Novel oral liquid formulation of Enalapril for children

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With today’s major research and development activities of pharmaceutical companies focusedon meeting the needs of an increasingly aging population, children who represent the bulk ofthe dependent population worldwide still remain a widely neglected niche market.The recognition of the rights of children to have access to safe and effective drugs and theneeds of healthcare providers to receive age-appropriate drug information continues to have amajor effect on all areas of paediatric pharmaceuticals. In line with this challenge, Proveca’sobjective is to develop a new dosage formula of an off-patent drug for the treatment of heartfailure in children and apply for the relevant authorisation. The currently available licensedmedicine is for adults; however children are either unable or unwilling to swallow tablets,proving problematic in the long-term use.Alternatives of the drugs are available in liquid form, however the lack of formalisedlicensing with an official regulatory body causes several concerns. With the formulation ofmedicines being a significant parameter to ensure optimal dosing levels with minimal toxicity,the high variation in the currently unlicensed liquid formulations dispensed to children in theUK raise significant issues related to patient safety and drug efficacy. With a growingpressure on drug safety and new requirements on risk evaluation and mitigation strategies(REMS), there is an increasing need to deliver accuracy and congruence of medication supplyto patients.Proveca’s new formulation has the potential to improve children’s physiologic status, qualityof life and length of life. The aim of this Proof of Concept is to enable Proveca to conductpreclinical feasibility studies and develop a basic prototype of the formulation which will befurther optimised during clinical trial stages.