The effect of scratched glass on dissolution rate of drug products

This article is about the effect of scratched glass on dissolution rate of drug products. Glass is widely used material in all sorts of laboratories, including pharmaceuticals. It is durable, chemically resistant, transparent, and relatively cheap compared to other chemically inert materials. But as all chemists know, the main ingredient the glass is made of, silica, is also an excellent sorbent. Ground, micronized, colloidal silica exhibits excellent sorbing properties, which are widely used to separate and purify various organic substances, including active pharmaceutical ingredients. Therefore, depending on the actual dose of pharmaceutical, the polarity of the active substance, and the actual amount of scratches, dissolution results may be significantly affected by the latter, leading to out-of-spec results, expensive investigations, and, on some occasions, product recall or utlization.

Usually, the lower the drug dose, the higher the sorbion effect, as scratches, from a physical point of view, are active microsites exhibiting, in some circumstances, strong affinity to analyzed APIs.

In our laboratory, we can quickly assess the impact of dissolution pot scratches on dissolution rate/profile at a competitive price starting from 2500 euros per full investigation. Bearing in mind the cost of pots is approximately 250 Euro per each unit (1500 Euro per 6 pots set) and the fact that once scratches are made, they are irreversible, an outsourced investigation carried out by experienced specialists is no doubt a financially justified option compared to on-site testing.