Engineering topics
Feng, Xin
Publications and source records attributed to Feng, Xin.
The effect of food vehicles on in vitro performance of pantoprazole sodium delayed release sprinkle formulation
Certain patient populations, including children, the elderly or people with dysphagia, find swallowing whole medications such as tablets and capsules difficult. To facilitate oral administration of drugs in such patients, a common practice is to sprinkle the drug products (e.g., usually after crushing the tablet or opening the capsule) on food vehicles before consumption which improves swallowability. Thus, evaluation of the impact of food vehicles on the potency and stability of the administered drug product is important. Here, the aim of the current study was to evaluate the physicochemical properties (viscosity, pH, and water content) of common food vehicles used for sprinkle administration (e.g., apple juice, applesauce, pudding, yogurt, and milk) and their impacts on the in vitro performance (i.e., dissolution) of pantoprazole sodium delayed release (DR) drug products. The food vehicles evaluated exhibited marked difference in viscosity, pH and water content. Notably, the pH of the food as well as the interaction between food vehicle pH and drug-food contact time were the most significant factors affecting the in vitro performance of pantoprazole sodium DR granules. For example, the dissolution of pantoprazole sodium DR granules sprinkled on food vehicles of low pH (e.g., apple juice or applesauce) for short durations remained unchanged compared with the control group (i.e., without mixing with food vehicles). However, use of high pH food vehicles (e.g., milk) with prolonged contact time (e.g., 2h) resulted in accelerated pantoprazole release, drug degradation and loss of potency. Overall, a thorough assessment of physicochemical properties of food vehicles and formulation characteristics are a necessary part of the development of sprinkle formulations.
Determining critical overlap concentration of polyethylene oxide to support excipient safety assessment of opioid products
Intravenous administration of abuse-deterrent opioid products poses high safety risks, in part due to the presence of high molecular weight polymeric excipients. Previous in vivo studies in animal models have shown that the higher molecular weight (Mw) polymeric excipients like polyethylene oxide (PEO) were directly linked to such adverse responses as intravenous hemolysis and kidney damage. PEO polymers have been widely used in abuse-deterrent formulations (ADF) of opioid products, adding to concerns over the general safety of the opioid category due to the unknown safety risk from abuse via unintended routes. Here, the current study focused on the determination of the critical overlap concentration (c*) at various PEO molecular weights to aid in explaining differences in observed adverse responses from previous animal studies on the intravenous administration of PEO solutions. Adverse in vivo responses may be related to the viscoelastic regime of the polymer solution, which depends not only on Mw but also on concentration. Having a localized polymer concentration in the blood above the c*, i.e., the transition from the dilute to semi-dilute entangled viscoelastic regime, may influence the flow behavior and interactions of cells in the blood. The relationship of c* to this combination of physical, chemical, and rheological effects is a possible driving force behind adverse in vivo responses.
Understanding syringeability and injectability of high molecular weight PEO solution through time-dependent force-distance profiles
Opioid medications play a vital role in treating moderate to severe pain. Unfortunately, many drug misusers and abusers attempt to alter the formulations or properties of these drugs by manipulation, (e.g., crushing, chewing, smoking, snorting, injecting). The intravenous (IV) route is most dangerous to abusers, as the drugs directly enter the circulatory system and produce intense euphoria. To obtain a full understanding of the impact of syringe factors (e.g., needle gauge size, needle length, syringe barrel size), on the ease of injection, we undertook a comprehensive assessment of syringeability and injectability of manipulated abuse-deterrent formulations (ADFs). A texture analyzer-based testing method was developed for the measurement of the resistance force of pulling, holding, and pushing phases of injections. Results showed that the finer needle gauge sizes required higher injection force to withdraw drug solutions. In addition, the syringed liquid volume was highly dependent on needle gauge size, holding time, and sample viscosity. In most cases, a lower needle gauge number and a longer holding time increased the syringed volume. Needle length was highly correlated to injection force (R 2 = 0.99). Using longer needles to inject drug solution requires greater force. Furthermore, large barrel size was correlated to pushing force (R 2 = 0.99); thus, increasing the difficulty of pushing the plunger of a large syringe with one hand. Lastly, relationships between injection force, sample viscosity, and testing conditions were elucidated using a mathematical model, which could be used in the future to assess and predict injection force of solution samples.
Assessment of Manufacturing Related Deficiencies for Modified Release Tablet in Abbreviated New Drug Applications
Not provided.
spopt: a python package for solving spatial optimization problems in PySAL
Spatial optimization is a major spatial analytical tool in management and planning, the significance of which cannot be overstated. Spatial optimization models play an important role in designing and managing effective and efficient service systems such as transportation, education, public health, environmental protection, and commercial investment among others. To this end, spopt (spatial optimization) is under active development for the inclusion of newly proposed models and methods for regionalization, facility location, and transportation-oriented solutions (Feng et al., 2021). Spopt is a submodule in the open-source spatial analysis library PySAL (Python Spatial Analysis Library) founded by Dr. Sergio J. Rey and Dr. Luc Anselin in 2005 (Rey et al., 2015, 2021; Rey & Anselin, 2007). The goal of developing spopt is to provide management and decision-making support to all relevant practitioners and to further promote the appropriate and meaningful application of spatial optimization models in practice.
An intelligent control and virtual display system for evolutionary space station workstation design
Research and development of the Advanced Display and Computer Augmented Control System (ADCACS) for the space station Body-Ported Cupola Virtual Workstation (BP/VCWS) were pursued. The potential applications were explored of body ported virtual display and intelligent control technology for the human-system interfacing applications is space station environment. The new system is designed to enable crew members to control and monitor a variety of space operations with greater flexibility and efficiency than existing fixed consoles. The technologies being studied include helmet mounted virtual displays, voice and special command input devices, and microprocessor based intelligent controllers. Several research topics, such as human factors, decision support expert systems, and wide field of view, color displays are being addressed. The study showed the significant advantages of this uniquely integrated display and control system, and its feasibility for human-system interfacing applications in the space station command and control environment.