Abstract: There is provided inter alia an aqueous liquid pharmaceutical formulation comprising (i) an insulin compound, (ii) ionic zinc, (iii) a zinc binding species at a concentration of 1 mM or more selected from species having a log K with respect to zinc ion binding in the range 4.5-12.3 at 25° C., and (iv) a non-ionic surfactant which is an alkyl glycoside; and wherein the formulation is substantially free of EDTA and any other zinc binding species having a log K with respect to zinc ion binding of more than 12.3 at 25° C.

Abstract: An aqueous solution composition of pH in the range 4.0-8.5 comprising: an antibody construct comprising an Fc domain; optionally one or more buffers being substances having at least one ionisable group with a pKa in the range 3.0 to 9.5 and which pKa is within 2 pH units of the pH of the composition; optionally one or more neutral amino acids; and an uncharged tonicity modifier; wherein the buffers are present in the composition at a total concentration of 0-5 mM; and wherein the total ionic strength of the composition excluding the contribution of the engineered protein construct is less than 20 mM.

Abstract: There is provided inter alia an aqueous liquid pharmaceutical formulation comprising (i) an insulin compound, (ii) ionic zinc, (iii) a zinc binding species at a concentration of 1 mM or more selected from species having a log K with respect to zinc ion binding in the range 4.5-12.3 at 25° C., and (iv) a non-ionic surfactant which is an alkyl glycoside; and wherein the formulation is substantially free of EDTA and any other zinc binding species having a log K with respect to zinc ion binding of more than 12.3 at 25° C.

Abstract: There is provided inter alia an injection pen system comprising an injector mechanism and a reservoir comprising an aqueous liquid pharmaceutical composition for delivery by means of said injector mechanism to a mammal wherein the composition comprises (i) an insulin compound, (ii) ionic zinc and (ii) an alkyl glycoside as a non-ionic surfactant.

Abstract: The present invention relates inter alia to an aqueous liquid pharmaceutical formulation comprising (i) an insulin compound, (ii) ionic zinc, (iii) a nicotinic compound (iv) a non-ionic surfactant; and (v) a salt selected from the salts formed between Group 1 metals and a mono or divalent anion. It also provides related methods, uses and pharmaceutical compositions.

Abstract: There is provided, inter alia, an aqueous solution composition of pH in the range 4.0-7.5 comprising: a peptide therapeutic agent; optionally one or more buffers being substances having at least one ionisable group with a pK a in the range 3.0 to 8.5 and which pk a is within 2 pH units of the pH of the composition; and a stabilizer; wherein the peptide therapeutic agent does not contain ionisable groups with pk a in the range 3.0 to 8.5, and wherein the buffers are present in the composition at a total concentration of 0-5 mM.

Abstract: There is provided inter alia an injection pen system comprising an injector mechanism and a reservoir comprising an aqueous liquid pharmaceutical composition for delivery by means of said injector mechanism to a mammal wherein the composition comprises (i) an insulin compound, (ii) ionic zinc and (iii) an alkyl glycoside as a non-ionic surfactant.

Abstract: The present application relates to aqueous solution compositions of engineered dimeric proteins comprising monomers that comprise at least one human serpin polypeptide operably linked to a human immunoglobulin Fc polypeptide or a polypeptide that is derived from an immunoglobulin Fc polypeptide, at low buffer concentrations and low ionic strength and containing a neutral amino acid. The aqueous solution compositions increase the stability of the an Fc domain in aqueous solution compositions, and in particular increase the stability of an engineered dimeric protein.

Abstract: According to the invention there is provided inter alia an aqueous liquid pharmaceutical formulation comprising insulin or an insulin analogue, ionic zinc, a chelating agent and polysorbate 80.

Abstract: The invention provides inter alia an aqueous solution composition of pH in the range 6.0 to 8.0 comprising: —daptomycin or an analogue thereof, or a salt thereof; —a divalent metal cation; and —one or more salts which are not divalent metal cation salts or amino acid salts or buffer salts at a total concentration of 300 mM or more.

