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Preformulation Study

Preformulation Study

Our preformulation service features both formulation selection and pharmaceutical preparation. To address low numbers of active pharmaceutical ingredients or candidate compounds with medicinal properties, we provide professional preformulation services delivering critical information.
Medicilon icon-diamond.pngService
  • Biological characteristics of drugs
  • Hygroscopicity and wettability
  • Micromeritic properties
  • Preclinical evaluation of candidate compounds:
    SolubilityAcid-base solubility curveSolubility in organic solventsSolubility in compound solutions of different salt formsSolubility in simulated fasting intestinal juices, simulated feeding intestinal juices, and simulated artificial gastric juices          StabilitySolution stabilitySolid state stabilityPhotostability based on ICH standards          Intrinsic propertiesDissociation constant (Pka)Oil-water distribution coefficient (LogP)Apparent distribution coefficient (LogD)Characteristic dissolution, etc.
  • Crystal form research
    Crystal form determination by X- ray diffraction or DSC
    Crystal form researchcrystal melting point, solubility, particle size, etc.Stability of crystal form under influencing factorsCrystal transformation of the proposed crystal formProposed API crystal form for animal testing, clinical trials, or drugs to marketProcess research of the proposed crystal formStirring method, standing and stirringCrystallization mode (natural , cooling, and seeding crystallization)Drying process ( water content standards, crystal water judgment – TG, DSC, and single crystal culture, drying method, and drying temperature)Preparation process simulation (grinding, wet granulation, tabletting, etc.)Quality standards for the proposed crystal form(melting point, solubility, particle size; IR, x-ray, DSC and TG)
  • Formulation selection
    Particle size distributionWet or dry methodCarrier screening (compatibility of ingredients, dissolution rate.)Interaction between APIs and selected ingredientsPH adjustment and co-solvent selectionSolubility under water and solutions with pH values of 1.2, 4.5 and 6.8 HygroscopicityWeight gain within 24 hours under different humidity conditions based on Chinese PharmacopoeiaFluidityEvaluation by angle of repose or Carr indexSurfactants solubilization and permeation enhancementNanosuspensions (nanocrystals, nanoparticles and liposomes)Microemulsions, microspheres and solid dispersionsDrug formulation component-drug packaging materials compatibility analysisResidual solventsGas phase detection methodsMicroscopic observation, melting point, Pka, moisture, optical isomers, related substances, etc.
Medicilon icon-diamond.pngService scope:
  • Preformulation preparation researchgel formulation researchCapsulesTabletsFormulation selection on granules
Relevant laboratories
  • preformulation lab
  • formulation equipment
  • Constant temperature culture vibration box
  • Transdermal diffusion tester
  • New generation medicated impactor
  • rheometer
  • Respiratory simulator
  • Constant temperature culture vibration box
  • pharmaceutical preformulation
  • Tablet hardness tester
  • pharmaceutical preformulation
  • Dissolution Tester
  • Sympatec Particle size analyzer
  • Polarimeter
  • A New Generation of Medicinal Impactors
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