Formulation Development

Formulation Development
Product Description

BioDuro-Sundia holds more than 25 years of experience formulating poor solubility and  poor permeability drugs for the clinical studies. Our comprehensive suite of advanced formulation technologies and extensive scientific know-how supports >95% of marketed dosage forms.

Pre-formulation & Discovery Support

  • Solubility, stability, compatibility, logP testing
  • Solid form screening & selection
  • Physicochemical profiling, drug ability assessment
Formulation & Process Development
  • Process development based on physicochemical and physical properties of drug candidates
  • Storage and shipping conditions assessment of drug candidates
  • Technology transfer of formulation and manufacturing process to clinical manufacturing sites
  • CMC document preparation for IND/NDA/ANDA submission
Filing Document Preparation
  • CMC document preparation and regulatory support
  • NMPA/FDA/EMA/TFDA dossier filling support
Pre-formulation Development
  • pH/Aqueous Solubility
  • Solid state characterization
  • Intrinsic Properties Profiling & Dissolution
  • Polymorph screening
  • Salt screening
  • Co-crystal Screening
  • Crystallization Process
SOLUBILITY ENHANCEMENT
  • Amorphous Solid Dispersion Development
  • Micronization
  • Nano-suspensions
  • SEDDS/SMEDDS
  • Evaluation at Lead Selection / Early Tox stage
TASTE MASKING STRATEGIES
  • Reduce drug/taste bud interaction utilizing API-excipient Complexation strategies
  • Improve taste profiles of Orally Dispersible Tablets (ODT) by suspension & multiple/dual emulsion technologies
  • Protect against salivary pH response by application of stimuli-responsive coatings
  • Functionally coat your drug using Reverse Enteric Polymers
HIGH POTENT FORMULATIONS
Pediatric Dosage Deliver

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BioDuro-Sundia

  • US
  • 2018
    On CPHI since
  • 2
    Certificates
  • 1000 - 4999
    Employees
Company types
Contract Service
View company profile
Categories
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BioDuro-Sundia

  • US
  • 2018
    On CPHI since
  • 2
    Certificates
  • 1000 - 4999
    Employees
Company types
Contract Service
View company profile

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