Our current R&D program within Patient-Specific Drug Formulation is focused on the development of tools and platforms to be able to predict the fate of a specific drug formulation under physiological conditions. The program will further refine existing in silico formulation modelling, develop specific intestinal cell models and implement formulation strategies that favor a specific drug release.
The Bioneer:FARMA group is located at the Department of Pharmacy at the University of Copenhagen and has access to all instruments and technologies essential for pharmaceutical R&D programs.
Patient-Specific Drug Formulation
The future drug development will focus on each individual patient to ensure the most optimal treatment for that patient. Bioneer:FARMA develops new services, that will allow for the development of drugs specific formulations for a defined patient group.
Bioneer:FARMA will develop state-of-the-art laboratory models based on clinical data that take into account changes in the GI tract for selected diseases or conditions. This includes intestinal diseases and conditions leading to a raised pH level in the stomach, which e.g. is commonly seen in elderly. The Dynamic Gastric Model (DGM), which is normally used to simulate a healthy individual, will be refined to also incorporate disease conditions.
Bioneer:FARMA will establish knowhow on computer-based PBPK-models, which can predict the pharmaceutical drug’s pharmacokinetic profile, also called ADME, within a specified patient group. So-called population-based pharmacokinetic models can be used to improve decision making early on in the drug development process. However, current models often do not take into account changes in patient physiology, such as changed gastric pH, changed transit time through the GI tract or reduced secretion of digestive enzymes, which is often the case during a period of treatment. Focus will be to simulate the same diseases as chosen for the disease-specific laboratory models.
Bioneer:FARMA will develop optimized formulation principles that target specific patient groups’ physiological condition and their therapy needs. The formulation work will be coordinated with activities in the two previous R&D descriptions. That could for example be formulations, which provide a quick release in the stomach regardless of pH or controlled release only taking place in proximity of an intestinal lesion, such found in Crohn’s disease. Furthermore, Bioneer:FARMA will continue to look into how to allow for more flexible formulations with dosage forms tailor-made for the individual patient’s need.
Development of a novel Blood Brain Barrier model based on human iPS cells.
Amorphous Drug Delivery Systems:
Edingera M, Knopp MM, Kerdoncuff H, Rantanen J, Rades T, Löbmann K. (2018) Quantification of microwave-induced amorphization of celecoxib in PVP tablets using transmission Raman spectroscopy. Eur J Pharm Sci 117:62-67 Pubmed
Knopp MM, Nguyen JH, Mu H, Langguth P, Rades T, Holm R. (2016) Influence of Copolymer Composition on In Vitro and In Vivo Performance of Celecoxib-PVP/VA Amorphous Solid Dispersions. AAPS J 18(2):416-23 Pubmed
Sassene PJ, Knopp MM, Hesselkilde JZ, Koradia V, Larsen A, Rades T, Müllertz A. (2010) Precipitation of a poorly soluble model drug during in vitro lipolysis: characterization and dissolution of the precipitate. J Pharm Sci 99(12):4982-91 Pubmed
Saaby L, Helms HC, Brodin B. (2016) IPEC-J2 MDR1, a Novel High-Resistance Cell Line with Functional Expression of Human P-glycoprotein (ABCB1) for Drug Screening Studies. Mol Pharm 13(2):640-52. Pubmed
Ozgür B, Saaby L, Langthaler K, Brodin B. (2018) Characterization of the IPEC-J2 MDR1 (iP-gp) cell line as a tool for identification of P-gp substrates. Eur J Pharm Sci 112:112-121. Pubmed
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