SoliTech® Technology

SoliTech® Research and Enabling Technology

Polymorph screening

  • Discover the best form for development
  • Ensure strong patent protection
  • Avoid patent infringement
Technical package
  • Prior art assessment
  • Crystallization with various approaches
  • Physicochemical characterization
  • Solid and solution stability
  • Polymorphic phase transformation
  • Form selection and recommendation
  • Technic report for patent application

Salt screening

  • Improve the physicochemical properties of drug molecules
  • Discover the best salt for development
  • Ensure strong patent protection
  • Avoid patent infringement
Technical package
  • Characterization of free form
  • Selection of counter-ions
  • Salt formation with various approaches
  • Physicochemical characterization
  • Solid and and solution stability
  • Salt selection and recommendation
  • Technic report for patent application
Polymorph screening
  • Discover the best form for development
  • Ensure strong patent protection
  • Avoid patent infringement
Cocrystalline screening
  • Improve the properties of drug molecules
  • Discover the best cocrystal for development
  • Ensure strong patent protection
  • Avoid patent infringement
Salt screening
  • Improve the properties of drug molecules
  • Discover the best salt for development
  • Ensure strong patent protection
  • Avoid patent infringement
Solid dispersion screening
  • Improve drug bioavailability
  • Discover the best solid dispersion for development
  • Ensure strong patent protection
  • Avoid patent infringement
Polymorphic phase transitions
  • Phase transformation among different polymorphs
Processibility of polymorphs
  • Impact of process parameters on different solid forms
  • Impact of solid form on product quality
Prior art evaluation
  • Prior art search and analysis
  • Identify the need and opportunity for discovering new solid form
Patent conception and writing
  • Evaluation and identification of patent creativity
  • Design and execute patent examples
  • Draft patent application document

Crystallization process development

  • Reject impurities
  • Obtain desired polymorph
  • Optimize bulk properties
  • Assess processibility
  • Control process cost
Technical package
  • Non-infringing process development
  • Process optimization within operation range
  • Solvent recovery process development
  • Automated crystallization process development
Technical package
  • Analytical method development & validation
  • Solvent screening
  • Solubility profile
  • Determination of metastable zone
  • Operation space for process parameters
  • Characterization of bulk properties
  • SOP

Preformulation

  • Physicochemical property characterization
  • Excipient compatibility study
  • Formulation design
Technical services
  • Preformulation study
  • CTD format report for submission
Technical package
  • Determination of pKa,log P,log D
  • Solid stability study
  • Solution stability study
  • Excipient compatibility
  • Solubility in various media
  • Intrinsic dissolution rate
  • Impact of process parameters on API polymorph
  • Tox formulation development

Analytical method development and validation

Testing and characterization
  • Phase identification: XRD / Raman / IR
  • Thermal analysis: DSC / TGA / hot stage microscopy / non-ambient stage-XRD
  • Bulk properties: particle size distribution / moisture content / hygroscopicity adsorption
Method development and validation
  • High performance liquid chromatography (HPLC)
  • Ion chromatography (IC)
  • Gas chromatography (GC)
  • Phase identification and quantification - Drug substance
  • Phase identification and quantification - Drug product
  • Particle size distribution
Structure elucidation
  • Single crystal growth
  • Single crystal X-ray crystallography
  • Raman spectroscopy
  • NMR structural analysis
  • Mass spectral structural analysis
Quality control
  • Root cause analysis
  • Risk analysis

Formulation development

  • Non-infringing formulation and process
  • Dissolution profile similarity factor f2>60
  • In compliance with agency and ICH guidance
  • Robust and scalable process
Technical services
  • Reverse engineering of reference listed drug
  • Preformulation design
  • Formulation process development
  • Process scale-up
  • Technology transfer to manufacture site
Technical package
  • RLD reverse engineering
  • Characterization of API and specification
  • Excipient compatibility
  • Formulation development report
  • HPLC method development and validation
  • Dissolution method development and validation
  • Preliminary stability study
  • Formulation process SOP