Advantages of API nanonization for drug development

corresponding

NIKLAS SANDLER
Nanoform, Helsinki, Finland

Abstract

A main cause of attrition in the drug development pathway is low solubility and bioavailability. Nanonization can increase dissolution rates and improve bioavailability by increasing the surface area of APIs. The technique has multiple advantages over conventional techniques such as milling and spray-drying, with the latest technology capable of reducing the diameter of nanoparticles down to 10 nm. This reduced particle size can lead to enhanced drug development in multiple areas, including novel treatments for pulmonary, ocular and CNS disorders.


INTRODUCTION

The enhancement of solubility and bioavailability in drug development is essential for reducing the vast number of drugs that do not progress to market. Nanonization™ – the process for reducing a material to particles at the nanometre scale – has the ability to help drug compounds reach their full therapeutic potential. The latest technological advances can produce API nanoparticles with improved dissolution rates at scale, substantially increasing the number of drugs that can be enhanced.

SOLUBILITY, BIOAVAILABILITY AND API DEVELOPMENT

Many drugs display sufficient potency, but fail to reach the market because of low bioavailability, where the drug is not effectively absorbed by the body. Increasing the solubility of orally administered drugs can significantly improve bioavailability.

Solubility defines how well a chemical substance dissolves in a solvent to produce a homogeneous solution. The property of solubility results from the concurrent and opposing processes of phase joining and dissolution acting in a dynamic equilibrium (1). This equilibrium is influenced by factors such a ...