Preformulation Study

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Service

• Biological characteristics of drugs
• Hygroscopicity and wettability
• Micromeritic properties
• Preclinical evaluation of candidate compounds:
  SolubilityurveAcid-base solSolubility 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, etc.)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 analysis<2135Residual solventsGas phase detection methodsMicroscopic observation, melting point, Pka, moisture, optical isomers, related substances, etc.

Service scope:

• Preformulation preparation researchgel formulation researchCapsulesTabletsFormulation selection on granules

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