Preliminary Agenda

Fiber Optic Advanced Training Course USA

Contact:        sales@pion-inc.com for registration and logistics

Note: Please bring your own laptop for the training course. An appropriate version of AuPRO is going to be installed for interactive practice.

Tuesday, May 12th

8:30 – 9:00   Attendee Arrival and Breakfast

9:00 – 9:15   Introduction to Pion and personnel

 

9:15 – 10:15  Method Development Part 1: Getting started with the technology and basic considerations

  •  Introduction to Pion Fiber Optic instruments

  • Principles and challenges of in situ concentration measurements

  • Pathlength selections

  • Generating good standard curve, “Blue Standards”
  • Baseline correction algorithms
  • 2nd derivative spectroscopy
  • Calculation settings
  • Sample Blank

 

10:15– 10:30 Break

10:30 – 11:00 User Case Study #1 (TBD)

11:00 – 11:30 Method Development Part 2: Advanced considerations

  • Spectral shape analysis
  • Blank and Reference Channel
  • Can standard curve be prepared in different media
  • Supersaturation considerations
  • Media conversion experiments

 

11:30 – 12:15 Interactive Group Discussion #1: Fiber Optic Method Development

- Recognizing issues, understanding and troubleshooting the data

12:15 – 1:15 Lunch (provided)

1:15 – 2:00 Towards in vivo predictive dissolution – Flux Measurements

  • Understanding the principles and driving forces of the flux
  • Flux configurations
  • Calculation and interpretation of flux data
  • In vivo predictions using flux data

 

2:00 – 2:45  Flux Measurements: Analytical work behind the scene Detecting artifacts

  • Membrane-excipient compatibility
  • Ensuring membrane integrity
  • Dual component flux
  • Potential limitation of the flux measurement

 

2:45 – 3:00 Break

3:00 – 3:45 Group Discussion #2: Practical aspects of flux measurements

Recognizing issues, understanding and troubleshooting the flux experiments and media change experiments

3:45 – 4:15 User Case Study #2 (TBD)

4:15 – 4:45 Advanced Features of AuPRO Version 6

  • Dealing with more than 2 components—multicomponent regression analysis
  • Scatter modelling—can we estimate particle size from the shape of baseline?
  • Creating Reports
  • Standards for nanoparticles and colloids
  • Automating flux calculations

 

4:45 – 5:15 Q&A / Roundtable

5:30 – 7:00 Social hour

 

Wednesday, May 13th

8:30 – 9:00 Attendee Arrival and Breakfast

9:00 – 9:45 Zero intercept Method: Principles and Applications of ZIM

  • Dual-component dissolution
  • Monitoring for spectral consistency
  • Solubility of nanoparticles
  • Liquid-liquid phase separation (LLPS)

 

9:45 – 10:30 Group Discussion #3

Practical aspects of ZIM method implementation – interactive practice. Nanoparticles solubility, dual-component dissolution, LLPS.

10:30 – 10:45 Break

10:45 – 11:15 User Case Study #3 (TBD)

11:15 – 11:30 Introduction to Pion Service

11:30 – 12:15  Pion FO in GMP Environment, DissoPRO software

  • Fiber optic in regulated environment
  • DissoPRO and 21 CFR Part 11 compliance
  • Validating fiber optic dissolution methods
  • DissoPRO software package
  • Preview of the next revision of DissoPRO

 

12:15 – 1:15 Lunch (provided)

1:15 – 2:00 Group Discussion #4

Practical aspects – interactive data analysis, different aspects. Data files for troubleshooting.

2:00 – 2:30 Advanced Tools: Dissolution Curve Analysis

  • Relations between dissolution, solubility, particle size, and hydrodynamics
  • Intrinsic dissolution rate (IDR) measurements
  • Predicting disk IDR from powder dissolution experiments
  • Effective particle size estimation from the powder dissolution profile

 

2:30 – 2:45 Break

2:45 – 4:00

Track 1: FO and Flux Lab Demo (optional for all interested participants)
Track 2: FO in Compliant Environment, GMP considerations round table

 

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