Pharmaceuticals and Medicine Manufacturing

The pharmaceutical and medicine manufacturing industry develops and produces a variety of medicinal and other health-related products that save the lives of millions of people from various diseases. This industry is primarily engaged in manufacturing biological and medical products, processing and isolating active medical principles from botanical drugs and herbs, manufacturing pharmaceutical products intended for internal and external consumption in such forms as tablets, capsules, ointments, powders and solutions.

HORIBA offers a large choice of innovative technologies such as Fluorescence spectroscopy, Raman spectroscopy, Surface Plasmon Resonance Imaging, Particle Size Analyzers, Capacitance manometer and gas monitor Micropole systems that contribute to the quality and performance of drugs manufacturing.

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Protein aggregation is an important concern when developing and manufacturing biotherapeutics. It is important to quantify protein aggregation and particle formulation as this data is needed to guide formulation development, evaluate handling requirements, and monitor product quality.

Raman Hyperspectral Imaging: An essential tool in the pharmaceutical field

Resulting from the combination of Raman spectroscopy and optical microscopy, Raman hyperspectral imaging has proven to be an indispensable tool in the pharmaceutical field. This article will broach a number of Raman hyperspectral imaging applications that were developed in our laboratory, in order to demonstrate the significance of the technique.

Many particle size measurements are made to track size reduction operations such as milling, mixing, homogenizing, etc. Laser diffraction is the most common analysis technique for monitoring size reduction operations due to its very broad dynamic range.

The Detection of a Low Molecular Weight Enzyme Inhibitor using the OpenPlex system

The use of low molecular weight molecules in the industries of drug discovery and agri-food has become increasingly important over the course of a century of drug research and science development in agriculture and in pharmaceutical field.

The study of protein aggregation encompasses a broad range of interactions and mechanisms. The LA-960 laser diffraction particle size analyzer possesses the unique ability to measure from 10 nanometers to 5 millimeters, accurately detecting the aggregates and, in some cases, the primary protein size.

The Detection of an Ultralow Molecular Weight Enzyme Inhibitor using the XelPleX™ system

Detection of low molecular weight molecules can be useful especially for pharmaceutical and agri-food applications. This application note is focused on the detection of a 157 Dalton molecule, the benzenesulfonamide, using the XelPleX system. The benzenesulfonamide is an inhibitor of the human carbonic anhydrase enzyme type II (CAII).

The size of a protein is an important physical characteristic that provides useful information including the presence of monomers, dimer and trimer, changes in conformation, aggregation state, and denaturation. Protein scientists typically discuss “protein size” or molecular weight, as opposed to using the phrase “particle size”, but particle size analyzers are often used in their studies.

Pharmaceutical aerosols including metered-dose inhalers (MDIs) and dry powder inhalers (DPIs) are devices that deliver a specific quantity of drug to the lungs. The particle size distribution and shape of the delivered dose is more critical for inhalation aerosols than for most other conventional drug products because these factors greatly influence the deposition profile in the lungs of the patient.

The particle size distribution of active ingredients and excipients is an important physical characteristic of the materials used to create pharmaceutical products. The size, distribution and shape of the particles can affect bulk properties, product performance, processability, stability and appearance of the end product.

Vitamins are classified by their biological and chemical activity, not by their structure. They are grouped under an alphabetized generic descriptor title such as vitamin A that includes the compounds retinal, retinol, and four carotenoids.

Nutraceuticals are food extracts that have been demonstrated to produce a physiological benefit or provide some protection against chronic disease. Nutraceuticals are the intersection of nutrition and pharmaceutical and can also include functional foods and dietary supplements.

Spectroscopic Methods for Sunscreens Characterization

This Application Note outlines three different kinds of spectroscopic tools being used for the characterization of sunscreens, and discusses the obtained results. These include Fluorescence spectroscopy for photoactivity, Particle Size analysis for composition and Raman microscopy for formulation investigation.

For determination of grain size and roundness of globules, quick and objective measurement methods are required to guarantee high analytical accuracy as well as high product throughput.

