In the course of the last months we, at Prolytic, have successfully carried out various interesting research projects. Here you will find a short overview of these recent research activities:
Topical application
The amount of drug administered can often be significantly reduced through topical application. This then results in the drug being present in plasma in extremely low concentrations. This calls on highly sensitive analytical methods to be used in order to determine these low concentrations of substance in plasma. Having optimized an HPLC-MS/MS method, Prolytic was able to analyse the active component of a registered pharmaceutical with a limit of detection of 2 pg/mL. Altogether, drug profiles of 30 subjects were generated.
Antibodies
Patient’s bodies often react by developing antibodies following the administration of larger molecules or peptides. This is frequently followed by the development of allergic reactions. At Prolytic, different test systems were set up in order to investigate reasons for these allergic side effects.
Protein binding
Most drugs tend to bind to plasma proteins present in patient’s blood. Only the unbound part of a drug substance is effective. It is therefore necessary to determine the protein binding when developing a new pharmaceutical. There are various methods for protein binding determination. Most of these are based on the separation of the bound and unbound fractions by membranes. Unfortunately, in many cases, a substantial amount of the drug substance binds to the membrane thus making determination of protein binding impossible. Here at Prolytic, we have developed a barrier-free system by using Sephadex, a polar substance suitable for the determination of protein binding (especially of non-polar substances).
Inhalation
Many different types of inhalers are used all over the world. An essential requirement for the use of inhalers is their ability to provide constant drug release. Together with a manufacturer of ultrasound inhalers, Prolytic has been investigating and checking the validity of inhalers by measuring the concentrations of nebulized drug substance.
Determination of hormones
Another very important investigation is that of hormones present in blood samples. Here, once again, there is the difficulty of having to measure very small quantities of these hormones. In fact, the determination of hormone concentration in plasma is mostly only possible with the help of immunological test systems. However, these systems frequently show cross-reactions with similar compounds thus allowing only limited specific measurements to be made. Meanwhile, specific measurements by HPLC-MS/MS have become possible through derivation of different hormones. At Prolytic, several hormones could be detected at extremely low concentrations, even ranging down to a few pikogram / mL plasma.
Recently, there has been a huge debate in science about Bisphenol A (BPA). This substance can be found in several daily used items like CDs, micro wave dishes, baby bottles but also dental inlays. Now it is the question, how dangerous this substance is. Does it already have mutagenic or carcinogenic effects in very low doses as it is proven with high doses? This question will be focused on in future studies and can not be answered so far. Nevertheless, Prolytic already now offers you to test your products ow much Bisphenol A your products are containing or exhibiting. This will give you the possibility to demonstrate the innocuousness of your products. For these investigations we use highly sensitive HPLC-MS/MS systems, which can determine smallest amounts depending on the sample down to 10 pg. In conclusion, you will be able to prove to your customers, that Bisphenol A is not contained or at least not exhibited from your products.
We offer our services to manufactures of plastics or articles containing plastics, who would like to have the evidence of innocuousness of their products. If you have questions or need a quotation, please contact us.
