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3D-Printing of Solid Lipid Tablets from Emulsion Gels

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3D-Printing of Solid Lipid Tablets from Emulsion Gels International Journal of Pharmaceutics 597 (2021) 120304 Contents lists available at ScienceDirect International Journal of Pharmaceutics journal homepage: www.elsevier.com/locate/ijpharm 3D-printing of solid lipid tablets from emulsion gels Jenny Johannesson a,1, Jamal Khan a,1, Madlen Hubert a, Alexandra Teleki b, Christel A. S. Bergstrom¨ a,* a Department of Pharmacy, Uppsala University, Uppsala Biomedical Center, P.O Box 580, SE-751 23 Uppsala, Sweden b Department of Pharmacy, Science for Life Laboratory, Uppsala University, SE-751 23 Uppsala, Sweden ARTICLE INFO ABSTRACT Keywords: Interest in 3D-printing technologies for pharmaceutical manufacturing of oral dosage forms is driven by the need Lipid-based formulation for personalized medicines. Most research to date has focused on printing of polymeric-based drug delivery Poorly water-soluble drug systems at high temperatures. Furthermore, oral formulation development is continuously challenged by the Emulsion gel large number of poorly water-soluble drugs, which require more advanced enabling formulations to improve oral 3D-printing bioavailability. In this work, we used semi-solid extrusion (SSE) printing of emulsion gels with three types of Semi-solid extrusion Solid lipid tablet emulsified lipid-based formulations (LBFs) to produce solid lipid tablets incorporating the poorly water-soluble drug, fenofibrate. Tablets were successfully 3D-printed from emulsion gels using SSE at room temperature, making the methodology particularly useful for thermolabile compounds. The tablets were well-definedin mass and disintegrated rapidly (<15 min). Importantly, the oil droplet size reconstituted after dispersion of the tablets and subsequent lipid digestion was similar to traditional liquid LBFs. This work demonstrates the successful use of SSE for fabricating solid lipid tablets based on emulsion gels. The method is further promising for on demand production of personalized dosage forms, necessary for flexible dosage adjustment in e.g., pediatric patients, when poorly water-soluble compounds constitute the core of the therapy. 1. Introduction and geriatric patients in particular, as physiological differences are pronounced in these age groups and compliance to medication is low (El ¨ Recently, 3D-printing technologies have revolutionized pharma­ Aita et al., 2020; Oblom et al., 2019; Trenfield et al., 2018). ceutical manufacturing and paved the way for the development of Only a few types of 3D-printing technologies have been explored for personalized drug products (Awad et al., 2018; Norman et al., 2017). pharmaceutical manufacturing. The most studied is fused deposition Interest in 3D-printing skyrocketed in 2015 after the US Food and Drug modeling (FDM), an extrusion-based 3D-printing technique, in which Administration (FDA) approved the first 3D-printed drug Spritam (lev­ polymeric filaments are melted, extruded through a nozzle, and then etiracetam), a highly porous tablet that disintegrates rapidly in the resolidifiedupon contact with the cool print bed. Complex dosage forms mouth. Traditional solid dosage forms, manufactured on large scale such can be produced with FDM printing using different types of filamentsin as tablets, are simple and uniform. Such tablets are produced on a one the same product, however, high temperatures are required and printing size fits all assumption and typically demand manipulation e.g., split­ speed is slow (Norman et al., 2017; Okwuosa et al., 2017). Another type ting, crushing, and dispersing fragments of a tablet prior to adminis­ of extrusion-based 3D-printing technique, semi-solid extrusion (SSE), is tration to children (Bjerknes et al., 2017; van der Vossen et al., 2019). In designed for printing gels and pastes that exhibit appropriate rheological contrast, 3D-printing technologies enable production of patient-tailored properties. The advantages of SSE are that it enables rapid printing at and flexible dosage forms, by easily adjusting dose, shape, and size of low temperature (Firth et al., 2018). From a pharmaceutical perspective, tablets on demand (i.e., in hospital pharmacies). These attributes align the latter attribute is of great importance for thermolabile drugs and with the vision of the pharmaceutical industry to create personalized heat-sensitive components of the formulation. SSE allows 3D-printing of dosage forms. This personalization of medicines can benefit pediatric personalized dosage forms with high drug loading and multiple drug Abbreviations: LBF, Lipid-based formulation; SSE, Semi-solid extrusion; FDM, Fused deposition modeling; FA, Fatty acid; O/W, Oil-to-water. * Corresponding author at: Molecular Pharmaceutics, Department of Pharmacy, Uppsala University, Box 580, SE-751 23 Uppsala, Sweden. E-mail address: [email protected] (C.A.S. Bergstrom).