Abstract

Paediatric practice requires various dosing forms that are acceptable for children of different ages and abilities. A straw prefilled with a drug formulation might serve as a dosing form, especially for children and patients with swallowing difficulties. Using a two-step procedure, we developed granulated coated particles of bitter tasting paracetamol that are appropriate for use in a newly developed straw with two valves to assure liquid flow towards the oral cavity. The paracetamol crystals were coated with five different polymers (water-soluble, entero-soluble) to assure the duration of the taste-masking properties for several minutes during sipping of the drug. As none of these polymer coats assured small enough liquid volumes needed to empty the straw (20 mL) or low enough vacuum for easy drug consumption (130 mbar), the coated crystals were granulated with trehalose-erythritol powder mixture. Acceptable results were obtained with these granulated coated paracetamol particles when polyvinyl alcohol/polyethylene glycol graft copolymer (Kollicoat IR) or a mixture of this polymer with polyvinyl alcohol (Kollicoat Protect) were used. Dissolution tests in water and acidic media confirmed the taste-masking functionality of these particles during drinking simulation and immediate release of paracetamol in the stomach (85% in <30 min at pH 1.2, 4.5).

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