公开(公告)号：CA2722602A1

公开(公告)日：2009-11-19

申请号：CA2722602

申请日：2009-05-08

Applicant: BAXTER INT ,  BAXTER HEALTHCARE SA

Inventor： KIPP JAMES E ,  WONG JOSEPH C T ,  NAIR LAKSHMY ,  MILLER REAGAN ,  RABINOW BARRETT E

IPC: A61K9/00 ,  A61K47/10 ,  A61K47/40

Abstract: Stable pharmaceutical formulations and methods of making same are provided. In a general embodiment, the present disclosure provides a method of making a stable pharmaceutical formulation comprising adding one or more vitrifying additives to an aqueous pharmaceutical solution to raise the glass transition temperature of the aqueous pharmaceutical solution. The aqueous pharmaceutical solution can be cooled to a temperature of about -50 C to about -10 C. The vitrifying additive enhances the formation of a glass or amorphous solid of the aqueous pharmaceutical solution at cryogenic temperatures (-50 to -10C), and the pharmaceutical formulation can be thawed to liquid form and administered to a mammalian subject.

公开(公告)号：AU2021233893A1

公开(公告)日：2022-08-25

申请号：AU2021233893

申请日：2021-03-11

Applicant: BAXTER INT ,  BAXTER HEALTHCARE SA

Inventor： WEGIEL LINDSAY ,  MILLER REAGAN

IPC: A61K9/00 ,  A61K9/19 ,  A61K31/00 ,  A61K47/26

Abstract: In an aspect, a method of manufacture of a pharmaceutically acceptable solid composition containing daptomycin includes drying an aqueous solution containing (i) water, (ii) the daptomycin, (iii) sorbitol in an amount of about 1.2 wt.% to about 9.0 wt.% of total volume of the aqueous composition and (iv) mannitol in an amount of about 0.6 wt.% to about 9.5 wt.% of total volume of the aqueous composition to form the solid composition. The drying can include an sublimation drying of about -25 °C to about 50 °C for a time period of about 15 hours to about 120 hours, most preferably about 15 °C for about 20 hours, optionally preceded and/or followed by one or more additional drying steps. Other aspects are the solid composition containing the daptomycin and also methods of treating a bacterial infection including administering a pharmaceutically acceptable product made by reconstituting the solid composition.

公开(公告)号：MX2010012451A

公开(公告)日：2010-12-07

申请号：MX2010012451

申请日：2009-05-08

Applicant: BAXTER INT

Inventor： KIPP JAMES E ,  RABINOW BARRETT E ,  WONG JOSEPH C T ,  NAIR LAKSHMY ,  MILLER REAGAN

IPC: A61K9/00 ,  A61K47/10 ,  A61K47/40

Abstract: Se proporcionan formulaciones farmacéuticas estables y métodos para elaborarlas. En una modalidad general, la presente descripción proporciona un método para elaborar una formulación farmacéutica estable que comprende agregar uno o más aditivos de vitrificación a una solución farmacéutica acuosa para elevar la temperatura de transición al vidrio de la solución farmacéutica acuosa. La solución farmacéutica acuosa puede ser enfriada a una temperatura de aproximadamente -50°C hasta aproximadamente -10°C. El aditivo de vitrificación mejora la formación de un sólido de vidrio o amorfo de la solución farmacéutica acuosa en temperaturas criogénicas (-50°C a - 10°C), y la formulación farmacéutica puede ser descongelada a una forma líquida y administrada a un sujeto mamífero.