Winning strategies for oral dosage form development and manufacturing

June 05, 2025

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OSD formulation is often complicated by issues such as poor API bioavailability, challenging physicochemical properties, and regulatory hurdles. AustinPx addresses these challenges through early, thorough molecular characterization and a risk-mitigated, data-driven development strategy. They emphasize that skipping pre-formulation analysis to accelerate timelines can result in costly delays later.

Key insights:

- Early Risk Identification: Identifying issues like bioavailability, stability, and processability early avoids downstream development failures.

- Simplicity Through Strategy: While sponsors desire simple dosage forms, molecular complexity often requires advanced formulation strategies.

- Expert Partner Role: AustinPx uses its background as a sponsor to guide clients with deep scientific expertise and real-world experience.

Special Capabilities:

- HPAPI Handling: AustinPx has purpose-built infrastructure and in-house expertise for safely managing highly potent compounds (OEB 5).

- Bioavailability Enhancement (BAE): Their core strength is KinetiSol™, a leading amorphous solid dispersion (ASD) technology, enabling formulation of poorly soluble molecules.

- Innovative Testing & Tools: The team employs unique in-house tests, in vitro/in silico modeling, and rapid API-sparing screening for optimized development.

- Added Value:

AustinPx brings sponsor-level insight, allowing for agile, science-driven development with the goal of faster clinical entry and long-term product success.

KinetiSol™ stands out for its broad applicability, offering IP advantages and flexibility beyond conventional ASD methods.