Small glass bottle having increased chemical resistance

A technology for glass and active pharmaceutical ingredients, used in glass blowing, glass molding, glass manufacturing equipment, etc., can solve the problems of reduced chemical stability, high production costs, and limited stability of quartz glass coatings

Pending Publication Date: 2020-10-30
肖特制药股份有限两合公司 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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...

Method used

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  • Small glass bottle having increased chemical resistance
  • Small glass bottle having increased chemical resistance
  • Small glass bottle having increased chemical resistance

Examples

Experimental program
Comparison scheme
Effect test

Embodiment Construction

[0145] figure 1A schematic cross-section of a glass vial 1 filled with a liquid 4 is shown. The glass vial 1 comprises a base 3 and walls 20 , 21 , which merge in the upper region of the glass vial 1 into a neck region 10 and end in a rim 11 . The walls form an outer wall 20 and an inner wall 20 , and only the inner wall 20 is in contact with the liquid 4 . The middle plane 12 of the container is defined by the bottom surface 13 of the base.

[0146] The rim volume of the glass vial 1 is less than 4.5 ml, which rim volume is understood to mean the entire inner volume of the glass vial up to the upper edge 11 . The actual filling volume 9 is determined by the volume of the liquid 4 . According to the invention, the fill volume 9 is at least four times smaller than the edge volume 11 . Thus, the fill level of the glass vial 1 (quotient of fill volume 9 and rim volume 11 ) is less than 0.25.

[0147] Due to the low filling level, the liquid mainly covers the inner wall 7 and...

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PUM

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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...

Claims

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Application Information

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IPC IPC(8): C03C4/20A61J1/06A61J1/14C03C23/00
CPCA61J1/065A61J1/1468C03C4/20C03C23/00C03C23/0075C03C3/091C03B9/335C03C3/089
Inventor R·弗罗斯特U·罗特哈尔F·布斯克B·赫拉迪克
Owner 肖特制药股份有限两合公司
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