Novel orodispersible compositions of nutraceuticals prepared by the technology of extrusion-spheronization

Abstract

European Medicines Agency (EMA) characterized liquid formulations as most appropriate for pediatric population but this includes drawbacks of lesser stability, more shelf space and dosing error in comparison to solid oral dosage forms. Orodispersible systems hold great promise for children as they are easy to administer, do not require additional water, are difficult to spit out, stable, thus combining advantages of solid and liquid oral dosage forms. The aim of the present research was development of orodispersible pellets of Calcium and Cholecalciferol, as nutraceuticals using the technology of Extrusion -Spheronization. Calcium deficiency is manifested in the bones and teeth of all young animal species, including humans. Effects include stunted growth, poor quality bones and teeth, bone malformation. The experimental work included optimization of the extrusion -spheronization processing parameters and choice of excipients, which critically affected the product quality to produce orodispersible pellets. The developed orodispersible pellets had satisfactory quality control parameters and formed soft palatable mass on contact with salivary fluid which could be easily swallowed. The in vitro dissolution studies indicated rapid release of active and the pellets were found to be stable. An additional advantage of these orodispersible pellets is sprinkling over soft food, juices etc for food fortification prior to administration. Key words:Orodispersible pellets, Calcium and Cholecalciferol, Extrusion -Spheronization, pediatric. INTRODUCTIONIn 2008, a WHO expert forum reviewed the existing pediatric formulations and attempted to identify future research needs to improve the development of preferred dosage forms for children. Previous references of EMA such as 'Reflection paper: formulations of choice for the pediatric population' characterized liquid formulations as most appropriate for young pediatric population (birth to eight years). Large volume doses may be inconvenient for both patient and care -giver. The reflection paper also encouraged oral multiparticulates in administering drugs to pediatrics aged 2-16 years (EMA, 2006;Batchelor et al., 2015). These can be dosed directly into the * Corresponding Author E-mail: purnima.amin @ yahoo.co.in mouth of the pediatric patient or by mixing the prescribed dose with a small amount of soft food or with a drink prior to administration. Formulations can be provided in a bottle with dosing scoop or single-dose sachets. They may also be supplied in the form of capsules, the contents of which can be sprinkled onto food. The reflection paper also discussed that orodispersible dosage forms hold great promise for children as they are easy to administer, do not require additional water and as long as dispersion is rapid, are difficult to spit out and could provide a range of dosages appropriate for use in younger children (EMA, 2006;Kristensen, 2012). The need for a multidisciplinary approach to pediatric medicines was highlighted and the potential of a ʹplatformʹ solid dosag...