There Is Still Room for Improvement: Presentation of a Neutral Borosilicate Glass with Improved Chemical Stability for Parenteral Packaging

PDA J Pharm Sci Technol. 2016 Jul-Aug;70(4):346-52. doi: 10.5731/pdajpst.2015.005934. Epub 2016 Apr 18.

Abstract

For pharmaceutical parenteral packaging the glass compositions have always been either Type I borosilicate or Type III soda-lime glass. As both the compositions and certain chemical and physical properties are mandated by international standards, there has not been room for any changes. However, by applying only minor adjustments, a borosilicate glass was developed that showed improved chemical stability. The chemical composition is still in the range of currently used borosilicate glasses, which makes it a Type I glass according to all current pharmacopeia. A study was performed on glass vials comparing the new glass with the standard FIOLAX(®) and two other publicly available glasses. In an extraction study with water at 121 °C the new glass showed the highest chemical stability with the lowest amount of extractables. In an accelerated ageing study, which was done with water, phosphate, and carbonate buffer at 40 °C for 12 months, the new glass also proved to have the lowest amount of leachables. In this article the new glass and the results from the studies are presented, showing the reader how much of an effect can be attained with only minor adjustments if the scientific fundamentals are clear.

Lay abstract: The pharmaceutical market has been quite constant and risk-oriented due to the high impact on the safety of the patient. As any change necessitates a complicated change process, this has, in consequence, lead the industry to resist changing the parenteral primary packaging material for decades. The main glasses have either been Type I borosilicate or Type III soda-lime glass. On the other hand, a combination of improved inspection systems and the development of more sensitive biologically based drugs has elevated the standards for parental packaging materials. For example, the measurement of extractables and leachables from the packaging material steadily came into focus. In this article, a new glass is presented that still belongs to the group of Type I borosilicate glasses according to all pharmacopeia. However, with some minor adjustments in the chemical composition it was possible to increase the chemical stability measurably. To prove this several studies were performed, of which the extraction study with water at 121 °C and the accelerated ageing study with water, phosphate, and carbonate buffer at 40 °C for 12 months are presented here.

Keywords: Accelerated ageing study; Borosilicate glass; Carbonate buffer; Chemical stability; Extractables and leachables; Glass; Phosphate buffer; Primary packaging.

MeSH terms

  • Drug Packaging / instrumentation
  • Drug Packaging / methods*
  • Drug Packaging / standards
  • Drug Stability
  • Glass* / standards
  • Humans
  • Parenteral Nutrition Solutions* / standards
  • Silicates* / standards

Substances

  • Parenteral Nutrition Solutions
  • Silicates