SoliTech®

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.

SoliTech® Overview

SoliPharma provides one-stop service to our partners worldwide for target markets including China, US and rest of world. SoliPharma excels at 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

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

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® Overview – from 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

SoliTech® 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 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

Goal

  • 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

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 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
  • CTD format dossier
Analytical development
  • Analytical method development
  • Analytical method validation
  • Release testing
  • Stability studies
Drug product development
  • Reverse engineering of RLD
  • Excipient and packaging compatibility
  • Formulation design
  • Quality by design
  • Process development
  • Process scale up
  • Stability study
  • 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