Pharmaceuticals
The Drug Development process requires precision and certainty to craft reliable, effective, and lasting products for the Pharmaceutical market. Step one on this path is identifying and developing the right materials. From bonding excipients to packaging, a detailed understanding of your materials is the key to success in pharmaceutical research and development.
At Particle Characterisation Laboratories (PCL), we have a unique array of characterization techniques available to provide a comprehensive analysis of the properties of your materials. Our expert in-house team will provide detailed insight across a range of factors, and assist your team in accurately predicting the performance of your materials.
Gain detailed material insights you can trust with our pharmaceutical research services.
Special Pharma Service: Amorphous Content Determination
Knowing the amorphous content of pharmaceutical materials is critical, as even small amounts can alter solubility, stability, and drug performance. Undetected amorphous fractions may lead to recrystallization, impacting shelf life, manufacturability, and regulatory compliance.
Our team at Particle Characterisation Laboratory (PCL) has deep expertise in detecting and quantifying amorphous content using advanced techniques such as Dynamic Vapor Sorption (DVS) and Inverse Gas Chromatography (iGC-SEA). Our reports provide the clarity drug developers need to design stable, effective formulations.
Contact us today to employ our Amorphous Content Service and ensure confidence in your formulations.
Pharmaceutical Research Analysis Techniques
- Dynamic Vapor Sorption
- Inverse Gas Chromatography
- Gas Pycnometry
- Particle Size Distribution
- Scanning Electron Microscopy
- Dynamic Light Scattering
- Volumetric Nitrogen Adsorption
- X-Ray Powder Diffraction
- Atomic Force Microscopy
- Raman Spectroscopy
- Differential Scanning Calorimetry
- Powder Rheology
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Thermogravimetric Analysis
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Nuclear Magnetic Resonance
Dynamic Vapor Sorption (DVS)
PCL is the only contract research organisation in South Asia to offer this advanced materials characterisation technique, offering unparalleled insight into the performance properties of solid-state materials. A gravimetric method, DVS accurately measures how a material responds to relative humidity and ambient organic vapor concentrations, allowing our in-house experts to accurately predict material performance in a range of applications.
Properties revealed:
- Moisture sorption/desorption isotherms
- Hygroscopicity
- Stability under varying humidity
Applications:
- Formulation stability
- Packaging material selection
- Drying processes
Inverse Gas Chromatography (iGC)
Operating the only commercially available, purpose-built instrument that employs Inverse Gas Chromatography, PCL is able to measure the interaction of a material’s surface with various gases to determine surface energy and other properties vital to developing successful pharmaceutical materials.
Properties revealed:
- Surface energy
- Adsorption behavior
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Thermodynamic properties
Applications:
- Optimization of coating adhesion
- API & Excipient compatibility studies
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Evaluation of polymer properties in pharmaceutical packaging
Gas Pycnometry
Gas Pycnometry measures the true density of a solid material by displacing a known volume of gas (typically helium) and applying the ideal gas law to determine the sample's volume, vital for several aspects of pharma material performance predictions, such as solubility and packaging permeation.
Properties revealed:
- True density
- Porosity
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Material packing characteristics
Applications:
- Characterization of excipients and APIs for tablet compression
- Understanding material porosity
- Optimizing formulations for controlled release
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Solubility enhancement
Particle Size Distribution (PSD)
Particle Size Distribution (PSD) is critical in pharmaceutical materials development for several reasons, as it directly impacts the performance, manufacturability, and quality of pharmaceutical products.
Properties revealed:
- Particle Size
- Size Distribution
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Uniformity
Applications:
- Drug delivery
- Optimizing dissolution rates
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Bioavailability of pharmaceutical products
Scanning Electron Microscopy (SEM)
SEM generates high-resolution images of a material's surface by scanning it with a focused electron beam and analyzing emitted electrons. This technique is invaluable for studying the morphology, texture, and structural integrity of pharmaceutical materials, such as active pharmaceutical ingredients (APIs), excipients, and tablet coatings. Surface features revealed by SEM can influence drug dissolution rates and mechanical properties, impacting both efficacy and manufacturability.
