FORMULATION AND PREPARATION OF ORALLY DISINTEGRATING TABLETS USING INNOVATIVE BINDER

The present study investigates the use of glyceryl palmitostearate (Precirol ATO 5 - coded PATO) as binder in orally disintegrating tablets (ODT), prepared by melt granulation. PATO has been mentioned in literature for its lipophilic nature and fine powder properties, providing excelent coating and slow release of active drugs, but it can also be used for taste masking purposes, with possible applications in ODT. In order to use it as an ODT excipient, some challenges must be overcome, given its lipophilicity. Our first goal was to study its potential to improve tablet properties (hardness, friability, disintegration time) and provide fast release of the model drug, by setting the optimal proportion to be used in ODT. We investigated a complete 33 experimental design with 9 formulations containing 300 mg acetaminophen; the independent variables were: proportion of PATO binder (2.5-7.5 %) and proportion of sodium starch glycolate (Explotab) as superdisintegrant (5-10 %). The regression equations and response surface plots showed the validity of the model, and a significant influence of PATO on the response variables: tablet hardness, disintegration time, and active drug release in a short time. We can conclude that Precirol ATO 5 can be used as binder in ODT (not more than 5 %), higher proportions having a slow-release effect. Also, together with 8 % disintegrant, it provides good tablet properties, fast disintegration and a release of 80 % acetaminophen after 10 min.