Tag: pharmaceutical

Zinc detected in clogged syringes

Zinc detected in clogged syringes

Employees of the technology transfer centre ANAXAM and researchers from the Paul Scherrer Institute PSI used the unique analytical methods available at PSI to look inside pre-filled syringes. They found that, in rare cases, zinc from the needle shield can leach into the drug solution to be injected and possibly contribute to syringe clogging.

The task which the employees of the technology transfer centre ANAXAM set themselves, together with colleagues at the Paul Scherrer Institute PSI, can be likened to looking for a needle in a haystack. They were asked by the pharmaceutical company MSD (a trade name of Merck & Co., Inc., Rahway, N.J., USA) to find out whether tiny amounts of the element zinc can get inside the needles of pre-filled syringes and, if so, where it lodges in the needles.

The background is the observation that, in rare cases, the needles of pre-filled syringes (PFS) can become blocked, for example if the syringes are not stored in a cool enough environment. This phenomenon has been known for some time and has already been studied by ANAXAM. However, what has remained unclear is exactly what triggers the blockage. One suggestion was that zinc from the needle shield – the rubber cap into which the needle is inserted when the syringe is manufactured – could leach into the drug solution to be injected, making it more viscous, which would ultimately lead to blockages. 

To investigate this theory, the team led by ANAXAM has now resorted to sophisticated methods of detection. These allowed them to look inside the blocked hypodermic needles and check whether and where zinc was present. The results have now been published in the journal Pharmaceutical Research. 

Convenient pre-filled syringes

Pre-filled syringes are widely available, practical and easy to use, both for healthcare professionals and for patients. The amount of solution to be injected is precisely measured, which virtually rules out dosing errors, for example. The fact that their needles can become clogged, especially when the solution to be injected is highly concentrated, is a well-known issue in the pharmaceutical industry and has also been raised during licensing applications. There have also been cases of clogged needles which have led to products being recalled. “So Merck was very interested in knowing whether zinc could in fact find its way into the needles and cause the blockage,” says Vlad Novak, project manager at ANAXAM. 

This meant that several questions had to be answered. Is there zinc inside the needle? And if so, where do they come from? What does the inside of a clogged needle look like? And is the zinc also present in the solution being injected, which could ultimately lead to the blockage?

Read more on the PSI website

Image: Employees of the technology transfer centre ANAXAM and researchers at the Paul Scherrer Institute PSI used the unique analytical methods available at PSI’s large research facilities to look inside pre-filled syringes.

Credit: © Adobe Stock

Key role of nickel ions in the Simons process discovered

Key role of nickel ions in the Simons process discovered

Researchers at the Federal Institute for Materials Research and Testing (BAM) and Freie Universität Berlin have discovered the exact mechanism of the Simons process for the first time. The interdisciplinary research team used the BESSY II light source at the Helmholtz Zentrum Berlin for this study.

The Simons process is of great importance for the production of fluoroorganic compounds and is used in the pharmaceutical, agrochemical, plastics production and electronics industries, among others. The process is named after its inventor, the American chemist Joseph H. Simons, and utilises an electrochemical process to synthesise fluoroorganic compounds. By passing a current through an electrolyte solution containing hydrogen fluoride at an anode and a cathode, fluorine-containing ions are formed which react with other ions or molecules in the solution to form the desired fluorine-containing compounds.

Although this process has been used for over 70 years, the exact mechanism of the Simons process has so far remained a mystery. All that was known was that a black film forms on the nickel anode during the electrolysis process. In order to be able to analyse this film more precisely, the interdisciplinary research team used the synchrotron source BESSY II at the Helmholtz-Zentrum Berlin for the first time. With the help of a specially developed measuring cell, it was possible to carry out in-situ measurements on the anode, which even allowed individual atoms to be observed during electrofluorination. The investigations revealed that centres of highly valent nickel ions are formed in the black layer during the Simons process, which are crucial for the success of electrofluorination.

Read more on the HZB website

Image: Accumulations of nickel ions form a dark film on an anode.

Credit: © BAM

Combination of techniques for effective pharmaceutical formulation

Combination of techniques for effective pharmaceutical formulation

The environment in your gastrointestinal tract affects the properties and effectiveness of medicines. Researchers have used MAX IV to investigate a technique for studying these changes. They found that the structural properties of the anti-inflammatory drug Indomethacin changed in the presence of common biomolecules.

The fluid in your gastrointestinal tract is a complex soup of biomolecules. When you take a pharmaceutical drug, the biomolecules may stick to its surface and alter how it’s dissolved and taken up by the body at a certain pH. Such effects need to be understood and taken into account when producing pharmaceuticals. But it’s not always easy to investigate. In the present paper, the authors tested the accessible technique of Low-Frequency Raman spectroscopy, in which inelastic scattered light is used to analyse the sample. They then controlled the accuracy using X-ray methods.

Read more on MAX IV website