Rapid-acting insulin formulation comprising a substituted anionic compound
AssigneeAdocia
InventorsGérard Soula, Bertrand Alluis
Life of this patent
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Abstract
A composition in aqueous solution includes insulin and at least one substituted anionic compound chosen from substituted anionic compounds consisting of a backbone formed from a discrete number u of between 1 and 8 (1≤u≤8) of identical or different saccharide units, linked via identical or different glycoside bonds, the saccharide units being chosen from the group consisting of hexoses, in cyclic form or in open reduced form, said compound comprising partially substituted carboxyl functional groups, the unsubstituted carboxyl functional groups being salifiable. A pharmaceutical formulation including the composition is also set forth.
Claims26
A rapid acting insulin pharmaceutical composition suitable for injection having a pH of 7.4±0.4, comprising:
- an insulin in hexameric form in the presence of zinc, wherein the insulin has a concentration between 100 to 200 IU/mL;
- a polyanionic compound in a concentration between 9.3 mM and 30 mM, wherein the polyanionic compound is citric acid or the Na+, K+, Ca2+ or Mg2+ salt thereof;
- zinc salts;
- sodium chloride;
- and
- a preservative;
- wherein the insulin is insulin lispro, and the composition has a circular dichroism signal at 251 nm of −300 deg cm2 dmol−1 or the insulin is human insulin, and the composition has a circular dichroism signal at 275 nm of −250 deg cm2 dmol−1 and wherein the insulin pharmaceutical composition does not include EDTA.
A rapid acting insulin lispro pharmaceutical composition suitable for injection and having a pH of 7.4±0.4, comprising:
- an insulin lispro in hexameric form;
- wherein the insulin has a concentration between 100 to 200 IU/mL;
- a polyanionic compound in a concentration between 9.3 and 30 mM, wherein the polyanionic compound is citric acid or the Na+, K+, Ca2+ or Mg2+ salt thereof;
- zinc salts;
- and a preservative;
- and
- wherein the insulin pharmaceutical composition has a circular dichroism signal at 251 nm of less than −300 deg cm2 dmol−1.
A rapid acting human insulin pharmaceutical composition suitable for injection and having a pH of 7.4±0.4, comprising:
- human insulin in hexameric form;
- wherein the insulin has a concentration between 100 to 200 IU/mL;
- a polyanionic compound in a concentration between 9.3 and 30 mM, wherein the polyanionic compound is citric acid or the Na+, K+, Ca2+ or Mg2+ salt thereof;
- zinc salts;
- and a preservative;
- and
- wherein the insulin pharmaceutical composition has a circular dichroism signal at 275 nm of less than −250 deg cm2 dmol−1.
A rapid acting insulin pharmaceutical composition suitable for injection having a pH of 7.4±0.4, comprising:
- an insulin in hexameric form in the presence of zinc, wherein the insulin has a concentration between 100 to 200 IU/mL;
- a polyanionic compound in a concentration between 9.3 mM and 30 mM, wherein the polyanionic compound is citric acid or the Na+, K+, Ca2+ or Mg2+ salt thereof;
- a surfactant;
- and
- a preservative;
- wherein the insulin is insulin lispro, and the composition has a circular dichroism signal at 251 nm of −300 deg cm2 dmol−1 or the insulin is human insulin, and the composition has a circular dichroism signal at 275 nm of −250 deg cm2 dmol−1 wherein the insulin pharmaceutical composition does not include EDTA.
Dependencies are inferred from the claim text.