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.