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New Rohm and Haas dissolution testing equipment for enhanced oral formulations

Rohm & Haas Co : 30 November, 2006  (New Product)
Rohm and Haas has designed new equipment in support of its GI and buccal dissolution testing that give an excellent level A IVIVC for oral dosage forms. Easy to use, they need no mathematical model and results can be interpreted quickly and effectively at the bench.
The equipment can handle a variety of oral dosage forms of the same drug (tablets, fast melts, capsules, syrups etc). The effectiveness of oral dosage forms relies on the drug dissolving in the fluids of the gastrointestinal tract prior to absorption into the systemic circulation. Drug dissolution or the rate of drug release from a finished drug product is becoming an increasingly important aspect, particularly with the advent of controlled-release dosage forms and the increasing use of poorly soluble drugs.

With Rohm and Haas GI dissolution testing you can determines how quickly and how efficiently tablets or other dosage forms dissolve and make the drug available to the human body. The method is also efficient with non-disintegrating dosage forms. As a QC/QA method it can give far more information than the standard USP type tests, because it assesses disintegration, dissolution, absorption and clearance under bio-relevant conditions. The pH and composition in the cells can be changed during a test, allowing the effects of pH changes in the intestinal tract to be incorporated.

But it is used efficiently not only in routine assessments of production quality to ensure uniformity between production lots or to assess the bioequivalence of various batches of a same product or of competitive products. As a research tool, it can help optimize the therapeutic effectiveness during product development and stability assessment. It enables to compare different formulations of a same drug and demonstrates agreement with in vivo performance. It is predictive of the “in vivo” availability, i.e. the amount of drug available to the body (bioavailability) across different dosage forms of the same drug, including immediate and modified release versions.

A similar yet simplified equipment is offered for the buccal dissolution testing to measure the efficiency of any excipients used for taste masking. For buccal dissolution the volume of saliva is very small compared to that of the stomach. The drug remains a very short time in the mouth. The dosage forms (except the lozenges) are swallowed within a minute. Complete dissolution is not required, nor desirable. It is therefore critical to remove finely divided solids from the test vessel to obtain a bio-relevant test. The method characterizes the amount of drug that dissolves during passage through the mouth. It allows to predict the intensity of the taste of a dosage form relative to another dosage form or of a performance target. The method can be used as a QC test to ensure dosage uniformity. It is rapid only 20 minutes are needed per test and it is repeatable.

Both dissolution tests have the potential to reduce the amount of animal testing, development time and cost.
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