Polymorphism in Lipids: Influence and Control in Pharmaceutical Applications
20. October 2023
Polymorphism is a fundamental phenomenon observed in lipid materials, encompassing a diverse group of biomolecules such as fats, oils, and phospholipids. This phenomenon refers to the ability of lipids to exist in multiple structurally distinct states of crystallinity. Polymorphism in lipid materials has significant implications, e.g. in pharmaceutical and industrial applications. Controlling lipid polymorphism can be of paramount importance in the development of lipid-based drug delivery systems.
Polymorphism results in different crystal structures with distinct physical properties. For lipids, this includes variations in melting point, density, hardness and optical characteristics. Different polymorphs of the same lipid thereby influence the release rate and bioavailability of drug products.
Understanding this property and how a lipid excipient transitions between different states of crystallinity plays a crucial role in lipid-based drug delivery systems.
The challenge for formulators arises from spontaneous phase transitions between crystal forms occurring under varying conditions over time, such as temperatures and pressure.
Randomness/ Spontaneity/ Lack of predictability of phase transition can impact stability and shelf life of formulated products, which makes understanding and controlling lipid polymorphism a key milestone during product development, preventing unwanted changes in product quality and functional characteristics like release profiles over time.
Practical relevance for this phenomenon is found, for example, in post-hardening and/or the formation of fat bloom in suppositories and ovules. Through our application engineers, we share experience made with these phenomena and, with customers, jointly adapt proven strategies that can be employed to minimize such effects. Similar effects can be experienced in the majority of dosage forms and manufacturing processes relying on lipid excipients.
Jointly reviewing and challenging established expertise and knowledge through new galenic approaches must be one of the most exciting opportunities for the community of pharmaceutical formulators and excipient manufacturers and suppliers.
As the leading manufacturer and innovator for lipid-based excipients, we are familiar with this inherent property.
Tanja Freichel
Dr Tanja Freichel studied chemistry at the University of Frankfurt, before moving to Düsseldorf to work on her PhD thesis at the Institute of Macromolecular Chemistry. During her thesis, Tanja broadened her experience in interdisciplinary fields by investigating the structure-activity relationship of synthetic biomimetics in biological applications. In 2019, Tanja joined IOI Oleo GmbH as a research chemist in the R&D team. She has been leading the R&D laboratories and mini pilot plants, developing and investigating new innovative products and sustainability-driven technologies with her team since 2020. In her free time, Tanja likes to travel to explore new countries and culinary cultures. Furthermore, she enjoys good live music and loves spending time with her family and friends.
