Quality-By-Design-Based Development Of Compliant Dosage Form For Paediatric

Abstract

Pediatric patients differed from adult patients in a number of ways relating to pharmacotherapy, such as the capacity for medication administration, drug-associated toxicity, and taste preferences. It is crucial that paediatric medications match the child's size, age, and varied physiologic circumstances in the best way possible. There may be a need for a variety of administration methods, dosage forms, and strengths to ensure that every paediatric child is receiving the best possible care. It might be difficult to choose and construct a dose form that is appropriate for young patients. In addition to the issues that are often encountered when creating dosage forms for adults, creating dosage forms for children presents additional difficulties due to the variability of the patient group in terms of size and physiological circumstances. Many of the current formulations for paediatrics, including tablets, capsules, suspensions, and syrups, are not appropriate. These formulations frequently cause a variety of issues in paediatrics, including choking due to larger size, vomiting due to the bitter taste of tablets and capsules, varying dosages in liquid dosage forms, intolerable pain during injections, and ethical concerns due to rectal forms. Therefore, it is necessary to provide some appealing and efficient dose forms for kids. Different dosage forms that provide the necessary therapeutic impact and appear to be acceptable to children were examined in the current investigation. One of the modern inventions that kids really enjoy is the medicated lollipops. Giving medicine to kids in the shape of a lollipop definitely draws their attention to the dose form and lowers their likelihood of rejecting it. In this research work, survey has been conducted on paediatric population concerning the perspectives of their parents. The study team as well as the parents were involved in the iterative process that was used to design the questionnaire. In the survey, parents were asked about their children's ages, the dosage form that was most preferred for their children, the benefits and drawbacks of various types of dosage forms, the medicine that was most frequently administered to their children, and which dosage form they would choose for their children if we formulate a new dosage form. On the basis of survey, paracetamol and ibuprofen was the two selected the most commonly used drugs in paediatric population and lollipop as the new innovative dosage form preferred by the most children. Medicated lollipop containing paracetamol and ibuprofen as model drugs were developed by heating and congealing method. Concept of Quality by Design was

Department of Pharmaceutical Sciences & Technology, MRSPTU IX applied for assuring the quality development of medicated lollipop. Central composite design was explored for the optimization of most significant factors. Developed medicated loliipop were characterized for various parameters and results were summarized. The formulation was evaluated for a variety of important quality features as well as accelerated stability investigations. The formulation demonstrated acceptable values for the parameters examined and was determined to be stable. In this study Formulation by Design was effectively employed for the application of Quality by Design principles. The current study might be appropriately scaled up for effective industrial use and could provide appealing alternatives in paediatric dosage forms for commercial benefits