A 3D-Printed Polymer–Lipid-Hybrid Tablet towards the Development of Bespoke SMEDDS Formulations

Abstract

3D printing is a rapidly growing area of interest within pharmaceutical science thanks to its versatility in creating different dose form geometries and drug doses to enable the personalisation of medicines. Research in this area has been dominated by polymer-based materials; however, for poorly water-soluble lipophilic drugs, lipid formulations present advantages in improving bioavailability. This study progresses the area of 3D-printed solid lipid formulations by providing a 3D-printed dissolvable polymer scaffold to compartmentalise solid lipid formulations within a single dosage form. This allows the versatility of different drugs in different lipid formulations, loaded into different compartments to generate wide versatility in drug release, and specific control over release geometry to tune release rates. Application to a range of drug molecules was demonstrated by incorporating the model lipophilic drugs; halofantrine, lumefantrine and clofazimine into the multicompartmental scaffolded tablets. Fenofibrate was used as the model drug in the single compartment scaffolded tablets for comparison with previous studies. The formulation-laden scaffolds were characterised using X-ray CT and dispersion of the formulation was studied using nephelometry, while release of a range of poorly water-soluble drugs into different gastrointestinal media was studied using HPLC. The studies show that dispersion and drug release are predictably dependent on the exposed surface area-to-volume ratio (SA:V) and independent of the drug. At the extremes of SA:V studied here, within 20 min of dissolution time, formulations with an SA:V of 0.8 had dispersed to between 90 and 110%, and completely released the drug, where as an SA:V of 0 yielded 0% dispersion and drug release. Therefore, this study presents opportunities to develop new dose forms with advantages in a polypharmacy context.

Three-Dimensional Printing of a Container Tablet: A New Paradigm for Multi-Drug-Containing Bioactive Self-Nanoemulsifying Drug-Delivery Systems (Bio-SNEDDSs)

“…The drug release from 3D-printed SNEDDS tablets is influenced by several factors, such as the physical properties of drug SNEDDS and polymer SNEDDS, the microstructural properties and thickness of the HPC-Soluplus tablet shell, the properties of the dissolution medium (such as temperature and pH), and properties of the fluid/tablet wall (e.g., wettability/contact angle) [ 41 ]. Previous, studies have shown the incorporation of a solidified lipid matrix inside a 3D-printed system [ 42 ]. However, we expanded the scope of a multi-drug delivery regiment using a lipid-based formulation through our study.…”

“…However, we expanded the scope of a multi-drug delivery regiment using a lipid-based formulation through our study. Semi-solid 3D printing of just lipid-based systems had poor printing fidelity and lacked consistency, which can be overcome by using the method employed in this study [ 24 , 26 , 42 ].…”

3D Printing Technologies in Personalized Medicine, Nanomedicines, and Biopharmaceuticals

“…Once all excipients and drugs were fully melted, they were transferred to a PAM cartridge for 3D printing. The dapagliflozin-loaded SNEDDS 3D-printed tablet showed an immediate release profile (>75% in 20 min) [ 142 ]. A similar approach was used to fabricate 3D-printed lidocaine-loaded SNEDDS suppositories to treat hemorrhoids by PAM [ 143 ].…”

Combinational System of Lipid-Based Nanocarriers and Biodegradable Polymers for Wound Healing: An Updated Review

“…Furthermore, it demonstrates a 3D-printed biodegradable tablet to deliver bespoke and combined therapies in a single multi-compartment tablet. The versatility of these 3D-printed tablets has the potential to circumvent challenges associated with the adherence and safety of polypharmacy, together with the 3DP of lipophilic drugs [ 168 ]. Additionally, the study reports that the versatility of these 3D-printed tablets has the potential to circumvent challenges associated with the adherence and safety of polypharmacy, together with those related to the 3DP of lipophilic drugs.…”