Formulations comprising actriia polypeptide variants
AssigneeMerck Sharp & Dohme Corp.
InventorsVikram Sadineni, Meena Nikhil Bhiwankar, Xiaoqing Liu
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Abstract
In certain aspects, the present disclosure provides lyophilized pharmaceutical formulations comprising a recombinant fusion protein comprising an extracellular domain (ECD) of human activin receptor type-IIA (ActRIIa) proteins or derivatives thereof linked to a constant domain of an immunoglobulin, such as human IgG1 Fc domain and one or more pharmaceutical additives and/or excipients.
Claims46
A pharmaceutical formulation comprising a human ActRIIa fusion protein, a buffer, a surfactant and a stabilizer, wherein the ActRIIa fusion protein comprises the amino acid sequence of SEQ ID NO:
- 32 or SEQ ID NO:41.
A lyophilized pharmaceutical formulation comprising a human ActRIIa fusion protein, a buffer, a surfactant and a stabilizer, wherein the buffer is selected to be physiologically compatible and to maintain a pH of 5.8 when reconstituted with Sterile Water for Injection and wherein the human ActRIIa fusion protein comprises the amino acid sequence of SEQ ID NO:32 or SEQ ID NO:41.
A lyophilized pharmaceutical formulation comprising a human ActRIIa fusion protein, citrate, polysorbate 80, and sucrose, wherein the ActRIIa fusion protein comprises the amino acid sequence of SEQ ID NO:32 or SEQ ID NO:41.
A lyophilized pharmaceutical formulation comprising 55.0 mg of a human ActRIIa fusion protein, 0.48 mg of citric acid monohydrate, 2.56 mg tri-sodium citrate dihydrate, 0.22 mg polysorbate 80, and 88.0 mg sucrose;
- wherein the human ActRIIa fusion protein comprises the amino acid sequence of SEQ ID NO:32 or SEQ ID NO:41.
A lyophilized pharmaceutical formulation comprising 72.5 mg of a human ActRIIa fusion protein, 0.64 mg of citric acid monohydrate, 3.37 mg tri-sodium citrate dihydrate, 0.29 mg polysorbate 80, and 116.0 mg sucrose;
- wherein the human ActRIIa fusion protein comprises the amino acid sequence of SEQ ID NO:32 or SEQ ID NO:41.
A reconstituted pharmaceutical formulation comprising 50 mg/mL of a human ActRIIa fusion protein, 10 mM citrate, 0.2 mg/ml polysorbate 80, and 80 mg/ml sucrose at pH 5.8, wherein the human ActRIIa fusion protein comprises the amino acid sequence of SEQ ID NO:32 or SEQ ID NO:41.
Dependencies are inferred from the claim text.