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In Vitro Dissolution Study

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Questions and Answers

Which of the following is the purpose of the dissolution test?

To confirm batch-to-batch reproducibility (correct)

To show typical variability in composition and manufacturing parameters

To assess drug product performance in vivo

To measure the time required for drug absorption

Which factor can affect the disintegration and dissolution of a tablet?

Particle size of drug substance (correct)

Drug solubility in solution

Drug release rate

Drug absorption rate

Which factor is the rate limiting factor for absorption of a slightly soluble drug?

Dissolution (correct)

Drug release

Particle size

Permeability

What does the dissolution test measure?

Time for drug substance to go into solution Signup and view all the answers

What are dissolution and drug release tests used for?

To assess drug product performance in vitro Signup and view all the answers

What is the purpose of the dissolution test?

The purpose of the dissolution test is to measure the time required for a given percentage of the drug substance in a tablet to go into solution under specified conditions. Signup and view all the answers

What is the rate limiting factor for absorption of a slightly soluble drug?

The rate limiting factor for absorption of a slightly soluble drug is dissolution. Signup and view all the answers

What are dissolution and drug release tests used as a measure of?

Dissolution and drug release tests are used as a measure of drug product performance, in vitro when linked to product performance in vivo. Signup and view all the answers

What does the dissolution test confirm?

The dissolution test confirms batch-to-batch reproducibility and shows typical variability in composition and manufacturing parameters. Signup and view all the answers

What are some factors that can affect the disintegration and dissolution of a tablet?

Some factors that can affect the disintegration and dissolution of a tablet include particle size of the drug substance, solubility, and formulation and manufacturing factors. Signup and view all the answers