In-vitro Studies for Solid Oral Dosage Forms in Pharma

Explore in-vitro studies and learn dissolution analysis techniques for drug development in R&D & quality control in QC!

Ratings: 4.41 / 5.00




Description

New Drug Application (NDA) and Abbreviated New Drug Application (ANDA)  submissions contain in-vivo (bioavailability or bioequivalence data) and in-vitro dissolution data.

In-vivo and in-vitro dissolution data, together with chemistry, manufacturing, and controls (CMC) data, are so important to characterize the quality and performance of the drug product.


  • In-vitro dissolution methods are developed to evaluate the in-vivo bioperformance of solid oral dosage forms.

  • In-vitro dissolution methods are quality control tests to ensure the consistency of product manufacturing and the bioperformance of solid oral dosage forms.

  • Dissolution test is the simulation of in-vivo conditions in the in-vitro environment.

  • Dissolution test is so important control tool because it is used for evaluating of in-vivo performance of drug product without any in-vivo performance.

  • Dissolution test is developed and performed in laboratory conditions (in-vitro conditions). Dissolution test is kind of simulation in lab conditions. Dissolution test is usefull to foresee the performance of drug products in biological environment (in-vivo conditions).

In the scope of course all technical details and requirements of dissolution analysis have been discussed.


IN-VITRO STUDIES FOR SOLID ORAL DOSAGE FORMS IN PHARMA

1 Introduction

2 In-vitro & In-vivo Studies for Drug Product

2.1. Reference Listed Drug (RLD) & Generic Drug

2.2. Drug Development

2.3. In-vitro & In-vivo Performance of Drug Product

3 Solubility

3.1. Solubility of Drug Product

3.2. Solubility & Dissolution

4 Dissolution & Dissolution Selectivity

4.1. Dissolution-1 (Dissolution Instrument)

4.2. Dissolution-2 (Variations on CMA, CPP, Formulation Component & Dissolution Selectivity)

4.3. Dissolution-3 (Particle Size Distribution & Dissolution Selectivity)

4.4. Dissolution-4 (Polymorphic Structure & Dissolution Selectivity)

4.5. Dissolution-5 (Excipients Composition & Dissolution Selectivity)

4.6. Dissolution-6 (Critical Process Parameters & Dissolution Selectivity)

5 Dissolution Test as a Tool

5.1. Dissolution Method as a Formulation Development Tool

5.2. Dissolution Method as a Quality Control Tool-1

5.3. Dissolution Method as a Quality Control Tool-2

6 Dissolution Test Method

6.1. Dissolution Apparatus

6.2. Stirring Rate

6.3. Dissolution Volume & Sink Condition

6.4. Dissolution Media (Medium) & Surfactant Usage

6.5. Dissolution Sampling & Sampling Point & Sampling Apparatus

6.6. Critical Issues for Dissolution

7 Evaluation of Dissolution Test Results

7.1. Dissolution Results & Similarity Factor

8 Selectivity of Dissolution Method

8.1. Selectivity of Dissolution Method-1

8.2. Selectivity of Dissolution Method-2

8.3. Selectivity of Dissolution Method-3

8.4. Selectivity of Dissolution Method-4

9 Dissolution in Pharmaceutical Development

9.1. Dissolution in Pharmaceutical Development

9.2. Discrimitive Dissolution Method Development

10 Dissolution in ICH

10.1. Dissolution in ICH

10.2. Dissolution for Immediate Release Tablet

10.3. Dissolution for Extended Release Tablet

11 Conclusion

What You Will Learn!

  • Define reference listed drug (RLD) & generic drug and their development processes
  • Understand importance of in-vitro & In-vivo studies for drug development processes
  • Understand importance of in-vitro & In-vivo studies for drug development processes
  • Learn dissolution theory and dissolution instrument
  • Evaluate dissolution selectivity for variations related with material, formulation and process
  • Learn dissolution method as a formulation development tool
  • Learn dissolution method as a quality control tool
  • Evaluate dissolution results and calculate similarity factor
  • Define dissolution apparatus, stirring rate, dissolution volume, dissolution media, dissolution sampling
  • Understand importance of dissolution test in pharmaceutical development
  • Learn strategy for discrimitive dissolution method development
  • Define dissolution specification and acceptance criteria for immediate release tablet
  • Define dissolution specification and acceptance criteria for extended release tablet

Who Should Attend!

  • Learners who desire to take a part in Pharmaceutical Industry
  • Existing pharma professionals who are looking to progress in their jobs
  • Anyone who is looking to get entry in pharmaceutical industry