As the coronavirus disease (COVID-19) continues to physically affect millions of people and counting, the run for effective treatments and vaccines is in full swing. More than 350 drugs are under development, destined to be administered to patients by injection. More than two thirds of these drugs for injection are large, complex molecule drugs that demand significant quality requirements of their primary packaging.
While there are multiple types of glass containers used to fill drugs for injection (e.g. pre-fillable syringes, vials, cartridges), vials stay the predominant packaging type. Especially in times of considerably increased demand, vials offer the option to switch from a 2 ml vial filled with one dose to 5, 10, or even 20 ml vials, filled with multiple doses, thereby reducing the overall quantity of vials to be manufactured.
Drug efficacy and ultimately patient safety are paramount, particularly when drug development cycles are under strain and “time to market” is of even greater essence than usual. The choice of primary containers with premium quality is intrinsic to ensuring the highest possible degree of drug container compatibility.
VIALEX™ - Long-term study reconfirms improved inner surface durability
A standard vial converting process alters the inner glass surface during parting and bottom forming. Glass components vaporize and condense in the heel, causing the formation of highly soluble sodium borate deposits and a weakened inner surface. Each of these effects may potentially lead to the unwanted increase of extractables, a shift in pH, and delamination incidents, thereby putting drug efficacy and patient safety at risk.
Nipro PharmaPackaging offers the VIALEX™ technology which mitigates both effects from the converting process on the inner glass surface of vials:
- Reduces the sodium concentration
- Improves the inner glass surface
Vials processed with the VIALEX™ technology, then filled and tested with various buffers, show less extractables and an enhanced chemical durability (less interactions) compared to industry-standard vials. Since the VIALEX™ technology does not include any additional materials (e.g. no coating, no difference in glass composition), it enables a fast and efficient time to market.
Benefits of VIALEX™ technology
Results of the long-term study were presented during the 2020 PDA - Parenteral Packaging.