Solid State Characterization
Solid State Characterization is a crucial aspect in the development of
pharmaceuticals as drug products are mostly produced as solid materials and it is
highly significant for the pharmaceutical industry. Even a slight change in
structure or particle size of a drug product can affect Pharmacological behavior of
a drug. This is why in order to develop safe and efficient drug products it is
important to study Active Pharmaceutical Ingredients (API) and excipient particle
size right from the drug development to manufacturing.
The need to investigate the solid-state properties of API has become important in
the pharmaceutical development industry. Physical properties can vary widely between
batches, leading to batch-to-batch variability.
The most critical aspect of pharmaceutical compounds development is selection of the
optimum solid form as they have the ability to exist in more than one form or
crystal structure (polymorphism). These polymorphs show different physical
properties which can affect their biopharmaceutical properties.
Solid state characterization of pharmaceuticals, determines physical properties such
as particle size, polymorph and morphology of solid dose drug forms. It is a vital
key to understand the physical properties of pharmaceutical solid materials and
ensure optimal physical form. Significantly, these physical properties can have an
impact on the material’s bulk properties, drug formulation performance, process,
stability and appearance.
Primarily, Solid state characterization is used to measure properties of solid
materials. Usually, characterization is done by measuring the material’s response to
external forces.
Significance of Solid-State Characterisation in Pharmaceutical Products
- The functional behavior, dissolution, bio-availability of any pharmaceutical product depends on DSC, HRD, and microscopy. It is important to control and analyse the solid-state characterization of the API in cases of excipients also.
- In crystal there can be different crystalline forms either polymers special arrangement of molecules which can lead to differences in lipid behavior like compression behavior so in order to characterize it we use technique like DSC which can become difference in the melting point or if there is an absence of melting point which can show that it is an amorphous system it can also be thermal stability of amorphous systems
Why choose us?
- Our highly skilled scientists can undertake studies that range from routine to highly complex and challenging characterization.
- We ensure our testing services are compliant with current regulatory requirements.
- Our State-of-the-art equipment supports development, stability and batch release in fast turnaround time.
- Our lab is equipped with XRD which plays an important role in the development of new drugs, as it helps to characterize active materials as well as tests material at different stages of manufacturing so that quality control is effectively maintained. All these procedures help to improve the formulation, analyze the compatibility of excipients, detect bioavailability and improve on factors of stability in different environments.The crystal morphology of the samples can be thoroughly analyzed and monitored with the help of the XRD Detector.