Drug Dissolution Testing and Establishing Plasma Drug Levels in Humans (Boston, MA, United States – December 7-8, 2017) – Research and Markets

Dissolution Testing and Establishing Plasma Drug Levels in Humans”

conference has been added to Research and Markets’

Drug dissolution testing is an essential and critical step for
appropriate and efficient product development such as tablet and
capsule. A number of approaches are used to conduct dissolution testing
using different apparatuses and methods. Making a choice for an
appropriate apparatus and method has always been confusing and
challenging. This seminar will provide relevant pharmacokinetics and
physiological background so that making this choice becomes easier and
instinctive. No prior knowledge of pharmacokinetic and/or physiology is
required; however, these will be explained in very simple terms to help
attendees in selecting or developing a dissolution method. This seminar
will describe in detail the theoretical aspect of the drug dissolution
testing including method development. Pros and cons of different
approaches will be explained in detail.

Furthermore, drug dissolution testing is extensively conducted to
provide an estimate/prediction of expected drug levels in humans.
Commonly, concepts of convolution/deconvolution and in vitro-in vivo
correlation (IVIVC) are described in this respect, unfortunately with
limited success. Difficulties and limitations of the currently suggested
approaches will be highlighted. This seminar will provide details of the
underlying scientific principles involved in convolution, deconvolution
and IVIVC techniques with simple practical examples. In this regard, a
unique and simple approach based on convolution technique using
spreadsheet software will be described.

Pharmaceutical product developments and assessments require extensive
use of in vitro drug dissolution testing and convolution/deconvolution
techniques for predicting plasma drug levels. Often such testing are
presented in isolation (independent to their physiological link or
relevance), however, this seminar will train attendees for developing
these techniques using the principles of pharmacokinetics and
physiology. The seminar will provide unique opportunity to learn
scientifically valid drug dissolution testing and establishing plasma
drug levels.

It would be an unmatched opportunity to learn from an internationally
recognized leader of the subject. A must attend seminar for anyone
involved in product developments and assessments of solid oral dosage

Areas Covered in the Session

Physiological and Pharmacokinetic Principles:

  • Dissolution and related physiological terms: Drug absorption,
    permeation, relevant GI tract environment
  • Basic and required pharmacokinetic principles including terminologies
    such as plasma drug concentration-time profiles/curves, rates of
    absorption and elimination, Cmax, Tmax, half-life, AUC, apparent
    volume of distribution, bioavailability/bioequivalence, etc.
  • Defining, and differentiating, drugs/medicines and drug/medicinal
  • Defining quality of drugs/medicines and drug/medicinal products
  • Generic vs innovator’s products (Similarities and differences)

Drug Dissolution Testing:

  • What is drug dissolution Testing and Why to conduct such tests?
  • Dissolution theory, sink conditions and intrinsic dissolution rate
  • Drug Dissolution Testing vs Solubility determination
  • Drug Dissolution vs Drug Release Testing – Is there a difference?
  • Dissolution Testing Apparatus:

    • Rotating basket (USP Apparatus 1)
    • Rotating paddle (USP Apparatus 2)
    • Reciprocating cylinder (USP Apparatus 3)
    • Flow-through cell (USP Apparatus 4)
    • Non-compendial (Crescent-shape)
  • Setting up a dissolution tester (e.g. Basket and paddle)
  • Dissolution equipment qualification (Performance Tablets vs Mechanical
  • Tolerances and results Interpretation

    • Immediate release
    • Extended release
    • Delayed release
    • Current Requirements And Interpretations
  • Dissolution Method Developments

    • General requirements
    • Selection of dissolution medium
    • Apparatus and agitation rate
    • Sampling (time points & filtration)
    • Acceptance criteria (Pharmacopeial, similarity factor (F2),
      physiologically relevant, etc.)
    • QC method, bio/clinical relevant methods
    • Discriminatory vs non-discriminatory dissolution methods
    • Product dependent vs product independent Methods
    • Dissolution method validation vs analytical (quantitation) method
    • (Specificity, Linearity/range, Accuracy/recovery, Precision,

Linking Dissolution Results to Plasma Drug Levels:

  • Concepts of convolution, deconvolution and in vitro in vivo
    correlation (IVIVC), their requirements and (un)suitability for
    predicting plasma drug levels
  • Requirements for appropriate and relevant dissolution results
  • Convolution vs deconvolution methods which one to use and why?
  • Predicting plasma drug levels (Linking dissolution results to
  • Theoretical background
  • Converting dissolution results into plasma drug levels/profiles
  • Practical application with step-by-step instructions
  • Practical hands-on interactive demonstration of predicting/estimating
    of plasma drug levels using Excel spreadsheet software. Attendees may
    use their computers as well to follow the instructions for obtaining
    plasma drug levels

For more information about this conference visit https://www.researchandmarkets.com/research/mrltmc/drug_dissolution


Research and Markets
Laura Wood, Senior Manager
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Topics: Pharmaceutical