Alginate beads as a carrier for omeprazole/SBA-15 inclusion compound: A step towards the development of personalized paediatric dosage forms.
The treatment of gastro-esophageal reflux disease (GERD) shows several issues among paediatric patients. This work aims to the formulation of enteric alginate beads loaded with omeprazole (OME) allowing age- and weight-related personalized dosages in children. OME was entrapped in SBA-15 mesoporous compound, characterized and loaded into alginate beads by prilling at different OME and alginate concentrations. The beads resulted of homogeneous size, spherical morphology and very consistent in drug loading and distribution. Formulations demonstrated limited swelling and release (about 10%) in simulated gastric fluid (SGF) after 2h and a prolonged release in simulated intestinal fluid (SIF), till 6h, due to a mixed diffusion-case II transport mechanism. The beads were superior to the market product, which showed lower release in SGF but immediate dissolution in SIF. The high alginate beads uniformity and release properties make them a potential novel tool for a personalized treatment of GERD in children.
Department of Pharmacy, University of Salerno, via Giovanni Paolo II, 132, 84084 Fisciano, SA, Italy. Electronic address: pdelgaudio@unisa.it.
Pasquale
P
Del Gaudio
Department of Pharmacy, University of Salerno, via Giovanni Paolo II, 132, 84084 Fisciano, SA, Italy.
Felicetta
F
De Cicco
Department of Pharmacy, University of Salerno, via Giovanni Paolo II, 132, 84084 Fisciano, SA, Italy.
Francesca
F
Sansone
Department of Pharmacy, University of Salerno, via Giovanni Paolo II, 132, 84084 Fisciano, SA, Italy.
Rita Patrizia
RP
Aquino
Department of Industrial Engineering, University of Salerno, via Giovanni Paolo II, 132, 84084 Fisciano, SA, Italy.
Renata
R
Adami
Department of Pharmaceutical Sciences, University of Perugia, via del Liceo 1, I-06123 Perugia, Italy.
Maurizio
M
Ricci
Department of Pharmaceutical Sciences, University of Perugia, via del Liceo 1, I-06123 Perugia, Italy. Electronic address: stefano.giovagnoli@unipg.it.
Stefano
S
Giovagnoli
D000464:Alginates / Q000737:chemistry*; D004337:Drug Carriers / Q000737:chemistry*; D065546:Drug Liberation; D005764:Gastroesophageal Reflux / Q000188:drug therapy; D020723:Glucuronic Acid / Q000737:chemistry; D006603:Hexuronic Acids / Q000737:chemistry; D008863:Microspheres; D009853:Omeprazole / Q000737:chemistry* / Q000627:therapeutic use; D010372:Pediatrics; D057285:Precision Medicine; D012822:Silicon Dioxide / Q000737:chemistry*; D013499:Surface Properties
D000464:Alginates; D004337:Drug Carriers; D006603:Hexuronic Acids; C509969:SBA-15; D012822:Silicon Dioxide; D020723:Glucuronic Acid; D009853:Omeprazole
Alginate beads; Enteric particles; Omeprazole; Paediatric formulations; Prilling; SBA-15