Wolfe Laboratories - Solid State Characterization

Analytical Method Development
Protein Characterization
Solid-State Characterization
Stability-Indicating Analytical Methods
Identification of Impurities and Degradation Products
Additional Analytical Applications

>	CASE STUDY 1 Advancement of an Early Development Candidate to Phase IIb Trials
>	CASE STUDY 2 Development of a Parenteral Formulation of a Cytotoxic Natural Product
>	CASE STUDY 3 Oral Formulation Development for Proof-of-Concept Animal Toxicology Studies
>	CASE STUDY 4 cGMP Analytical Release Testing of a Cytotoxic Drug, as Well as Other Analytical and Bioanalytical Services
>	CASE STUDY 5 Parenteral Dosage Form Development of a Highly Insoluble Molecule

Solid State Characterization

Solid state characterization (SSC) is an important aspect of a drug development program, particularly for a pharmaceutical that is intended for oral delivery. Assays used for solid state characterization, such as x-ray powder diffractometry (XRPD or XRD) and differential scanning calorimetry (DSC) also may be used as release assays or may be useful in establishing intellectual property rights, usually in combination with other analytical techniques. Solid state properties of an active pharmaceutical ingredient (API) may influence its performance in several disparate contexts, from oral bioavailability to storage stability to ease of processing. In addition, investigation of solid state properties of an API may be beneficial for patent protection purposes.

WLI offers a suite of analytical services for characterization of solids, including XRPD, DSC, thermogravimetric analytis (TGA), and dissolution testing. Frequently, several complimentary techniques are used to determine solid state properties of an analyte. However, assays based on each analytical technique are available on a fee-per-sample basis.

Cross-polarized optical microscopy is a useful technique for rapid profiling of pharmaceutical solids.

The picture above was recorded at WLI with 90 degree cross-polars using the Zeiss Axioscop 40 Pol microscope and the Zeiss MRc5 digital camera. The instrument is configured such that no light is observed by the receiver, as indicated by the black background of the slide. However, light is observed in the areas covered by the solid sample, which is indicative of birefringence. Birefringence, in turn, means that the solid contains a crystalline component.

Similar examinations by optical microscopy are performed routinely in the course of salt screening studies, solid state stability testing, drug substance hygroscopicity testing, development of solid dosage forms, etc.

WLI provides solid state characterization work with a variety of drug substances, including small molecules, peptides, proteins, oligonucleotides, and cytotoxic materials.

To watch WLI's presentation on solid state characterization, click here.
To download a PDF of this presentation, click here.