Article
Pharmacology & Pharmacy
Martin Mueller, Florian Platten, Martin Dulle, Bjorn Fischer, Werner Hoheisel, Peter Serno, Stefan Egelhaaf, Joerg Breitkreutz
Summary: The precipitation process and physicochemical properties of precipitates formed by regorafenib in amorphous solid dispersions were investigated. Different crystalline and amorphous precipitates were identified, and the controlled formation of defined amorphous structures in-vivo could be a promising future drug formulation strategy.
INTERNATIONAL JOURNAL OF PHARMACEUTICS
(2021)
Article
Chemistry, Analytical
Dina Kottke, Bjoern B. Burckhardt, Joerg Breitkreutz, Bjoern Fischer
Summary: The development of peptide drugs and alternative routes of administration has become increasingly important to the pharmaceutical industry in recent years. A new HPLC-coupled coaxial liquid-core waveguide fluorescence detector has been developed and evaluated for sensitive detection of large molecules and peptides. The validation results showed increased sensitivity, with a limit of detection of 4.7 ng/mL and a lower limit of quantification of 9.5 ng/mL, demonstrating successful observation of desmopressin permeation in clinically relevant dosages and time periods.
Article
Pharmacology & Pharmacy
Ard Lura, Valentine Elezaj, Marcel Kokott, Bjoern Fischer, Joerg Breitkreutz
Summary: The study demonstrated the feasibility of using isomalt and Ludiflash (R) for the development of ODMTs, in accordance with the guidelines of the FDA and EMA. ODMTs produced on a compaction simulator and a rotary tablet press showed similar characteristics and texture, but during scale-up process, the disintegration time significantly increased.
INTERNATIONAL JOURNAL OF PHARMACEUTICS
(2021)
Article
Pharmacology & Pharmacy
Anja Goebel, Joerg Breitkreutz
Summary: This paper presents a modification of the solvent casting technique to divide oral films into multiple compartments, aiming to improve handling properties, safety of application, drug release kinetics, and long-term stability. Feasibility studies showed that combination of different film-forming polymers can achieve these objectives.
Article
Pharmacology & Pharmacy
Rebecca Chamberlain, Hellen Windolf, Simon Geissler, Julian Quodbach, Joerg Breitkreutz
Summary: The aim of this research was to produce low-dosed filaments via hot-melt extrusion (HME) with a model drug for Parkinson's disease treatment. It was found that deviation from target drug concentration occurred due to degradation products in certain formulations. Material temperature and the formation of anhydrous drug in the extruded filaments should be considered for the calculation of recovered API. The study showed that equilibrium condition for drug content was reached relatively late in the process, and the calculated RSD by Stange-Poole equation can be used to evaluate the deviations of drug content in equilibrium conditions.
Article
Pharmacology & Pharmacy
Rebecca Chamberlain, Hellen Windolf, Bjoern B. Burckhardt, Joerg Breitkreutz, Bjoern Fischer
Summary: Individual dosing of pharmaceutics and personalized medicine have become important for therapeutic safety, including dose adjustments, biorelevant drug release, and combination of multiple active substances. This requires both innovative drug products and new analytical methods for drug development and quality control. The liquid-core waveguide UV absorbance flow cell detector coupled to an existing HPLC-UV system allows for simultaneous determination of different active ingredients and wide concentration ranges, increasing sensitivity and reducing analysis time.
Article
Pharmacology & Pharmacy
Valentinee Elezaj, Ard Lura, Luis Canha, Joerg Breitkreutz
Summary: Epidermolysis bullosa is a skin fragility disorder that can be treated with mini-tablets containing losartan potassium. The development process faced several challenges, but successful formulation of the mini-tablets was achieved through dry granulation and appropriate coating, meeting pharmacopoeial requirements and demonstrating promising stability.
Article
Pharmacology & Pharmacy
Hellen Windolf, Rebecca Chamberlain, Joerg Breitkreutz, Julian Quodbach
Summary: Treating Parkinson's disease is challenging, and personalized therapy is crucial due to specific requirements of drug therapy. This study utilized 3D printing to create personalized medication, including both rapid and prolonged drug release formulations, to meet the varying drug release needs. This provides a more personalized and effective treatment option for patients with Parkinson's disease.
Article
Pharmacology & Pharmacy
Stephanie Laeer, Willi Cawello, Bjoern B. Burckhardt, Laszlo Ablonczy, Milica Bajcetic, Johannes M. P. J. Breur, Michiel Dalinghaus, Christoph Male, Saskia N. de Wildt, Joerg Breitkreutz, Muhammed Faisal, Anne Keatley-Clarke, Ingrid Klingmann, Florian B. Lagler
Summary: This study investigated the pharmacokinetics of enalapril in pediatric heart failure patients using a novel oral disintegrating tablet formulation, finding the rate and extent of enalapril and its active metabolite, and supporting the tolerability and safety of the appropriate dosing schedule.
Article
Pharmacology & Pharmacy
Bakul Sarker, Mariele Fligge, Tanja Knaab, Joerg Breitkreutz
Summary: A novel electronic liquid dispensing system (ELDS) was investigated for producing individualized dose strengths of hard capsules. The ELDS showed good dosing accuracy and content uniformity compared to manual preparation, with almost no drug loss.
Article
Pharmacology & Pharmacy
Lena Hoffmann, Joerg Breitkreutz, Julian Quodbach
Summary: The aim of this research was to produce extrudates for the treatment of hypertension and heart failure and investigate the degradation of the drug enalapril maleate during hot-melt extrusion (HME). The study found that the use of specific polymer formulations prevented thermal degradation and maintained high dissolution. These findings have important implications for developing similar drug formulations.
Article
Pharmacology & Pharmacy
Malin Hermeling, Christoph Nueboldt, Roman Heumann, Werner Hoheisel, Joerg Breitkreutz
Summary: Amorphous solid dispersions (ASD) are a prominent formulation approach for poorly soluble drugs. This study introduces a novel process technology called Nano-Dry-Melting (NDM) as an alternative option for ASD manufacturing. Feasibility studies and proof-of-concept experiments demonstrate the successful production of amorphous samples with NDM, even for drug candidates that cannot be processed by conventional methods.
Article
Pharmacology & Pharmacy
Mariele Fligge, Ilse Letofsky-Papst, Miriam Baeumers, Andreas Zimmer, Joerg Breitkreutz
INTERNATIONAL JOURNAL OF PHARMACEUTICS
(2023)
Article
Pharmacology & Pharmacy
Lena Hoffmann, Joerg Breitkreutz, Julian Quodbach
Summary: In this study, 3D printed tablets containing enalapril maleate were produced using Fused deposition modeling (FDM) technology, and two different formulations were prepared to investigate drug degradation during the printing process. Despite attempts to prevent degradation using various methods, it was not completely successful, but significant differences in degradation levels were observed between formulations with different polymers.
Article
Pharmacology & Pharmacy
Lukas C. Lammerding, Joerg Breitkreutz
Summary: The study investigated the use of inkjet printing as a manufacturing technology for dissolvable microneedle array patches. It was found that using printing method could precisely control the dosage and reduce drug waste. This study demonstrated the potential of inkjet printing technology in the manufacturing of personalized microneedle array patches.
INTERNATIONAL JOURNAL OF PHARMACEUTICS
(2023)