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Fast and Flexible: Metrics' Pharmaceutical Development Services

Fast and Flexible: Metrics' Pharmaceutical Development Services

Our pharmaceutical development services lab supports a range of non-GMP analytical needs for fast track formulation development and testing. The lab is a development area that offers flexibility and speed, allowing for in-process testing to determine end points, coating evaluation and dissolution timing. The results are fast and direct, enabling scientists to make decisions on the spot.

“Testing at this stage helps us accurately determine where we are towards our target,” said Pharmaceutical Development Manager Troy Stox. “It is timely and cost-effective for troubleshooting development issues. We have methods to run a quick assay and determine if the result is on target or if dissolution time is trending favorably. This direction helps decisions moving forward.”

The fast turnaround provided by this lab’s equipment allows scientists to adjust the formulation or manufacturing process without involving the GMP lab, prior to GMP manufacturing.

Metrics also has a relationship with East Carolina University's College of Engineering and Department of Chemistry in which they assist in analyzing samples using scanning electron microscopy (SEM) and a microcalorimeter. The SEM produces images by scanning a sample with a high-energy beam of electrons, which results in greater magnification than an optical microscope. SEM can be beneficial in providing a qualitative assessment of size, porosity, morphology, shape, crystal form, size distribution and consistency of powders or compressed dosage forms during the early phases of the formulation development process.

These physical characteristics can be correlated to assess factors of dissolution, crystalline structure and even bioavailability. It can further assist in determining if blends/tablets are maintaining their desired physical characteristics throughout the manufacturing process or evaluate a cross section of coated material to determine thickness of the coating in extended release and sustained release formulations. Microcalorimetry can be used as a screening method for early indication of excipient compatibility prior to performing formal excipient compatibility stability studies with actual chemical assay methods. This tool can assist in guiding formulation options even before the first batch is made.

Employing the lab for early phase formulation development, testing and screening helps streamline processes, improves timelines, and decreases risks to clinical manufacturing activities. Metrics Contract Services can tailor release testing programs to client requirements and can provide services ranging from basic tests to more specialized techniques. We work with clients to understand their analytical needs and leverage our experience to develop solutions that meet scientific, quality, and regulatory requirements.