SP <711>
Dissolution Testing

USP <711> dissolution testing helps pharmaceutical manufacturers understand the efficacy of different pharmaceutical product dosage forms by providing insight into the dissolution rate. USP <711> testing provides critical knowledge that helps manufacturers make decisions about drug delivery methods based on data collected about effectiveness in different forms.

USP General Chapter 711 defines six different apparatus testing methods for pharmaceuticals. BA Sciences provides expertise in each method, including multiple Dissolution Apparatus IV options. We also feature HPLC (high-performance laser chromatography) systems as a testing option.

We offer USP <711> dissolution test services for each of the six apparatus methods:

• USP Dissolution Apparatus I – Basket
• USP Dissolution Apparatus II – Paddle
• USP Dissolution Apparatus III – Reciprocating Cylinder
• USP Dissolution Apparatus IV – Flow-Through Cell
• USP Dissolution Apparatus V – Paddle over Disk
• USP Dissolution Apparatus VI – Reciprocating Holder Apparatus

In keeping with USP dissolution Chapter 711 guidelines, a standard dosage, or article, for each test is defined as one tablet or capsule, or a specified standard amount. Below, we will briefly describe the core principles of each USP <711> testing method in which we offer expertise and services.

In this method, the article is placed in a transparent, inert vessel (typically made of glass) that is partially submerged in a water bath. A drive shaft rotates at a constant rate of speed to create rotation of the water at a constant speed and a constant temperature of 37 degrees Celsius, and the dissolution rate is measured under these conditions.

This method is similar to the basket method described above except that a paddle element drives rotation of the water bath rather than a drive shaft. In this method, the article is allowed to sink to the bottom of the vessel so that it is only agitated by the rotation of the water bath, not by the paddle apparatus itself.

The reciprocating cylinder method uses a set of vertically reciprocating glass cylinders that are submerged in a corresponding set of vessels. The vertical reciprocating motion of the cylinders provides the agitation, which results in dissolution of the article.

In this method, the article is placed within a flow-through cell — a transparent, inert container with an integrated filter system. A pump forces a dissolution medium through the cell at a constant rate. This method is well suited for special dosage forms since a tablet holder can be built into the cell as well.

This method uses the same paddle assembly as Apparatus II but also incorporates a stainless steel disk into the bottom of the vessel to hold a transdermal system.

The reciprocating holder method uses a similar assembly to Apparatus I, except that the basket and shaft are replaced with a stainless steel cylinder rotational element and the temperature is maintained 5 degrees lower, at 32 C.