Formulation development of paracetamol instant jelly for pediatric use

Abstract

Objective: Paracetamol is a common antipyretic and analgesic medicine used in childhood illness by parents and physicians worldwide. Paracetamol has a bitter taste that is considered as a significant barrier for drug administration. This study aimed to develop an oral dosage form that is palatable and easy to swallow by pediatric patients as well as to overcome the shortcomings of liquid formulations. Methods: The paracetamol was encapsulated in beads, which were prepared mainly from alginate and chitosan through electrospray technique. The paracetamol beads were sprinkled on the instant jelly prepared from glycine, ι-carrageenan and calcium lactate gluconate. The paracetamol instant jelly characteristics, in terms of physical appearance, texture, rheology, in vitro drug release and palatability were assessed on a human volunteer. Results: The paracetamol instant jelly was easily reconstituted in 20 mL of water within 2 min to form jelly with acceptable consistency and texture. The jelly must be ingested within 30 min after reconstitution to avoid the bitter taste. The palatability assessment carried out on 12 human subjects established the similar palatability and texture of the paracetamol instant jelly dosage comparable to the commercial paracetamol suspension and was found to be even better in overcoming the aftertaste of paracetamol. Conclusion: Such findings indicate that paracetamol instant jelly will compensate for the use of sweetening and flavoring agents as well as develop pediatric dosage forms with limited undesired excipients.

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“…Suppositories and syrups are the most used dosage forms in infants and children. Paracetamol has a bitter taste, which forms an obstacle for its administration to pediatrics and geriatrics where a large amount of the drug (from some hundreds of milligrams to 1 g) is needed for one dose; hence, it is important to mask the bitter taste of paracetamol upon administration to achieve good compliance [ 152 , 153 , 154 ]. In a comparison of paracetamol with phenacetin and acetanilide, which have a very slightly bitter taste and bitterless taste, respectively, it was found that the para position of the benzene ring is the only difference among these three compounds, where paracetamol has a hydroxyl group, phenacetin has an ethoxy group, and acetanilide has a hydrogen atom.…”