	US 12,485,160 B2
	Stable lyophilized formulation for hybrid Fc fused G-CSF
Hatice Oncel, Istanbul (TR); Emine Duygu Daglikoca, Istanbul (TR); Adem Sahin, Ankara (TR); Meltem Çorbacioglu Pala, Istanbul (TR); Aylin Özkan, Istanbul (TR); Onur Pinarbasli, Çankaya-Ankara (TR); and Nagehan Sarracoglu, Çankaya-Ankara (TR)
Assigned to ILKOGEN ILAÇ SANAYI VE TICARET A.S., Pendik/Istanbul (TR)
Appl. No. 17/608,351
Filed by ILKOGEN ILAÇ SANAYI VE TICARET A.S., Istanbul (TR)
PCT Filed May 22, 2020, PCT No. PCT/TR2020/050444 § 371(c)(1), (2) Date Nov. 2, 2021, PCT Pub. No. WO2020/242419, PCT Pub. Date Dec. 3, 2020.
Claims priority of application No. 19177024 (EP), filed on May 28, 2019.
Prior Publication US 2022/0288167 A1, Sep. 15, 2022
Int. Cl. A61K 38/19 (2006.01); A61K 9/16 (2006.01); A61K 9/19 (2006.01)

CPC A61K 38/193 (2013.01) [A61K 9/1623 (2013.01); A61K 9/1641 (2013.01); A61K 9/19 (2013.01)]

7 Claims

1. A stable pharmaceutical lyophilized formulation prepared by lyophilizing an aqueous preparation comprising:

(i) 10-80 mg/ml of hybrid Fc fused G-CSF (granulocyte colony-stimulating factor) comprising the sequence of SEQ ID NO: 1;

(ii) a stabilizer that is a combination of trehalose dihydrate and sorbitol, wherein a concentration of trehalose dihydrate of the aqueous preparation is between 5.0% (w/v) and 7.0% (w/v) based on a total volume of the aqueous preparation, and wherein a concentration of sorbitol of the aqueous preparation is between 1.5% (w/v) and 2.5% (w/v) based on a total volume of the aqueous preparation;

(iii) at least one poloxamer-based non-ionic surfactant; and

(iv) an acetate buffer;

wherein a pH value of the aqueous preparation is between 3.8 and 5.2.