Small glass bottle having increased chemical resistance

Abstract

The invention relates to a small glass bottle with increased chemical resistance made of a boron-containing multi-component glass, comprising a fluid pharmaceutical active agent preparation and a closure. The small glass bottle has a total volume < 4.5 ml, and the filling level of the small glass bottle with the pharmaceutical active agent preparation is max. 0.25. According to one variant, when measured at a measuring site below the plane of the container centre, based on a concentration depth profile at a depth in the region of 10 to 30 nm, the concentration of the boron-ions has a value averaged over the measurement values of the concentration depth profile, which has an increase of max. 30% in relation to the concentration of boron-ions, when measured based on a concentration depth profile at a depth in the region of 10 to 30 nm with a measuring site in the plane of the container centre. According to another variant of the invention, the glass at the base has a composition on the internal wall with a higher SiO2 proportion than on the side wall and on the transition thereof into the base

Description

technical field [0001] In general, the present invention relates to glass vials for storing active pharmaceutical ingredients. In particular, the present invention relates to glass vials that can also be used to store small amounts of active pharmaceutical ingredients, wherein the potency of the active pharmaceutical ingredient changes only little, if at all, during storage in the glass vial. Background technique [0002] Some active pharmaceutical ingredients, such as therapeutic proteins, as well as active ingredients produced through biotechnology, such as monoclonal antibodies and vaccines, are often administered in very small doses. The corresponding fill volumes here are generally significantly smaller than the nominal volumes of the smallest commercially available primary packaging media made of neutral glass. [0003] Nominal volume is understood here to mean the product volume, eg the volume of the active pharmaceutical ingredient preparation which should be presen...

AI Technical Summary

Problems solved by technology

However, ammonium sulfate treatment does not prevent migration of non-alkaline metal components and diffusion of glass components to the glass surface and subsequent migration into the contents during storage

Another disadvantage of the ammonium sulphate treatment is damage to the glass surface due to the high temperatures involved in the process and the associated reduction in chemical stability

However, in addition to the high production costs, it is also disadvantageous that the quartz glass coating has a limited stability of pH values ​​in the alkaline range

The above problem is exacerbated when the glass vial is underfilled due to the increased ratio of wetted surface area to filled volume

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