EMD Millipore Introduces Silica-based Excipient
EMD Millipore, the Life Science division of Merck KGaA, introduced Parteck SLC, a new excipient with an innovative surface structure that delivers significantly increased loadability for active pharmaceutical ingredients (API). The company says Parteck SLC for drug delivery enables loading of oral dosage forms with amorphously distributed API to the highest levels, dramatically increasing API solubility.
"Many promising drug candidates fail during development due to poor bioavailability and represent a significant loss of time and resources invested in drug development," noted Matthias Bucerius, Ph.D., Head of Pharmaceutical Raw Materials. "With the addition of Parteck SLC to our extensive portfolio of excipients, drug developers now have a new option to help increase solubility and bioavailability and advance drug development. With Parteck SLC, molecules can also be reformulated, potentially extending the life cycle of the drug."
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 always kept stable. Feasibility studies have proven the superior performance on dissolution of Parteck® SLC both in vitro and in vivo.
A user-friendly particle size (5-25 μm) and bulk density (0.32 g/ml) allow easy loading, tableting, or capsule creation. In conjunction with Parteck ODT, a directly compressible excipient, Parteck SLC helps to produce stable and fast acting tablets. The loaded granulate retains its performance during dissolution in solid dosage forms.
As an EMPROVE product, Parteck SLC comes with ready-to-use documentation in CTD-format, saving time and money in the registration of the final drug. Feasibility studies concerning loading and in vitro dissolution are also available. For more information, visit www.emdmillipore.com/bioavailability.