---
title: "FORMULATION FORUM: How Poorly Water Soluble APIs Present 505(b)(2) Opportunity"
description: More than half of all approved drugs on the market contain poorly water soluble APIs. In this Formulation Forum, Ascendia […]
---

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# [FORMULATION FORUM: How Poorly Water Soluble APIs Present 505(b)(2) Opportunity](https://ascendiacdmo.com/newsroom/2020/05/05/formulation-forum-how-poorly-water-soluble-apis-present-505b2-opportunity)

 Written by [Admin](https://ascendiacdmo.com/newsroom/author/admin) | May 4, 2020 4:00:00 AM

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](https://drug-dev.com/formulation-forum-revitalization-of-older-drug-products-using-innovative-formulation-technologies-by-505b2-regulatory-pathway/).

[View full post](https://ascendiacdmo.com/newsroom/2020/05/05/formulation-forum-how-poorly-water-soluble-apis-present-505b2-opportunity)

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