VERONIQUE HENNER-KULKARNI^*, ANDREAS SAUER
*Corresponding author
SE Tylose GmbH & Co. KG, Wiesbaden, Deutschland

Abstract

Enhancing the palatability is one of the challenges faced in the development of bitter drugs. Within the methods available, covering the taste of the drug by applying a coating layer can be considered as easy to implement. However, one of the major challenges during the development of taste-masking coatings is to have a fast feedback on the performance in laboratory trials. 

The present study summarizes the development and efficiency of an user-friendly taste-masking coating formulation based on cellulose derivatives. 

The masking property is assessed with a screening method using low volume dissolution testing with simulated saliva via UV detection.(7) As a result, the ratio of enteric polymer and pore former as well as the coating weight gain have to be considered with regards not only to the taste-masking performance but also the resulting dissolution profile at pH 1.2 that is variating from fast to slow release of the API (active pharmaceutical ingredient).

INTRODUCTION

Patient compliance is an important topic when considering children and the elderly population. 

For pharmaceutical companies the patient centric approach is an added value in the development of drugs targeting these population (1).

Especially amongst solid dosage forms, mini-tablets (diameter ≤3 mm) are a flexible solution combining several advantages. They are easy to swallow and one can imagine that dosing a specific amount of mini-tablets to provide an exact amount of API is advantageous for heterogeneous patient groups compared to syrups (2-3).

Looking into the development of medicines for children, taste is one of the major concern for formulators as it is a key factor for the children adherence. To cover the bitter taste of an API contained in a tablet, several formulation strategies are available. 

Examples are the addition of flavours and sweeteners or application of a coating. However, during the development of taste-masking coatings in the laboratory, it is challenging to rapidly assess the performance of the c ...