Extended Release
Drug-resin complexes ("resinates") for extended release are known and have been successfully used commercially.
Typically, the formation of the resinate occurs as a separate manufacturing process prior to the final formulation work on the finished dosage form.
However, during the course of the research programme supporting the Advanced Release Technologies programme, it was discovered that under certain circumstances, simply formulating the appropriate ion exchange resin with a free form of the drug resulted in the same formulation performance as the resinate itself thus greatly simplifying the manufacturing and regulatory aspects of using functional polymers in the formulation.
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An example of this technique is shown in the graph which is based on an extended release form of diclofenac.
This technique is applicable to certain drugs which have particular characteristics in terms of their relatively affinity for the polymers being used. |
Rohm and Haas has developed a novel GI dissolution system to demonstrate the performance of the improved formulations.
Products Guidelines:
Drugs with cationic functionality (e.g. -COOH or Na / K salts)
Drugs with anionic functionality (-NH2, HCl salts etc.)
