Solid State Characterization

At Solitek, we specialize in Solid State Characterization, a critical component of our Solid Form Services. Understanding the solid-state properties of Active Pharmaceutical Ingredients (APIs) is vital for ensuring stability, bioavailability, and manufacturability. Whether your drug is designed as a solution or as a solid dosage form, our expertise helps address challenges related to its preparation, storage, development, and manufacturing.

A cornerstone for successful pharmaceutical development

Our tailored, in-depth approach combines advanced techniques like XRPD (X-Ray Powder Diffraction), TGA (Thermogravimetric Analysis), DSC (Differential Scanning Calorimetry), and DVS (Dynamic Vapor Sorption) to provide reliable insights into your drug’s physical properties, thermal stability, and hygroscopicity.

Key concepts

Why solid state characterization matters

Uncovering and optimizing the solid-state properties of APIs provides significant advantages:

Understanding of batch to batch variability: Highlights the differences in seemingly identical batches that lead to differences in performance.

Enhanced stability and storage: Identify and mitigate potential storage issues early.

Improved development efficiency: Support the design of optimized solid dosage forms.

Customized solutions: Tailor strategies to meet the specific needs of each client and project.

Our advanced techniques and technologies

Solitek employs cutting-edge technologies to deliver precise and reliable results:

Polymorph identification: Identification of the polymorph or polymorphs present in a sample for Quality Control (QC) purpose.

Polymorph quantification: Quantification of different polymorphs present in a sample or a drug product, and investigation of the evolution of this system over time.

Physical property analysis: Assess critical parameters like crystallinity, hygroscopicity, thermal stability, particle size, density, and flow properties to optimize manufacturability.

Optimization of Physical Properties: Identification of the crystalline form with the optimal dissolution, stability and bioavailability properties for the solid dosage form for which the drug was designed.

Applications in drug development

Our Solid State Characterization services are essential for:

Understanding the physical properties of active pharmaceutical ingredients

Investigating differences in the properties of different batches of drug substances or intermediates Supporting formulation and development of solid dosage forms with improved performance.

Identifying critical properties to guide manufacturing strategies.

A client-centric and innovative approach

At Solitek, we combine expertise, innovation, and an unwavering commitment to quality. Our solutions are tailored to each client’s needs, ensuring outstanding results from discovery to market.

We provide:

Comprehensive support for solid state characterization and solid dosage form formulation development.

Understanding of solid state behavior of drug candidates and mitigation of risks derived from solid form challenges

Continuous assistance to overcome pharmaceutical development challenges.

Case Studies and Success Stories

Our collaborations with leading pharmaceutical companies highlight the impact of our services:

Characterization of new polymorphs: We establish the physical properties of new polymorphs and identify those with superior properties, which can lead to potentially extending the lifecycle of a drug.

Effective formulation strategies: Optimization of the physical properties of drug substances to enable appropriate drug formulations for preclinical development

Batch optimization: Identified and addressed inconsistencies in batches, preventing regulatory concerns and ensuring product reliability

Contact us

Looking for expert guidance in Solid State Characterization? At Solitek, we elevate your drug development program with sour expertise in characterization techniques like XRPD, DSC, TGA or DVS. Partner with us for unparalleled support in achieving pharmaceutical success.

Contact us today to discuss how we can support your next breakthrough.

Discover more services

Solid Form Screening and Selection

Crystallization Process Development

Early Enabling Formulation Development

Advanced Computational Solid - State Services

Training and Consultancy