As an analytical testing laboratory, we could not survive without some of our bread-and-butter instruments, including gas chromatography (GC) and high performance liquid chromatography (HPLC). However, other instrumentation has quickly become pivotal to the growth of Avomeen. Keep reading to find out which instruments made our “Top 5” list.
5) Dissolution Apparatus
The purpose of our fifth favorite instrument, the dissolution apparatus, is similar to that of the diffusion chamber. Both instruments allow the rate of API transferred out of the drug to be measured. However, there are two notable differences. The first is that in the case of the dissolution apparatus, we are measuring the rate of the API becoming dissolved in a biological media, typically simulated gastric or intestinal fluid. The second is that the dissolution apparatus is used for tablets, not topicals. In short, a tablet is dropped into a vessel containing a buffered solution and is stirred at a rate mimicking the agitation found in the intended site of delivery. After various time points, aliquots of the solution are taken and analyzed via HPLC to determine how quickly the API is dissolving into the media. Our lab currently houses 3 diffusion apparatuses: two Distek Evolution 6100s and one Vankel VK 7000.
The quadrupole time-of-flight, or QTOF, mass spectrometer is our fourth pick and our go-to for analyzing samples needing high resolution. These samples tend to be proteins, large organic molecules, or mixtures containing numerous unknown components. When a project calls for QTOF-MS, our scientists use a Xevo G2-S QTOF combined with a Waters Acquity UPLC.
3) Diffusion Chamber
When developing a drug product, it is necessary to measure the rate at which the active pharmaceutical ingredient (API) is transferred from the drug to its intended biological site. In the case of topical formulations, an instrument containing a layer of artificial biological membrane is used. A predetermined quantity of the drug product is added to the membrane and samples are collected from the other side at various time points, and samples are then quantified on an HPLC. A Perme Gear Franz diffusion chamber rounds out our top three and is our instrument of choice for such analyses.
2) Tablet Press
Our Clinical Trials Manufacturing (CTM) capabilities rely heavily on tablet presses, our second favorite instrument. Our longstanding workhorse has been the B3B Manesty Rotary Press, but a recently acquired Versa Press Rotary Press has allowed for an increased output in production.
1) Inductively Coupled Plasma – Mass Spectroscopy (ICP-MS)
ICP-MS is our number one pick and our go-to instrument for analyzing elemental impurities. Various metals are ionized via a plasma source and are then separated based on their mass. Our elemental analysis team uses an Agilent 7500ce series as well as a recently acquired Agilent 7800.