Millions of people are currently physically affected by the coronavirus (Covid-19), and the run for effective treatments and vaccines is in full swing. More than 350 drugs are under development to be administered to patients by injection. More than two-thirds of these are complex, large molecule drugs, which have significant quality requirements for their primary packaging.
Glass is the prevailing primary packaging material of the pharmaceutical industry. The inherent robustness and inertness of glass, combined with the available scientific data to back it up, have rendered it the predominant material to store drug products in.
While there are multiple types of glass containers used to fill drugs for injection in, such as pre-fillable syringes, vials and cartridges, vials are still the predominant packaging type. Especially in times of considerably increased demand, vials offer the option to switch from a 2ml vial filled with one dose to 5ml, 10ml or even 20ml vials, filled with multiple doses, thereby reducing the overall quantity of vials required.
Drug efficacy and, ultimately, patient safety is paramount, especially when drug development cycles are under strain and ‘fast time to market’ is of even more essence than usual. High-quality primary containers that offer a high degree of drug container compatibility need to be selected.
VIALEX™ – Improved inner surface durability of vial for better drug container compatibility
A standard vial converting process alters the inner glass surface during parting and bottom forming. Glass components vaporise and condense in the heel, causing the formation of highly soluble sodium borate deposits on one side and a weakened inner surface on the other side.
Nipro PharmaPackaging is offering the VIALEX™ technology, which mitigates those effects from the converting process on the inner glass surface of vials twofold. Firstly, it reduces sodium concentration, and secondly, it improves the inner glass surface. The technology offers multiple advantages when compared to other technologies on the market.
The advantages of VIALEX – Re-confirmed by a new long-term study
SEM – 24 weeks @ 40oC – 51exp
Vials processed with the VIALEX technology show enhanced chemical durability (fewer interactions) versus various buffers when examined via a scanning electron microscope (SEM), compared to industry-standard vials.
Phosphate: 24 weeks @ 40°C – 51exp
High Purity Water: 24 weeks @ 40°C – 51exp
Citrate: 24 weeks @ 40°C – 51exp
Sodium chloride (NaCl) with term sterilisation (TS): 24 weeks @ 40°C – 51exp
Vials processed with the VIALEX technology and filled with various buffers show fewer extractables when compared to industry standard vials.
VIALEX-processed vials will give you an additional increase in drug container compatibility and provide you with valuable drug products in a fast and efficient way.