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Solid-State Characterization of APIs & Excipients

Solid-State Characterization of Pharmaceuticals

In an overwhelming majority of cases, pharmaceutical and similar products are produced in solid form to ensure that consumption provides a predictable, well-balanced, and rapid effect. Consistent drug product manufacturing, patent protection, and formulation viability require a comprehensive understanding of the solid-state characteristics and behavior of both active pharmaceutical ingredients (API) and excipients. Both API and excipients may exist in a variety of solid forms, including salts, hydrates, solvates, and polymorphs. The physical and chemical stability, solubility, tabletability, flowability, and reactivity of these materials may vary depending on the final solid dose form. These interactions may or may not be beneficial to the formulation and may change over time with exposure to elevated humidity and temperature.

Selecting an optimal solid form is a critical aspect of biopharmaceutical development, due to the fact that different forms or crystal structures (polymorphisms) can exhibit different functional properties and behaviors, impacting the performance, stability, processability, and appearance of a formulation. Characterizing the solid-state of these materials is key to reducing potential issues with biopharmaceutical drug formulation and manufacturing. In short, comprehensive solid-state analysis can reduce both the cost and time associated with drug product development by determining the optimal solid form of a material. Avomeen’s accomplished and experienced pharmaceutical scientists have exceptional pride in their ability to expertly design and deliver solid-state characterization studies using a variety of techniques and instrumentation.

Avomeen brings:

Expertise in a wide range of solid-state analysis techniques, including those that are amenable to sensitive drug products that are susceptible to form change with handling.

A proven track record of developing robust methods for process control of the solid-state form, including those using DSC, TGA, FTIR, solid-state NMR, or XRD analysis

Expertly designed solid-state characterization and ingredients testing studies, drawing from a breadth of expertise, which extends to an array of diverse disciplines within the Life Sciences.

 

Polymorph Screening

Current drug polymorph screening techniques are remarkably effective at identifying and characterizing solid-state substances. With such powerful information on hand, pharmaceutical scientists can more accurately establish the optimal physical form for a drug product as well as develop methods to ensure it does not convert to another form over time. Avomeen’s industry experts are adept at a wide range of physical processing and solid-state characterization techniques, including those that are amenable to sensitive drug substances that are highly susceptible to form change during handling.

Solid-State Characterization Lab Services:

Thermal Analysis

  • Thermal decomposition
  • Melting point
  • Phase and glass transitions
  • Compound characterization
  • Thermodynamic properties
  • Degree of hydration or solvation

Solid-state Analysis

  • Racemic mixture relationship determination
  • Salt form identification
  • Salt form quantification

Structure Determination

  • Atom-to-atom connectivity
  • Inter-molecular interactions
  • Intra-molecular interactions
  • Degree of hydration and solvation determination

Polymorph, Co-Crystal, & Salt Screening

  • Crystallization screening
  • Salt screening and selection
  • Solid dispersion screen
  • Co-crystal screening
  • Crystallization via salt or co-crystal formation

Solid Form Selection

  • Solubility and dissolution rate
  • Thermal characterization
  • Determination of partition coefficients
  • Determination of pKa
  • Drug-excipient compatibility
  • Particle size distribution
  • Hygroscopicity

Amorphous Solid Dispersion

  • Drug polymer ratio
  • Surfactant and solvent impact
  • Surfactant level
  • Solvent effect
  • Environmental factors (temperature and humidity)
  • Form conversion analysis

 

Solid-state Characterization Services Tailored to Your Drug Product

Selecting the optimum solid form for an incredible variety of medicinal compounds is critical to the development of today’s pharmaceuticals and requires solid-state characterization. Our experienced scientists customize testing protocols and screening activities based on the functionalities of specific intermediates and APIs, which ensures effective screening, selection, and process development during and after ingredients analysis. Avomeen’s Ph.D.-led team of industry experts extend biopharmaceutical and therapeutic product lifecycles while providing invaluable insight into the physical characteristics of your materials. Get in touch with an expert to explore a partnership with Avomeen.

Let’s work together to achieve your vision

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