Solubility-Enhancing Excipients for Amorphous Solid Dispersions.

Lubrizol’s Apinovex™ polymers are high molecular weight polyacrylic acid excipients designed to provide both processing and formulation benefits for spray-dried amorphous solid dispersions (ASDs).

Apinovex polymers enable formulators to enhance the solubility of BCS Class II and IV APIs and develop more efficient oral dosage forms with high, stable drug loading.

Prescription Bottle

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Oral Solid

Enhance Oral Solubility with Apinovex™ Polymers

  • High, stable drug loading (up to 80%) via spray drying.
  • Significantly improved drug release profile compared to crystalline APIs.
  • Enables IP protection and 505(b)(2) formulations/lifecycle management.

Apinovex Spray

Apinovex™ Polymers Enable Solubility With Ease

Apinovex™ polymers can be easily incorporated into your drug project via spray drying or other solvent-based processes. This novel excipient has a broad API and solvent compatibility to produce Amorphous Solid Dispersions (ASD) of your brick-dust API. 

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Test Results
Acute oral toxicity Not acutely toxic (LD50>5000 mg/kg)
Mutagenicity in bacteria (AMES) Non-mutagenic
28-day oral repeat dose study Testing underway

Oral Safety Profile

Apinovex chemistry is similar to LLS Health’s IID-listed Carbopol® polymers, which have been used in oral drug products for decades.

In case studies with itraconazole and ritonavir (BCS Class II drugs), Apinovex enabled:

  • 2x more drug loading than other solubility-enhancing excipients (Soluplus® and AFFINISOL™ HPMC).
  • Up to 10x improvement in dissolution for Apinovex dispersions compared to crystalline APIs.
  • Stable amorphous solid dispersions, even after 6 months under accelerated conditions.

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Infographic: Transform Your Brick-Dust API into an Effective oral Drug Candidate with Apinovex™ Polymers

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Apinovex Polymer One Pager

One-Pager: Solubility-enhancing polymers for oral amorphous solid dispersions

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Contact us today to evaluate Apinovex technology for yourself!

Discover how our excipient can solve solubility issues for your most challenging oral drug projects. 

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