Design of flexible dispersible tablet with high drug loading using quality by Design: Proof of concept study using third generation cephalosporins model drug Govindan Saravana Perumal1*, Senthamarai R.2, Anbarasu K.3 1Research Scholar, Department of Biotechnology, PMIST, Vallam, Thanjavur (Tamil Nadu)-613403, India. 2Principal, Periyar College of Pharmaceutical Sciences, Tiruchirappalli-620021, (Tamil Nadu)-620021, India. 3Assistant Professor, Department of Biotechnology, PMIST, Vallam, Thanjavur (Tamil Nadu)-613403, India. *Corresponding Author E-mail: gsaravana23@yahoo.co.in
Online published on 30 April, 2021. Abstract There are particular interests in the challenges to develop a flexible dispersible tablet with high drug loading to cover the age groups between >2 years to > 65 yearsin the condition of swallowing and chewing difficulty using a single dosage form design. The aim of this study to design asingle dosage form design, which facilitates dosage adjustment without the necessity of manufacturing different dosage forms. This quality by design concept seeks to provide a scientific basis for the design of a flexible dispersible tablet. This proof of concept study through quality by designwas demonstrated using a suitable model drug, the ceftibuten, one of third generation cephalosporin which fulfills the prerequisites for flexible dispersible tablet design, helps to, understand the feasibility and to identify the critical quality factors affecting the design of a flexible dispersible tablet with high drug loading. The outcome of this formulation design from proof of concept study through quality by design has demonstrated that the designed dispersible tablet with the model drug, ceftibuten has the potential as a flexible single dosage form design in the condition of swallowing and chewing difficulty.
Top Keywords Flexible Dispersible tablet, High drug loading, Third generation cephalosporin, Ceftibuten, Swallowing difficulty, Chewing difficulty. Top |