GERMANY – BASF has developed a packaging system for pharmaceutical polyvinylpyrrolidone (PVP) that the company claims sets will new quality standards.
The new packaging system, PeroXeal, offers better protection for the pharmaceutical excipient Kollidon against contact with oxygen and subsequent oxidation. PeroXeal makes it possible to significantly reduce the peroxide level of Kollidon, making the excipient suitable for use in oxygen-sensitive formulations as well. Under the trade name Kollidon, PVP is used in tablets as a binder and as disintegrant.
"With PeroXeal, BASF is setting new standards for excipients in terms of formula stability and purity and can thus help its customers in the pharmaceuticals industry achieve higher levels of patient safety," says Dr. Boris Jenniches, head of Global Business Management PVP at BASF.
"With our new packaging concept we can significantly reduce peroxide values to a level comparable with that of naturally-based raw materials. This makes Kollidon a viable alternative to naturally-based raw materials".
Generally, Kollidon as synthetic polymer shows less variability in processing compared to its natural counterparts. Moreover, by using PeroXeal, the shelf life of the excipient is extended and by-products in the formulation are reduced.
The multi-layered and heat-sealed plastic film of the PeroXeal packaging system, used as inner packaging material, is completely aluminum-free and thus more environmentally friendly.
In addition, because the transparency of the PeroXeal film makes the NIR (Near-Infrared Spectroscopy) test possible, packaging can remain sealed until the product is used, keeping the excipient Kollidon stable.
According to the global chemicals company PeroXeal does not mean any additional cost for the customer. The new packaging concept has already been introduced for the most important Kollidon products at the Ludwigshafen and Minden sites and BASF will offer all grades of the Kollidon line starting 2013 with its new technology.
PVP was developed over than 70 years ago by BASF chemist Walter Reppe in Ludwigshafen. Using acetylene and pyrrolidone, he was able to produce a new monomer, vinylpyrrolidone, which itself can be turned into the polymer polyvinylpyrrolidone.
PVP is water soluble, but is also capable of absorbing large quantities of water; it is not a skin irritant, poses no health risks, is temperature resistant, pH-stable, non-ionic and colorless. Its widely varied properties make PVP ideal for a broad spectrum of applications.
As a binder, PVP holds together the individual active ingredients in the tablet to form a homogenous whole, while as disintegrant it ensures that tablets dissolve in liquids and quickly release their active ingredients. The polyvinylpyrrolidones BASF manufactures are used for the most part in the pharmaceuticals sector.