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AssigneeMedImmune, LLC
InventorsSajal Manubhai PATEL, Sureshkumar Bhanaram CHOUDHARY
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The present invention relates to improved pharmaceutical compositions that contain high concentrations of one or more protein biomolecule(s). In particular, the invention relates to such pharmaceutical compositions that include one or more amino acid molecules, particularly arginine, alanine, glycine, lysine or proline, or derivatives and salts thereof, or mixtures thereof, as stabilizing compounds. The inclusion of such stabilizing compounds decreases reconstitution time whilst improving and/or maintaining the long-term stability of the protein biomolecule, so as to facilitate the treatment, management, amelioration and/or prevention of a disease or condition by the pharmaceutical composition. The invention particularly pertains to such pharmaceutical compositions that lack, or substantially lack, a sugar stabilizing agent.
A pharmaceutical composition comprising a protein biomolecule as an active agent or component thereof, wherein said composition comprises:
The pharmaceutical composition of any one of claims 1-8, wherein the composition comprises at least two protein biomolecules.
The pharmaceutical composition of any one of claims 1-9, wherein said stabilizing compound is arginine or a derivative or salt thereof.
The pharmaceutical composition of claim 10, wherein said arginine is present at a concentration from about 2.0% (w/v) to about 5.0% (w/v), preferably at a concentration of 2.0% (w/v), a concentration of 3.5% (w/v) or a concentration of 5.5% (w/v).
The pharmaceutical composition of claim 12, wherein said alanine is present at a concentration from about 2.5% (w/v) to about 5.5% (w/v), preferably at a concentration of about 2.5% (w/v), about 3.5% (w/v), about 4.0% (w/v), or about 5.5% (w/v).
The pharmaceutical composition of claim 12 or 13, wherein arginine is additionally present at a concentration of about 1.25% (w/v), about 1.75% (w/v), about 2.0% (w/v) or about 2.75% (w/v).
The pharmaceutical composition of claim 15, wherein said glycine is present at a concentration from about 2.5% (w/v) to about 5.5% (w/v), preferably at a concentration of about 2.5% (w/v), about 3.5% (w/v), about 4.0% (w/v) or about 5.5% (w/v).
The pharmaceutical composition of claim 15 or 16, wherein arginine is additionally present at a concentration of about 1.25% (w/v), about 1.75% (w/v), about 2.0% (w/v) or about 2.75% (w/v).
The pharmaceutical composition of any one of claims 1-17, wherein the composition comprises at least two stabilizing compounds.
The pharmaceutical composition of any one of claims 1-18, wherein the pH of said pharmaceutical composition is from about 3 to about 11, from about 4 to about 9, from about 5 to about 8, from about 5 to about 7.5, preferably 6.0 or 7.4.
The pharmaceutical composition of any one of claims 1-19, wherein said buffer is present in a range from about 5 mM to about 50 mM, about 20 mM to about 30 mM, or about 23 mM to about 27 mM, preferably wherein the buffer is present at 25 mM.
The pharmaceutical composition of any one of claims 1-20, wherein said buffer comprises histidine, phosphate, acetate, citrate, succinate, Tris, or a combination thereof.
The pharmaceutical composition of claim 21, wherein said buffer is histidine/histidine-HCl.
Use of one or more amino acids, such as arginine, alanine, glycine, lysine or proline, as a replacement of one or more sugars in a pharmaceutical formulation to decrease reconstitution time.
Dependencies are inferred from the claim text.