Abstract
Amoxicillin is one of the most prescribed antibiotics in the paediatric population. Currently available formulations (i.e., suspensions and tablets) suffer from limited acceptability often responsible for the therapeutic failure. In the present study it is proposed an innovative formulation for amoxicillin oral administration that could meet acceptability requirements of the paediatric population. Chewable gummy tablets were produced by the Pressure-Assisted Microsyringe 3D printing technology.
Highlights
- 3D printed starch based chewable gummy tablets were developed and characterized.
- The antibiotic amoxicillin was successfully loaded (200 mg/dosage unit).
- The formulation is visually appealing showing acceptable mechanical properties.
As “ink” it was used a gel obtained by the co-formulation of corn starch with acacia honey. The optimized formulation, having a final dose of 200 mg per unit, resulted visually appealing. Good accuracy between the computer-aided design and final 3D-printed product was evident as well. The fabricated gummy tablets (1.07 ± 0.05 g) showed acceptable mechanical properties such as hardness (150.52 ± 5.67 N), and gumminess (68.13 ± 6.51 N) when exposed to simulated salivary fluid.
Moreover, the 3D-printed gummy tablets determined the almost complete release of the drug in the gastric environment within 2 h and assured its permeation through the PermeaPad® membranes. The obtained results suggest that 3D printing is a versatile and scalable technology useful in the pharmaceutical industry to fabricate customized chewable formulations as a suitable alternative to conventional formulations for amoxicillin administration in the paediatric population.
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Materials
Corn starch (“Maize starch” European Pharmacopoeia −Ph. Eur. 11th Ed.) and amoxicillin trihydrate were purchased from A.C.E.F. s.p.a. (Fiorenzuola d’Arda, Italy). Glycerol E422 food additive–vegetable origin was a gift of Spiga Nord Spa (Carasco, Italy). Organic (certified according to Regulation CE 848/2018) acacia honey produced by hives on the farm ‘La raia’, was bought at NaturaSì (Corciano, Perugia, Italy). The honey microbiological quality complies with the limits reported in the Ph. Eur. 11th Ed. par. 5.1.4. “Microbiological quality of non-sterile pharmaceutical preparations and substances for pharmaceutical use”. In fact, the limits for non-aqueous preparations for oral use are: 103 CFU/mL TAMC (total aerobic microbial count) and 102 CFU/g TYMC (total combined yeast/moulds counts). For the honey the microbial characteristics reported in the producer datasheet are: mesophilic microbial load ≤ 1.000 CFU/mL; moulds ≤ 50 CFU/g; yeasts: ≤ 50 CFU/g; Sulphite-reducing Clostridia: absent. Ultrapure water was obtained by reverse osmosis in a MilliQ Millipore system (Roma, Italy). All other products and reagents were of analytical grade.
Anna Imbriano, Costanza Fratini, Giulia Bondi, Ilenia D’Abbrunzo, Serena Bertoni, Mattia Tiboni, Angela Abruzzo, Dritan Hasa, Cinzia Pagano, Luca Casettari, 3D-printed chewable gummy tablets: A new tool for oral amoxicillin administration in paediatric population, International Journal of Pharmaceutics, Volume 677, 2025, 125645, ISSN 0378-5173, https://doi.org/10.1016/j.ijpharm.2025.125645.
Read also our introduction article on 3D Printing here:
