Merck Millipore, the life-science division of Merck, has developed a new solubility/bioavailability enhancement excipient, Parteck SLC, which has a unique pore structure that enables higher loading of amorphous APIs, thereby, improving dissolution rates and increasing drug solubility.
Parteck SLC’s mesopores (2–7 nm) create a surface area of up to 1000 m2/g for depositing an API in its amorphous form needed for supersaturation. The internal surface area of Parteck SLC is also easily accessible and the API is kept stable. A user-friendly particle size (5–25 μm) and bulk density (0.32 g/ml) allow easy loading, tableting, or capsule creation.
Parteck SLC is not a novel excipient. Regulatory requirements, therefore, remain the same as it conforms to the silica monographs of Ph Eur and USP. Parteck SLC comes with ready-to-use documentation in CTD-format. Feasibility studies on loading and in vitro dissolution are also available.
Matthias Bucerius, PhD, head of pharmaceutical raw materials, commented in a press statement, that many promising drug candidates fail to get pass the development hurdle because of poor bioavailability and this problem causes significant loss of time and resources to companies. The addition of Parteck SLC to Merck Millipore’s portfolio of excipients provides drug developers with a new option to increase the solubility/bioavailability of their APIs or reformulate their drugs to extend product lifecycle.
Source: Merck Millipore