Storage stable sincalide formulations
AssigneeMaia Pharmaceuticals, Inc.
InventorSrikanth Sundaram
Life of this patent
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Abstract
Disclosed herein are solid compositions that comprise sincalide and are storage stable and which lack a buffer, and optionally, also lack a surfactant/solubilizer, wherein such compositions are storage stable. Also disclosed herein are liquid compositions that comprise sincalide, wherein such compositions are storage stable, and may lack buffer and/or surfactant/solubilizer. Also provided are methods of making and administering the solid or liquid storage stable compositions to a patient in need of, e.g., for the treatment, prevention, and/or diagnosis of gall bladder- and/or pancreatic disorders; or other diagnostic imaging.
Claims19
A solid composition comprising:
- (i) from 2.5 to 10 mcg of sincalide;
- (ii) from 1 to 4 mg of pentetic acid;
- (iii) from 15 to 45 mg of arginine hydrochloride;
- (iv) from 2 to 8 mg of L-methionine;
- (v) from 7.5 to 30 mg of L-lysine hydrochloride;
- (vi) from 0.02 to 1 mg of sodium metabisulfite;
- and
- (vii) from 85 to 340 mg of mannitol,
- wherein the solid composition comprises a pH of about 6.5 to about 7.5 when reconstituted in a pharmaceutically acceptable diluent,
- wherein the solid composition does not contain a phosphate buffer,
- wherein the solid composition does not contain a surfactant, a solubilizer, polysorbate 20, or polysorbate 80,
- wherein the solid composition is formulated to be reconstituted in a pharmaceutically acceptable diluent for a quantity sufficient to 2.5 to 10 mL, and
- wherein the solid composition maintains total impurities less than 5% after 15 months of storage at 25° C., 60% relative humidity or after 3 months of storage at 40° C., 75% relative humidity and optionally wherein the solid composition also maintains a sincalide level of at least 90% after 15 months of storage at 25° C., 60% relative humidity when tested by high-performance liquid chromatography.
A solid composition comprising:
- (a) 2.5 to 10 mcg of sincalide,
- (b) 1 to 4 mg pentetic acid,
- (c) 15 to 45 mg arginine hydrochloride,
- (d) 2 to 8 mg methionine,
- (e) 7.5 to 30 mg lysine hydrochloride,
- (f) 0.02 to 1 mg sodium metabisulfite, and
- (g) 85 to 340 mg mannitol,
- wherein the solid composition comprises a pH from 6.5 to 7.5 when reconstituted in a pharmaceutically acceptable diluent,
- wherein the solid composition does not contain a phosphate buffer,
- wherein the solid composition does not contain a surfactant, a solubilizer, polysorbate 20, or polysorbate 80,
- wherein the solid composition does not contain a buffer having a pKa within one unit of the pH, and
- wherein the solid composition maintains total impurities of less than 5% after 15 months of storage at 25° C., 60% relative humidity or after 3 months of storage at 40° C., 75% relative humidity and optionally wherein the solid composition also maintains a sincalide level of at least 90% after 15 months of storage at 25° C., 60% relative humidity when tested by high-performance liquid chromatography.
Dependencies are inferred from the claim text.