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In fact, it has been observed that around 40% of the pharmaceutical products approved by regulatory organizations exhibit poor bioavailability / solubility. Further, every year, poor bioavailability is one of the prime reasons that leads to failure in obtaining approval authorization. Nanoparticles ContractManufacturing.
Therefore, a variety of excipients, which are pharmacologically inert substances themselves, are used to stabilize biologics during the manufacturing process and storage. Additionally, biopharmaceutical excipients act as bulking agents, antioxidants or preservatives.
For over a decade, the company and its team have been leaders in the design, testing and manufacture of thin film drug formulations, particularly transdermal patches and sub-lingual (oral) strips for the delivery of active pharmaceutical ingredients (“API”) for the treatment of pain and neurological conditions.
GlobalData’s Contract Small Molecule API Manufacturing Industry by the Numbers (2021) analyzed 2,787 small molecule API contractmanufacturing facilities. Of those, only 935 (34%) small molecule API facilities offered some type of containment capabilities.
The ingredients used in these drugs are high potency, even at small doses, and pose a risk to both human health and cross-contamination with other drugs in a manufacturing environment. The team required narrow nanoparticle size distribution with a short processing time and a stable low temperature milling profile.
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