SSCI can help solve your most difficult solid-state problems. For example, improvement of properties when clinical data suggests the compound is not optimal. Additionally, when the solid form of a pharmaceutical company's clinical trial material inadvertently varies from batch to batch, we can determine the properties of the different forms used, perform dissolution testing, recommend whether a bridging study needs to be carried out, and propose specific bridging study content. Finally, when a new polymorph appears during clinicals or after commercialization, we can analyze the solid form issues and assist in rapid reformulation or recommend effective process changes.
SSCI scientists strongly recommend that investigation of possible solid forms of a new chemical entity be carried out as early in the development process as drug supply will allow. Staging the screening in this way optimizes the balance among the factors of early knowledge of options, probability of commercial success, and judicious investment of R&D dollars.
The ideal screening/selection strategy includes the following steps:
- Identify the optimum solid form early in drug development
- Make the same form for clinical material and commercial API
- Develop a crystallization process that assures control of solid form and
- Produce a drug product with solid form stability through expiration
XRPD is preferred over Raman spectroscopy at SSCI for first-pass evaluation of polymorph screen samples because experience teaches that it has a low miss rate, it can be applied to large and small samples in various containers, it allows easy identification of mixtures, particularly when one component is non-crystalline, and the resulting data can provide structural information.
We hold both federal and state DEA licenses allowing us to receive and investigate controlled substances. Our licenses include schedule 2 - 5 controlled substances. Our handling procedures and isolated laboratory areas enable us to safely handle your most hazardous materials, including reproductive hazards and potent compounds.
There is a surcharge for research and analysis involving controlled substances, potent compounds, reproductive hazards, and other materials that require special handling. Contact us for details.
We are called on routinely to analyze composition, solid form, purity, or other properties in tablets, capsules, transdermal patches, time release formulations, microspheres, surgical stents, drug in bottle, parenterals, topicals, nasal sprays, metered dose inhalers, dry powder inhalers, and suspensions.
SSCI has developed cutting edge computational approaches to X-ray powder pattern analysis. SSCI's Software Suite is the first software capable of rapidly providing accurate structural information from standard laboratory x-ray powder diffraction data.
SSCI's Software enables SSCI scientists to quickly obtain structural information such as correct unit cell parameters, molecular packing information, and electron density distribution within the unit cell. This information can be used in many ways to speed your drug development and address manufacturing issues for both drug substance and drug product. Please see Case Studies for selected examples.
Yes. We are experienced in the design of crystallization-based separation of individual enantiomers from racemic mixtures (resolution). Like polymorphs, solid forms attained by the racemic mixture and pure enantiomer of a given compound can be crystallographically distinct. Use of SSCI's solids analysis capabilities allows determination of these relationships. For example, XRPD can often be used to determine if a racemic mixture exists as a racemic compound or a conglomerate.
Resolution efficiencies may be predicted based on binary phase diagrams, which SSCI can construct from thermal or solubility data. For example, the diagram for a hypothetical racemic mixture shown below reveals that crystallization will not yield optical purification unless the starting material contains at least an 85% excess of one enantiomer.
You may contact any of the following individuals directly or use our web-based request for information form and the appropriate individual will reply within 24 hours.
SSCI Inc.
3065 Kent Avenue
West Lafayette, IN 47906-1076
Phone: 765.463.0112
Toll Free: 800.375.2179
Fax: 765.497.2649 or 765.463.4722
Email info@ssci-inc.com
Dr. Jan-Olav Henck, Sr. Director of Chemistry:
jan-olav.henck@aptuit.com
Dr. Pamela Smith, Sr. Director of Analytical Chemistry:
pam.smith@aptuit.com
Dr. Jerry Becker, VP of Biochemistry
jerry.becker@aptuit.com
Dr. Ann Newman, VP of Materials Science:
ann.newman@aptuit.com