Solid form services for pharmaceutical development
Why Solid State Screening?
The solid-state properties of an active pharmaceutical ingredient (API) can determine whether a drug product succeeds or fails. Polymorphism, crystallinity, amorphous content, and solvate or hydrate formation all directly influence solubility, dissolution rate, stability, and ultimately bioavailability. For this reason, solid form studies are a critical part of drug development and regulatory approval.
At Particle Analytical, we provide comprehensive solid form services for pharmaceutical companies worldwide. Using advanced analytical techniques and a GMP-certified laboratory, we perform solid form analysis and solid form screening to identify, characterize, and select the most suitable forms of APIs and formulations. Our expertise ensures that your drug development program is supported by reliable, regulatory-compliant data.
Why solid form analysis matters
Selecting the right solid form of an API is one of the most important decisions in pharmaceutical development.
An inappropriate choice can lead to poor solubility, low bioavailability, or instability, resulting in formulation failure or even product recalls. Conversely, thorough solid form analysis provides a clear understanding of the drug’s behavior and ensures that development proceeds on a stable foundation.
Solid form studies support:
- Bioavailability – by optimizing solubility and dissolution rate.
- Stability – by identifying the most stable polymorph under manufacturing and storage conditions.
- Regulatory approval – by providing data required by agencies such as the FDA and EMA.
Patent strategy – since solid forms can be patented, solid form screening supports intellectual property protection.
What are solid form studies?
Solid form studies investigate the different physical forms an API can adopt and evaluate their impact on drug performance. APIs can exist in multiple crystalline forms (polymorphs), amorphous forms, salts, co-crystals, hydrates, or solvates. Each form has distinct physical properties that influence dissolution, bioavailability, manufacturability, and stability.
By conducting solid form analysis, pharmaceutical scientists can identify which form is optimal for development, ensuring consistent therapeutic performance and minimizing risks during manufacturing and storage.
Techniques used in solid form analysis
Solid form analysis relies on a suite of complementary analytical techniques, each providing unique insights into the structure, stability, and properties of an API. By integrating the techniques listed below, we provide comprehensive solid form services that deliver actionable results.
X-ray powder diffraction (XRPD)
XRPD is the gold standard for identifying polymorphs and crystalline phases, allowing precise phase identification and quantification.
Raman spectroscopy and Raman confocal microscopy
Raman provides molecular fingerprints, while confocal mapping reveals spatial distribution. Raman is especially powerful for detecting polymorphs and amorphous content.
Differential scanning calorimetry (DSC)
DSC measures melting points, glass transitions, and thermal behavior, helping to identify polymorphic transitions and stability.
Thermogravimetric analysis (TGA)
TGA provides insights into solvate and hydrate formation by measuring weight changes under controlled heating.
Particle size and morphology analysis
Laser diffraction and microscopy provide information on particle size distribution and morphology, which directly influence dissolution and manufacturability.
Advantages of outsourcing solid form studies
Outsourcing solid form services to a GMP-certified laboratory provides multiple benefits. Pharmaceutical companies gain access to advanced instrumentation, experienced analysts, and regulatory-ready reports. Outsourcing reduces internal costs, accelerates timelines, and ensures compliance with international standards.
At Particle Analytical, we work as a reliable partner, supporting pharmaceutical companies in identifying, characterizing, and selecting the most appropriate solid forms for development.
Challenges in solid form analysis
Solid form analysis presents several challenges. APIs may exist in multiple polymorphic forms, and some polymorphs may be metastable, converting to more stable forms during storage. Amorphous APIs may crystallize unpredictably, compromising product stability. Environmental factors such as humidity and temperature can influence transitions, requiring careful control and monitoring.
Our team addresses these challenges by combining multiple analytical techniques with deep expertise in solid-state characterization, ensuring accurate and reproducible results even for complex APIs.
Regulatory relevance of solid form studies
Regulatory authorities such as the FDA and EMA require solid form studies as part of drug approval submissions. ICH guidelines emphasize the importance of characterizing polymorphism, crystallinity, and other solid-state attributes as Critical Quality Attributes (CQAs).
By outsourcing to Particle Analytical, companies gain access to solid form services conducted under GMP certification, ensuring that data is compliant, reliable, and audit-ready.
Applications of solid form services in pharma
Solid form services support pharmaceutical development across the entire value chain.
Discovery and preclinical development
Selecting the optimal solid form for bioavailability and stability.
Clinical development
Supporting regulatory submissions with validated data.
Manufacturing
Ensuring that the selected form remains stable and consistent across batches.
Lifecycle management
Monitoring for polymorphic transitions or stability issues during long-term storage.
Intellectual property
Protecting innovations through patenting of specific solid forms.
Frequently asked questions about solid form services
What is solid form analysis?
Solid form analysis is the study of the physical and structural properties of an API, including polymorphism, crystallinity, amorphous content, and hydrate or solvate formation.
What is solid form screening?
Solid form screening is the systematic process of identifying all possible forms of an API, including polymorphs, salts, co-crystals, solvates, and hydrates, to ensure the most stable and effective form is selected.
Why are solid form services important?
They help optimize bioavailability, ensure stability, support regulatory submissions, and protect intellectual property.
Which techniques are used in solid form analysis?
Techniques include XRPD, Raman spectroscopy, DSC, TGA, laser diffraction, and microscopy, each providing unique insights into structure and stability.
When should solid form studies be performed?
They should be performed early in development, prior to clinical trials, and monitored throughout manufacturing and lifecycle management.
Partner with Particle Analytical
At Particle Analytical, we deliver comprehensive solid form services tailored to pharmaceutical development and manufacturing. Our GMP-certified laboratory uses advanced solid form analysis and solid form screening techniques to provide reliable, regulatory-ready data.
Whether you need to select the most stable form of an API, investigate polymorphic transitions, or support a regulatory submission, we provide the expertise and results you need.
Contact us today to discuss your project or request a quote for solid form services.