Laser diffraction particle size analyzers offer the same benefits in speed, precision, and reliability to nutraceutical materials that have made the technique popular in the pharmaceutical industry.

In this study, dynamic image analysis is used in the pharmaceutical industry to define the size and shape of granules created through a dry granulation process.

API image taken by PSA300

This application note summarizes the reasons why static image analysis is becoming a popular technique for characterizing APIs.

Sub-visible Particles from ViewSizer 3000

The ViewSizer™ 3000 enables scientists to visualize and quantify the kinetics of protein aggregation in real-time for biologic therapeutics under a variety of stress conditions.

Fast and non-invasive determination of skin

Biological tissues contain chromophores that absorb light, as well as fluorophores that absorb and reemit light (fluorescence effect). Light absorption depends on the chromophores’ content and their distribution within the organic matter.

The choice of protecting group is of crucial importance in the success of many steps in organic synthesis and the manipulation of polyfunctional molecules, since they can prevent the formation of undesired side products and reactions.

Freeze Dry_Pharma

Spectroscopic Methods for Sunscreens Characterization

This Application Note outlines three different kinds of spectroscopic tools being used for the characterization of sunscreens, and discusses the obtained results. These include Fluorescence spectroscopy for photoactivity, Particle Size analysis for composition and Raman microscopy for formulation investigation.

Many cosmetic products include particulate material or emulsions. Some examples of cosmetic products consisting of or including particulates include facial powders, moisturizers, and lipstick. The particle size distribution of these components effects appearance, stability, and protection.

Valuable analysis tool for cosmetics and skin characterization

Confocal Raman Spectroscopy is an important analytical tool in various fields and it has shown high efficiency for specific applications in the cosmetic and/or pharmaceutical fields. Its non-invasive behavior, and its high molecular sensitivity make it one of the preferred label-free analytical techniques to characterize materials such as skin and cosmetic products.

This study utilizes the PSA300 automated image analysis system to quantify the size and shape of various ointments and creams.

Fast and non-invasive determination of skin

Biological tissues contain chromophores that absorb light, as well as fluorophores that absorb and reemit light (fluorescence effect). Light absorption depends on the chromophores’ content and their distribution within the organic matter.

Teeth are naturally fluorescent and changes in their composition, caused by decay for example, affect their fluorescence behavior.

The fluorescence spectra of intrinsic protein fluorophores have been studied extensively and used in investigating biological events.

Noninvasive In-Vivo Determination of Sunscreen-UVA Protection Factors

The development and evaluation of UVA (320–400 nm) sunscreens is important because UVA sunlight can penetrate deep into human skin and cause severe internal damage, as well as erythema and photoaging.

Confocal Raman spectroscopy is beginning to be recognized as a high potential technique for the non invasive study of biological tissues and human skin under in vivo conditions. Raman spectroscopy can be applied to obtain information regarding the molecular composition of the skin down to several hundred micrometers below the skin surface.

Many solid oral dosage forms are based upon coating sugar spheres with layers of active ingredient, binders, and coatings. The size and shape of the beginning sugar spheres (also called nonpareil beads) are critical physical characteristics that should be carefully measured and controlled.

The LA-960 Particle Size Analyzer and SZ-100 Nanoparticle Analyzer may be used to measure the particle size distribution and zeta potential for drug delivery vehicles. These characteristics directly affect bioavailability, dissolution, immunotoxicity, amongst other critical formulation factors.

The Detection of a Low Molecular Weight Enzyme Inhibitor using the OpenPlex system

The use of low molecular weight molecules in the industries of drug discovery and agri-food has become increasingly important over the course of a century of drug research and science development in agriculture and in pharmaceutical field.

The Detection of an Ultralow Molecular Weight Enzyme Inhibitor using the XelPleX™ system

Detection of low molecular weight molecules can be useful especially for pharmaceutical and agri-food applications. This application note is focused on the detection of a 157 Dalton molecule, the benzenesulfonamide, using the XelPleX system. The benzenesulfonamide is an inhibitor of the human carbonic anhydrase enzyme type II (CAII).

