Introduction: Integrating 3-dimensional (3D) printing with lipid-based formulation (LBF) is impacting pediatric pharmaceutical manufacturing by enabling personalized oral dosage forms tailored to children's specific needs. Serious challenges are created by manipulating conventional adult dosages to produce suitable dosages for the pediatric population. The study explores an emulsion gel with two model lipophilic drugs, Aprepitant and Irbesartan, using semi-solid extrusion (SSE) as a 3D printing method to produce patient-centered dosages. Method: The solubility of the two model drugs in the studied LBF type IIIA – MC was determined using the shake-flask method combined with High-Performance Liquid Chromatography with Ultraviolet Detection (HPLC-UV) analysis. Once determined, LBF was loaded with 90% of the soluble drug amount to later produce the emulsion by mixing the drug-loaded LBF with Milli-Q water. The emulsion gel was produced as the next step by adding three different polymers to the emulsion. The three polymers were Methylcellulose Methocel (A4C), Methylcellulose Methocel (A4M), and Sodium Crosscarmellose (AcDiSol). Lastly, tablets were 3D-printed using a BIO X 3D printer with a pneumatic printhead. The tablets were vacuum-dried and analyzed for mass and content uniformity, and disintegration time. Results: The thermodynamic solubility of Aprepitant in LBF IIIA – MC was determined to be 11.30 mg/g while the solubility of Irbesartan was 4.08 mg/g. The produced tablets contained lower concentrations of the drugs compared to the traditional dosages available on the market. The 3D-printed tablets passed the European Pharmacopeia requirements for mass and content uniformity, and disintegration time. Conclusion: The study showed justified results indicating the emulsion gel can be used to produce tablets loaded with different poorly water-soluble drugs. All characterization studies done on the 3D-printed tablets carried out according to the European Pharmacopeia guidelines showed correct mass and content uniformity together with reasonable disintegration time. This suggests that the emulsion gel has the potential to be used to produce tablets loaded with any other lipophilic drug, potentially multiple drugs loaded at the same time.
| Identifer | oai:union.ndltd.org:UPSALLA1/oai:DiVA.org:uu-532995 |
| Date | January 2024 |
| Creators | Matossian, Lilit |
| Publisher | Uppsala universitet, Institutionen för farmaci |
| Source Sets | DiVA Archive at Upsalla University |
| Language | English |
| Detected Language | English |
| Type | Student thesis, info:eu-repo/semantics/bachelorThesis, text |
| Format | application/pdf |
| Rights | info:eu-repo/semantics/openAccess |
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