This "security for purity" helps provide confidence to pharmaceutical manufacturers that the excipient
product will be acceptable in their formulations, and also may save a step for manufacturers so they do not have to perform individual quality audits of Dow's PG production facilities.
If you think of our competitors as other excipient
producers, then I say we have an advantage because of the fact that our application base is so broad, and the fact that our expertise extends well beyond a single cellulose or one coating.
play an essential role in the development of safe and effective medicines," said Andrew Bulpin, Executive Vice President of Process Solutions, Merck Millipore.
Also, increased excipient
concentrations in silicone samples lead to increased DMA elution into a sodium phosphate saline buffer solution at 6.
Consequently, it is in the best interest of all global excipient
manufacturers to evaluate their current GMP compliance programmes and identify any gaps that may need to be addressed well before this anticipated new legislation becomes law.
It prepares CTD format documentation on the safety of the excipient
and data which allows the FDA to later shorten and simplify the regulatory approval.
SEPPIC demonstrates a dual expertise in active substances and excipients
(emulsifiers, rheology modifiers, foaming agents, texturizing agents, emollients, preservatives).
com/mb53), finds that the non-therapeutic use of human albumin as an excipient
has generated plenty of interest from the industry and will create a potential customer base comprising academics, research institutes, and pharmaceutical and biopharmaceutical companies.
ROQUETTE is a leading global partner of the nutraceutical industry and has been actively developing diverse starch-based functional nutraceutical excipients
to provide innovative solutions and enable outstanding formulations.
complies with the isomalt monographs of the current EP, BP and USP-NF and is approved for use in China and Japan.
First, the ideal excipient
should have a good safety profile and meet all the prerequisites of compatibility with APIs.
The API to excipient
ratio in the tablet is 1 to 9.
Spress B825 is a binder for fluid bed, continuous and conventional high-intensity granulations, while Spress B820 is a direct-compression tableting excipient
BASF has extensive ingredient formulation and material science expertise, as well as world-class excipient
products and has been a leader in developing hot melt extrusion technology solutions.
Ismael Hidalgo, Chief Scientist of Absorption Systems, commented that "This work highlights the possibility of excipient
substitution when developing biowaiver-eligible Class III drug products.