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Dissolution testing. 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. [1]
Dissolution is the process in which a substance forms a solution. Dissolution testing measures the extent and rate of solution formation from a dosage form, such as tablet, capsule, ointment, etc. The dissolution of a drug is important for its bioavailability and therapeutic effectiveness.
The primary functions of a dissolution test during early stages of development are to characterize therapeutic efficacy, bioequivalence, and bioavailability of API. During later stages of the development process, dissolution testing is also used for quality control (QC) purposes.
A dissolution experiment evaluates the rate and extent that a compound forms a solution under carefully controlled conditions. The dissolution test in a USP drug product monograph helps evaluate the performance of a drug product (article) and indicates when the drug product performs in a substandard fashion.
Dissolution testing provides critical information to support the realisation of drug release goals, for comparing the performance of different drug substances, for bioequivalence (BE) testing and for product QC.
Dissolution testing is an important physiochemical test for the development of solid oral dosage forms, tablets, and capsules. As a quality control test, the dissolution test is used for assessment of drug product quality and is specified for batch release and regulatory stability studies.
Dissolution testing provides crucial in-vitro drug release information that is routinely used for quality-control (QC) and quality-assurance (QA) purposes in the pharmaceutical industry.
Dissolution testing has emerged as a very important tool in the generic pharmaceutical industry. It is very widely used in formulation development, in monitoring the manufacturing process and as a quality control test. It can also be used to predict the in vivo performance of certain products.
The dissolution test (ing) and the resulting drug release testing data are crucial tests that interface all phases of the life cycle of a pharmaceutical product. Drug dissolution/release testing (studies) interfaces virtually all aspects of the life cycle of a pharmaceutical product.
The dissolution test is an in vitro test typically performed on oral dosage forms to measure the performance of the drug products.