page_title: Dissolution testing
section_title: Equipment
hierarchical_section_title: Dissolution testing / Equipment
caption_attribution_description: English: Image of various Dissolution unit with different apparatuses (USP Paddle and Basket)
context_page_description: In the pharmaceutical industry, drug dissolution testing is routinely used to provide critical in vitro drug release information for both quality control purposes, i.e., to assess batch-to-batch consistency of solid oral dosage forms such as tablets, and drug development, i.e., to predict in vivo drug release profiles. There are three typical situations where dissolution testing plays a vital role: formulation and optimization decisions: during product development, for products where dissolution performance is a critical quality attribute, both the product formulation and the manufacturing process are optimized based on achieving specific dissolution targets. Equivalence decisions: during generic product development, and also when implementing post-approval process or formulation changes, similarity of in vitro dissolution profiles between the reference product and its generic or modified version are one of the key requirements for regulatory approval decisions. Product compliance and release decisions: during routine manufacturing, dissolution outcomes are very often one of the criteria used to make product release decisions.
context_section_description: Several dissolution apparatuses exist.  In United States Pharmacopeia (USP) General Chapter <711> Dissolution, there are four dissolution apparatuses standardized and specified. They are:
  USP Dissolution Apparatus 1 – Basket (37 °C ± 0.5°C )
  USP Dissolution Apparatus 2 – Paddle (37°C ± 0.5°C)
  USP Dissolution Apparatus 3 – Reciprocating Cylinder (37 °C ± 0.5°C)
  USP Dissolution Apparatus 4 – Flow-Through Cell (37 °C ± 0.5°C)
caption: Different types of Dissolution Units: A Water-bath unit equipped with USP Dissolution Apparatus 2 - Paddle (Top-left), A amber vessel water bath unit that has been equipped with USP Dissolution Apparatus 1 without baskets being placed on yet (Top-right), and a dissolution unit that uses a heating jacket (bottom)
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