one aspect, the invention provides stable non-aqueous formulations of peptide compounds, said formulations comprising at least one peptide compound in at least one non-aqueous protic solvent. Particularly preferred formulations include at least about 10% (w/w) peptide compound.

In another aspect, the invention provides methods for preparing a stable non-aqueous formulation of an peptide compound, said methods comprising dissolving at least one peptide compound in at least one non-aqueous protic solvent. Preferred formulations comprise at least about 10% (w/w) peptide compound.

In yet a further aspect, the invention provides methods for treating a subject suffering from a condition which may be alleviated by administration of an peptide compound, said methods comprising administering to said subject an effective amount of a stable non-aqueous formulation comprising at least one peptide compound in at least one non-aqueous protic solvent.

Claim 1 of 13 Claims

1. A method for treating a subject suffering from a condition which may be alleviated by administration of a peptide compound comprising administering to said subject an effective amount of a stable non-aqueous formulation of a peptide compound comprising:

a) at least one peptide compound; and

b) at least one non-aqueous protic solvent.

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