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.

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.

Series B results

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

See the full brochure on “Apisolex™ Polymer” here

(click the picture to download the brochure)

MORE ON LUBRIZOL

Source: Lubrizol brochure “Apisolex™ Polymer”

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