Future of Manufacturing and Exposure Limitation with High Potency Medicines

High potency medicines are pharmaceuticals or drugs consisting of “Highly Potent Active Pharmaceutical Ingredients (HPAPI)”  which are ingredient or pharmaceutical agents that have been deemed potent/active and their biological activity are registered at 15 micrograms or lower per kilogram of total body weight. The dosage of these ingredients is provided as 1 milligram or lower per day. The growing usage of these active agents in the manufacturing of drugs currently under development is because of their intense focused therapeutic system along with their effectiveness in treatment of chronic disorders even with a lower dosage resulting in limited side effects of drugs. The usage of these agents represents a transforming trend that major pharmaceutical companies are adopting in usage of small molecules for development of specialized patient therapies. Currently, high potency drugs are being transformed due to the increased need for better therapeutics and treatment method thereby increasing the precise nature of the API (Active Pharmaceutical Ingredients) present in them. The more specific effects of API present in the drugs inadvertently reduce the dosage required for the patient to treat their disorders. The development of high potency medicines involves a large amount of control, containment and limitation to exposure of individuals to the ingredients that they are working with, and the main suggestion provided by various authorities regulating the manufacturing of pharmaceuticals is utilizing continuous processing. The major trend currently being followed is adoption of continuous machinery/equipment that does not require human intervention for the supply chain to continue operating. This trend of continuous production results in better environmental efficiency and limitations of exposure of these ingredients to individuals as they do not require transferring or initiation of manufacturing manually. This process is similar to closed manufacturing/processing although there is a difference between the two, as closed processing involves containment of products, ingredients, components and equipments from the outside world with the requirement of human supervision to provide efficient operating. This generally involves closure of the manufacturing area in a confined, isolated location with protective suits being worn by the individuals dealing in the manufacturing of high potency medicines. The truth regarding the future of high potency medicines is that major regulatory authorities will restrict the open manufacturing processing of pharmaceuticals in general, let alone high potency medicines. So, to complement the significant demands of highly effective pharmaceuticals major pharmaceutical organizations and specialized manufacturers are adopting the usage of continuous machinery, where the exposure to active ingredients is limited to just weighing of ingredients and the remaining steps of a manufacturing is moderate exposure. Conclusion Although, the usage of these ingredients require extra care, expenses, a longer drug approval process which is significantly more complex yet the manufacturers and various organizations that are employed in production of pharmaceuticals have increased its usage. More and more medicines are currently under developments that are highly potent requiring the need to be produced with an integrated and combined manufacturing method of closed processing and continuous processing, otherwise the effects of this will be drastic and life-threatening.