FORMULATION FORUM: How Poorly Water Soluble APIs Present 505(b)(2) Opportunity

More than half of all approved drugs on the market contain poorly water soluble APIs. In this Formulation Forum, Ascendia CEO Jim Huang, PhD, opines how this presents a huge opportunity in generating 505(b)(2) products.

As explained in the column, Ascendia has developed patented 505(b)(2) drug products using its nano-technologies platforms to address unmet medical needs. Three examples are cited:

1) ASD-002 – a ready-to-use, room temperature storage, nano-emulsion parenteral form of a blockbuster oral antiplatelet medicine for the treatment of Acute Coronary Syndrome.

2) ASD-004 – an ophthalmic nano-emulsion indicated to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca.

3) ASD-005 – liposome-like lipid nanoparticles for sustained release of a non-selective β and α adrenergic receptor blocker by the parenteral route.

Read the entire Formulation Forum from Dr. Huang here.