Premixed Ultra-Stable Single-Chain Insulin Analogue Formulations
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Sep 8, 2022
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Aug 3, 2020
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Aug 2, 2019
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Abstract
A premixed acidic solution contains two single-chain insulin analogues. One has isoelectric point between 6.5 and 8.0 (SCI-A) and the other has isoelectric point between 4.5 and 6.0 (SCI-B), such that biphasic basal and prandial insulin activity is provided on subcutaneous injection. Each protein is an analogue of a mammalian insulin, such as human insulin, with insertion of engineered C domain of length 5-11 residues; the respective C domains of SCI-A and SCI-B may be different. SCI-A contains a Glycine, Alanine, Serine or Glutamine substitution at position A21 and may contain a basic residue at position A8 and Glutamine at position B13. SCI-B may contain a non-beta-branched substitution at position A8, either Alanine or Glutamic Acid at position A14, and substitutions at positions B28 and/or B29 to confer rapid action. A method of treating a patient comprises administering the insulin analogue or a physiologically acceptable salt thereof to a patient.
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