Pharmaceutical compositions of drug-oligomer conjugates and methods of treating diseases therewith
AssigneeNobex Corporation
InventorsRichard Soltero, Nnochiri N. Ekwuribe, Foyeke Opawale, Bruce Rehlander, Anthony Hickey, Bovet Li Li
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Abstract
Pharmaceutical compositions that include a drug-oligomer conjugate, a fatty acid component, and a bile salt component are described. The drug is covalently coupled to an oligomeric moiety. The fatty acid component and the bile salt component are present in a weight-to-weight ratio of between 1:5 and 5:1. Methods of treating diseases in a subject in need of such treatment using such pharmaceutical compositions are also provided, as are methods of providing such pharmaceutical compositions.
Claims130
A pharmaceutical composition comprising:
- a drug-oligomer conjugate comprising a drug covalently coupled to an oligomeric moiety;
- a fatty acid component comprising a fatty acid;
- and
- a bile salt component comprising a bile salt;
- wherein the fatty acid component and the bile salt component are present in a weight-to-weight ratio of between 1:5 and 5:1, wherein the fatty acid component is present in an amount sufficient to lower the precipitation point of the bile salt compared to a precipitation point of the bile salt if the fatty acid component were not present in the pharmaceutical composition, and wherein the bile salt component is present in an amount sufficient to lower the solubility point of the fatty acid compared to a solubility point of the fatty acid if the bile salt were not present in the pharmaceutical composition.
A pharmaceutical composition comprising:
- a drug-oligomer conjugate comprising a drug covalently coupled to an oligomeric moiety;
- a bile salt component comprising a bile salt;
- and
- a fatty acid component comprising a fatty acid, wherein the fatty acid component and the bile salt component are present in a weight-to-weight ratio of between 1:5 and 5:1, and wherein the fatty acid component is present in a first amount such that, at the precipitation point of the bile salt, the bile salt precipitates as first bile salt particles that, upon a return to a pH above the precipitation point of the bile salt, re-solubilize more quickly than second bile salt particles that would have precipitated if the fatty acid component were not present in the composition.
A pharmaceutical composition comprising:
- a drug-oligomer conjugate comprising a drug and an oligomeric moiety;
- between 0.1 and 15% (w/v) of a fatty acid component;
- and
- between 0.1 and 15% (w/v) of a bile salt component;
- wherein the fatty acid component and the bile salt component are present in a weight-to-weight ratio of between 1:5 and 5:1.
A method of treating a bone disorder in a subject in need of such treatment, said method comprising administering to the subject a pharmaceutical composition comprising (a) a therapeutically effective amount of a calcitonin drug-oligomer conjugate that comprises a calcitonin drug covalently coupled to an oligomeric moiety;
- (b) a fatty acid component comprising a fatty acid;
- and (c) a bile salt component comprising a bile salt, wherein the fatty acid component and the bile salt component are present in a weight ratio of between 1:5 and 5:1, wherein the fatty acid component is present in an amount sufficient to lower the precipitation point of the bile salt compared to a precipitation point of the bile salt if the fatty acid component were not present in the pharmaceutical composition, and wherein the fatty acid component is present in an amount sufficient to lower the solubility point of the fatty acid compared to a solubility point of the fatty acid if the bile salt were not present in the pharmaceutical composition.
A method of treating a bone disorder in a subject in need of such treatment, said method comprising administering to the subject a pharmaceutical composition comprising (a) a therapeutically effective amount of a calcitonin drug-oligomer conjugate that comprises a calcitonin drug covalently coupled to an oligomeric moiety;
- (b) a bile salt component comprising a bile salt;
- and (c) a fatty acid component comprising a fatty acid, wherein the fatty acid component and the bile salt component are present in a weight ratio of between 1:5 and 5:1, and wherein the fatty acid component is present in a first amount such that, at the precipitation point of the bile salt, the bile salt precipitates as first bile salt particles that, upon a return to a pH above the precipitation point of the bile salt, re-solubilize more quickly than second bile salt particles that would have precipitated if the fatty acid component were present in a second amount less than the first amount.
A method of treating a bone disorder in a subject in need of such treatment, said method comprising administering to the subject a pharmaceutical composition comprising (a) a therapeutically effective amount of a calcitonin drug-oligomer conjugate that comprises a calcitonin drug and an oligomeric moiety;
- (b) between 0.1 and 15% (w/v) of a fatty acid component;
- and (c) between 0.1 and 15% (w/v) of a bile salt component, wherein the fatty acid component and the bile salt component are present in a weight to weight ratio of between 1:5 and 5:1.
Dependencies are inferred from the claim text.