Dose dumping is a problem in the formulation of relationship

Dissolution Testing for Generic Drugs: An FDA Perspective

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The aim of the study was the formulation and in vitro characterization of a reservoir type prolonged release system with felodipine, over a 12 hours period using the Simplex method.

  • Dissolution Testing for Generic Drugs: An FDA Perspective
  • Medicinal products susceptible to 'dose dumping' should be fully tested
  • Dose dumping

Methods The first step of the Simplex method was to study the influence of the granules coating method on the felodipine release. Furthermore the influence of the coating polymer type, the percent of the coating polymer and the percent of pore forming agent in the coating on the felodipine release were studied.

Afterwards these two steps of the experimental design the percent of Surelease applied on the felodipine loaded granules and the percent of pore former in the polymeric coating formulation variables were studied. The in vitro dissolution of model drug was performed in phosphate buffer solution pH 6. The released drug quantification was done using an HPLC method.

The release kinetics of felodipine from the final granules was assessed using different mathematical models. Conclusion We have prepared prolonged release coated granules with felodipine using a fluid bed system based on the Simplex method.

Development of a reservoir type prolonged release system with felodipine via simplex methodology

The API from the studied final formulations was released over a 12 hours period and the release kinetics of the model drug substance from the optimized preparations fitted best the Higuchi and Peppas kinetic models. The first use is a cosmetic one non-functional in order to improve the visual characteristics of the product and to distinguish it from others similar preparations and the second one is functional [ 12 ].

The functional coating can be used: The multi-particulate preparations granules or pellets are frequently coated with different types of polymers in order to obtain prolonged release formulations and they are in general formulated as hard gelatin capsules or tablets [ 3 — 6 ].

In comparison with the monolithic preparations, the multi-particulate preparations offer some important advantages: Because the entire drug content is distributed in many units they are less susceptible for dose dumping due to film imperfections burst-effect [ 378 ]. The objective of this article is to summarize how dissolution testing is used for the approval of safe and effective generic drug products in the United States US. Dissolution testing is routinely used for stability and quality control purposes for both oral and non-oral dosage forms.

The dissolution method should be developed using an appropriate validated method depending on the dosage form. There are several ways in which dissolution testing plays a pivotal role in regulatory decision-making.

It is very widely used in formulation development, in monitoring the manufacturing process and as a quality control test.

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It can also be used to predict the in vivo performance of certain products. Dissolution testing has been successfully used for development and approval of generic solid oral dosage forms. Most recently, the use of dissolution testing has been extended to other solid generic dosage forms; in these cases it is generally called as in vitro release testing or simply drug release testing 12. The purpose of this article is to summarize how dissolution testing is used for the approval of safe and effective generic drug products in the USA.

This article also reflects the current thinking of the US-Food and Drug Administration US-FDAon using dissolution and other in vitro drug release testing in consistently producing high-quality generic drug products and reducing the regulatory burden for the pharmaceutical industry.

In developing a dissolution test for a generic product intended to be marketed in the USA, investigators should consider the official methods and standards published in the United States Pharmacopeia USP.