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 preventing the formation of lamellar silica formation in a borosilicate glass container storing a pharmaceutical formulation in an interior of the glass container in accordance with embodiments of the disclosure can include washing the container and drying the container under extended dry conditions of at least 3000 ms.
Claims28
A method for preventing lamellar silica formation in a borosilicate glass container storing a pharmaceutical formulation in an interior of the glass container, comprising:
- prior to filling the glass container with the pharmaceutical formulation, washing the interior of the glass container with a pressurized water jet;
- and
- drying the glass container by blowing compressed air into the interior of the glass container for at least 3000 ms wherein the glass container is washed and dried using a batch washer.
A method for preventing lamellar silica formation in a borosilicate glass container storing a pharmaceutical formulation in an interior of the glass container, comprising:
- prior to filling the glass container with the pharmaceutical formulation, washing the glass container with a pressurized water jet under conditions sufficient to remove contaminants,
- drying the washed glass container;
- and
- depyrogenizing the glass container by heating the dried glass container in an oven at a temperature of at least about 250° C., wherein the glass container remains stationary in the oven during heating.
A method of preventing lamellar silica formation in a borosilicate glass container containing a pharmaceutical formulation in an interior of the glass container, comprising:
- prior to filling the glass container with the pharmaceutical formulation, washing the glass container with a pressurized water jet under conditions sufficient to remove contaminants,
- drying the washed glass container by blowing compressed air into the interior of the glass container for at least 3000 ms,
- placing the dried glass container in a heat-safe container and covering the heat-safe container containing the dried glass container with a lid;
- depyrogenizing the dried glass container contained in the covered heat-safe container.
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A method of screening a glass container storing a pharmaceutical formulation for susceptibility to lamellar silica formation when filled with a 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 containers 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 the absence of delamination-type deformation of the interior surface of the glass container indicates susceptible to lamellar silica formation.
Dependencies are inferred from the claim text.