Formulation Development
Products
Information
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 SupportSolubility, stability, compatibility, logP testingSolid form screening & selectionPhysicochemical profiling, drug ability assessmentFormulation & Process Development Process development based on physicochemical and physical properties of drug candidatesStorage and shipping conditions assessment of drug candidatesTechnology transfer of formulation and manufacturing process to clinical manufacturing sitesCMC document preparation for IND/NDA/ANDA submissionFiling Document Preparation CMC document preparation and regulatory supportNMPA/FDA/EMA/TFDA dossier filling supportPre-formulation Development pH/Aqueous SolubilitySolid state characterizationIntrinsic Properties Profiling & DissolutionPolymorph screeningSalt screeningCo-crystal ScreeningCrystallization ProcessSOLUBILITY ENHANCEMENT Amorphous Solid Dispersion DevelopmentMicronizationNano-suspensionsSEDDS/SMEDDSEvaluation at Lead Selection / Early Tox stageTASTE MASKING STRATEGIES Reduce drug/taste bud interaction utilizing API-excipient Complexation strategiesImprove taste profiles of Orally Dispersible Tablets (ODT) by suspension & multiple/dual emulsion technologiesProtect against salivary pH response by application of stimuli-responsive coatingsFunctionally coat your drug using Reverse Enteric PolymersHIGH POTENT FORMULATIONS Pediatric Dosage Deliver
