Pharmaceutical Industry: Drug Dissolution Testing

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What is the main objective of developing and evaluating an IVIVC?

To assess batch-to-batch consistency of solid oral dosage forms

To predict in vivo drug release profiles

To optimize product formulation based on achieving specific dissolution targets

To establish the dissolution test as a surrogate for human studies (correct)

When does dissolution testing play a vital role in the pharmaceutical industry?

During routine manufacturing for product release decisions (correct)

During generic product development for regulatory approval decisions

During post-approval process or formulation changes for equivalence decisions

During optimization of product formulation and manufacturing process

What are the typical situations where dissolution testing plays a vital role?

Reference product comparison, product development, batch-to-batch consistency assessment

Drug development, post-approval process changes, human studies

Clinical trials, manufacturing process optimization, regulatory approval decisions

Formulation and optimization decisions, equivalence decisions, product compliance and release decisions (correct)

What does dissolution testing provide critical in vitro drug release information for?

Quality control purposes and drug development Signup and view all the answers

What is the purpose of dissolution testing in drug development and manufacturing?

To establish safety and efficacy of a drug product without in vivo tests Signup and view all the answers

Which apparatus is standardized and specified in the United States Pharmacopeia (USP) General Chapter Dissolution?

USP Dissolution Apparatus 1 – Basket Signup and view all the answers

What is the temperature maintained for the dissolution medium within the vessels?

37 °C ± 0.5 °C Signup and view all the answers

What is the main target of hydrodynamic studies in dissolution apparatuses?

USP Dissolution Apparatus 2 Signup and view all the answers

Why is degassing the dissolution medium important?

The presence of dissolved gases may affect results Signup and view all the answers

How are sample solutions collected from dissolution testing commonly analyzed?

HPLC or Ultraviolet–visible spectroscopy Signup and view all the answers

What is initiated if there is a deviation from the acceptable Q values at S3 testing?

An OOS (Out of Specification) investigation Signup and view all the answers

What do researchers suspect about USP Dissolution Apparatus 2 based on hydrodynamic studies?

It provides inconsistent and sometimes faulty data Signup and view all the answers

Which type of solutions can be used as a dissolution medium?

Degassed or sonicated deionized water to pH adjusted chemically-prepared solutions and mediums that are prepared with surfactants Signup and view all the answers

How are vessels of the dissolution method usually heated?

Partially immersed in a water bath solution or heated by a jacket Signup and view all the answers

What is the main purpose of drug dissolution testing according to Qureshi and Shabnam (2001)?

To establish safety and efficacy of a drug product without in vivo tests, following minor formulation and manufacturing changes Signup and view all the answers

Pharmaceutical Industry: Drug Dissolution Testing

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