A5022672286- Crystallization and Solubility Studies
- Analytical Chemistry and Chromatography
- X-ray Diffraction in Crystallography
- Analytical chemistry methods development
- Viral Infectious Diseases and Gene Expression in Insects
- Analytical Methods in Pharmaceuticals
- Drug Solubulity and Delivery Systems
- Crystallography and molecular interactions
- Protein purification and stability
- Radioactive element chemistry and processing
- Organometallic Complex Synthesis and Catalysis
- Innovative Microfluidic and Catalytic Techniques Innovation
- Iron Metabolism and Disorders
- Chemical Synthesis and Characterization
- Coordination Chemistry and Organometallics
- Antibiotics Pharmacokinetics and Efficacy
- Advanced Drug Delivery Systems
- Thallium and Germanium Studies
- Trace Elements in Health
- Spectroscopy and Chemometric Analyses
- Hemoglobinopathies and Related Disorders
- Ocular Surface and Contact Lens
- Medical Device Sterilization and Disinfection
- Aluminum toxicity and tolerance in plants and animals
- Magnetism in coordination complexes
Quality Research
2015-2024
United States Food and Drug Administration
2017-2024
Center for Drug Evaluation and Research
2015-2024
University of Iowa
2013
Purdue University West Lafayette
2011
Continuous manufacturing (CM) is an emerging technology in the pharmaceutical sector, and understanding of impact on product quality currently evolving. As final purification isolation step, crystallization has a significant physicochemical properties drug substance considered critical process step achieving continuous substances. Although many publications previously focused various innovative techniques to continuously make crystals with desired properties, engineering difficulties such as...
Trivalent Cp*(2)U(2,2'-bpy) (2) (Cp* = C(5)Me(5), 2,2'-bpy 2,2'-bipyridine), which has a monoanionic bipyridine, was treated with p-tolualdehyde (a), furfuraldehyde (b), acetone (c), and benzophenone (d). Reduction of the C[double bond, length as m-dash]O bond followed by radical coupling bipyridine forms U(iv) derivatives [Cp*(2)U(2,2'-bpy)(OCRR')] (3a-d).
Crystallization has a significant impact on the properties of active pharmaceutical ingredient (API) since it is final step in manufacturing drug substance and determines particle size distribution, purity, shape, polymorphs. Many publications have focused implementation Process Analytical Technology (PAT) tools for monitoring batch continuous operation; however, comprehensive method development validation Raman spectroscopy to monitor crystallization not been presented. This work...
Pharmaceutical crystallization affects the properties of APIs as it determines purity and crystal size distribution, among other attributes. This work presents two CLD–CSD models, theoretical empirical, for a model compound.
Mitigation of failure modes in the continuous synthesis (CS) a drug substance (DS) has potential to widen adoption manufacturing (CM) technologies by pharmaceutical industry.
A scalable continuous manufacturing process for the synthesis and crystallization of form III carbamazepine (CBZ) from iminostilbene (ISB) has been established. high-yielding was first obtained using a plug flow reactor (PFR) then scaled up oscillatory baffled (COBR). real-time in-line Raman spectroscopy method implemented to ensure that conversion starting material ISB product CBZ maintained above 99.0%. The monitored stream telescoped into mixed-suspension mixed-product crystallizer...
Developing a crystallization model that accurately predicts crystal growth and nucleation has been an important topic in the pharmaceutical industry for past few decades. Particularly, as shifts toward continuous manufacturing, modeling will both reduce workload experimental optimization allow development of model-based control systems yield more consistent quality output. In this work, unique approach size-dependent was applied to set batch cooling crystallizations. The carbamazepine (CBZ)...
Relative biodistribution of FDA-approved innovator and generic sodium ferric gluconate (SFG) drug products was investigated to identify differences in tissue distribution iron after intravenous dosing rats. Three equal cohorts 42 male Sprague-Dawley rats were created with each cohort receiving one three treatments: (1) the SFG product dosed intravenously at a concentration 40 mg/kg; (2) (3) saline equivalent volume products. Sampling time points 15 min, 1 h, 8 week, two weeks, four six weeks...
Context. Prussian blue, ferric hexacyanoferrate is approved for (oral) treatment of internal contamination with radioisotopes cesium or thallium. Cyanide makes up 35–40% blue's molecular composition; thus, cyanide may be released during transit through the digestive tract under physiological pH conditions. Objectives. The purpose this study to assess long-term stability blue drug products and active pharmaceutical ingredients its impact on release. involves determination comparison loss in...
Doxycycline hyclate drug product impurities and rapid quantification using a validated UPLC method.