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Abstract

Dissolution tests have been in use in the pharmaceutical industry for over 20 years, and they are official in The United States Pharmacopeia since the early 1960s. The dissolution test, reviewed primarily as a quality control tool, replaced the use of disintegration tests which had been official in The United States Pharmacopeia since 1950. Refinements in the dissolution test equipment and methodology have occurred over the years in order to enhance its relevance. The Subcommittees of the USP Committee of Revision dealing with these issues have developed and refined compendial dissolution standards and policies for conventional solid-oral dosage forms and modified-release dosage forms.

Current Perspectives on the Dissolution Stability of Solid Oral Dosage Forms

“…If a product fails to meet the established specifications during its shelf-life, it becomes unsuitable for usage and marketing. Since current good manufacturing practice (CGMP) regulations apply to the manufacture of commercial as well as clinical products, it is required that drug products made for Phases I, 11, and I11 clinical trials should be stable at least for the duration of the clinical investigation when the product is stored under the conditions specified on the label. Stability studies should be viewed as an integral part of formulation development, whether a clinical or commercial formulation.…”

Drug Transport across Porcine Intestine Using an Ussing Chamber System: Regional Differences and the Effect of P-Glycoprotein and CYP3A4 Activity on Drug Absorption

“…Methods to predict intestinal drug absorption in humans in vivo range from purely in silico computational techniques to preclinical animal studies in vivo. In vitro tests range from relatively simple solubilization or permeation studies to more advanced systems, mimicking several steps or even the complete passage through the gastrointestinal tract [1,2,3,4,5,6,7]. High-throughput methods (e.g., PAMPA or Caco-2 cell lines) are frequently used in early, preclinical stages.…”

Widening the applications of the Just-Dip-It approach: a solid contact screen-printed ion-selective electrode for the real-time assessment of pharmaceutical dissolution testing in comparison to off-line HPLC analysis

“…The results are consistent with the acceptance dissolution criteria, as stated by USP. 35 From Fig. 6 , it can be easily concluded that SC-SP-ISE has equivalent performance to the traditional HPLC for tracking the PIO release from the pharmaceutical preparations.…”