FIELD: pharmacology.
SUBSTANCE: group of inventions relates to an albumin-free liquid formulation of the long-acting human growth hormone (hGH) conjugate, wherein the conjugate contains human growth hormone bound to the Fc region of immunoglobulin and has a prolonged stability in vivo compared to the native form. Liquid composition of the hGH conjugate contains a buffer with a pH of 5.0-6.0, sugar alcohol, sodium chloride and a nonionic surfactant, does not contain human serum albumin and other hazards that may be potentially contaminated with viruses.
EFFECT: group of inventions provides excellent storage stability, adapted for the hGH prolonged-action conjugate, and stability in vivo compared to the native form.
17 cl, 2 dwg, 11 tbl, 7 ex
Title | Year | Author | Number |
---|---|---|---|
LIQUID COMPOSITION OF LONG-ACTING ALPHA INTERFERON CONJUGATE | 2011 |
|
RU2613905C2 |
LIQUID FORMULATIONS FOR LONG-ACTING CONJUGATE OF G-CSF | 2011 |
|
RU2519031C1 |
SUSTAINED TYPE HUMAN GROWTH HORMONE PREPARATION | 2014 |
|
RU2683823C2 |
LIQUID FORMULATION OF LONG-ACTING INSULINOTROPIC PEPTIDE CONJUGATE | 2013 |
|
RU2671576C2 |
LIQUID FORMULATIONS FOR LONG-ACTING ERYTHROPOIETIN CONJUGATE | 2011 |
|
RU2682720C2 |
PROTEIN COMPLEX, OBTAINED BY USING FRAGMENT OF IMMUNOGLOBULIN, AND METHOD OF SUCH COMPLEX OBTAINING | 2004 |
|
RU2356909C2 |
LIQUID COMPOSITION OF LONG-ACTING INSULIN AND INSULINOTROPIC PEPTIDE | 2013 |
|
RU2643766C2 |
LIQUID FORMULATION OF LONG-ACTING INSULIN CONJUGATE | 2013 |
|
RU2670270C2 |
PHARMACEUTICAL COMPOSITION CONTAINING Fc-REGION OF IMMUNOGLOBULIN AS CARRIER | 2004 |
|
RU2352583C2 |
METHOD OF CONTROLLING CONDITIONS FOR SITE-SPECIFIC BINDING OF POLYPEPTIDE AND NON-PEPTIDE POLYMER | 2010 |
|
RU2495881C2 |
Authors
Dates
2017-06-21—Published
2011-07-14—Filed