Drug Product

Balancing Speed with Depth in Formulation Development

We specialize in early-phase drug product formulation development. Our philosophy is to develop “fit-for-purpose” formulations in early phases to minimize complexity and accelerate timelines.

• Design formulations, e.g., API-in-bottle, API-in-capsule, capsule, tablet, solution, semisolid, and injectable, based on the API characteristics, route of administration, and available safety/pharmacokinetic data.
• Select functional excipients that are compatible with the API, as well as enhance stability and solubility.
• Conduct accelerated stability studies to ensure the formulation maintains its quality attributes.
• Develop and validate analytical methods for drug products.
• Test the feasibility of producing the formulation with reliable performance.

Establishing a Seamless Interface between Drug Substance and Drug Product

We can simultaneously develop both drug substance and drug product within the same J-STAR team. This integrated approach enables robust drug products by combining our expertise in drug substance crystal screening and form control with enabling technologies for drug product or intermediate. This synergistic development effort provides desired quality attributes, such as improved powder flowability, optimized particle shape and size, increased bulk density, enhanced solubility, and improved stability. Our exceptional ability to bridge the gap between drug substance and drug product offers significant value to our customers. By minimizing unexpected issues arising from drug substance–drug product mismatches, we deliver cost and time savings and improve the likelihood of success in early-phase development.

Enabling Technologies and Specialized Capabilities

J-STAR’s Drug Product R&D has developed formulation technologies to optimize API properties, such as in situ salt formation, localized pH adjustment, co-solvents, cyclodextrin complexation, particle size reduction, amorphous solid dispersions, hot-melt extrusion, DS-DP coprocessing, co-precipitation, lipid-based formulation and nanosuspension. We excel in solving challenging problems in early phase drug product development and extend these capabilities into our GMP manufacturing for preclinical, Phase I and II clinical batches, providing a rapid transition from development to manufacturing. We also apply a Quality by Design (QbD) approach to improve late phase and commercial processes. With a commitment to responsive customer service, J-STAR is your reliable partner for your drug product development needs. Experience the difference with J-STAR as your trusted “one-stop shop” for drug development success.

Featured Drug Product Equipment