Surface area and porosity are important physical characteristics that determine the quality as well as the utility of pharmaceutical materials. The most popular method when it comes to characterising raw materials is specific surface area analysis. This type of measurement is fundamental in the field of particle characterisation, having numerous other applications. Even though there are other technologies that can be used to evaluate the specific surface area and pore size distribution of pharmaceutical materials like mould or powder, such as gas absorption analysis or BET (Brunauer, Emmett and Telle) technique, this physical characterization method is the preferred choice.
The Medicines and Healthcare products Regulatory Agency and international regulatory communities expect medicinal dosage form developers to put in place a thorough, science-based knowledge of their products and processes. Consequently, it is necessary to determine the exact excipients for a formulation and solve problems related to product performance, such as dissolution. A major concern when it comes to the variability of the surface area measurement is the rate at which the API goes into the solution. The range of the material can change as the result of particle size reduction. When salt selection is combined with active pharmaceutical ingredients, which are mostly crystalline, but also amorphous, the solubility of the product is affected. Usually, pharmaceutical materials with a higher surface area will go into the solution faster. knowledge of the extent of the product, safety issues can occur and the pharmaceutical product is inevitably rejected.
It is not thus surprising that pharmaceutical separation science relies mostly on specific surface area analysis. This instrument is able to fully characterise medicinal materials, in other words it provides crucial and useful information. Surface area management can and should be implemented as a quality control tool. More and more material suppliers and manufacturers are using measurements of absorbency and specific surface area as the main way of preventing mistakes or defects. Despite the fact that this method used for surface area and porosity measurements is an essential part, it only represents part of the puzzle. Other measurements, like laser diffraction particle size, can prove to be useful as well. Those who what to enjoy successful drug production and process development should get in touch with escubed limited, a company specialised in material characterisation.
Specific surface area analysis provides a good understanding of physical properties, like a measure of the total extent or porosity of medicinal raw materials and the effectiveness of their use. Most importantly, this process reveals possible problems such as failing disintegration time or content homogeneity. These are root causes of some of the most common issues. A key aspect of material characterisation is sample preparation. The way the sample is prepared for a specific test influences test results, but professionals know this all too well and are vigilant in testing implementation. To sum up, scientific evaluation can provide useful details early in the development process, which is the reason why companies should include this instrument in their way of preventing mistakes or defects. This is not an option, but rather a necessity.Read More