Apisolex™ Polymer – by Lubrizol

Solubility-enhancing polymer for use in bolus injections and IV infusions

Lubrizol Life Science Health’s (LLS Health’s) Apisolex™ GMP, injectable-grade excipient is a safe, polyamino acid-based polymer that enhances the solubility of BSC Class II and IV APIs.

Formulation Benefits

  • Increases the solubility of hydrophobic APIs by up to 50,000-fold.
  • Allows high drug loading (up to 40:100 API:solubilizer ratio).
  • Forms stable, lyophilized drug product that reconstitutes in saline in under 30 seconds.
  • Enables IP protection and 505(b)(2) formulations/lifecycle management.


Apisolex™ Polymer_Lubrizol_Benefits

Apisolex™ Polymer_Lubrizol_Processing Benefits

Processing Benefits

  • Simple formulation techniques – solution mixing or oil-in-water emulsion formation.
  • Minimal API loss (recovery >90%).
  • Standard, scalable formulation techniques.

Competitive Advantage

  • Higher drug loading than other solubility-enhancing excipients.
  • Substantially increases achievable concentration of API in water.
  • Non-toxic, non-immunogenic, biocompatible, and biodegradable alternative to PEG.

Putting Apisolex™ Polymer to the Test

  • The solubilization properties of Apisolex polymer were evaluated in comparison with other excipients for a series of poorly water soluble active pharmaceutical ingredients.
  • The experiments were conducted by non-optimized, standard dispersion techniques (mixing or homogenization), followed by dilution or lyophilization and reconstitution.
  • Target API concentration in final product after dilution or reconstitution was 500 μg/ml. The criteria for solubilization were turbidity (NMT 100 NTU), particle diameter (NMT 150 nm), and drug recovery after filtration (NLT 80%).

Series A results

Compared to solubilizers that utilize a dissolution and
dilution technique, only Apisolex polymer enabled
successful solubilization of all APIs evaluated and at a
much lower ratio of excipient to API.

Apisolex™ Polymer_Lubrizol_Serie A
Apisolex™ Polymer_Lubrizol

Series B results

Compared to solubilizers processed using the same
lyophilization and reconstitution technique, only
Apisolex polymer enabled successful solubilization of all
APIs evaluated.

Apisolex™ Polymer_Lubrizol_Serie B
Apisolex™ Polymer_Lubrizol

See the full brochure onApisolex™ Polymerhere

(click the picture to download the brochure)

Apisolex™ Polymer_Lubrizol


Source: Lubrizol brochure “Apisolex™ Polymer”

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