Development of pharmaceutical formulation of a syrup containing double dose Inosine acedoben dimepranol

Bulgarian Medical Journal, 2023, 17(2), 38-44.

K. Kafedjiiski

Medical College, Trakia University – Stara Zagora

Abstract. Inosine acedoben dimepranol (isoprinosine), which is a synthetic complex derivative of purine, belongs to the group of immunomodulators currently used in medical practice. The aim of this research is to establish a stable, reproducible and stable formulation and process for an oral dosage form – syrup containing 100 mg/ml active substance Inosine acedoben dimepranol. The main problems in the development of a double-dose syrup (100 mg/ ml) based on Inosine acedobene dimepranol are defined – testing of the solubility of the active substance, necessary for the preparation of a more concentrated form of syrup and stability of Inosine acedoben dimepranol with respect to degradation products. The effect of reducing the content of sugar syrup was studied in accordance with the guidelines of the European guidelines for the development of medicines intended for use in pediatrics – compositions with large amounts of sugar should be avoided in the treatment of pediatric patients suffering from diabetes. As a result, the optimal conditions and composition of the syrup were determined through which the target characteristics of the syrup are achieved – masking the bitter taste of the active substance, a stable solution with the adopted dose of 100 mg/ml and with good organoleptic properties for oral pediatric use – acceptable viscosity, density and texture, with sufficient sweetness and a pleasant aroma of natural raspberry.

Key words: inosine acedoben dimepranol, inosine pranobex, syrup 100 mg/ml, preparation, analysis, stability

Address for correspondence: Krum Kafedjiiski, e-mail: k_kafedjiiski@yahoo.com