In drug formulation studies, the pH of active ingredients and excipients is one determinate of how well a formulation functions. That makes it important to document the pH at each step of developing a new formulation. In Analytical Sciences, pH measurement is important for identifying substances at the molecular level and revealing their structure, composition and properties in the study of:
- Molecular composition
- Crystallography
- Polymer branches
- Protein complexes
Some of the departments that use the Rapid_pH are pre-formulations, formulations, downstream processing and analytical sciences.
As leads are found through High Throughput Screening, and active compounds are selected for further development, pre-formulation will begin to examine solubility and other characteristics of the leads in various solutions, like 0.1N HCL, and simulated gastric fluids (FASSIF/FESSIF). This is meant to examine how a drug might behave in the body, from the stomach with a pH of 1.8 to a higher pH in the colon, 5.5 to 6.5. The pre-formulations group then puts out a report with a solubility profile of the drug, and pKa values (the pH of where the drug is in ionic form). This is one key for the analytical department when designing tests to evaluate a drug’s performance in tablet, capsule, and other dosage forms. Additives may be examined here to alter the pH of the drug locally as it dissolves.
Many departments involved with pH measurement are under pressure for faster results. In addition, the ability to import and export pH sample data into a report, with an audit trails is becoming more important. Scientists in the lab are looking for automated solutions allowing them to walk away from tedious tasks to focus on more important and challenging work. The Rapid_pH family of laboratory pH meters use robotics to automatically measure pH in microplates, tubes and vials, reducing the time and tedium associated with manual pH measurement in the lab.