Modern pediatric formulations of the soft candies in the form of a jelly: determination of metoclopramide content and dissolution

• Published in: Pharmaceutical development and technology 2020-01, Vol.25 (1), p.20-27
• Main Authors: Karaiskou, Sofia G., Kouskoura, Maria G., Markopoulou, Catherine K.
• Format: Article
• Language: English
• Subjects: HPLC; Metoclopramide hydrochloride; pediatric dosage; soft jelly formulation; taste masking
• ISSN: 1083-7450; 1097-9867
• DOI: 10.1080/10837450.2019.1609499

In pediatrics, it is crucial to ameliorate the unpleasant taste of oral pharmaceutical formulations in order to facilitate patient compliance. Scientists' attempt to develop modern products for children is included among the new trends in pharmaceutical technology. Designing the preparation procedures and selecting the age-appropriate dosage form should be based on a benefit-risk approach, taking into account safety, efficacy, ease of use and accessibility to the patient. Part of this process should examine the necessity for taste masking, considering organoleptic and physicochemical properties of the active pharmaceutical ingredient. This research describes the incorporation of metoclopramide hydrochloride in the form of a soft candy (jelly) containing pomegranate juice. The low cost excipients and the ease of preparation are such characteristics that qualify the proposed technique as one of the alternative methods for modern drug formulations. At the same time, metoclopramide is quantitatively determined by developing a reverse phase HPLC method. The method is accurate (%RSD = 2.63, %mean recovery = 100.75) and can be used for routine analysis. The stability of metoclopramide was satisfactory after 6 months of storage (recovery 103.43%). Dissolution of the drug exceeded 92%. The proposed formulation enclosing metoclopramide in a jelly is modern, palatable and can be administered to children.