Ion exchange resins have been used in the pharmaceutical industry for over 60 years. The applications for their use include modified release, taste masking, improved bioavailability of poorly soluble materials, stability and abuse deterrence. In recent years, increasing patient compliance, especially in the pediatric and geriatric populations, has driven the direction of drug delivery towards ease of administration and reduced adverse taste. This presentation will demonstrated by loading ionizable active pharmaceutical ingredients (APIs) onto ion exchange resins lend a formulation strategy that works well in suspension formulations and there are several existing examples of this the most well know being Delsym® and Tussionex®.<br/>The ion exchange resin can modify release of the API in the buccal cavity for taste masking or in the GI track for a sustained release effect and in some cases both are achieved with one formulation. Varying product and processing parameters can dial in the desired effect that the formulator is looking for.<br/>The patented flow through dissolution method used to obtain case study data employed using the Dow’s FloVitro™ technology which gives level A IVIVC with no mathematical modeling and is predictive of extended release. This method’s concepts and use will be explained during the case studies portion of the presentation. Additionally, a flow through buccal dissolution test was used to obtain data for the taste masking case studies and Dow also holds a patent for the technology which predicts taste masking efficacy using concentration as a proxy for bitter taste.

Use of ion exchange resins in pharmaceutical formulations

251st National Meeting (2016)

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