Ascendia recently partnered with a pharmaceutical company to formulate a compound just out of the discovery labs with no pre-formulation or animal pharmacokinetics (PK) data. To add to the challenge, the project had a three-month window and limited active pharmaceutical ingredient (API) supply. The Ascendia scientific team – utilizing the company’s proprietary nanotechnologies – delivered the compound within the tight timeframe.
Initially, Ascendia conducted essential pre-formulation studies to understand the compound’s properties related to solubility and in vitro performance. The Ascendia team utilized EmulSol, NanoSol, and AmorSol nanotechnologies to screen the prototype formulations within the three-month window. A multiple-fold increase in oral exposure in animal models was realized, leveraging multiple formulation principles that enabled a smooth and rapid transition of the project in the IND-enabling tox study.
It’s the most recent example of how Ascendia uses its experience and proprietary technologies to make the impossible possible for pharma companies. This success story was included in a Bioavailability & Solubility Special Report published by Drug Development & Delivery.
Ascendia Featured in Special Report
Jim Huang, PhD, CEO, Ascendia Pharmaceutical Solutions, was quoted in the article. The special report focused on that fact that the number one impediment to improving bioavailability and solubility is the intrinsic properties of the compounds, particularly those with low permeability through the GI membrane, i.e. BCS IV compounds. In the article, Dr. Huang explained how Ascendia achieves systemic absorption of BCS IV compounds in several ways, including:
♦ Utilize permeation-enhancers – including lipid, surfactant, and other GRAS excipients – using its technology platforms to open tight junction or enhance absorption through GI membrane or lymphatic routes after oral administration
♦ Explore the intranasal route of administration to overcome the GI barrier and potentially to overcome the blood-brain barrier or GI membrane barrier
♦ Develop injectable or topical dosage forms that can achieve high drug loading and high systemic bioavailability.
Contact us to learn more about Ascendia Pharmaceutical Solution’s approach to overcoming the challenges of poorly soluble drugs. Let us show you how we can add value to your product portfolio and pipeline.