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      Pharmaceutical Dissolution Testing in Boston

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      June 8, 2020

      Monday   8:30 AM - 4:30 PM (daily for 4 times)

      Boston, Massachusetts 02101

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      Pharmaceutical Dissolution Testing

      Pharmaceutical Dissolution Testing
      About this Event


      Pharmaceutical dissolution testing helps to ensure the safety and efficacy of a variety of different formulated drug products. This three-day course covers the theory behind drug solubility and dissolution rate, regulatory expectations, experimental technique, interpretation of test results, investigating anomalous data, setting suitable dissolution specifications and the development and validation of dissolution tests. It also includes details of the USP and US FDA approaches for equipment qualification as well as the use of in vitro dissolution testing to establish bioequivalence. The establishment and uses of in vitro-in vivo correlations (IVIVC) will also be discussed.

      The focus of the course will be on solid oral dosage forms, but apparatus and techniques for other types of drug product will also be presented, including transdermal drugs and dosage forms designed for release over a period of weeks or months. The course consists of lectures and exercises/workshops designed to reinforce the taught component.

      By the end of the course, you will understand the science underpinning dissolution/drug release testing, and have the knowledge required to:

      Avoid practical errors in the dissolution/release testing of drug products
      Select appropriate test conditions (dissolution medium, apparatus, agitation rate, time points)
      Validate dissolution methods in accordance with regulatory expectations
      Reduce dissolution result variability
      Troubleshoot anomalous results
      Set scientifically-sound acceptance criteria
      Implement a compliant dissolution equipment qualification strategy
      Use in vitro data to establish bioequivalence
      Understand the potential for establishing an in vitro-in vivo correlation (IVIVC) and the regulatory application of different IVIVC classes
      Seminar Fee Includes:


      AM-PM Tea/Coffee

      Seminar Material

      USB with seminar presentation

      Hard copy of presentation

      Attendance Certificate

      $100 Gift Cert for next seminar

      Learning Objectives:

      Reasons for dissolution testing
      Factors affecting drug solubility and dissolution rate
      Apparatus for the dissolution/release testing of different dosage forms
      Instrument qualification approaches
      Dissolution tests for immediate-release and modified-release drug products
      Release testing of transdermal products
      Accelerated dissolution testing of novel dosage forms (e.g. implants, polymeric microspheres etc.)
      Calculation and interpretation of test results
      Dissolution method development
      Options for the analytical finish
      Dissolution method validation
      Troubleshooting anomalous data
      The role of dissolution testing in establishing bioequivalence (biowaivers)
      In vitro-in vivo correlation

      Who will Benefit:

      Laboratory staff responsible for developing dissolution methods
      Personnel responsible for equipment qualification
      Quality control analysts
      Regulatory affairs professionals
      Quality management


      DAY 01(8:30 AM - 4:30 PM)

      08:30 AM – 09:00 AM – Registration Process, Meet & Greet

      9:00 AM -10:30 AM

      Reasons for dissolution testing



      Dissolution testing in the context of other quality parameters

      Dissolution theory

      Factors affecting solubility

      10:30 AM -10:45 AM Break

      10:45 AM -12:00 Noon

      Dissolution theory (continued)

      Dissolution rate

      Dissolution medium

      Intrinsic and apparent dissolution

      12:00 Noon -1:00 PM Lunch

      1:00 PM -3:00 PM

      Dissolution apparatus

      Regulatory references

      Apparatus for solid oral dosage forms (USP apparatus 1, 2 3 and 4)

      Non-compendial options (e.g. small-volume apparatus and peak vessels)

      Apparatus for transdermal dosage forms (USP apparatus 5, 6 and 7)

      3:00 PM -3:15 PM Break

      3:15 PM - 4:30 PM

      Dissolution apparatus (continued)

      Apparatus for topical semi-solid dosage forms (vertical diffusion cell)

      Intrinsic dissolution testing

      Ph. Eur. apparatus for medicated chewing gum

      Requirements for different release types

      Immediate release

      Delayed release

      Extended release

      DAY 02(8:30 AM - 4:30 PM)

      8:30 AM-8:59 AM Attendees arrive

      9:00 AM -10:30 AM

      Requirements for non-oral dosage forms

      Transdermal patches

      Topical semi-solids

      Dissolution testing for novel dosage forms

      Experimental options

      Accelerated release testing

      10:30 AM -10:45 AM Break

      10:45 AM -12:00 Noon

      Interpretation of results

      Meaning of Q

      Results calculation

      Immediate release

      Delayed release

      Extended release

      12:00 Noon-1:00 PM Lunch

      1:00 PM-3:00 PM

      Equipment qualification

      Regulatory/industry body guidance

      USP approach (PV tablets)

      US FDA approach (enhanced mechanical qualification)

      Equipment factors influencing result variability

      3:00 PM -3:15 PM Break

      3:15 PM - 4:30 PM

      Dissolution test troubleshooting

      Troubleshooting approach

      Records and observations that aid troubleshooting

      DAY 03(8:30 AM - 4:30 PM)

      8:30 AM - 8:59 AM Attendees arrive

      9:00 AM - 10:30 AM Method development

      Choice of dissolution medium

      pH range



      Biorelevant media

      10:30 AM-10:45 AM Break

      10:45 AM -12:00 Noon

      Method development (continued)


      Agitation rate

      Sampling points


      Acceptance criteria

      12:00 Noon-1:00 PM Lunch

      1:00 PM -3:00 PM

      Method validation

      Regulatory guidance

      Experimental approaches to method validation

      Justifying acceptance criteria

      System suitability tests

      3:00 PM -3:15 PM Break

      3:15 PM - 4:15 PM

      In vitro approaches to bioequivalence

      Regulatory guidance (including ICH M9)

      Solubility and permeability

      Measuring permeability in vitro – Caco-2 and PAMPA models

      Oral bioavailability and first-pass metabolism

      Limitations for in vitro bioequivalence

      In vitro-in vivo correlation (IVIVC)

      IVIVC classes

      Experimental methods for establishing IVIVCs

      Regulatory uses of IVIVCs

      4:15PM-4:30 PM Final questions, feedback and close


      Mark Powell

      Director, Mark Powell Scientific Limited

      Dr Mark Powell is a Fellow of the Royal Society of Chemistry (RSC) with over thirty years’ experience as an analytical chemist. Mark was Honorary Treasurer of the RSC’s Analytical Division and led a working group on continuing professional development until July 2016, when his term of office ended. Between 2003 and 2013, he was the Analytical Development Manager, and later Scientific Manager, of a UK-based contract research organization which specialized in early-stage oral drug development. During this time, he was responsible for method validation, verification and transfer activities, as well as the qualification of laboratory instruments and computerized data systems. In 2013, he set up Mark Powell Scientific Limited, which provides training and consultancy services to pharmaceutical companies. Mark has since enjoyed working with companies of all sizes around the world on a variety of training and consultancy assignments, and has recently co-authored a White Paper on Pharmaceutical Data Integrity for the laboratory supply company VWR.

      Cost: $2,699

      Categories: Conferences & Tradeshows

      This event repeats daily for 4 times:

      Event details may change at any time, always check with the event organizer when planning to attend this event or purchase tickets.

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