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US 8,796,210 B2Granted
Stable formulation of growth hormone comprising lactate anion
AssigneeArecor Limited
InventorJan Jezek
Life of this patent
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Abstract
An aqueous composition comprising a therapeutic protein further characterized in that (i) the pH of the composition is adjusted to be between about 5.9 and 6.3, preferably about 6.1; (ii) the composition comprises at least one displaced buffer having a pKa within 1 to 3 pH units of the pH of the composition; (iv) the osmolarity of the composition is between 150-500 mOsm/L.
Claims27
An aqueous composition comprising human growth hormone as a therapeutic protein characterized in that:
- (i) the pH of the composition is between about 5.9 and 6.3;
- (ii) the composition comprises at least one displaced buffer having a pKa within 1 to 3 pH units of the pH of the composition and wherein the at least one displaced buffer is lactate anion;
- and
- (iii) the osmolarity of the composition is between 150-500 mOsm/L.
1 more element
An aqueous composition comprising human growth hormone as a therapeutic protein, characterized in that:
- (i) the pH of the composition is between about 5.9 and 6.3;
- (ii) the composition comprises lactate anions;
- (iii) the composition comprises a preservative selected from phenol, m-cresol, benzyl alcohol, propylparaben, benzalkonium chloride and benzethonium chloride;
- and
- (iv) the osmolarity of the composition is between 150-500 mOsm/L.
2 more elements
Dependencies are inferred from the claim text.