RA802 pharmaceutical analyser www.renishaw.com/raman

Solving problems in the pharmaceutical industry with Raman imaging Understanding how a formulation’s properties determine its performance continues to be a key challenge for the pharmaceutical industry. There are many examples of drugs which were thought to be the next ‘magic bullet’ but never made it to market because of the difficulties they posed to formulators. In the last few decades this problem has become more pronounced with the rise of computational chemistry as a method of drug design. This has resulted in the emergence of drugs with increasingly large, complex combinations of active...

apply innovation™ What is Raman spectroscopy and how can it be applied? Raman spectroscopy is an information-rich analytical technique. Each molecule has a unique Raman spectrum that is highly specific; it is sometimes referred to as a ‘molecular fingerprint’. So unique is each ‘fingerprint’, Raman spectroscopy is able to easily differentiate between species which are chemically very similar, including polymorphs, amorphous forms, salt forms and hydrates. The RA802 pharmaceutical analyser uses Raman imaging to generate high-definition images of pharmaceutical materials. By collecting Raman spectra...

The RA802 pharmaceutical analyser The RA802 pharmaceutical analyser is the only dedicated high-speed Raman imaging system designed for pharmaceutical analysis. It can generate a comprehensive Raman image of the sample surface in as little as 5 minutes using Renishaw’s unique LiveTrack™ and StreamLine™ technologies. You can collect high specificity chemical information from micro-regions and generate large chemical images of the sample surface When generating Raman images, chemical components can be segregated using false colours and characterised using particle statistics. This gives users a...

Raman image of the outer surface of counterfeit and authentic tablets revealing differences in constituents. Raman image of an analgesic tablet split in half showing caffeine (red) and aspirin (yellow). Raman image of an allergy relief spray showing the distribution of API (cyan) and micro crystalline cellulose (red). Raman image of powder mixture showing form III (blue) and form V (green) API. Raman image of a tablet showing the distribution of API (cyan).

Case study: analysing drug efficacy It is important that dissolution profiles between batches are equivalent to maintain therapeutic consistency. If the dissolution profiles are different then this can have a marked effect on the bioavailability. Examples of two different blood serum concentration profiles are shown below. Example blood serum concentration of different in-spec and out-of-spec batches Therapeutic window Blood serum concentration (µg/ml) In-spec batch Time (hours) An example of how different dissolution profiles can influence drug efficacy. One of the factors that can cause differences...

apply innovation™ Particle statistics for the API granules Particle statistics (average of 5 tablets) It is possible to infer the following outcomes in batches with aggregated granules, where the API is less uniformly dispersed throughout the tablet: 1. The aggregation would attenuate the dissolution of API as it passed through the gastrointestinal tract and thus, less drug would be available for absorption into the systemic circulation. 2. This would lead to not only a delayed and lower maximum concentration but also a shorter duration of action and a weaker therapeutic effect. The RA802 pharmaceutical...

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