Achieving consistent drug absorption remains one of the most critical challenges in pharmaceutical development. A drug’s clinical performance is directly influenced by its ability to dissolve and enter systemic circulation. Poor aqueous solubility is a major barrier, limiting exposure and therapeutic effectiveness across multiple delivery routes.
Today, a significant portion of both approved medicines and development-stage active pharmaceutical ingredients (APIs) exhibit low water solubility. Particle size reduction through nanotechnology has emerged as a highly reliable strategy to address this limitation, enabling enhanced dissolution behavior and improved in vivo performance.
Producing stable nanosuspensions requires deep technical knowledge, precise process control, and extensive hands-on experience across diverse molecular profiles. Our teams bring years of expertise in nanoscale formulation development, supporting APIs that range from straightforward chemistries to highly complex and high-potency compounds.
Using advanced wet milling systems, we routinely convert coarse drug particles into uniform nanoscale dispersions. Our infrastructure supports end-to-end processing—from milling and formulation optimization to aseptic vial filling and final packaging—under controlled and compliant conditions.
Key capabilities include:
Reducing API particles to the nanoscale significantly increases surface area, allowing for faster dissolution without the need for aggressive solvents or extreme pH adjustments. This is particularly beneficial for parenteral formulations, where high drug loading enables smaller injection volumes, and for pulmonary delivery, where optimized particle size supports deep lung deposition.
Nanomilling processes are highly scalable. Once formulation parameters are established, transitions from development to larger batch sizes can be achieved with minimal variability, ensuring consistent dispersion quality and performance across production runs.
Wet nanomilling is performed within closed systems, providing effective containment for potent compounds. This controlled environment minimizes operator exposure while maintaining formulation integrity throughout processing.
Additional benefits include:
Pharmaceutical compounds are commonly categorized under the FDA-defined Biopharmaceutics Classification System (BCS), which evaluates drugs based on solubility and intestinal permeability. APIs with low solubility—particularly those in BCS Class II—are prime candidates for particle size reduction, as dissolution is the primary limitation to absorption.
Nanomilling applies controlled mechanical forces to fracture coarse API particles into significantly smaller units. As particle size decreases, total surface area increases dramatically, allowing greater interaction with aqueous media. This enhanced surface exposure accelerates dissolution, leading to improved absorption and higher bioavailability.
Nanomilling is a versatile and broadly applicable platform, suitable for APIs with water solubility below 200 μg/mL and adaptable to oral, injectable, inhalable, and buccal drug delivery systems.