Apinovex™ Polymers - the Key to Addressing Solubility Challenges in Oral Formulations

Between 40-70% of marketed drugs and up to 90% of all new chemical entities (NCEs) suffer from poor water solubility, meaning they don’t readily dissolve in an aqueous solution. This has significant negative consequences for the bioavailability of the active pharmaceutical ingredient (API), with an impact on therapeutic effect.

When developing drug products, formulating APIs into amorphous solid dispersions (ASD) is becoming increasingly attractive as an approach for improving the solubility and bioavailability of poorly water-soluble oral drugs. The addition of high-quality excipients that stabilize the drug in amorphous form is essential to ensuring the success of the final drug product.

Although there are several excipients that stabilize drugs as ASDs, there is no “one-size-fits-all” excipient capable of having a positive impact on solubility in all cases. As the number of poorly soluble NCEs increases, the market need for new excipients will grow.

LLS Health is dedicated to ensuring there are effective and reliable excipients available to address solubility issues; we recently developed a new excipient, the Apinovex™ polymer, to address oral API solubility challenges.

Apinovex™ polymer for drug amorphous solid dispersions

The Apinovex™ polymer is a high molecular weight linear polyacrylic acid excipient designed to improve the solubility of oral active pharmaceutical ingredients belonging to BCS Class 2 and 4.

The Apinovex™ polymer enables physically stable drug amorphous solid dispersions with flexibility in drug loading levels (up to 80%) via spray drying.

Benefits of the Apinovex™ polymer include:

Enables physically stable drug amorphous solid dispersions with flexibility in drug loading levels (up to 80%) via spray drying
Achieves higher drug loading levels when compared to commercially available excipients used for ASD
API/Apinovex polymer ASD demonstrates significantly improved drug release profile, even at high drug loading levels, when compared to crystalline API
Expected to be safe for oral use based on literature survey and preliminary TOX studies
Amorphous character is successfully maintained after 6 months (as demonstrated with accelerated stability studies)

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