Novel properties of Super-APIs

Solubility and permeability issues often determine the difference between a good drug candidate that is druggable and the one that is not. Pharmaceutical approaches addressing these issues are limited and can have significant impact on activity and/or stability of the active compounds under development.

The NanoActive Technology enables the development of proprietary Super-APIs having the ability to transform multiple physicochemical properties by simple physical transformation. This allows the successful oral administration of drugs with challenging profiles as well as enabling utilization of previously unutilizable alternative routes of administration, such as pulmonary, transdermal, inhalational, buccal and intravenous.

The novel nanostructured Super-APIs have demonstrated unique properties that, in a wide and diverse universe of drug structures, enhances solubility, dissolution rate and bioavailability. These demonstrated properties represent a significant new option to improve drug utility for “undruggable” novel compounds development or to change the clinical utility and proprietary position of currently marketed drugs.

Novel characteristics of the Super-APIs are:

  • Improved ADME profile;
  • Increased bioavailability, efficacy and utility;
  • Enhanced solubility, dissolution rate and permeability characteristics that result in improved druggability of novel drugs;
  • Altered side effect and toxicity profiles by reducing total administered dose to achieve targeted AUC, T-Max, time to T-Max and half-life, that result from improved pharmacokinetics;
  • Providing a means to extend proprietary protection for currently marketed drugs by creating new IP.

 

NanoActive Super-API compared to the conventional NanoCrystal® technology

Increased solublity of Super-API

 

Pampa Assay

  

Increased solubility of Super-API

 

Enhanced bioavailability of Super-API

 

Instantaneous dissolution of Super-API tablet