For sustained-release oral solid dose formulations
Merck Millipore has added Parteck SRP 80, a new functional excipient for oral sustained-release formulations, to its portfolio.
Parteck SRP 80 is a polyvinyl alcohol (PVA)-based excipient for modified-release applications, for optimisation of pharmacokinetics and pharmacodynamics, as well as the bioavailability of actives.
The new excipient is fully synthetic, ensuring batch-to-batch and performance consistency and facilitating quality by design (QbD) and validation processes, the US-based firm says.
Parteck SRP 80 is suitable for direct compression processes and is compliant with European Pharmacopoeia (Ph. Eur.), United States Pharmacopoeia (USP) and Japanese Pharmacopoeia Excipients (JPE) and will be part of Merck Millipore's Emprove programme to facilitate regulatory filing and registration processes.
'Pharmaceutical excipients play an essential role in the development of safe and effective medicines,' said Andrew Bulpin, Executive Vice President of Process Solutions, Merck Millipore.
'Parteck SRP 80 represents a new choice for customers looking to formulate prolonged release oral dosage forms with reliable performance profiles as well as robust and cost efficient production processes, which can translate into improved patient safety and compliance.'