SSPI Screening and Crystallization Services

SSPI workflows have been developed by combining fundamentals of crystallization and solid form science with years of experience and high throughput techniques. For more details on workflows, please contact us.

Services for Early Phase Pharmaceuticals

Polymorph Screening

http://www.solidstatepharma.com/wp-content/themes/salient/css/fonts/svg/ecommerce_diamond.svg

FAST-MORPHTM
Identifies the most stable and most viable polymorph for development as a drug candidate.

Salt Screening and Selection

http://www.solidstatepharma.com/wp-content/themes/salient/css/fonts/svg/ecommerce_diamond.svg

FAST-SALTTM
Rapidly identifies a viable salt with minimum number of experiments. This helps discovery scientists to produce a workable salt in precilinical phases where the lead candidate has not been selected.

http://www.solidstatepharma.com/wp-content/themes/salient/css/fonts/svg/ecommerce_diamond.svg

OPTIM-SALTTM
Identifies the most viable salt for development as a drug candidate. This in-depth workflow is specificto the molecular structure of the drug substance.

Crystal Formation

http://www.solidstatepharma.com/wp-content/themes/salient/css/fonts/svg/ecommerce_diamond.svg

CRYSTAL-ITTM
Finds a crystalline state for drug substances which are amorphous and difficult to crystallize.

Chiral Resolution

http://www.solidstatepharma.com/wp-content/themes/salient/css/fonts/svg/ecommerce_diamond.svg

RESOLTM
Chiral resolution through salt screening.

Crystallization Process Development

http://www.solidstatepharma.com/wp-content/themes/salient/css/fonts/svg/ecommerce_diamond.svg

CRYS-DEVTM
Crystallization process development which produces the right polymorph. Resolving crystallization challenges such as oiling out, stickiness, etc.

Spray Drying

http://www.solidstatepharma.com/wp-content/themes/salient/css/fonts/svg/ecommerce_diamond.svg

SPRAY-ITTM
Helps to control particle size distribution of the API and also amorphous dispersion with pharmaceutically acceptable polymers.

pKa, log P/log D Measurements

http://www.solidstatepharma.com/wp-content/themes/salient/css/fonts/svg/ecommerce_diamond.svg

pKa-LIPOPHILICITYTM
Measures pKa values by potentiometric or spectrophotometric methods either in the absence or presence of a suitable co-solvent. Log P is experimentally measured in water by potentiometric method and log D shows the change in lipophilicity as a function of pH.

Services for Late Phase Pharmaceuticals

Polymorph Screening

http://www.solidstatepharma.com/wp-content/themes/salient/css/fonts/svg/ecommerce_diamond.svg

MAX-MORPHTM
Identifies maximum number of polymorphs including the most stable and most viable polymorph. Provides extended IP coverage for the drug candidate.

Co-Crystal Screening

http://www.solidstatepharma.com/wp-content/themes/salient/css/fonts/svg/ecommerce_diamond.svg

COFORM-IPTM
Discovers the co-crystals of a drug substance. This is a combination of molecular descriptor calculations and experimental work. The discovered co-crystals extend the IP protection of the drug substance and can result in higher bioavailability and improved properties for the API.

Crystallization Engineering

http://www.solidstatepharma.com/wp-content/themes/salient/css/fonts/svg/ecommerce_diamond.svg

CRYS-ENGTM
Engineers a process with controlled supersaturation that results in specific particle size distribution and morphology. Resolve drug product flowability issues by modifying drug substance physical properties. This workflow requires integrated PAT tools that monitors the supersaturation and particle size in real time and manipulates the rate of supersaturation release by changing the cooling rate or addition rate.

Spray Drying

http://www.solidstatepharma.com/wp-content/themes/salient/css/fonts/svg/ecommerce_diamond.svg

SPRAY-ITTM
Helps to control particle size distribution of the API and also amorphous dispersion with pharmaceutically acceptable polymers.

Equipment

The following equipment is used to generate and characterize samples.

  • EasyMax 402

  • Multi-well crystallization blocks

  • X-ray Powder Diffractometer (XRPD)

  • Modulated Differential Scanning Calorimetry (DSC)

  • Thermal Gravimetric Analysis (TGA)

  • TGA-IR Module

  • pKa, log P/log D Titration System
  • Buchi Spray Dryer
  • Bench-Top Jet Mill for Micronization
  • Raman Microscope and FT-Raman Spectrometer

  • Dynamic Vapor Sorption (DVS)

  • Particle Size Analyzer

  • High Performance Liquid Chromatography (HPLC)

  • Liquid NMR

  • Ziess Microscope with Linkam Hot Stage

  • Scanning Electron Microscope (SEM)

  • In-Line Particle Size Monitoring System (FBRM)