For determination of grain size and roundness of globules, quick and objective measurement methods are required to guarantee high analytical accuracy as well as high product throughput.

This application note describes two experiments where laser diffraction proved capable of determining both the base biopolymer nanoparticles and also larger particles outside of the range of DLS.

The choice of protecting group is of crucial importance in the success of many steps in organic synthesis and the manipulation of polyfunctional molecules, since they can prevent the formation of undesired side products and reactions.

Raman Microscopy in Pharmaceutical Salt Analysis

Pharmaceutical and crystallographic samples typically require detailed characterization and analysis to optimize a samples stability, physical properties and indeed general efficacy where an active drug substance is involved.

In this study, dynamic image analysis is used in the pharmaceutical industry to define the size and shape of granules created through a dry granulation process.

Samples can be valuable. Either you don’t want to waste them, or you may not have very much starting material. Biological proteins and enzymes, for example, are often obtained in small volumes and may be expensive.

Determination of pH as Quality Control Test in Culture Media-01

The Detection of a Low Molecular Weight Enzyme Inhibitor using the OpenPlex system

The use of low molecular weight molecules in the industries of drug discovery and agri-food has become increasingly important over the course of a century of drug research and science development in agriculture and in pharmaceutical field.

The Detection of an Ultralow Molecular Weight Enzyme Inhibitor using the XelPleX™ system

Detection of low molecular weight molecules can be useful especially for pharmaceutical and agri-food applications. This application note is focused on the detection of a 157 Dalton molecule, the benzenesulfonamide, using the XelPleX system. The benzenesulfonamide is an inhibitor of the human carbonic anhydrase enzyme type II (CAII).

Monitoring Cell Culture Media Variability using A-TEEM Spectroscopy

With the rise of protein production using mammalian cell culture, it has become increasingly important to control the quality of the cell culture media for use in production processes. Cell culture media are usually prepared as aqueous solutions and should provide everything a cell line needs for optimal cell growth as well as product yield and quality.

Holistic Analysis of Mammalian Cell Proliferation using Fluorescence Spectroscopy

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5401 DO Electrode Tip

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Reference Electrode 2565A-10T

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84 uS/cm Conductivity Standard Solution

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3553-10D Conductivity Cell (Submersible Type)

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9680S-10D Long ToupH electrode (for large containers and long tubes)

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pH 9.18 Buffer Solution

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Temperature Compensation Electrode 4163-10T

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12.88 mS/cm Conductivity Standard Solution

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3561-10D Conductivity Cell (Flow Type)

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1000 mg/L Ammonium Ion Standard Solution

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9681S-10D Sleeve ToupH electrode (for viscous and non-aqueous samples)

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pH 10.01 Buffer Solution

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111.8 mS/cm Conductivity Standard Solution

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Salt electrode S021

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pH 12.46 Buffer Solution

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Calcium ion electrode tip 7683S

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100 mg/L Calcium Ion Standard Solution

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TPNA-500

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9630-10D (for low conductivity samples)

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9631-10D (for hydrofluoric acid or HF samples)

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Cyanide ion electrode 8001-10C

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1000 mg/L Fluoride Ion Standard Solution

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9632-10D (for strong alkali samples)

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Chloride ion electrode 8002-10C

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6367-10D (for high accuracy pH measurement)

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Sulfide ion electrode 8003-10C

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100 mg/L Nitrate Ion Standard Solution

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PSA300*

Static Image Analysis System Particle Size

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6377-10D (for low-conductivity samples and non-aqeous solvents)

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Bromide ion electrode 8005-10C

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6252-10D (for food samples)

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LAQUA DO210

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For measurement of low-conductivity water and non-aqueous solvents.

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6069-10C (for very slender test tubes)

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Lead ion electrode 8008-10C

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MESA-50

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FS-01FC-SL Series

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Sanitary Conductivity Sensor (Flow Through type) for Low Concentrations