Abstract: There is provided inter alia an aqueous solution composition of pH in the range of about 4.0 to about 8.5 comprising: —an engineered protein construct comprising an Fc domain; —optionally one or more buffers being substances having at least one ionisable group with a pKa in the range of about 3.0 to about 9.5 and which pKa is within 2 pH units of the pH of the composition; —optionally one or more neutral amino acids; and—an uncharged tonicity modifier; wherein the buffers are present in the composition at a total concentration in the range of about 0 mM to about 10 mM; and wherein the total ionic strength of the composition excluding the contribution of the engineered protein construct is less than 20 mM.

Abstract: There is provided, inter alia, an aqueous solution comprising an antibody protein and a stabilizing amount of (i) a chelating agent which is a multi-anion; and (ii) a C3 polyol.

Abstract: The present invention relates to novel liquid pharmaceutical compositions of adalimumab, which include adalimumab or a biosimilar thereof, EDTA, and a small polyol stabiliser such as glycerol. Such a combination of components furnishes formulations having a stability (e.g. on storage and when exposed to stress) which is comparable to or an improvement upon those known in the art, and with fewer ingredients. Such advances will help adalimumab treatments to become more widely available at lower cost, and prolong the viability of pre-loaded delivery devices (e.g. pre-filled syringes) to reduce unnecessary waste of the drug.

Abstract: There is provided, inter alia, an aqueous solution comprising (i) an antibody protein; and (ii) a antibody protein stabilizing mixture of arginine, methionine, and a C3 polyol.

Abstract: The present invention relates to novel liquid pharmaceutical compositions of adalimumab, which include adalimumab or a biosimilar thereof, arginine and/or methionine, and a small polyol stabiliser such as glycerol. Such a combination of components furnishes formulations having a stability (e.g. on storage and when exposed to stress) which is comparable to or an improvement upon those known in the art, and with fewer ingredients. Such advances will help adalimumab treatments to become more widely available at lower cost, and prolong the viability of pre-loaded delivery devices (e.g. pre-filled syringes) to reduce unnecessary waste of the drug.

Abstract: There is provided, inter alia, an aqueous liquid pharmaceutical formulation comprising (i) a fast acting insulin analogue; (ii) ionic zinc; and (ill) citrate, said formulation being substantially free of a zinc binding species having a logK with respect to zinc ion binding of greater than 12.3 at 25° C.; for use in the treatment of a human subject suffering from diabetes mellitus by administration by subcutaneous injection or subcutaneous infusion at or close to a meal-time wherein the administration of 0.3 U/kg of the formulation leads to one or more specified pharmacokinetic and/or pharmacodynamic parameters.

Abstract: There is provided, inter alia, an aqueous solution comprising (i) an antibody protein; and (ii) a antibody protein stabilizing mixture of arginine, methionine, and a C3 polyol.

Abstract: The present invention relates to novel liquid pharmaceutical compositions of adalimumab, which include adalimumab or a biosimilar thereof, EDTA, and a small polyol stabiliser such as glycerol. Such a combination of components furnishes formulations having a stability (e.g. on storage and when exposed to stress) which is comparable to or an improvement upon those known in the art, and with fewer ingredients. Such advances will help adalimumab treatments to become more widely available at lower cost, and prolong the viability of pre-loaded delivery devices (e.g. pre-filled syringes) to reduce unnecessary waste of the drug.

Abstract: The present invention relates to novel liquid pharmaceutical compositions of adalimumab, which include adalimumab or a biosimilar thereof, arginine and/or methionine, and a small polyol stabiliser such as glycerol. Such a combination of components furnishes formulations having a stability (e.g. on storage and when exposed to stress) which is comparable to or an improvement upon those known in the art, and with fewer ingredients. Such advances will help adalimumab treatments to become more widely available at lower cost, and prolong the viability of pre-loaded delivery devices (e.g. pre-filled syringes) to reduce unnecessary waste of the drug.

Abstract: An aqueous solution composition of pH in the range 4.0-8.5 comprising: an antibody construct comprising an Fc domain; optionally one or more buffers being substances having at least one ionisable group with a pKa in the range 3.0 to 9.5 and which pKa is within 2 pH units of the pH of the composition; optionally one or more neutral amino acids; and an uncharged tonicity modifier; wherein the buffers are present in the composition at a total concentration of 0-5 mM; and wherein the total ionic strength of the composition excluding the contribution of the engineered protein construct is less than 20 mM.