Easy to Swallow "Instant" Jelly Formulations for Sustained Release Gliclazide Delivery.

It is a challenge to safely administer sustained release medicines to patients with dysphagia. Sustained release tablets must not be crushed and multiparticulates with large particle sizes cause gritiness reducing patient acceptability. The aim of this study was to develop "instant" jellies as delivery vehicles incorporating sustained release microparticles for patients with dysphagia. Dry powder mixtures containing gelling agents such as sodium alginate and calcium ions were hydrated in 20 mL of water and formed a jelly texture within 10 min. The "instant" jellies demonstrated comparable properites to commercial "read-to-eat" jellies in appearance, rheological/textural properties and in vitro swallowing performance in an artificial throat model. Gliclazide sustained release microparticles were produced by fluidized bed coating using Eudragit® NM 30 D and achieved 99% production yield and final coated particle size (D50) of 198 ± 4.3 μm. Sustained gliclazide release was achieved over 15 h and the incorporation of the particles into the jellies significantly decreased the drug release rate. This novel drug delivery system offers a patient-centric solution to the long-standing challenge of administering sustained release medicines to patients with dysphagia and can potentially be used for paediatric patients.