Apisolex™ Polymer – by Lubrizol
Solubility-enhancing polymer for use in bolus injections and IV infusions
- 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.
- Simple formulation techniques – solution mixing or oil-in-water emulsion formation.
- Minimal API loss (recovery >90%).
- Standard, scalable formulation techniques.
- 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.
Series B results
Compared to solubilizers processed using the same
lyophilization and reconstitution technique, only
Apisolex polymer enabled successful solubilization of all
See the full brochure on “Apisolex™ Polymer” here
(click the picture to download the brochure)
Source: Lubrizol brochure “Apisolex™ Polymer”
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