Oral Solid Dose

Particle Sciences has experience partnering with our clients to develop unique formulations, including oral solid dosage forms (OSD).

Our customer-focused staff utilizes several technologies to accelerate your product to market and introduce critical properties such as controlled release and improved bioavailability.

Nanomilling

Nanomilling and nanoparticle formulation is at the forefront of much of our CDMO work. Particle size reduction via nanomilling improves bioavailability by increasing the surface area of API molecules, resulting in faster dissolution. Numerous BCS class II and IV APIs have benefited from this technology and 10+ nanomilled drug products have gained FDA approval since 2000, including multiple OSD products. This process also has the added benefits of:

  • No harsh organic solvents or pH extremes
  • High API concentrations
  • Scalability and reproducibility

Click here to learn more about our 8 week Nanomilling Feasibility Program.

Hot melt extrusion

Hot melt extrusion (HME) is a core strength for us at Particle Sciences and we can work with you to evaluate if this process is well-suited for your product. Our team has extruded products containing the most challenging APIs, including highly potent compounds and controlled substances. HME offers many advantages for complex OSD drug development, including:

  • Enhanced bioavailability of poorly soluble compounds
  • Reduced production time, fewer processing steps, and continuous operation
  • Compatibility with other sustained, modified, and targeted release components

Related Services

Formulation

Our formulation team employs a data-driven approach to find solutions for even the most challenging APIs employing a range of technologies to maximize bioavailability, control release rate, and enhance stability.  Our scientists work on projects from early-stage development through scale-up and transition to our clinical and commercial manufacturing teams.

Clinical Manufacturing

We offer GMP manufacturing for many dosage forms, and our integrated approach creates a smooth transition from pre-clinical activities through clinical validation. We have GMP manufacturing space that is supported by in-house analytical services, bioanalytical services, physicochemical characterization, and ICH-compliant stability programs.

Drug Release Testing

We have over two decades of experience developing and validating release assays for a variety of drug products, including semi-solid formulations, implantable devices, and oral solid dosage forms. Our GMP/GLP facilities are equipped with specialized equipment and seasoned analytical scientists who perform both routine and custom drug release testing.