Easy to Swallow “Instant” Jelly Formulations for Sustained Release Gliclazide Delivery

Abstract

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 (D 50) of 198 ± 4.3 mm. 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.

A novel oral medicated jelly for enhancement of etilefrine hydrochloride bioavailability: In vitro characterization and pharmacokinetic evaluation in healthy human volunteers

“…This dispersion was stirred for 25 min to aid in the hydration of the jellifying agents ( Karaiskou et al 2020 ). After completely dissolving the jellifying agent, calcium chloride (0.5 % w/v), utilized as the crosslinking agent, was added to that beaker ( Patel et al, 2020 , Bakre and Akinsanyam, 2019 ). In another beaker, sugar syrup was prepared by dissolving 67.7 gm of sucrose in distilled water (100 ml) ( Katman et al 2014 ).…”

“…Calcium chloride was added as a crosslinking agent. Pectin, similar to sodium alginate, forms stronger gels via intramolecular crosslinking with divalent ions, such as calcium, due to the polyanionic nature of both components ( Patel et al, 2020 , Šešlija et al, 2018 ). Such cations can fix multiple binding sites to pectin or sodium alginate and form a three-dimensional structure that provides swelling by holding large amounts of water molecules in the structure ( Freitas et al, 2013 , Junmahasathien et al, 2018 ).…”

Review on Starter Pellets: Inert and Functional Cores

“…One in nine older communitydwelling adults have symptoms that amount to dysphagia, which are likely to be underreported and under-recognized [138]. Patel et al developed a coated pellet in an easy-toswallow gel formulation for the sustained release of gliclazide for patients with dysphagia [139].…”

Better Medicines for Older Patients: Considerations between Patient Characteristics and Solid Oral Dosage Form Designs to Improve Swallowing Experience

“…Food aids with semi-solid consistency such as oral jellies, are commonly applied as an administration vehicle by older patients, because their rheological properties allow for the formation of a bolus that incorporates the SODF and promotes a better swallowing experience [77][78][79][80][81]. Different reports have shown that the use of viscous oral jellies in the replacement of water tend to reduce the cases of aspiration and choking with large SODF for older patients with dysphagia [82].…”