Pharmaceuticals

Pharmaceutical research and discovery is a challenging yet rewarding process that results in the treatment of a disease or clinical condition through new medicine. First, researchers must find a biological target that plays a role in the disease and can be singled out for treatment. During lead discovery, researchers find small molecules or biological therapeutics that they can test as a development candidate. Lead optimization and pre-formulation involve testing and improving crucial characteristics in the lead so it can be properly absorbed for the intended treatment.

Calorimetry is used to characterize minute interactions between macromolecules, while gas analysis and sorption analysis measures the thermal stability and moisture content of pharmaceutical compounds.

Drug formulation and development requires highly accurate characterization of biomolecules to predict their behavior in the body and the efficacy of their treatment. Active pharmaceutical ingredients (APIs) and their inactive carriers, or excipients, must be tested for their compatibility and chemical stability. Pharmaceutical developments are also optimized for bioavailability in the body. Rheology helps developers measure the flow behavior of liquids during drug production as well as the viscosity and yield stress of formulations to maintain drug suspension. In topical ointments, emulsion stability is optimized to prevent phase separation.

Sorption Analysis (SA) is used to assess hygroscopicity, amorphous – crystalline phase changes, and hydrate formation.

Once a drug formulation passes initial tests, it moves on to manufacturing and quality control evaluation. Pharmaceutical manufacturers test critical quality attributes (CQAs) and identify the critical material attributes (CMAs) which must remain stable throughout production and until the drug reaches consumers. End user satisfaction also depends upon drug delivery and packaging, which must be tested to eliminate damage to the products. Quality control testing detects any batch-to-batch variation, and manufacture troubleshooting and root cause analysis helps manufacturers identify issues in their process.

Rheology measures critical attributes such as viscosity of injectables as well as viscoelasticity and yield stress of topicals, all which impact drug delivery. Differential Scanning Calorimetry (DSC) and Thermogravimetric Analysis (TGA) detect thermal stability and product changes, aiding in process and delivery optimization.

Successful pharmaceutical products are scaled up to meet consumer demand, which requires rigorous testing and process optimization. Manufacturers must test their process safety and assess risk when designing scaled up manufacturing. Thermal analysis techniques, including DSC, TGA, and Kinetics, measure the thermal stability and phase changes of pharmaceutical products in newly designed manufacturing systems.

Sorption Analysis measures moisture uptake and can help optimize processing systems to minimize negative effects on drug efficacy.