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A straw for paediatrics: How to administer highly dosed, bitter tasting paracetamol granules
Tilen Simšič1, Boris Nolimal2, Jasmina Minova1
1Faculty of Pharmacy, University of Ljubljana, Aškerčeva 7, 1000 Ljubljana, Slovenia; Alterno Labs d.o.o., Brnčičeva 29, 1231 Ljubljana-Črnuče, Slovenia.
Insights
Developing palatable paracetamol particles for pediatric use, this study created a novel drug-eluting straw. Granulated coated particles mask the bitter taste, improving medication adherence for children and patients with swallowing difficulties.
Area of Science:
- Pharmaceutical Technology
- Pediatric Drug Delivery
- Taste Masking
Background:
- Pediatric drug formulations require age-appropriate dosage forms.
- Swallowing difficulties are common in children and some patient groups.
- A novel drug-eluting straw offers a potential solution for administering liquid medications.
Purpose of the Study:
- To develop palatable, granulated coated paracetamol particles for a novel drug-eluting straw.
- To ensure effective taste masking during sipping and immediate drug release in the stomach.
- To optimize particle properties for easy drug consumption via the straw.
Main Methods:
- Paracetamol crystals were coated with various polymers for taste masking.
- Coated crystals were granulated with a trehalose-erythritol mixture.
- Particles were evaluated for taste-masking duration, liquid volume, and vacuum requirements.
- Dissolution tests were performed in aqueous and acidic media to assess drug release.
Main Results:
- Granulated coated paracetamol particles using Kollicoat IR or Kollicoat Protect showed promising results.
- These particles provided taste-masking during simulated sipping.
- Immediate release of paracetamol was confirmed in acidic conditions (85% in <30 min at pH 1.2, 4.5).
Conclusions:
- Optimized granulated coated paracetamol particles are suitable for the novel drug-eluting straw.
- This formulation effectively masks paracetamol's bitter taste.
- The developed system facilitates pediatric drug administration and improves patient compliance.
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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