US 12,251,743 B2
Method of preventing lamellar silica formation in glass container
Yasser Nashed-Samuel, Thousand Oaks, CA (US); and Jeremy Gastwirt, Thousand Oaks, CA (US)
Assigned to AMGEN INC., Thousand Oaks, CA (US)
Filed by AMGEN INC., Thousand Oaks, CA (US)
Filed on Apr. 23, 2024, as Appl. No. 18/643,578.
Application 18/643,578 is a division of application No. 16/959,663, granted, now 12,042,830, previously published as PCT/US2019/012119, filed on Jan. 3, 2019.
Claims priority of provisional application 62/613,173, filed on Jan. 3, 2018.
Prior Publication US 2024/0342771 A1, Oct. 17, 2024
Int. Cl. B08B 9/093 (2006.01); A61J 1/06 (2006.01); A61J 1/14 (2023.01); B08B 17/02 (2006.01); C03C 23/00 (2006.01); G01N 21/90 (2006.01); G01N 23/2251 (2018.01); G01N 33/38 (2006.01)
CPC B08B 9/093 (2013.01) [A61J 1/065 (2013.01); A61J 1/1468 (2015.05); B08B 17/02 (2013.01); C03C 23/007 (2013.01); C03C 23/0075 (2013.01); C03C 23/0085 (2013.01); G01N 21/9027 (2013.01); G01N 23/2251 (2013.01); G01N 33/386 (2013.01); C11D 2111/18 (2024.01); G01N 2223/652 (2013.01)] 6 Claims
OG exemplary drawing
 
1. A method of screening a glass container for storing a pharmaceutical formulation for susceptibility to lamellar silica formation when filled with the pharmaceutical formulation, comprising:
filling a washed and depyrogenized glass container with a buffer for the pharmaceutical formulation, wherein the glass container comprises ions selected from the group comprising sodium, calcium, hydroxide, silicate, and combinations thereof;
storing the filled glass container at a temperature of 40° C. for at least 14 days;
optically analyzing the buffer after storage for formation of one or more particles in the buffer;
when particle formation is observed, isolating the one or more particles from the buffer for structural and elemental analysis;
analyzing the isolated one or more particles using one or more of optical microscopy, scanning electron microscopy/energy dispersive X-ray spectroscopy (SEM/EDS), Fourier-transform infrared spectroscopy (FTIR), x-ray photoelectron spectroscopy (XPS), differential interference contrast microscopy (DIC), microflow imaging (MFI), and combinations thereof to determine a morphology of the particles and chemical composition; and
analyzing an interior surface of the glass container, once emptied and after isolating the one or more particles, for delamination-type deformation of the interior surface, wherein the presence of particles having a chemical composition comprising silicon, oxygen, and carbon, and an absence of the delamination-type deformation of the interior surface of the glass container indicates the susceptibility to lamellar silica formation.