SoliTech® Solutions

SoliPharma relies on its keen foresight to target products that both require high demands/leaps in current technology are unique in its field to conduct product development for high-end generic and innovative drugs.

SoliPharmaprovides one-stop service to our partners worldwide for target markets including China, US and rest of world. SoliPharma excelsat pharmaceutical solid-state research and enabling technology, especially in the development of generic and products with challenging issues, such as narrow therapeutic index drugs, poorly soluble drugs, low stability drugs, highly variable drugs, etc.

SoliTech® Solutions identify optimal strategies, develop products and methods, supply products, organize clinical studies and complete product registrations. In our nine years of excellent research, we have embraced 300+ pharmaceutical companies to advance 500+ challenging molecules in their product development pipeline.

SoliTech® technology covers early API development (solid form screening/crystallization process), drug product development (formulation/analytical chemistry) anddossier compiling to obtain the final approval of market authorization (FDA GMP/regulatory affair).

SoliTech platform – form concept to submission

Strategize

IP
Regulatory Pathway
Product Lifecycle Mgmt

Develop

Products
Processes
Methods

Supply

Clinical batches
BE batches
Submission bathes

Orangize

BE Studies
Clinical Trials
Agency meetings

Deliver

e-DCT Dossiers
Patents
Technical Reports

Technical Expertise

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
  • Stability relationships among different polymorphs
  • 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
Polymorph interrelations analysis
  • 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 crystallization process development
  • Process optimization within operation range
  • Solvent recovery process development
  • Substitute fractionating columns with crystallization processes
  • Automated crystallization process development
Technical package
  • HPLC analysis method development and validation
  • Solvent screening
  • Solubility curve
  • Determination of metastable zone
  • Determination of key parameters' operating interval
  • Characterization fo product 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

General 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

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

One-stop service for drug development

  • Drug substance and drug development for submission to USFDA or NMPA
  • eCTD format dossier
Drug substance development
  • Structural Elucidation
  • Solid Form Screening and Analysis
  • Preformulation
  • Crystallization process development
  • Analytical method development and validation
  • CTD format dossier
Technical services
  • One-stop R&D for drug development
  • Analytical method development and validation
  • CTD format dossier
Drug product development
  • Reverse engineering of RLD
  • Excipient and packaging compatibility
  • Formulation design
  • Process development
  • Preliminary stability study
  • Process scale up
  • CTD format dossier

Quality consistency evaluation of generic drugs

SoliPharma develops solid orals, injectables and topical dosages for USFDA and China NMPA approval.

Our full-range R&D service assists pharmaceutical companies from early stage strategic planning to product development until commercialization.

Our effective management of BE and clinical studies with domestic and oversea CROs offer reliable in-vivo study results to support drug development and submission.

Our Regulatory Affairs team communicate frequently with the U.S. FDA and NMPA to ensure accurate and up-to-date information.

Our excellent record in GMP, safety, and environmental compliance allows flawless agency inspection.

Regulatory Affair

  • Drug applications in compliance with current agency and ICH guidances
  • Flawless response to agency to ensure clear communication and up-to-date information
Technical package
  • Drug applications dossier in compliance with agency and ICH guidance
  • eCTD dossier preparation submission to USFDA and NMPA
  • Flawless response to FDA and NMPA
  • File encryption and sharing system to protect valuable intellectual properties

USFDA GMP consulting

  • GMP system improve to meet compliance with target markets
  • GMP education course to prepare/manage/escort FDA inspection
Technical package
  • Gap analysis of the current GMP status and target market requirement
  • Multiple audits and reports
  • Improvement measures
  • Mock GMP inspections
  • GMP education course for preparing and managing inspection
  • Escorting FDA GMP inspection

Intellectual property services

Polymorph patents are one of core intellectual properties of pharmaceutical substances. The rational mapping of crystal-related intellectual property is an important strategy for maxium extension of the drug life span. Solipharma provides IP-related advices and technical support to pharmaceutical companies.

Technical package
  • Patent survey and assessment
  • New salt / polymorph / co-crystal screening
  • Patentability assessment
  • Patent application drafting
  • Patent document review