Inkjet printing of a thermolabile model drug onto FDM-printed substrates: formulation and evaluation

Abstract

Objective: The inkjet printing (IP) and fused deposition modeling (FDM) technologies have emerged in the pharmaceutical field as novel and personalized formulation approaches. Specific manufacturing factors must be considered in each adopted methodology, i.e., the development of suitable substrates for IP and the incorporation of highly thermostable active pharmaceutical compounds (APIs) for FDM. In this study, IP and FDM printing technologies were investigated for the fabrication of hydroxypropyl methylcellulose-based mucoadhesive films for the buccal delivery of a thermolabile model drug. Significance: This proof-of-concept approach was expected to provide an alternative formulation methodology for personalized mucoadhesive buccal films. Methods: Mucoadhesive substrates were prepared by FDM and were subjected to sequential IP of an ibuprofen-loaded liquid ink. The interactions between these processes and the performance of the films were evaluated by various analytical and spectroscopic techniques, as well as by in vitro and ex vivo studies. Results: The model drug was efficiently deposited by sequential IP passes onto the FDM-printed substrates. Significant variations were revealed on the morphological, physicochemical and mechanical properties of the prepared films, and linked to the number of IP passes.The mechanism of drug release, the mucoadhesion and the permeation of the drug through the buccal epithelium were evaluated, in view of the extent of ink deposition onto the buccal films, as well as the distribution of the API. Conclusions: The presented methodology provided a proof-of-concept formulation approach for the development of personalized mucoadhesive films.

3D-Printed Mesoporous Carrier System for Delivery of Poorly Soluble Drugs

“…It offers a fast and facile formulation development in a patient-tailored manner. This technology has given rise to drug delivery systems combining multiple active pharmaceutical ingredients (APIs) [34,35], tunable release characteristics [36,37], and formulations intended for various routes of administration [38][39][40]. The tradeoffs of the aforementioned advantages are that thermosensitive APIs are excluded from consideration due to the high temperatures needed during printing, the scalability of the process is problematic, and the selection of pharmaceutical thermoplastic polymers suitable for FDM is limited.…”

Characterization of Hydrophilic Polymers as a Syringe Extrusion 3D Printing Material for Orodispersible Film

“…Syringe extrusion 3D printing has been applied across a range of research fields, with particular advantages over other printing techniques in terms of Polymers 2021, 13, 3454 2 of 14 cost-effectiveness, the wide availability of printing materials, and room temperature printing capability for thermo-labile drugs [10]. A range of dosage forms have been designed and fabricated using syringe extrusion 3D printing, such as immediate-release tablets, local drug delivery patches, contraceptive vaginal rings, and oromucosal films (buccal films and orodispersible films) [11][12][13][14][15][16][17].…”

Development and Characterization of Inkjet Printed Edible Films for Buccal Delivery of B-Complex Vitamins

“…Furthermore, the 2D inkjet printing technology provides the potential to advance the loading of poorly soluble drugs in a medicinal formulation, following the exploitation of suitable solvents in the development of inks [6]. The inkjet printing technique has been coupled with other formulation approaches, to fabricate hybrid drug delivery systems [7][8][9].…”

“…Clobetasol, omeprazole, and hydrocortisone are representative model drugs which have been formulated for buccal delivery [22][23][24]. The applicability of various printing technologies for patient-centric buccal formulations has been demonstrated by previous reports, in terms of (i) incorporating personalized doses or thermolabile drugs, and (ii) fabricating multi-layered buccal films [4,8,9,25]. B-complex vitamins are vital compounds for the proper functioning of the nervous system, the conversion of glucose into energy, and the metabolism of fats and proteins [26].…”

“…These hydrophilic macromolecules contain hydrogen bond forming groups, thus favoring the adhesion to the buccal mucosa [39][40][41]. Propylene glycol was incorporated in the liquid ink as viscosity modifier, and has been reported to enhance the permeation and adhesion properties of buccal films [8,9,42]. Solubility studies, surface tension, and viscosity measurements were performed to determine the optimal liquid ink.…”