Optimising the therapeutic trinity of active ingredient, delivery system and functional packaging.
This paper introduces the "therapeutic trinity" concept for formulating and developing optimal drug products. It starts with the recognition that all drug products are constituted of three distinct elements: the active ingredient, the delivery system and the packaging. Union of these three elements into one trinity will bring therapeutic value to the patient under the condition that active ingredient, delivery system and packaging are developed and optimised interdependently. Optimisation should be performed with the patient in mind, taking into account the relevant efficacy and safety parameters, and the relevant quality and cost parameters. Since the patient plays the central role in the performance of the drug product, biopharmaceutical robustness of and patient compliance towards the active ingredient/delivery system/packaging trinity should be considered important determinants of therapeutic success.
Sam
Tom
T
NV Organon, PO Box 20, 5340 BH Oss, The Netherlands. tom.sam@organon.com
D002626:Chemistry, Pharmaceutical; D016503:Drug Delivery Systems / Q000379:methods*; D004349:Drug Packaging / Q000379:methods*; D006801:Humans; D004364:Pharmaceutical Preparations / Q000138:chemical synthesis; D013678:Technology, Pharmaceutical / Q000379:methods*
D004364:Pharmaceutical Preparations