- Drug Solubulity and Delivery Systems
- Protein purification and stability
- Material Dynamics and Properties
- Crystallization and Solubility Studies
- Analytical Chemistry and Chromatography
- Liquid Crystal Research Advancements
- Thermodynamic properties of mixtures
- Microfluidic and Capillary Electrophoresis Applications
- Chemical Thermodynamics and Molecular Structure
- Viral Infectious Diseases and Gene Expression in Insects
- Safe Handling of Antineoplastic Drugs
- Inhalation and Respiratory Drug Delivery
- Glass properties and applications
- Microencapsulation and Drying Processes
- Crystallography and molecular interactions
- Pharmaceutical studies and practices
- Intravenous Infusion Technology and Safety
- Surfactants and Colloidal Systems
- Analytical Methods in Pharmaceuticals
- Advanced Drug Delivery Systems
- Theoretical and Computational Physics
- Pharmaceutical Quality and Counterfeiting
- Proteins in Food Systems
- Biosimilars and Bioanalytical Methods
- Polysaccharides Composition and Applications
Merck & Co., Inc., Rahway, NJ, USA (United States)
2012-2025
United States Military Academy
2017-2020
University of Wisconsin–Madison
2005-2015
Abbott (United States)
2010
Australian National University
2008
Cross-nucleation between polymorphs is a newly discovered phenomenon important for understanding and controlling crystal polymorphism. It contradicts Ostwald's law of stages other theories crystallization in polymorphic systems. We studied the spontaneous seeded melt 5-methyl-2-[(2-nitrophenyl)amino]-3-thiophenecarbonitrile (ROY), currently most system known structures. observed extensive sometimes selective cross-nucleation ROY polymorphs. Certain could not nucleate without aid others. The...
A remarkable property of certain glass-forming liquids is that a fast mode crystal growth activated near the glass transition temperature Tg and continues in glassy state. This mode, termed GC (glass-crystal), so it not limited by molecular diffusion bulk liquid. We have studied growing seven polymorphs from liquid ROY, currently top system for number coexisting known structures. Some did show growth, while others did, with latter having higher density more isotropic packing. The showing...
Molecular liquids can develop a fast mode of crystal growth ("GC growth") near the glass transition temperature. This phenomenon remains imperfectly understood with several explanations proposed. We report that GC in o-terphenyl conserves overall volume, despite 5% higher density crystal, and produces fine grains same unit cell as normally grown crystals. These results indicate continuously creates voids free surfaces, possibly by fracture. aspect has not been considered previous treatments...
Formulation development of biologics is key for ensuring the safety and efficacy drug products such as monoclonal antibodies (mAbs) due to their complex degradation aggregation pathways. Work has been completed by collaborators on linking cluster formation viscosity1 employing coarse grained modeling understand protein-protein interactions in relevant formulations2. While formulation screening approaches exist dilute concentration regime (1-10 mg/mL), a deeper understanding needed with...
The liquid dynamics of 5-methyl-2-[(2-nitrophenyl)amino]-3-thiophenecarbonitrile, named ROY for its red, orange, and yellow crystal polymorphs, was characterized by dielectric spectroscopy differential scanning calorimetry. Four these polymorphs show fast “diffusionless” growth at low temperatures while three others do not. found to be a typical fragile organic liquid. Its α relaxation process has time-temperature superposition symmetry across the viscous range (τα=100 s–100 ns) with width...
Crystal engineering of pharmaceuticals through co-crystallization provides a new strategy for altering the physical and chemical properties solid forms active pharmaceutical ingredients (APIs). The understanding structure–property relationship co-crystals containing chiral agent (PA) co-crystal former (CCF) is great importance to application in pharmaceuticals. We report here first example solutions formed between opposite enantiomers: (ibuprofen)2(4,4′-dipyridyl) (1) co-crystals. discovered...
The objective of this study was to develop hydroxypropyl methylcellulose (HPMC) based controlled release (CR) formulations via hot melt extrusion (HME) with a highly soluble crystalline active pharmaceutical ingredient (API) embedded In the polymer phase. HPMC is considered challenging CR for due its high glass transition temperature (Tg), low degradation temperature, and viscosity. These problems were partially overcome by plasticizing up 40% propylene glycol (PG). Theophylline selected as...
o -terphenyl is one of the organic liquids in which a fast mode crystal growth activated near glass transition temperature Tg and continues deep glassy state. This mode, termed glass-crystal (GC), not limited by molecular diffusion bulk liquid, contrast to diffusion-controlled at higher temperatures. The GC has been previously described as abruptly emerging having constant rate fixed temperature, two features important for testing its various explanations. We report here that already exists...
Particles in biopharmaceutical products present high risks due to their detrimental impacts on product quality and safety. Identification quantification of particles drug are important understand particle formation mechanisms, which can help develop control strategies for during the formulation development manufacturing process. However, existing analytical techniques such as microflow imaging light obscuration measurement lack sensitivity resolution detect with sizes smaller than 2 μm. More...
Silicone oil is often applied to the inner surface of glass syringes and cartridges reduce friction between elastomeric plunger stopper. This can appear as intrinsic non-proteinaceous particles in ejected fluid or drug product. Limited data available understand impact age (time syringe manufacture filling) on silicone migration into study compares subvisible particle count extrusion force siliconized from two different manufacturers stored at ambient condition for 2-3 (fresh syringes) 13-14...
High-concentration protein formulation is of paramount importance in patient-centric drug product development, but it also presents challenges due to the potential for enhanced aggregation and increased viscosity. The analysis critical quality attributes often necessitates transfer samples from their primary containers together with sample dilution. Therefore, there a demand noninvasive, situ biophysical methods assess products directly sterile containers, such as prefilled syringes, without...
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Protein drugs exhibit challenges of biophysical and biochemical instability due to their structural complexity rich dynamics. Solid-state biologics aim enhance stability by increasing molecular rigidity within the formulation matrix, representing a primary category drug products alongside sterile liquid formulations. Understanding mechanisms behind stabilization destabilization protein drugs, influenced composition drying processes, provides scientific rationale for product design. This...
Microsymposia P21 with Z = 2.The molecules are stacking along the b axis(Figs.)to construct two types of water channel structures (I and II) in dihydrate crystal.The hydrogen bond donor/accepter distances suggest that I forms stronger bonds than II.Therefore, first dehydration from may occur through II to form monohydrate crystal without m a j o r l e c u n f t i change.Then be eliminated w h p y s Lisinopril molecule.