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Challenges in thedevelopmentand manufactureof oral dosage forms containing potent actives


Juniper Pharma Services, 8 Orchard Place,
Nottingham Business Park, Nottingham NG8 6PX, United Kingdom


Therapeutic agents are being designed to be very selective in their mode of action. Consequently, new drugs are becoming increasing more potent. High potency drugs present issues with safe handling for production operators and analysts. Another challenge presents itself to formulation scientists – to develop formulations containing very low doses of the active component. This article provides an insight into both the handling aspects and formulation approaches which apply to the development and manufacture of high potency/low dose products.


 New therapeutic agents are being designed to be more selective in their activity with biological targets. Greater target selectivity leads to lower incidence of off-target interactions and the intended pharmacological action can be achieved with smaller quantities of drug – or to be more precise, new compounds are becoming more potent. Patients benefit as there is less risk of undesirable side-effects and the manufacturers benefit as they provide an effective medication and higher potency means less drug required per unit dose, thus reducing cost of goods. However, the manufacture of potent drug substances and their associated drug products requires use of specialised techniques and practices. For products containing potent compounds the unit doses inevitably contain very small quantities of drug. Achieving satisfactory drug content uniformity th ... ...