Method of preventing lamellar silica formation in glass container
AssigneeAmgen Inc.
InventorsYasser Nashed-Samuel, Jeremy Gastwirt
Life of this patent
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Abstract
Methods of screening a glass container for storing a pharmaceutical formulation for susceptibility to lamellar silica formation includes filling the container with a buffer for the pharmaceutical formulation, storing the container with the buffer and optically analyzing the buffer after storage for one or more particles in the buffer. The one or more particles can be analyzed to determine a morphology and chemical composition and the interior surface of the container, once emptied, can be analyzed for delamination type deformation. The presence of particles in the buffer having a chemical comprising silicon, oxygen, and carbon and the absence of delamination type deformation is indicative of susceptibility to lamellar silica formation.
Claims6
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.
Dependencies are inferred from the claim text.