Arsenal of physicochemical tools from Pion grows to include excipient screening with biopharmaceutics classification gradient maps and API-sparing dissolution/solubility determinations
"With our expertise in in vitro ADME-related measurements, we've developed API-sparing techniques that allow our customers to focus on the winning candidates earlier in the process".
"As with all of our products, these new techniques are also available for client in-house use depending on capacity and budgetary needs", said Cynthia Berger, CFO of Pion.
"Over the last few months, we've seen an increase in the number of clients outsourcing the determination of pKa, log P, and solubility.
"Our knowledge and the close working relationship ensure that they get exactly what they need".
Excipient screening by the BCG-Mapping procedure is a patent-pending technique, developed as part of the two-year collaborative research agreement with Hoffman-La Roche.
This technique determines the impact of excipients on API solubility and permeability as a function of pH.
The results are then combined into a flux absorption potential, rank-ordered in decreasing effectiveness and plotted as color-coded response surface maps.
"It is important to look at the flux function, due to the reciprocal relationship between solubility and permeability".
"Typically, an enhancement of one parameter often results in a decline in the other." says Berger.
"We need to know the net effect that the flux absorption potential provides".
The BCG-Mapping allows the client to quickly grasp the regions of greatest benefit, even in large datasets.
The API-sparing dissolution and solubility service is built upon the recently released uDiss Profiler, which has generated a lot of interest since its introduction.
Using the contract analytical service, clients interested in uDiss technology can investigate a wide variety of factors in greater detail before they decide to invest in purchase.
Salts, polymorphs, particle size, excipients and other factors can influence the rate of dissolution and solubility of their API.