Properties revealed:
- Surface morphology
- Particle size
- Texture
-
Distribution
Applications:
- Coating optimization
- Excipient interaction studies
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Failure analysis
Dynamic Light Scattering (DLS)
DLS measures the scattering of light by particles suspended in a liquid, determining their size based on Brownian motion. It is particularly useful for characterizing nanoparticles, colloids, and emulsions in drug formulations. These properties are critical for developing advanced drug delivery systems, such as liposomes or nanocarriers, where particle size impacts bioavailability and targeting.
Properties revealed:
- Particle size & Distribution
-
Zeta potential
Applications:
- Nanoparticle drug delivery
- Colloidal stability
-
Formulation development
Volumetric Nitrogen Adsorption
This technique determines the surface area and pore structure of a material by measuring the adsorption and desorption of nitrogen gas at various pressures. Understanding porosity and surface area is crucial for controlled drug release systems and optimizing carrier materials. Porous structures can affect the loading and release of active ingredients in pharmaceutical formulations.
Properties revealed:
- Surface area
- Pore size
-
Pore volume
Applications:
- Controlled release formulations
- Adsorbent material development
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Excipient optimization
X-Ray Powder Diffraction
XRPD identifies crystalline structures by analyzing the diffraction patterns of X-rays passing through a powdered sample. This is vital in pharmaceutical research for detecting polymorphism, a phenomenon where the same compound can exist in multiple crystalline forms. Polymorphism significantly affects solubility, stability, and bioavailability, making XRPD a key tool in drug development and quality control.
Properties revealed:
- Crystallinity
- Polymorphism
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Phase transition
Applications:
- Polymorphism studies
- Counterfeit drug detection
-
Stability analysis
Atomic Force Microscopy (AFM)
AFM scans the surface of a material at the nanoscale using a sharp tip to measure surface roughness, adhesion, and mechanical properties. In pharmaceuticals, AFM is used to study coatings, tablet surfaces, and nanomaterials. This detailed surface analysis helps optimize drug delivery systems and ensures uniformity in coatings that influence drug release rates.
Properties revealed:
- Surface roughness
- Stiffness
- Adhesion
-
Mechanical properties
Applications:
- Coating analysis
- Nanomaterial development
-
Mechanical property assessment
Raman Spectroscopy
Raman spectroscopy analyzes vibrational modes of molecules by scattering monochromatic light, providing a molecular fingerprint. It is a non-destructive technique for identifying chemical composition, molecular structures, and polymorphism in pharmaceutical products. This ensures quality control and helps detect contamination or counterfeit drugs.
Properties revealed:
- Molecular structure
- Polymorphism
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Chemical composition
Applications:
- Quality control
- Contamination detection
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Polymorphic analysis
Differential Scanning Calorimetry (DLS)
DSC measures heat flow associated with thermal transitions, such as melting, crystallization, and glass transitions, as a material is heated or cooled. This is crucial for studying the thermal properties of drug compounds and excipients, which influence stability, shelf life, and formulation strategies. It is especially relevant for identifying and controlling polymorphic forms of drugs.
Properties revealed:
- Melting point
- Glass transition temperature
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Crystallization behavior
Applications:
- Stability studies
- Polymorphism analysis
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Formulation optimization
Powder Rheology
Powder rheology evaluates the flow and deformation behavior of powders under applied stresses. This is critical in pharmaceutical manufacturing, where powder flow impacts mixing, filling, and compressing during tablet production. Poor flowability can lead to inconsistencies in dosage and tablet weight, making this technique essential for quality control.
Properties revealed:
- Flowability
- Compressibility
- Cohesion
Applications:
- Tablet manufacturing
- Capsule filling
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Process improvement
Thermogravimetric Analysis (TGA)
TGA monitors weight changes in a material as it is subjected to controlled heating, revealing thermal stability, decomposition, and moisture content. It is widely used to study the thermal behavior of drug compounds and excipients, which is critical for ensuring stability during storage and processing.
Properties revealed:
- Thermal stability
- Decomposition temperature
- Moisture content
Applications:
- Stability testing
- Impurity detection
-
Formulation development
Nuclear Magnetic Resonance (NMR)
NMR analyzes the magnetic properties of atomic nuclei to determine molecular structure and dynamics. It is an essential tool for elucidating the structure of drug molecules, studying excipient interactions, and ensuring the purity of pharmaceutical products. This detailed molecular information supports drug discovery and formulation design.
Properties revealed:
- Molecular structure
- Chemical interactions
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Purity
Applications:
- Structural elucidation
- Drug interaction studies
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Quality control
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