Method and Apparatus for Detecting Microorganisms Within a Liquid Product in a Sealed Vial

An apparatus and method are provided for the noninvasive and nondestructive detection of microorganisms within a liquid product contained within a sealed vial. The apparatus includes a near-IR light source that produces both incident and reference beams having a wavelength between 800 and 2500 nm and, more preferably, 1100 and 1360 nm. The apparatus also includes an integrating sphere having incident and reference beam ports and a sample window opposite the incident beam port. A detector is mounted in the integrating sphere substantially adjacent the sample window. A substantially U-shaped mirror is provided to hold the vial. The U-shaped mirror is of a size substantially corresponding to the diameter of the vial. In operation, the incident beam is directed through a sample window so as to enter the vial adjacent a sidewall of the mirror. In this way the U-shaped mirror reflects the incident beam so that it passes through the vial three times before returning to the detector. A computer analyzes the resulting signals from the detector

Apparatus and Method for Noninvasive Chemical Analysis

A method and apparatus are provided for magnetohydrodynamic acoustic-resonance, near-IR spectroscopy. The method includes a step of applying to a subject under study a magnetic field having a strength between 2,00-10,000 gauss, near-IR radiation having a wavelength between 800-3,000 nm and an acoustic wave having a frequency between 10 khz-1 Mhz. The method also includes the steps of inducing vibration of ions in the magnetic field and detecting an electric wave generated magnetohydrodynamically by the acoustic wave induced vibration of the ions. Next is the collecting of the electrical, acoustical and near-IR spectra and the analyzing of the collected spectra. The spectra is analyzed in a hyphenated, multidimensional fashion

Method and System for In Situ Spectroscopic Evaulation of an Object

A method and system for spectroscopically determining surface and product characteristics is employed for rapid detection of product characteristics and/or the presence or absence of suspected analytes, and the concentration of the analyte. The method and system uses a signal wide band detector that does not require focusing optics in many environments. It can be used for cleaning validation of pharmaceutical products and process equipment

Apparatus and Method for Noninvasive Chemical Analysis

A method and apparatus are provided for magnetohydrodynamic acoustic-resonance, near-IR spectroscopy. The method includes a step of applying to a subject under study a magnetic field having a strength between 2,00-10,000 gauss, near-IR radiation having a wavelength between 800-3,000 nm and an acoustic wave having a frequency between 10 khz -1 Mhz. The method also includes the steps of inducing vibration of ions in the magnetic field and detecting an electric wave generated magnetohydrodynamically by the acoustic wave induced vibration of the ions. Next is the collecting of the electrical, acoustical and near-IR spectra and the analyzing of the collected spectra. The spectra is analyzed in a hyphenated, multidimensional fashion

Data-Driven Design of an Ebola Therapeutic

Formulation is very important in drug delivery. The wrong formulation can render a drug product useless. The amount of preclinical (animal and in vitro) work that must be done before a new drug candidate can be tested in humans can be a problem. The cost of these cGxP studies is typically $3-$5 million. If the wrong drug product formulation is tested, new iterations of the formulation must be tested with additional costs. Data-driven computational science can help reduce this cost. In the absence of existing human exposure, a battery of preclinical tests must be performed in at least two species before FDA will permit testing in humans. However, for many drugs (such as those beginning with natural products) there is a history of human exposure. In these cases, computer modeling of a population to determine human exposure may be adequate to permit phase 1 studies with a candidate formulation in humans. The CDC’s National Health and Nutrition Examination Survey (NHANES) is a program of studies designed to assess the health and nutritional status of adults and children in the United States. The survey is unique in that it combines interviews and physical examinations including laboratory results. The NHANES database can be mined to determine exposure to a food additive, and early human formulation testing conducted at levels beneath those to which the US population is ordinarily exposed through food. These data can be combined with data mined from international chemical shipments to validate an exposure model. This paper describes the data driven formulation testing process using a new candidate Ebola treatment that, unlike vaccines, can be used after a person has contracted the disease. This drug candidate’s mechanism of action permits it to be potentially used against all strains of the virus, a characteristic that vaccines might not share

