Formulations and dosages for administering a compound that inhibits MCL1 protein
AssigneeAmgen Inc.
InventorsRon C. Kelly, Michael T. Kennedy, Stevedat K. La
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Abstract
The present disclosure is drawn to pharmaceutical formulations, aqueous solutions, and methods of treating cancer using the disclosed pharmaceutical formulations and aqueous solutions. The formulations and solutions comprise compounds of Formula I and may further comprise a cyclodextrin compound, such as hydroxypropyl-β-cyclodextrin and a buffer, such as glycine. The methods of treating cancer include the treatment of hematological malignances such as acute myelogenous leukemia, multiple myeloma, and non-Hodgkin's lymphoma.
Claims22
A pharmaceutical formulation for intravenous administration, the formulation comprising:
- a) a compound of Formula I or a salt thereof, wherein the compound of Formula I has the following structure:
- b) a cyclodextrin compound;
- c) a buffer;
- and
- d) water,
- wherein, the concentration of the compound of Formula I or the salt thereof in the formulation ranges from 15 mg/mL to 30 mg/mL and the pH of the formulation ranges from 8.7 to 9.9;
- wherein the buffer is glycine at a concentration ranging from 80 mM to 120 mM;
- and
- wherein the cyclodextrin compound is hydroxypropyl-β-cyclodextrin, and the amount of the cyclodextrin compound in the formulation ranges from 7.5 to 13 percent weight by weight.
An aqueous solution of a therapeutic agent, the solution comprising:
- (a) a compound of Formula I or a salt thereof, wherein the compound of Formula I has the following structure:
- b) a cyclodextrin compound;
- c) a buffer;
- d) sodium chloride;
- and
- e) water,
- wherein, the amount of the compound of Formula I or the salt of the compound of Formula I in the solution ranges from 25 mg to 400 mg;
- wherein the buffer is glycine at a concentration ranging from 80 mM to 120 mM;
- and
- wherein the cyclodextrin compound is hydroxypropyl-β-cyclodextrin, and the amount of the cyclodextrin compound in the formulation ranges from 7.5 to 13 percent weight by weight.
An aqueous solution of a therapeutic agent, the solution comprising:
- a compound of Formula I or a salt thereof, wherein the compound of Formula I has the following structure:
- wherein, the compound of Formula I or the salt of the compound of Formula I is present in an amount ranging from 25 mg/m2 to 960 mg/m2;
- wherein the aqueous solution further comprises a cyclodextrin compound, a buffer, and sodium chloride;
- wherein the buffer is glycine at a concentration ranging from 80 mM to 120 mM;
- and
- wherein the cyclodextrin compound is hydroxypropyl-β-cyclodextrin and the amount of the cyclodextrin compound in the formulation ranges from 7.5 to 13 percent weight by weight.
Dependencies are inferred from the claim text.