Red Blood Cells and Lipoproteins: Important Reservoirs and Transporters of Polyphenols and Their Metabolites.

Dietary polyphenols are protective for chronic diseases. Their blood transport has not been well investigated. This work examines multiple classes of polyphenols and their interactions with albumin, lipoproteins, and red blood cell (RBC) compartments using four models and determines the % polyphenol in each compartment studied. The RBC alone model showed a dose-response polyphenol association with RBCs. A blood model with flavanones determined the % polyphenol that was inside RBCs and bound to the surface using a new albumin washing procedure. It was shown that RBCs can methylate flavanones. The whole blood model separated the polyphenol into four compartments with the aid of affinity chromatography. More polyphenols were found with albumin and lipoproteins (high-density lipoproteins and low-density lipoproteins) than with RBCs. In the plasma model, the polyphenols associated almost equally between lipoproteins and albumin. RBCs and lipoproteins are shown to be important reservoirs and transporters of polyphenols in blood.

A case study: application of statistical process control tool for determining process capability and sigma level.

Statistical process control is the application of statistical methods to the measurement and analysis of variation process. Various regulatory authorities such as Validation Guidance for Industry (2011), International Conference on Harmonisation ICH Q10 (2009), the Health Canada guidelines (2009), Health Science Authority, Singapore: Guidance for Product Quality Review (2008), and International Organization for Standardization ISO-9000:2005 provide regulatory support for the application of statistical process control for better process control and understanding. In this study risk assessments, normal probability distributions, control charts, and capability charts are employed for selection of critical quality attributes, determination of normal probability distribution, statistical stability, and capability of production processes, respectively. The objective of this study is to determine tablet production process quality in the form of sigma process capability. By interpreting data and graph trends, forecasting of critical quality attributes, sigma process capability, and stability of process were studied. The overall study contributes to an assessment of process at the sigma level with respect to out-of-specification attributes produced. Finally, the study will point to an area where the application of quality improvement and quality risk assessment principles for achievement of six sigma-capable processes is possible. LAY ABSTRACT: Statistical process control is the most advantageous tool for determination of the quality of any production process. This tool is new for the pharmaceutical tablet production process. In the case of pharmaceutical tablet production processes, the quality control parameters act as quality assessment parameters. Application of risk assessment provides selection of critical quality attributes among quality control parameters. Sequential application of normality distributions, control charts, and capability analyses provides a valid statistical process control study on process. Interpretation of such a study provides information about stability, process variability, changing of trends, and quantification of process ability against defective production. Comparative evaluation of critical quality attributes by Pareto charts provides the least capable and most variable process that is liable for improvement. Statistical process control thus proves to be an important tool for six sigma-capable process development and continuous quality improvement.

A biomechanical analysis of the effect of lateral column lengthening calcaneal osteotomy on the flat foot.

BACKGROUND: Biomechanical models have been used to study the plantar aponeurosis, medial arch height, subtalar motion, medial displacement calcaneal osteotomy, subtalar arthroereisis and the distribution of forces in the normal and flat foot. The objective was to examine the hypothesis that increased load on the medial arch in the adult flat foot can be reduced through a 10mm lateral column lengthening calcaneal osteotomy 10 mm proximal from the calcaneal cuboid joint. METHODS: A three dimensional multisegment biomechanical model was used with anatomical data from a normal foot, a flat foot and a foot corrected with a 10mm lateral column lengthening calcaneal osteotomy. The response of a normal foot, a flat foot and a flat foot with a 10mm lateral column lengthening calcaneal osteotomy to an applied load of 683 N was analyzed using the biomechanical model. Data for the biomechanical model was obtained from a cadaver foot using the direct linear transformation method. Direct linear transformation uses multiple cameras to determine the spatial location of anatomical landmarks. FINDINGS: Load on the first metatarsal increases to 37% body weight in the flat foot compared to 12% for the normal foot and the moment about the talo-navicular joint increases from 5.6 N m to 21.6 N m. Lateral column lengthening shifts the load toward the lateral column, decreasing load on the first metatarsal to 10% and decreasing the moment about the talo-navicular joint to 8.1 N m. INTERPRETATION: The analysis shows that a 10mm lateral column lengthening calcaneal osteotomy reduces the excess force on the medial arch in an adult flat foot and adds biomechanical rationale to this clinical procedure.