LIQUID PHARMACEUTICAL FORMULATIONS OF PTH CONJUGATES Russian patent published in 2024 - IPC A61K9/08 A61K38/29 A61K47/10 A61K47/26 A61K47/60 A61P5/18 

FIELD: medicine.

SUBSTANCE: group of inventions discloses a liquid pharmaceutical composition for preparing a drug for treating, controlling, delaying or preventing one or more diseases, which can be treated, controlled, delayed or prevented by PTH, where the pharmaceutical formulation contains a PTH conjugate, a buffer agent, an isotonicity regulating agent, a preservative and optionally an antioxidant, and wherein the PTH conjugate comprises a PTH moiety which is covalently and reversibly conjugated with a water-soluble carrier, wherein the PTH conjugate has formula (IIf-i), where the unmarked dashed line indicates attachment to nitrogen -D, which is a PTH moiety through amide bond formation, and where the dashed line marked with an asterisk indicates attachment to the fragment, where m and p independently represent an integer in the range and including 400–500; where the pharmaceutical formulation contains a PTH conjugate, in which the PTH fragment is 0.05–5.0 mg/ml; succinic acid 0.25–24 mg/ml; D-mannitol 10–200 mg/ml; m-cresol 1–10 mg/ml, and wherein the pH is in range of 3.0 to 6.0. Group of inventions also relates to a method of producing a liquid pharmaceutical formulation (versions) and to use of the liquid pharmaceutical formulation (versions).

EFFECT: providing stable long-term storage and reducing aggregation of the PTH conjugate in the liquid pharmaceutical formulation.

25 cl, 25 tbl, 5 ex