Pharmaceuticals and Medicine Manufacturing

Multiple Characterizations of a Blister Pack Using the XGT-9000

The XGT-9000 is HORIBA’s new X-ray microscope. Its analytical versatility allows, multiple characterizations to be performed on a blister pack, from mapping of the full pack to particle size measurements of the capsule content.

We have measured solutions of lysozyme under conditions known to effect its physical state in order to investigate the potential of Raman spectroscopy as a non-invasive and label-free tool to assess protein formulation stability. Results from this study identified specific Raman signature bands in this protein that can be used to identify individual amino acid residues that are reflect structural changes in proteins.

In this note, the upstream process of analyzing viral preparations is addressed, as well as the use of multi-laser nanoparticle tracking analysis (NTA) as a cost and time efficient method to measure size, count virus particles, and correlate to infectious titer.

Pharmaceutical compounds distribution and cosmetic products analyzed by confocal Raman spectroscopy

In the final step of the formulation process, pharmaceutical and cosmetic industries have to control their products to check if the compounds' distribution in the final product, or in its application form, i.e. dispersed on a skin for an intracutaneous product, are homogenous and stable in order to guarantee the product's efficacy. In this paper, we present why confocal Raman microscopy is an excellent tool for product characterization after formulation.

X-ray Fluorescence photons can be partially absorbed by the encapsulated material and will not show in the spectrum. The X-ray transmission image provides a complete picture.

Polymorphisms characterization: when Raman microscopy supports the pharmaceutical industry

Polymorphisms characterization of active molecules is one piece of important information for the pharmaceutical industry, not only on raw powders, but also in the final form. Raman microscopy remains the most appropriate solution for this application. In this paper, we present an example of polymorphisms characterization by Raman microscopy using the super low frequency module.

Application note: Morphological and chemical characterization of pharmaceutical formulations

In order to control formulations of pharmaceutical products, characterizing their active compounds is critical, especially in terms of morphological and chemical characterization of particles. In this application note, two formulations from a generic and an innovator nasal spray have been analyzed to compare their compounds size and shape, and chemically characterized to compare the two formulations based on the ParticleFinderTM app for LabSpec 6. A focus is done on the active compound.

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 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.

Liposomes are bilayer vesicles made of phospholipids derived from natural or man-made materials. They are mainly used in the pharmaceutical field for treatment of cancers as carriers of chemotherapeutic drugs to the tumor area.

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.

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.

In the final step of the formulation process, pharmaceutical and cosmetic industries have to control their products to check if the compounds' distribution in the final product, or in its application form, i.e. dispersed on a skin for an intracutaneous product, are homogenous and stable in order to guarantee the product's efficacy. In this paper, we present why confocal Raman microscopy is an excellent tool for product characterization after formulation.

Iron oxides are magnetic black materials. The methicone treatment adds a degree of “slip” to the particles allowing for better color saturation although they still remain magnetic.

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.

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.

The XGT-9000 is HORIBA’s new X-ray microscope. Its analytical versatility allows, multiple characterizations to be performed on a blister pack, from mapping of the full pack to particle size measurements of the capsule content.

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 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.

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.

The XGT-9000 is HORIBA’s new X-ray microscope. Its analytical versatility allows, multiple characterizations to be performed on a blister pack, from mapping of the full pack to particle size measurements of the capsule content.

In the final step of the formulation process, pharmaceutical and cosmetic industries have to control their products to check if the compounds' distribution in the final product, or in its application form, i.e. dispersed on a skin for an intracutaneous product, are homogenous and stable in order to guarantee the product's efficacy. In this paper, we present why confocal Raman microscopy is an excellent tool for product characterization after formulation.

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.

We have measured solutions of lysozyme under conditions known to effect its physical state in order to investigate the potential of Raman spectroscopy as a non-invasive and label-free tool to assess protein formulation stability. Results from this study identified specific Raman signature bands in this protein that can be used to identify individual amino acid residues that are reflect structural changes in proteins.

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

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.

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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