ADVANCING YOUR DRUG PRODUCT TOWARDS A SUCCESFULL FORMULATION
Advanced lipid formulation technologies are attracting a great deal of interest – and with good reason, because when e.g. active drug substances are encapsulated in liposomal phospholipid bilayer membranes, it can improve their biodistribution in the body. In some cases it means that the active substance reaches the target tissues and cells better or the pharmacokinetics is improved. To see whether the drug substance can be encapsulated in a lipid formulation and to achieve the desired dosing, LIPOSOMA starts each project with a feasibility study.
Based on the desired administration route, target cells, dosing, release time and structure of the compound, a specific formulation can be designed. Liposomes, Nanostructured Lipid Carriers (NLC) and nucleic-acid loaded Lipid Nanoparticles (LNP) are the most common advanced lipid formulations. Key excipients that constitute these formulations include triglycerides, wax esters, sterols, phospholipids and polymeric surfactants.
After conducting a successful feasibility study, LIPOSOMA can further optimize the lipid formulations and produce toxicology batches and (pre)clinical batches. Furthermore, LIPOSOMA offers R&D strategic support, IP support, documentation and regulatory support, advanced analytics, freeze-drying and spray-drying technology.
If a customer already has a prototype liposomal product, or has developed a prototype, LIPOSOMA Research & Development can examine whether industrial-scale production is feasible. We will make this decision based on a number of feasibility criteria:
- Can the product be produced cost-effectively and on a large scale?
- Can the product be stored adequately and can storage conditions be improved?
- Can our own freeze-drying expertise preserve the final product better upon storage?
- How can the quality of the final product best be controlled?
- How can we help the customer to implement analysis methods for industrial production?
Together with the customer, we will prepare a specification list that clearly defines the quality of every batch.