Apisolex Excipient by Lubrizol Backs Phase I Drug Success

A promising drug candidate using Lubrizol Life Science Health's new polymer excipient Apisolex has begun Phase I clinical trials. This marks a big step forward for the technology that boosts solubility.

Key Insights:
• Apisolex enters Phase I trials in a promising injectable drug candidate
• Apisolex is GMP-compliant and supports various dosage forms
• Lubrizol aims to expand Apisolex's global impact in drug formulation

Apisolex aims to solve formulation problems for BCS Class II and IV active pharmaceutical ingredients (APIs). It's a polymer based on polyamino acids designed to make drugs much more soluble and absorbable. These factors play a key role in how well a drug works.

In the early trial, scientists will check the safety, pharmacokinetics, and how well patients tolerate a formulation with Apisolex that's given by injection. The company behind this and the specific drug remain secret. However, this trial is part of a bigger worldwide effort to tackle APIs that are hard to formulate.

Research has shown that Apisolex can boost the solubility of certain APIs by up to 50,000 times. This makes it a game-changing option for scientists working on formulations with insoluble compounds.

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Apisolex follows GMP standards and works with many dosage forms, including parenteral applications. This makes it a flexible tool in today's drug development.

Kevin Song, Senior Director of Lubrizol’s Global Pharmaceutical and Nutraceutical Business, said, “This milestone demonstrates Apisolex’s ability to solve some of the toughest formulation challenges in parenteral delivery, and we remain committed to expanding its global impact and collaborating with manufacturers navigating solubility barriers.”

Many drugs are stuck in development because they don't dissolve well. Lubrizol's Apisolex is set to play a key role in opening up new treatment options.