Pharmaceuticals require high standards in quality and safety, being its active principle ingredient specifications one of the most relevant parameters to control during industrial manufacturing processes. For a wide range of API from medicinal herbs and other natural sources, as valerian extracts, Supercritical CO2 Extraction ensures high efficiency and extraction rates, helping to control dose and excipicients required.
Dose flexibility can be defined as the ability to easily and accurately deliver dosing according to a patient’s individual needs. It is a growing need for all segments of the population, especially the geriatric and pediatric populations. Moreover, it is a crucial property for controlled-release (CR) medications, which offer many clinical and convenience advantages for patients as compared to immediate-release (IR) formulations, to ensure its suitability for splitting.
To ensure the dose flexibility required in theses products, novel tablet technologies are available which may address this problem (ACCU-TTM (tri-layer) tablets), but considering the manufacturing processes, why not consider more efficient extraction processes to achieve tighter specifications?.
Many natural active ingredients with pharmaceutical applications are extracted with organic solvents, far from the “green chemistry” concept and with a lack of uniformity in active ingredients concentration. In fact, in some particular cases, this variable concentration in active ingredients with the presence of strong and undesirable off-flavours force to formulate the product with lots of excipients (to mask theses flavours) which ultimately means big size of final formats.
Nowadays industrial extraction processes operate under controlled operating conditions to ensure good manufacturing practices and facilitate the operations of handling large volumes of raw materials and solvents. These high operational demands often require focusing all efforts on these issues, obviating strategies to improve process efficiency.
But at least, traditional solvents are no longer the only option: Supercritical CO2 extraction is a competitive, sustainable and innovative solution for a wide range of API from medicinal herbs and other natural sources. Its advantages include high efficiency (up to 95% in some cases), high extraction rates and more selectivity. And for example, CO2 extraction technology produces a Valerian supercritical CO2 extract with more than ten times the Pharmacopoeia specification as a solution to current oversize of valerian pills.
If this is your case, do not hesitate to contact us at High Extraction Technology – Altex, S.A, where all Supercritical CO2 and Subcritcal CO2 interests will be assisted