Microsphere offers on-site expertise in Solid-state Characterization to support our clients through the complete formulation development process.
Monitoring the solid state of a formulation is essential for evaluating its performance and ensuring long-term stability.
Solid-state Characterization provides valuable insight into potential changes that may occur over time, enabling us to evaluate formulation stability throughout its lifecycle.

Formulation Development

Successful formulations start with a deep understanding of solid-state API properties and their impact on product performance.

Pharmaceutical formulation enables the development of dosage forms that optimize API delivery, stability, bioavailability, and patient compliance.

At Microsphere, our expertise in formulation development, combined with advanced manufacturing capabilities, streamlines the scale-up process for even the most complex formulations, helping accelerate project timelines and speed up development.

Polymorphic control

Polymorphic control evaluates the ability of an Active Pharmaceutical Ingredient (API) to exist in different crystalline forms.

Since each polymorph can exhibit distinct physical and chemical properties, controlling the solid state is crucial to optimizing product bioavailability and stability, while also strengthening intellectual property protection and patent strategies.

Amorphous Quantification

Amorphous quantification studies evaluate the crystalline and amorphous content of pharmaceutical materials.

At Microsphere, advanced analytical tools such as XRPD, DSC, mDSC and DVS are available to support comprehensive solid-state characterization.

Solid-state & Stability Studies

Solid-state and stability studies are essential to understand how Drug Substances and formulations behave under environmental stress conditions.

By evaluating crystallinity, solid phases stability, purity, excipient compatibility and late-appearing polymorph. These studies support the development of stable, efficient and high-quality pharmaceutical products.

Particle Engineering Services

Our Particle Engineering expertise, supported by innovative technologies, ensures that your drug substances meet critical quality attributes, bioavailability requirements, and formulation targets, driven by a robust solid state.

Why Particle Engineering matters in API Engineering:

  • Precise control over particle size and morphology
  • Improved bioavailability
  • Enhanced stability and formulation efficiency
  • Greater performance of the final Drug Product