The development of the dosage form with L-carnitine for children

Abstract

Treatment of metabolic disorders in children and adults of all ages is the current serious problem. Nowadays much attention is paid to the treatment with drugs based on L-carnitine. The drug for children in the form of a syrup containing L-carnitine has been researched and developed. Drugs with the dosed L-carnitine for children are absent at the modern pharmaceutical market of Ukraine. Suitable dosage forms for children of all ages are liquid forms, including syrups. The drug technology has been developed and tested in the academic research technological laboratory of the National University of Pharmacy for introduction into the pharmaceutical industry of the country. To develop this technology the literature has been analyzed; a number of similar drugs has been identified and their qualitative composition has been studied. The quantitative composition of the drug developed has been determined experimentally. Based on the data of the pharmacological activity of L-carnitine the concentration of the active substance has been selected. The preservatives, modifiers of acidbase properties and flavours have been selected. The sequence of manufacturing operations, which allows creating a quality product, has been determined. A stepwise manufacture of the drug in the flowchart of the technological process has been described. The pharmacotechnological quality characteristics of the medicinal dosage form proposed, namely the drug appearance, pH, relative density and transparency of the resulting solution, have been studied. The results of this work have been included in the pharmaceutical development of the drug.