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Pharmaceutical Preformulation Studies

 

Preclinical Candidate Characterization

Solubility:

– pH Solubility Profile
– Solubility in Organic Solvents

– Solubility in Fasted State Simulated Intestinal Fluid (FaSSIF), Fed State Simulated Intestinal Fluid (FeSSIF) and Simulated Gastric Fluid (SGF)

Stability:

– Solution Stability, Solid State Stability, ICH Photostability

Inherent Properties:

– pKa, Log p/Log D, Intrinsic dissolution, etc.

Enabling Formulation Development for Screening

    – Vehicle Selection
– pH Adjustment and Co-Solvent
– Surfactant Solubilization
– Nanosuspension
– Microemulsion
– Amorphous Solid Dispersion

Medicilon brings the right equipment, facilities and highly dedicated formulation specialists to help you arrive at the optimal dosage form for your API and application. We ensure any forms we develop are scalable, compliant and commercializable for our customers.  For more details, please click preformulation studies.

Preformulation is a branch of pharmaceutical sciences that utilizes biopharmaceutical principles in the determination of physicochemical properties of a drug substance. The objectives of preformulation studies are to choose the correct form of your drug substance, evaluate its physical properties and generate a thorough understanding of the material’s stability under various conditions, leading to the optimal drug delivery system.

goals of preformulation

Medicilon offers a wide range of analytical approaches to achieve these goals. These approaches are designed to help moving your compound from drug candidate to marketable product.  We can test for a full spectrum of requirements including forced degradation studies, solubility, pH stability, polymorphism and unknown compound identification.

Preformulation Studies

We offer a full spectrum of Pharmaceutical Preformulation testing capabilities, including:

  • Solubility Studies
  • pH Stability Studies
  • Particle Size Analysis
  • Powder Flow Testing
  • Polymorphism Studies
  • Structural Identification
  • Forced Degradation Studies
  • Microstructural Analysis
  • Unknown Compound Identification
  • Analytical R&D
  • Technical Consulting

Preformulation: A stage of development during which the physicochemical properties of drug substance are characterized.

Some commonly evaluated parameters:

  • Solubility
  • Dissolution Behavior
  • Stability
  • Partition Coefficient
  • Ionization Constant (pKa)
  • Solid State Properties such as crystal forms/polymorphs, water sorption behavior, surface properties, particle size and shape and other mechanical properties, et. al.

Contact Us 

Email : marketing@medicilon.com
Tel : +86 021 58591500

Tips : Above is part of pharmaceutical preformulation studies and pharma preformulation companies . You can also CONTACT US with any question or enquiry you may have. We will be happy to discuss your needs in detail and design an appropriate plan of action.

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