Abstract
<p class="PaperKeywordTitle">In vitro dissolution/release tests are an indispensable tool in the drug product development, its quality control and the regulatory approval process. Mucosal drug delivery systems are designed to provide both local and systemic drug action following ocular, nasal, oromucosal, vaginal or rectal administration. They exhibit significant differences in formulation design, physicochemical characteristics and drug release properties. Therefore it is not possible to devise a single method which would be suitable for release testing of such versatile and complex dosage forms. Different apparatuses and techniques for in vitro release testing for mucosal delivery systems considering the specific conditions at the administration site are described. In general, compendial apparatuses and methods should be used as a first approach in method development when applicable. However, to assure adequate simulation of conditions in vivo, novel biorelevant in vitro dissolution/release methods should be developed. Equipment set up, the selection of dissolution media and volume, membrane type, agitation speed, temperature, and assay analysis technique need to be carefully defined based on mucosal drug delivery system characteristics. All those parameters depend on the delivery system and physiological conditions at the site of application and may vary in a wide range, which will be discussed in details.</p>
Highlights
In vitro dissolution/release tests are an indispensable tool in the drug product development, its quality control and the regulatory approval process
Different apparatuses and techniques for in vitro release testing for mucosal delivery systems considering the specific conditions at the administration site are described
The drug dissolution/release test is a key test of dosage form performance both during formulation development as well as for quality control purposes
Summary
The drug dissolution/release test is a key test of dosage form performance both during formulation development as well as for quality control purposes. It should be noted that the terms drug dissolution and drug release are often not appropriately distinguished in the literature and even in regulatory documents. Upon the contact with the aqueous dissolution medium, water penetrates into the matrix of the delivery system and dissolves the drug. The matrix of the delivery system might undergo several changes such as swelling and consequent dissolution in the aqueous medium, all contributing to the overall drug release process [2,3]. Considering the complexity of mucosal delivery systems, often containing nanoparticulate carriers included in soluble or insoluble matrices, in vitro drug release seems to be the appropriate term when describing the liberation process of the drug from such formulations
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