Optical Monitoring System with Molecular Filters

An optical monitoring system for determining the constituents of a sample or specimen. An absorption spectrum is obtained from a sample and is passed through one or more filters having a specified absorption spectrum defined by a single atom or a compound. If the filter\u27s absorption spectrum is included in the sample\u27s absorption spectrum, then the sample contains that atom or compound. The apparatus includes a switching assembly that sequentially places one or more filters into the light path to determine if the subject atom or compound is contained in the sample

Apparatus and Method for Multiple Wavelength of Tissue

An apparatus for analyzing the chemical composition of tissue includes a near infrared light source, a fiber-optic probe, a mechanism for directing the light from the light source onto the tissue and detectors for detecting light reflected by the tissue. The light source transmits an incident beam having a wavelength ranging from 1000 to 2500 nm. A compound parabolic concentrator (CPC) is connected to a distal end of the fiber optic probe to focus or concentrate the wavelengths of light simultaneously and in parallel on a particular spot of tissue. Alternatively, an inverted, substantially conical reflector is positioned to scatter the incident light across the tissue. The method includes the steps of (1) focusing light onto the tissue to be analyzed; (2) detecting light reflected by the tissue; and (3) analyzing the resulting spectra across the full wavelength of the originally focused light. A color image is then produced for subsequent study

D-Tagatose-Based Compositions and Methods for Preventing and Treating Atherosclerosis, Metabolic Syndrome, and Symptoms Thereof

Pharmaceutical compositions including D-tagatose along with a stilbene or stilbenoid component, or a salt or derivative thereof. Methods of prophylaxis and therapy by administering to a mammal a pharmaceutically effective amount of D-tagatose, optionally in combination with a stilbene or stilbenoid component, or a salt or derivative thereof to prevent or treat atherosclerosis, the metabolic syndrome, obesity, or diabetes

Innovative Computational Methods for Pharmaceutical Problem Solving a Review Part I: The Drug Development Process

Computational methods have provided pharmaceutical scientists and engineers a means to go beyond what\u27s possible with experimental testing alone. Providing a means to study active pharmaceutical ingredients (API), excipients, and drug interactions at or near-atomic levels. This paper provides a review of this and other innovative computational methods used for solving pharmaceutical problems throughout the drug development process. Part one of two this paper will emphasize the role of computational methods and game theory in solving pharmaceutical challenges

A Brief Review of FDA’s Novel Tools for Ensuring Pharmaceutical Quality in the Human Drug Supply Chain

Purpose Pharmaceutical manufacturers execute quality control operations and Good Manufacturing Practices (GMP) to provide safe drugs. The Federal Drug and Food Administration (FDA) is tasked with ensuring manufacturers are performing such procedures. Faced with limited resources the FDA has developed novel tools to aid pharmaceutical manufacturing oversight. This paper briefly reviews these tools. Methods Current inspection approaches employed by the FDA are identified by searching the FDA’s guidances, the Code of Federal Regulations, public reports and other online resources. Outcomes Industry A risk-based site selection model (SSM) is used to prioritize on-site inspections for FDA investigators. Theoretically, the SSM allows FDA investigators to focus on critical firms that are at high risk of failing to meet quality standards. Analytical testing of drugs is performed by FDA laboratories as well as manufacturers’ laboratories. Despite this, two of the highest profile recalls in the last couple years (valsartan and ranitidine) were not initially identified by the FDA. Instead, Valisure, an online pharmacy that tests each batch of inventory, detected the issues. Physicians and Consumers The FDA has provided easy-to-use online tools for patient and physician reporting of drug quality problems. The FDA has also created consumer education campaigns to aid in protecting patients from fraud and counterfeiting. Conclusion The FDA has developed novel methods of redistributing their workforce to maximize product quality and consumer safety with limited resources. The methods include a risk-based SSM for prioritizing on-site inspections, providing education tools, and online reporting of quality problems. FDA laboratories also provide analytical testing to ensure purity standards are met. The recent publicized discoveries of Valisure are leading other pharmacies such as the University of Kentucky Central Pharmacy to begin testing incoming drugs. It is critical for these pharmacies and the FDA to cooperate to protect the pharmaceutical supply chain