Small Molecule Drugs

Raman Spectroscopy is a powerful and widely used analytical tool within the pharmaceutical industry. Excipients and active pharmaceutical ingridients (APIs) can be analysed within seconds, and extensive Raman spectral libraries allow easy chemical identification.

The objective of the measurements is to identify the unknown components and their respective dispersion within pharmaceutical tabs by Raman and FT-IR microspectrometry.

Resulting from the combination of Raman spectroscopy and optical microscopy, Raman hyperspectral imaging has proven to be an indispensable tool in the pharmaceutical field, especially to study the distribution of active(s) and excipients in a pharmaceutical drug product.

We introduced a fast and non-destructive imaging method for inorganic minerals on a multivitamin supplement tablet containing various essential minerals to body functions. We used the HORIBA XGT-9500 X-ray Analytical Microscope for the imaging, and we could visualize the distribution of the key inorganic elements on the tablet less than 20 minutes even though the concentration of the elements are tens of mg or less per tablet.

Exosomes are small extracellular vesicles, 30-150 nm in diameter, which have been determined to play a crucial role in extracellular signaling. They have been observed in both prokaryotic and eukaryotic organisms, meaning they are incredibly widely spread in nature. Exosomes bud off from their parent cells in a sealed package, taking the properties of their parent cell walls with them and encasing many intracellular components.

To an outsider to the pharmaceutical industry, the notion of D-values (e.g. D10, D50, D90) being a measure of particle size and distribution is a difficult concept to accept. Basic statistics and a common understanding of distributions might dictate that, provided one is allowed to assume that the particles are relatively spherical, the most logical means of quantifying the particle size of a sample would be to use the mean diameter and standard deviation values.

One of the major challenges in the pharmaceutical development of a new product consists in its formulation, highly impacting the release and the efficiency of the active molecules in the body.

An imaging platform that combines Raman microscopy with enhanced darkfield and hyperspectral imaging technology was used to study lung tissue sections containing carbon nanotubes. It enabled easy identification of the regions containing the carbon nanotubes followed by spectroscopic characterization of chemical composition.

Packaging must provide protection, minimize the loss of constituents and should have no physical or chemical interaction which could alter the quality or present a toxicity risk. With its high degree of versatility, the XGT-9500, HORIBA’s new X-ray microscope, is the perfect tool for the pharmaceutical industry as it can be easily applied within industrial settings, as well as R&D.

Nutraceuticals are the intersection of nutrition and pharmaceutical and is an umbrella term that can also include functional foods and dietary supplements. Nutraceutical researchers working to improve the bioavailability, biocompatibility, and stability of various formulations measure particle size, particle shape, and zeta potential.

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.

Dry powder inhalers (DPIs) are devices that deliver medications to the lungs to treat respiratory diseases such as asthma and chronic obstructive pulmonary disease (COPD). Microscopic analysis provides useful information on both particle size and shape distributions of the powder products. Automated image analysis now facilitates quantitative particle size and shape distribution data that can prove valuable to both formulators and quality control efforts.

Metered-dose inhalers (MDIs) are devices that deliver a specific quantity of drug to the lungs. The size and shape of the micronized drug greatly influence the deposition profile in the lungs of the patient. Although the compendial tests for MDIs are based on cascade impactors, microscopic analysis is recommended by regulatory guidance documents and delivers important information.

For the study of a pharmaceutical drug product, particle characteristics (count, size and chemistry) and compound distributions (size and spatial) are among key parameters that strongly determine the quality of the product due to their huge impact on the dissolution rate (and thus bioavailability) for the final solid dosage form. Laser diffraction and Raman microscopy were applied to highlight the benefits of combining two technologies for particle characterization.

Many particle size measurements are made to track size reduction operations such as milling, mixing, homogenizing, etc. The choice of particle size analysis technique can be based on the size distribution of the input, output, or both. Laser diffraction is the most common analysis technique for monitoring size reduction operations due to its very broad dynamic range.

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.

Since the physical state can affect the pharmaceutical behavior of drug substances, it is important to know what controls crystallization, solid state reactions, phase stability, and solubility.

During the last 5-10 years, the molecular solid state has gained recognition by the pharmaceutical industry for its role in drug manufacturing, stability, and activity. In addition, definition of the crystalline phase has become as important as molecular composition in patent protection.

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.

Raman spectroscopy is well known as a powerful analytical method for qualitative chemical analysis. Less well known is that under certain conditions Raman spectroscopy can also be an effective method for quantitative analysis. Here we demonstrate that capability for quantitative analysis under a variety of conditions, involving different solutes in a solution and solution mixtures, and its applications to pharmaceutical analysis such as content uniformity.

Raman Spectroscopy has many useful properties which can be explored and exploited in the analysis of pharmaceutical formulations.

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.

Pharmaceutical and crystallographic samples typically require detailed characterisation and analysis to optimise a samples stability, physical properties and indeed general efficacy where an active drug substance is involved. Furthermore, strict regulatory and manufacturing procedures demand precise characterisation of a solid salt form drug candidate and the possible influence of environmental conditions. The hydration and structure of such samples under varying conditions is important in this full characterisation.

Full and detailed characterization of pharmaceutical formulations is required before release of new drugs. When exposed to warm and humid weather over time, ingredients may undergo change in their hydration level, thus affecting the properties and/or efficiency of the drug. Raman spectroscopy, combined to a temperature and humidity controller can mimic such harsh conditions and can be used to monitor the properties of the different ingre-dients and track their modifications induced by environmental changes.

Successful ophthalmic drug delivery is a combination of pre-corneal retention time, corneal permeability, effectiveness of drug absorption, and dose-to-dose consistency. Whether the drug product is a suspension or microemulsion, it is a complex application involving careful analyses, research, and development efforts.

Process Analytical Technology, or “PAT” is the term given to analytical instruments developed to measure certain attributes of product within the manufacturing process, eliminating, or substantially minimizing the need for sampling for off-line analysis. This approach offers process measurements in-situ with instant access to data, which facilitates rapid decisions during product development and manufacture.

The most common application for static image analysis systems is currently the characterization of active pharmaceutical ingredients (APIs). Pharmaceutical laboratories around the world are investing in image analysis systems as a valuable tool for complete particle size and shape characterization of dosage forms including solid oral, aerosol, and transdermal.

The use of the transmission raman mode instead of the traditional backscattering one brings additional flexibility for the analysis of material, especially when averaged information of bulky samples is required.

A virus particle consists of several parts including the genetic material (DNA or RNA), a protein coat that protects these genes, and in some cases an envelope of lipids that surrounds the protein coat when they are outside a cell. The size of viruses ranges from a few tens to a few hundreds of nm, which is equal to 1/100 to 1/1000 of the cell (a few to a few tens of μm in size) of any other common living organism.

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