Formulation Development & Optimization of Milk Dissolving Tablets as Novel Pediatric Dosage Form

Abstract

Oral formulations have carved a niche amongst the different drug delivery systems. Ease of administration and patient compliance are gaining significant importance in the design of dosage forms. Paracetamol is an orally administered antipyretic and anti-inflammatory drug, used in the management of fever and pain. Difficulty in swallowing (dysphagia) is common among paediatric patients and hence liquid dosage form need to be prepared. Although unpleasant taste is masked in paediatric formulations, accurate dose administration cannot be ensured through syrup. In light of all above facts and challenges, it was decided to formulate and optimize Milk dissolving tablets for paediatric patients, which could provide patient compliance, accurate dose and taste masking. Milk is an important diet for children and hence it was selected as the medium of dosage administration. Different taste masking approaches were evaluated, where in taste masking was achieved by using β-cyclodextrin. The excipients like mannitol, sucrose, sucralose, sodium starch glycholate and flavouring agent were evaluated.The tablets were formulated by wet granulation method and were evaluated for thickness, weight variation, drug content, hardness,friability, dispersion time and dissolution.The optimized batch showed drug release more than 85% within 15 min at three different pH,along with all the desired organoleptic properties. The developed unit dosage form,milk dissolving tablets, was found to be a very promising approach to administer drugs in paediatric population.