Our outstanding industry leading performance in Polymorph Screening is all part of the advantage of the Pii experience.

Join our Mailing List

Your Email

Polymorph Screening

Polymorphism is central to gaining regulatory approval of a product. It is critical that an optimum solid form is chosen for manufacture as the polymorphic form can have severe implications on physical characteristics, such as bioavailability. Pii performs polymorph screening using state of the art analysis including DSC, XRPD, FTIR and dissolution/solubility testing to determine the best polymorphic form or to identify other forms for IP protection.

Pii’s polymorph screening services supports clients at all phase of development. Depending on your budget, API availability or timeline, Pii tailors the polymorph screen to your specific needs. We offer a range of screening services from conventional to  high throughput polymorph screens. Our goal is to rapidly and efficiently provide the information you and advice you need to make an informed decision on your development program. Pii’s screens are run by highly trained chemists with long-term experience in solid state chemistry.

High throughput screening (HTS)

  • Pii has state-of-the-art instrumentation including a 96 well plate reading TRANSMISSION X-ray diffractometer which can detect across a wide range of 2 theta angles, for a small sample mass, with excellent sensitivity. Unlike other service providers who use a reflectance set up with a more limited range of 2 theta values, our ability to cover a wider range provides greater success in identification of different forms.
  • Outstanding chemometrics– our data processing and cluster analysis software allows information to be gained rapidly and reliably for different forms in our 96 well plate studies.
  • Two techniques are better than one. – we use our 96 well plate on our transmission X-ray and also on our plate reading Raman microscope. Two different methods, two different data analysis chemometric clustering systems and then cross referencing of findings for confirmation of hits = A very reliable rapid screen results.

The outcome: We can do a high throughput 300 solvent screen on less than 500 mg of material, crystallize, do the full analysis and report the data in 5 working days. This outstanding industry leading performance is all part of the advantage of the Pii experience.

Medium throughput screening (MTS)

While our high throughput screening services are an outstanding way of developing large amounts of reliable data, there are customers who wish to have work carried out with scientist involvement in every step of the screen, handle the material, deal with the crystallizations and data interpretation. We are delighted to provide a high quality service with our expert scientific team working on your projects.

With a minimal amount of product, we can screen a broad and diverse parameter space in a short space of time. Intelligent experimental planning and procedures yield an impressive throughput of conditions and results reported in a week or two (depending on the size of screen required).

Low throughput screening and scale up

The final stage of any screen will be to scale up and define the crystallization conditions and carry out a full characterization of the polymorphs including DSC, TGA, X-ray (powder and single crystal if required), GVS, intrinsic solubility and a range of other tests as agreed with the client.

© Copyright 2017 Pharmaceutics International, Inc. | Privacy Policy | Terms & Conditions