Boltres Bettine, Tratzky Stephan, Kass Christof, Eichholz Rainer, Naß Peter
Schott AG Mitterteich, Mitterteich, Germany
Schott AG Mitterteich, Mitterteich, Germany.
PDA J Pharm Sci Technol. 2016 Jul-Aug;70(4):346-52. doi: 10.5731/pdajpst.2015.005934. Epub 2016 Apr 18.
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.
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.
对于药物注射用包装，玻璃成分一直要么是I型硼硅酸盐玻璃，要么是III型钠钙玻璃。由于成分以及某些化学和物理性质均由国际标准规定，所以没有任何改变的空间。然而，仅通过进行微小调整，就研发出了一种化学稳定性有所提高的硼硅酸盐玻璃。其化学成分仍在当前使用的硼硅酸盐玻璃范围内，根据所有现行药典，它仍属于I型玻璃。对玻璃小瓶进行了一项研究，将这种新型玻璃与标准的FIOLAX(®)以及另外两种市面上可得的玻璃进行比较。在121°C的水提取研究中，新型玻璃显示出最高的化学稳定性，可提取物的量最低。在一项加速老化研究中，该研究在40°C下用水、磷酸盐和碳酸盐缓冲液进行了12个月，新型玻璃也被证明可浸出物的量最低。本文介绍了这种新型玻璃及其研究结果，向读者展示了如果科学基础明确，仅通过微小调整就能取得多大的效果。
由于对患者安全影响重大，药品市场一直相当稳定且以风险为导向。由于任何改变都需要一个复杂的变更过程，因此这导致该行业几十年来一直抵制改变注射用的主要包装材料。主要的玻璃材料一直要么是I型硼硅酸盐玻璃，要么是III型钠钙玻璃。另一方面，改进的检测系统与更敏感的生物基药物的开发相结合，提高了注射用包装材料的标准。例如，包装材料中可提取物和可浸出物的测量逐渐成为焦点。本文介绍了一种新型玻璃，根据所有药典，它仍属于I型硼硅酸盐玻璃类别。然而，通过对化学成分进行一些微小调整，有可能显著提高化学稳定性。为了证明这一点，进行了多项研究，本文展示了在121°C下用水的提取研究以及在40°C下用水、磷酸盐和碳酸盐缓冲液进行12个月的加速老化研究。
