Bibliographic Details
| Title: |
The Design of Novel 3D-Printed, Moulded, and Oral Viscous Budesonide Formulations for Paediatrics: A Comparative Evaluation of Their Mucoadhesive Properties |
| Authors: |
María Magariños-Triviño, Eduardo Díaz-Torres, Javier Suárez-González, Ana Santoveña-Estévez, José B. Fariña |
| Source: |
Pharmaceutics, Vol 16, Iss 10, p 1338 (2024) |
| Publisher Information: |
MDPI AG, 2024. |
| Publication Year: |
2024 |
| Collection: |
LCC:Pharmacy and materia medica |
| Subject Terms: |
3D printing, individualised medicines, paediatric, eosinophilic oesophagitis, budesonide, orodispersible, Pharmacy and materia medica, RS1-441 |
| More Details: |
Background/Objectives: Paediatric eosinophilic oesophagitis (EoE) treatment is challenging due to the limited number of age-appropriate formulations. This study aims to develop and evaluate oral viscous suspensions and solid formulations of budesonide (BUD), focusing on their in vitro mucoadhesive properties, to enhance drug delivery and therapeutic outcomes in paediatric EoE. Methods: This study encompasses the development of oral viscous suspensions and orodispersible solid formulations (moulded tablets and 3D-printed dosage forms) containing BUD. The formulations underwent quality control tests as per the European Pharmacopoeia, chemical stability assessments, and an in vitro evaluation of their mucoadhesiveness properties. Results: A validated analytical method enabled accurate BUD quantification and efficient extraction, and all developed formulations demonstrated chemical stability for 30 days, meeting Ph. Eur. quality standards. Three-dimensional printing using SSE successfully produced 1 mg and 0.5 mg BUD printlets, complying with quality tests for conventional tablets. Formulations containing xanthan gum (L2-XG and P1-0.5-XG) exhibited superior mucoadhesive properties. L2-XG showed significantly higher mucoadhesion than L1-MC. Among the solid formulations, P1-0.5-XG demonstrated the highest mucoadhesive properties. Conclusions: This is the first study to develop solid oral dosage forms of BUD at a very low dose, specifically for paediatric use. The results highlight the potential of 3D printing for developing individualised orodispersible BUD formulations with improved bioadhesion for paediatric EoE treatment. The L2-XG formulation and the XG-containing printlets are the most promising formulations in terms of increasing contact time with the oesophageal mucosa, which could translate into improved therapeutic efficacy in this patient population. |
| Document Type: |
article |
| File Description: |
electronic resource |
| Language: |
English |
| ISSN: |
1999-4923 |
| Relation: |
https://www.mdpi.com/1999-4923/16/10/1338; https://doaj.org/toc/1999-4923 |
| DOI: |
10.3390/pharmaceutics16101338 |
| Access URL: |
https://doaj.org/article/841f6b763c9747e98f64283652bb8104 |
| Accession Number: |
edsdoj.841f6b763c9747e98f64283652bb8104 |
| Database: |
Directory of Open Access Journals |
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