Beneficjent: Physiolution Polska sp. z o.o.
Nr umowy: POIR.01.02.00-00-0011_17-00
Tytuł projektu: Wdrożenie innowacyjnej metody oceny uwalniania i absorpcji leków neurologicznych w przewodzie pokarmowym
Opis projektu: Celem projektu jest opracowanie dedykowanego lekom neurologicznym prototypu urządzenia do badania zachowania postaci farmaceutycznej leku w przewodzie pokarmowym. Prototyp wymagać będzie testowania innowacyjnych komór przepływowych, a także opracowania metod testowych. Zadania tego podjąć się zamierza Partner – oddział niemieckiej firmy Physiolution Polska sp. z o.o., która na potrzeby rozwoju urządzenia dedykowanego m.in. lekom neurologicznym zamierza rozwijać laboratorium w Polsce. Równolegle, aby dysponować wiarygodnymi danymi nt. działania urządzenia w porównaniu z metodami badania leków in vitro, zostaną przeprowadzone pełne ścieżki rozwoju dwóch leków neurologicznych o wysoce istotnym znaczeniu klinicznym. Zadania tego podejmie się Lider – Biofarm sp. z o.o., która zbadała potencjał rynkowy wdrożenia leków generycznych: wortioksetyny i lurazydonu. Na polskim rynku nie zarejestrowano leków generycznych zawierających w/w substancje czynne.
Wartość projektu: 7.311.904,38 PLN
Dofinansowanie ze środków funduszy Unii Europejskiej: 4.467.183,62 PLN
Key features of our company
Mission
Empowering the development of reliable oral medicines
Vision
Developing bio-predictive tests to improve biopharmaceutical reliability of oral medicines, reduce the risk and the cost of clinical trials and shorten the time to market.
Services
The cutting-edge methods for characterizing oral medicines are originally developed by our team using the latest advances in physiology, pharmacokinetics and engineering
Devices
Modern technology and engineering in the mission of creating new pharmakokinetic simulations method and modeling
CEO & Founder
An important part of our work is related to the development and characterization of analytical methods. We offer support to our customers with development of analytical methods based on UV-VIS spectroscopy and High-Performance Liquid Chromatography (HPLC) for the determination of small molecules and In our work we use Shimadzu H/UPLC systems equipped with Diode Array Detector (DAD), Refractive Index Detector (RID) and fluorescence detector (FD).
In our research, we pay great attention to the simulation of physiological and pathophysiological conditions of the gastro-intestinal tract. Our methods realistically simulate temperature and flow rate gradients of the dissolution medium, as well as its physiological composition - including the reproduction of actual human pH gradients with hydrogen carbonate buffers. Moreover, our outstanding experience lies in the simulation of physiological pressure events, linked with gastro-intestinal motility patterns. We model formulation susceptibility to such stresses and identify probable dose dumpers. Everything in our in-house designed devices.
Owing to our unique expertise and innovative dissolution testers, we effectively support the rational, physiology-oriented development of oral medicines. Our experts support the development cycle of oral medicines and help to improve the biopharmaceutical quality, reduce the risk of clinical trials and consequently reduce the cost of the development and shorten the time to market. From the early characterization of API with solubility tests in hydrogen carbonate buffers, and through the development of analytical methods in complex dissolution media like full fat milk. We are here to guide formulation development with the definition of dosage form, preformulation screening and strategy development. Our experience shines in preclinical research, where we provide bio-predictive dissolution tests coupled with top-notch PK simulations to support the choice of clinical batches. Also, we support clinical trials, by an adjustment of clinical protocols and data analysis. And finally, if your clinical trials failed and you are looking for the root cause, we are here to help to turn the project into a success!
In Physiolution we believe that only tests in bio-relevant conditions provide answers to the most burning questions of pharmaceutical development. That is why we use complex dissolution media and also build our own disintegration and dissolution testers! As our long-term experience shows, everything starts with disintegration. We thoroughly investigate it in our disintegration tester, which examines the spontaneous disintegration in complex media, like full fat milk. Next, we stress a formulation in our devices that ensure truly physiological conditions. We treat each formulation individually, with fit-for-purpose tests, and offer unique methods for both immediate, and modified release drugs. Everything to support the bio-predictive characterization of medicines and relieve you from the burden of clinical studies.
We evaluate pharmaceutical and biopharmaceutical equivalence. Starting from dissolution testing in pharmacopeial and simulated intake conditions, through pharmacokinetic models and IVIV correlations; to a comprehensive analysis of clinical trial results. Our pharmacokinetic models and protocols enable simulating individual profiles, as well as populations. We thoroughly analyze and interpret the results of pharmacokinetic studies and identify physiological mechanisms affecting the pharmacokinetic characteristics of oral drugs.Using this knowledge, we aid the rational planning of clinical trials.
As a company devoted to thorough dissolution testing, we strive to take our highly specialized methods one step further and translate the in vitro test results to reliable in vivo predictions. We collaborate with acknowledged pharmacokinetics experts who apply established semi-mechanistic models to predict the formulation’s performance. We diligently investigate each case and take an individualized approach. Either for standard immediate-release formulations, or modified-release systems prone to mechanical agitation - we put our best efforts to understand how the formulations in vitro characteristics influence the in vivo exposure. We have successfully solved many challenging examples, and as a team we are ready to undertake even the most demanding cases.
Tired with complicated software and overly elaborate models? We have a solution named LADMEos2 - a pharmacokinetic simulation software that predicts the drug exposure in both fasted and fed conditions, and accounts for the variability of the human gastrointestinal tract. We constantly develop and improve it, adding new features and modules. For example, our software offers a unique solution for investigating the formulation’s disintegration, and how it can affect pharmacokinetics. Also, we designed COMPASS - a unique program that may significantly aid early-stage development of immediate release dosage forms. COMPASS assesses the probability of bioequivalence trial in fasted conditions using biopredictive dissolution profiles and basic pharmacokinetic parameters of the API. Using COMPASS will help you investigate if a newly developed formulation will be bioequivalent to the reference product under highly variable conditions of the fasted human stomach.
Both biomolecules, such as peptides, proteins or oligonucleotides, and amorphous solid dispersions attract attention in modern medicine and pharmacy. However, they may lose their properties during manufacturing, formulation and storage. In our laboratory, we have developed a protocol including tests at different pH and with the presence of digestive enzymes for assessing the stability of peptides in the human gut. On the other hand, our dissolution and solubility tests in bio-relevant conditions provide a valuable tool to study amorphous solid dispersions' interactions with physiological hydrogen carbonate buffer components. Therefore we support the selection of the most robust molecules as drug candidates, by predicting an oral administration efficacy for a developed formulation.
We are constantly designing and developing equipment for bio-relevant dissolution testing. Our company experience is based on the unique hand in hand cooperation between lab practitioners and hardware and software engineers. As a result of this thriving cooperation we solve challenging problems in our and clients lab works by designing, modifying and manufacturing equipment tailored for researchers’ needs. Our laboratory team and engineers are ready to find a solution for your most challenging problems!
Staff with higher education.
Higher Education
Successfully accomplished projects.
Project Sucess
Returning customers.
Satisfied Customers
Success rate of predictions.
Successful Predictions
Sales to highly developed countries.
Sales
ul. Piłsudskiego 74/51B, 50-020 Wrocław, Poland
Phone: +48 713 357 648
Email: info@physiolution.pl
Commercial Register: KRS 0000668599
VAT No.: PL8992813028
Commercial bank: Santander Bank Polska
IBAN: PL 60 1090 2226 0000 0001 3428 1513
SWIFT-BIC: WBKPPLPP
