A greater understanding of materials science is helping pharmaceutical companies to control the manufacture of solid dosage forms to produce tabletted, granulated and dry powder dosage delivery systems. The industry is increasingly embracing the principles of Quality by Design (QbD) to improve efficiency and ensure good quality and reduced variability throughout the drug production process. Consideration of the physicochemical properties of the active compound and all associated excipients as they pass through the manufacturing process allows the prediction and control of the resultant products. This allows faster delivery of new products to market and makes it easier to safeguard quality standards.
QbD calls for exploration of the design space of a product and the identification of Critical Quality Attributes (CQAs) those physical, chemical, biological, or microbiological properties or characteristics that impact and define clinical efficacy. These activities rely on good research and development that fully characterizes the physicochemical properties all the relevant raw materials. This can then be coupled with a PAT (Process Analytical Technologies) methodology to identify which properties can be measured in-line or at-line within the production environment, or off-line in QC, to allow the measurement, maintenance and control of the CQAs. This combination of complete off-line analysis to give a full understanding, linked to a limited range of in-process measurements, allows for full process control and the reliable manufacture of products to minimize batch to batch variation, maximize dose uniformity and deliver high quality, safe and effective medications.
Micromeritics offers a comprehensive portfolio of analytical solutions for the physical characterization of API and excipient powders that extends to systems for measuring:
- Surface area
- Powder flow
- Particle size
- Particle shape
- Surface morphology
These systems provide a range of technological solutions to identify the CQAs, via off-line analysis, and then measure and control them at-line. So, we have products that are applicable in R&D, manufacturing and QC environments. These systems provide detailed, repeatable and highly sensitive results that in combination elucidate how oral solid dosage forms and other pharmaceutical products will perform.
To find out more about our solutions for pharmaceutical characterization please see the pharma characterization home page.