Pharmaceutical Formulation and Development
Analytical solutions for rapid formulation development
We recognize the importance of our customers’ requirements to develop robust formulations to provide a bioavailable and stable drug product and our range of complimentary analytical tools are designed to save you time and money in selecting and advancing the optimal dosage form.
Drug product formulation
Analytical techniques with a place in the oral solid dosage formulation toolkit
How Malvern Panalytical’s technology directly supports the development of oral solid dosage (OSD) forms by efficiently generating the data needed to drive formulation.Read the whitepaper
The increasingly complex requirements for achieving reproducible drug delivery are a common challenge for formulation development scientists. Many new active pharmaceutical ingredients (APIs) are poorly soluble, meaning that traditional oral solid dose delivery is no longer relevant. Formulation complexity is therefore increasing, either to enable increased bioavailability for oral administration, or to enable local delivery so that the drug concentration at the site of action meets therapeutic requirements.?
Novel drug delivery systems, based on liposomes or other nanoparticle delivery systems, are being utilized more frequently to improve drug targeting. Malvern Panalytical’s range of complementary analysis techniques enables formulation developers to understand API and excipient formulation and stability. This aids the optimization of complex formulations, saving time in selecting an effective candidate formulation.
Particle characterization using the Zetasizer Nano is a growing area of demand among a whole arsenal of research methods available for use at the Nanotechnology Research Center (NRC) at the Georgia Institute of Technology.Read the press release
The challenges of developing complex formulations also extend to the development of generic drug products. Regulators around the world have recognized the impact of a lack of successful complex generic product introductions on healthcare costs. In response, they have released product-specific guidance which highlights the role of assessing physicochemical, or Q3, equivalence as part of the evaluation of the bioequivalence of a test generic product compared with a reference listed drug (RLD) product.?
Application of an in vitro bioequivalence testing approach has the potential to significantly reduce the time to market for new generics by removing the need for clinical endpoint studies. Malvern Panalytical’s toolkit of physicochemical analysis techniques and expertise which enables assessment of the properties of both the drug and the drug product formulation has a critical role to play in enabling successful in vitro bioequivalence studies.
This webinar will consider the workflows associated with evaluation of physicochemical (Q3) bioequivalence with reference to the measurement solutions offered by Malvern Panalytical.Watch the Webinar
Pharmaceutical Deformulation and Root Cause Analysis
Development of a sucessful generic formulation starts with an understanding of the structure and performance of the reference listed drug (RLD) product. Here, as in in vitro bioequivalence assessments, physicochemical analysis has an important role to play in advancing the understanding of pharmaceutical formulation requirements. Proactive, quantative, structural and morphological characterization of the API and excipients present within the RLD product can prototype formulation optimization and? significantly reduce development risks.
The benefits of this deformulation approach are not limited to generics companies. Similar methods are also applied in the development and manufacture of new drug products, providing insight to help pinpoint the root cause of changes in formulation performance during scale-up. It can also aid companies in understanding the impact of post-marketing changes to the manufacturing process or manufacturing location on the performance of a drug product.
Dr Deborah Huck-Jones and Dr Paul Kippax examine the deformulation workflow, demonstrating the value of the technique of Morphologically Directed Raman Spectroscopy (MDRS).Read the whitepaper
Quickly monitor size and concentration of liposomes and nanoparticles to detect any effects of stress conditions, such as temperature, formulation or processing steps
Monitor the size and size distribution of drug substance and excipient particles, as required by your delivery route
Monitor changes in your drug substance due to processing or storage conditions. Control the results of your scale-up activities by monitoring polymorphs present in your drug product.
characterize polymer excipients to find the right conditions for your drug products.
Understand shape changes to excipient and API particles during processing, Identify the chemical composition of different particle populations in your formulation.