Interpretation and optimization of the dissolution specifications for a modified release product with an in vivo-in vitro correlation (IVIVC)

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Measuring & Monitering Plant Populations

The U.S. Pharmacopoeia (USP) general monograph provides a standard for dissolution compliance with the requirements as stated in the individual USP monograph for a tablet or capsule dosage form. The USP monograph sets performance limit on dissolution in terms of a specific percentage Q that the drug product is required to be dissolved at a specified time. Japan Pharmacopoeia provides acceptance rules different from USP. However the objective of the acceptance rules was not defined in terms of the inference of the whole lot by either USP, European Pharmacopoeia (EP) or Japan Pharmacopoeia (JP). The operating characteristics’ curves of these rules are all shown to be sensitive to the true mean dissolution and do not reject a lot which has a large percentage of tablets that dissolve with less than the specified limit Q. This is especially true when the mean dissolution is close to the specification value. We proposed that the goal of the dissolution test sampling plan is to accept a lot at least 90%...

Three-stage sequential statistical dissolution testing rules.

The U.S. Pharmacopeia (USP) general monograph provides a standard for dissolution compliance with the requirements as stated in the individual USP monograph for a tablet or capsule dosage form. The acceptance rules recommended by USP have important roles in the quality control process. The USP rules and their modifications are often used as an industrial lot release sampling plan, where a lot is accepted when the tablets or capsules sampled are accepted as proof of compliance with the requirement. In this paper, the operating characteristics of the USP acceptance rules are reviewed and compared to a selected modification. The operating characteristics curves show that the USP acceptance rules are sensitive to the true mean dissolution and do not reject a lot or batch that has a large percentage of tablets that dissolve with less than the dissolution specification. This is especially true when the mean dissolution is close to the specification. Although the modified USP rule, as proposed by Givand, improve...

Dissolution test acceptance sampling plans.

Introduction The dissolution test as defined in the United States Pharmacopoeia (1) is used in judging the quality of pharmaceutical products. Dissolution testing is a method for evaluating physiological availability that depends upon having the drug in a dissolved state. The USP Dissolution testing involves three stages and the acceptance criteria are defined for each stage as a function of a quantity Q,a percentage of the label value that is established for each drug product in its monograph. Acceptance criteria are shown in Table 1. These acceptance criteria are complex and the behavior of the test for samples of varying quality levels is not easily predictable from the knowledge of its drug properties. Pharmaceutical manufacturers are interested in many of the statistical properties of the dissolution test. The following aspects of immediate release dissolution were studied:

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Statistical Properties of the Dissolution Test of USP

Evaluation of U. S. Pharmacopeia Sampling Plans for Dissolution

Resampling Stats: User Guide, Resampling: The New Statistics

The United States Pharmacopeia presents sampling plans and specifications for pharmaceutical products which are used in judging the quality of these products. Previously accepted and revised sampling plans for product dissolution are evaluated and compa..

Charles B. Pheatt

Papers

Evaluation of U. S. Pharmacopeia Sampling Plans for Dissolution

Resampling Stats: User Guide, Resampling: The New Statistics

Reviews of Standards and Specifications: Evaluation of U.S. Pharmacopeia Sampling Plans for Dissolution