Small Molecule Drugs

HORIBA offers a comprehensive suite of spectroscopic and particle characterization methods for small molecule therapeutics, crucial throughout the drug development lifecycle from formulation to quality control.

Spectroscopic Techniques:

• Raman Spectroscopy: This non-destructive technique excels at providing detailed chemical and molecular information, enabling the identification and characterization of small molecule APIs, excipients, and potential polymorphs. It's valuable for verifying raw materials, detecting counterfeit drugs, analyzing formulations, and identifying contaminants. Raman microscopy allows for spatial distribution analysis within solid dosage forms like tablets. HORIBA offers confocal and non-confocal Raman solutions to meet a variety of industrial and academic needs.
• Fluorescence Spectroscopy: While less universally applicable to all small molecules, fluorescence can be highly sensitive for specific compounds or for studying interactions between drug molecules and other components in a formulation. A-TEEM (Absorbance, Transmittance, and Fluorescence Excitation-Emission Matrix) spectroscopy can provide a comprehensive spectral fingerprint. Fluorescence is typically effective for molecules with an aromatic ring and conjugated bonds.
• X-ray Fluorescence (XRF): This technique is particularly useful for elemental analysis and can be employed to identify inorganic components or contaminants in small molecule formulations.

Particle Characterization Techniques:

For solid small molecule therapeutics, particularly powders and formulations, HORIBA offers a range of particle sizing and characterization methods:

• Laser Diffraction: This is a widely used technique for determining the particle size distribution of powders and suspensions, crucial for controlling dissolution rates, bioavailability, and formulation stability.
• Dynamic Light Scattering (DLS): Ideal for characterizing the size of nanoparticles and molecules in solution, DLS can also provide information about molecular weight. HORIBA also offers a DLS solution that can measure Zeta potential and size distribution.
• Nanoparticle Tracking Analysis (NTA): This technique allows for the determination of particle size distribution and concentration of nanoparticles in liquid formulations. As a qualifier, NTA is only applicable to small molecules that are conjugated to a nanoparticle or interact with nanoparticles.
• Image Analysis: Automated image analysis systems can provide information on particle size, shape, and count, which is important for solid dosage form development and quality control.
• Zeta Potential Measurement: This technique assesses the surface charge of particles in suspension, which is critical for predicting stability and preventing aggregation in liquid formulations.

By offering this diverse array of spectroscopic and particle characterization tools, HORIBA enables pharmaceutical scientists to gain a deep understanding of the physicochemical properties of small molecule therapeutics, ensuring their quality, efficacy, and safety throughout their development and manufacturing.