Pre-Formulation Activity

Pertecnica Engineering is excited to offer a specialized training program on Pre-Formulation Activity. This program is designed to provide professionals with a thorough understanding of the critical steps involved in pre-formulation, which is essential for the successful development of pharmaceutical formulations.

Program Overview

Our Pre-Formulation Activity Training program covers the essential processes and techniques involved in pre-formulation, from initial drug substance characterization to formulation design. Participants will gain insights into the scientific principles and practical applications that underpin effective pre-formulation strategies.

Comprehensive Syllabus

  1. Introduction to Pre-Formulation
    • Overview of pre-formulation and its role in pharmaceutical development
    • Objectives and importance of pre-formulation studies
    • Key components of a pre-formulation study
  2. Drug Substance Characterization
    • Physical Properties: Analysis of solubility, particle size, and polymorphism
    • Chemical Properties: Stability, reactivity, and compatibility of the drug substance
    • Biopharmaceutical Properties: Assessment of absorption, distribution, metabolism, and excretion (ADME)
  3. Formulation Design Considerations
    • Formulation Strategies: Selecting appropriate dosage forms and excipients
    • Compatibility Studies: Evaluating interactions between drug substances and excipients
    • Stability Testing: Designing and conducting stability studies to ensure formulation integrity
  4. Pre-Formulation Testing Methods
    • Solubility Testing: Techniques for determining drug solubility in various solvents
    • Particle Size Analysis: Methods for characterizing particle size and distribution
    • Compatibility Testing: Assessing the compatibility of drug substances with excipients
  5. Physicochemical Characterization
    • Techniques for evaluating physicochemical properties such as melting point, pH, and viscosity
    • Methods for assessing the mechanical properties of powders and granules
    • Analysis of crystalline and amorphous forms of the drug substance
  6. Pharmaceutical and Analytical Techniques
    • Spectroscopy: Use of UV, IR, and NMR spectroscopy in pre-formulation studies
    • Chromatography: Applications of HPLC and TLC for drug substance analysis
    • Microscopy: Techniques for particle size and morphology analysis
  7. Regulatory and Compliance Considerations
    • Understanding regulatory requirements for pre-formulation studies (FDA, EMA, ICH)
    • Documentation and reporting of pre-formulation results
    • Preparing for regulatory submissions and inspections
  8. Case Studies and Practical Applications
    • Analysis of real-world pre-formulation studies and case studies
    • Hands-on practice with pre-formulation testing and analysis techniques
    • Problem-solving exercises based on practical challenges
  9. Emerging Trends and Technologies
    • Innovations in pre-formulation methodologies and technologies
    • The role of digital tools and automation in pre-formulation studies
    • Future trends in drug development and formulation design

Training Methodology

  • Expert Lectures: Comprehensive coverage of pre-formulation principles, techniques, and regulatory considerations by experienced trainers.
  • Interactive Workshops: Practical sessions focused on pre-formulation testing, formulation design, and data interpretation.
  • Case Studies: Examination of real-world pre-formulation scenarios and successful case studies.
  • Group Discussions: Collaborative learning and sharing of best practices related to pre-formulation activities.

Program Duration and Schedule

The Pre-Formulation Activity Training Program is available in both full-time and part-time formats to accommodate professional schedules. The course typically spans [X] weeks, with sessions held [X] times per week.

Who Should Attend?

  • Pharmaceutical scientists and researchers
  • Formulation development teams
  • Quality control and assurance professionals
  • Regulatory affairs specialists

Certification

Participants who successfully complete the program will receive a certification from Pertecnica Engineering, demonstrating their expertise in pre-formulation activities.

Enroll Now

Advance your understanding of pre-formulation activities with our specialized training program. For more information on course dates, fees, and registration, please contact us