SoliTech®Solutions

SoliPharma relies on its keen foresight to target products that both require high demands/leaps in current technologyand are unique in its field to conduct high-end generic drug development.

SoliPharma registers products initially with USFDA and China NMPA before bringing its products to the rest of world. The quality of the products is assured with USFDA approval as benchmark.

SoliPharma, relying on is robust research capability and extensive international product registration experience, has established extremely high-trust collaborative relationships with API supplierin the field of high-end generic drugs

Solitech platform – form concept to submission

Technical Expertise

Polymorph screening

  • Discover the best form for development
  • Ensure effective patent protection
  • Avoid infringement of the prior art
Technical package
  • Evaluation of the prior art
  • Various crystallization techniques
  • Physicochemical characterization
  • Solid and solution stability
  • Polymorphs relative stability analysis
  • Form selection and recommendation
  • Provide patent filing material

Salt screening

  • Improve the properties of the drug candidates
  • Discover the best salt for development
  • Ensure effective patent protection
  • Avoid infringement of the prior art
Technical package
  • Characterization of the free base
  • Selection of counterions
  • Various salt forming techniques
  • Physicochemical characterization
  • Solidand and solution stability
  • Salt selection and recommendation
  • Provide patent filing material
Polymorph screening
  • Discover the best form for development
  • Ensure effective patent protection
  • Avoid infringement of the prior art
Cocrystalline screening
  • Improve the properties of the drug candidates
  • Discover the best cocrystal for development
  • Ensure effective patent protection
  • Avoid infringement of the prior art
Salt screening
  • Improve the properties of the drug candidates
  • Discover the best salt for development
  • Ensure effective patent protection
  • Avoid infringement of the prior art
Solid dispersion screening
  • Improving the bioavailability of API
  • Discover the best solid dispersion for development
  • Ensure effective patent protection
  • Avoid infringement of the prior art
Polymorph interrelations analysis
  • The relative stability of polymorphs
Form selection and processibility evaluation
  • Assessing the effects of process parameters on different polymorph
  • Assess the impact of different crystals on product quality
Prior art evaluation
  • Prior art search and analysis
  • Assess the necessity and feasibility of screening projects
Patent design and drafting
  • Evaluation and identification of patent creativity
  • Design and execute patent examples
  • Draft patent application document

Crystallization process development and scale up

  • Purity control and improvement
  • Polymorph control to ensure the desire crystal forms
  • API powder property optimization to facilitate formulation development and quality control
  • Process optimizationa and cost control
Technical Services
  • Crystallization process development of new product
  • Non-infringing crystallization process development
  • Process optimization without major process changes
  • 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

Pre-formulation evaluation

  • Study on basic properties of drugs
  • Screening suitable excipients
  • Formulation design
Technical services
  • Pre-formulation evaluation of new drugs
  • Evaluation of generic non-patent forms or new forms
  • Draft of CTD format application
Technical package
  • Determining BCS classification of drugs
  • Determination the pKa,log P,log D
  • Solid stability study
  • Solution stability study
  • Study on the compatibility of API and excipients
  • Solubility in different solution systems (water. buffers. organic solvents. simulated gastrointestinal fluids)
  • Intrinsic dissolution
  • Study the effects of formulation process parameters on the stability of crystalline forms
  • Toxicology study formula screening

Drugs analytical methods

General characterization
  • Phase analysis: XRD,Raman,IR
  • Thermal analysis: DSC, TGA, variable-temperature microscope, variable-temperature XRD
  • Powder properties: particle size,moisture content,moisture adsorption
Method development and validation of qualitative, quantitative, and limit tests
  • HPLC method development and validation
  • Ion chromatography method development and validation
  • Crystallinity of API and phase impurity analysis of API
  • Phase identification and quantification of API in drug products
  • Particle size distribution method development and validation
Compound structure confirmation
  • Single crystal preparation and structural analysis
  • Infrared and Raman spectroscopy
  • NMR and Mass spectral structural analysis
Quality control
  • Identify the cause of quality problems
  • Provide solutions to quality issues

Drug product development and manufacturing

Target
  • Compared with the dissolution curve of the reference formulation f2>60
  • Meet the drug product requirements in pharmacopeias
  • Meet the specs of imported drugs
  • Preparation of CTD format documents
Technical services
  • Preformulation and formulation study
  • Formulation process development and manufacturing
  • Conformity evaluation of the quality of generic solid drug products
Technical package
  • HPLC method development and validation
  • Characterization of API and RLD
  • Dissolution method development and validation
  • Compatibility study of API and excipients
  • Stability study
  • Key parameters operation interval of small and pilot scales
  • Formulation process SOP

One-stop service for drug development

  • Development of API and drug product which meets the registration requirements CFDA or FDA
  • CTD format application
API development
  • API structure confirmation
  • API analytical method development and validation
  • API physicochemical properties characterization
  • Study of polymorphism of API
  • API stability test
  • API specification establishment
  • CTD format document preparation
Technical services
  • One-stop service for drug development
  • Quality studies of API and drug product
  • Prepare CTD format document
Drug product development
  • Testing for API and excipients
  • Drug product method development and validation
  • Compatibility study of API and excipients
  • Process development of formulations
  • Compatibility study of package materials
  • Stability test for drug product
  • Drug product specification establishment
  • CTD format document preparation
Target
  • Assessing the safety for clinical Phase I
  • Bioequivalency assessment
Technical package
  • Clinical research institution selection
  • R&D plan design
  • Project management and cordination

Solutions for consistency evaluation of generic drugs

R&D Team Led by several repatriated pervious senior scientists from Pharma Multinationals in the U.S.

R&D Services Provide full-range R&D services that assist pharmaceutical companies from initial idea conception to final drug product submissions

Expertise Specializes in drug product R&D that requires extensive studies and researches on molecule’s solid state (e.g. polymorphs, salts and etc.)

RA Team In-house Regulatory Affairs team that is in frequent communication with the U.S. FDA and Chinese FDA (SFDA)

Record Excellent safety, regulatory and environmental compliance record

ANDA filing and official response to FDA and CFDA

  • Drug registration applications comply with the regulatory requirements (US FDA or NMPA)
  • Accurate response to FDA or NMPA
Technical package
  • Preparation of ANDA applications that comply with FDA and ICH or CFDA guidelines
  • Filing ANDA applications to FDA through the Electronic Submission (ESG) /to NMPA
  • Submit product label information in SPL format to FDA/submit product label information to NMPA
  • Response to FDA or NMPA

美国FDA的GMP咨询

  • Help pass FDA inspection on GMP facilities
Technical package
  • FDA cGMP compliance for equipments and facilities
  • Assessing cGMP compliance for equipment and facilities
  • Guidence on cGMP-compliant confirmation and verification
  • FDA cGMP compliance for quality system
  • Evaluate and improve the quality system in accordance FDA GMP six-system requirments
  • Improving quality system
  • Guides on FDA's GMP on-site inspections
  • Guides on FDA inspection observation responses
  • GMP training

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
  • Project assessment: patent research and analysis
  • Develop new salt/new crystal/new process
  • Example development
  • Patent drafting
  • Patent document review