¨ 1 These authors contributed equally to this work. https://doi.org/10.1016/j.ijpharm.2021.120304 Received 3 December 2020; Received in revised form 19 January 2021; Accepted 20 January 2021 Available online 1 February 2021 0378-5173/© 2021 The Authors. Published by Elsevier B.V. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/). J. Johannesson et al. International Journal of Pharmaceutics 597 (2021) 120304 release profiles from different printed compartments (Khaled et al., 2.2. Lipid-based formulations and drug loading 2018, Khaled et al., 2015a, 2015b). Moreover, the first application of SSE in a clinical setting was recently demonstrated by Goyanes and Table 1 shows the LBF compositions included in this study: type II colleagues (Goyanes et al., 2019). Using 3D-printing, they produced long-chain (II-LC), type IIIA long-chain (IIIA-LC), and medium-chain personalized chewable dosage forms for the treatment of pediatric pa­ (IIIA-MC) (Table 1) (Williams et al., 2012). The LBFs were prepared as tients with a rare metabolic disease. described previously (Alskar¨ et al., 2016). In brief, excipients were ◦ Most research on 3D-printed dosage forms has focused on water- preheated to 37 C in an incubator (Termaks, Bergen, Norway), weighed ◦ soluble drugs without the demand for advanced formulation strategies directly into glass vials, vortexed, and placed on a shaker at 37 C to enable oral drug absorption. Incorporation of poorly water-soluble overnight under an inert N2 atmosphere. The equilibrium solubility of drugs into 3D-printed medicines has not been explored in detail, fenofibratein the LBFs was determined at room temperature, according despite the large number of such drug candidates in pharmaceutical to a previously described protocol (Alskar¨ et al., 2016). An excess of discovery (Bergstrom¨ et al., 2016; Boyd et al., 2019). Lipophilic drugs fenofibratewas added to the LBF in a glass vial and left on a plate shaker have poor solubility in gastrointestinal fluids, so their oral administra­ at room temperature to equilibrate for 96 h before sampling. Prior to tion typically relies on enabling formulations to improve bioavailability. sampling, the vials were centrifuged (Eppendorf centrifuge 5810R, ◦ A well-established enabling formulation is the use of lipid-based for­ Hamburg, Germany) at, 2800g for 30 min at 22 C. The supernatant mulations (LBFs). Typically, the drug is predissolved in the liquid (~30 mg) was transferred to a volumetric flaskand diluted to 5 ml with formulation, which is filledinto gelatin capsules for oral administration. 2-propanol. The drug concentration was determined at 287 nm in a 96- In recent years, LBFs that are mixtures of oils and surfactants, have well UV-plate reader (Tecan, Safire, Zürich, Switzerland). Solubility gained increased interests as a means to increase absorption of poorly measurements were performed in duplicate. Subsequently, the LBFs water-soluble drugs. These self-emulsifying drug delivery systems were loaded with 80% of the determined fenofibrate equilibrium solu­ spontaneously form emulsion droplets in contact with aqueous media bility to reduce the risk of drug precipitation upon emulsification (Ta­ (Pouton, 1997; Rani et al., 2019). However, stability and manufacturing bles 1 and S1). The required amount of fenofibrate and LBF were ◦ challenges associated with liquid LBFs hinder their commercial devel­ weighed into glass vials, vortexed, and placed on a shaker at 37 C until opment and transformation of liquid LBFs into solid dosage forms would the drug dissolved completely. therefore be beneficial (Jannin et al., 2008; Joyce et al., 2019). To date, only a few studies have incorporated LBFs for poorly water- 2.3. Preparation of emulsions soluble drugs into 3D-printed solid dosage forms. A particular challenge is to ensure the rapid disintegration of the 3D-printed dosage form and Emulsions with an oil-to-water (O/W) ratio of 3:7 were prepared subsequent release of the enabling drug formulation in the gastrointes­ (Fig. 1a) by adding the required amount of drug loaded LBF (oil phase) tinal tract. In a previous study, a drop-wise 3D-printing technique was to Milli-Q water (continuous phase; Merck, Darmstadt, Germany), fol­ used to produce an amorphous and self-emulsifying dosage form of lowed by a two-step emulsification process (Fig. 1b). First, the O/W celecoxib (Içten et al., 2017). In a proof of concept, Vithani and col­ phases were ultrasonicated using a Vibra-Cell sonicator mounted with a leagues 3D-printed a solid LBF incorporating the poorly water-soluble 13 mm probe tip (Sonics, Newtown, CT, USA) operating at 20% drugs, fenofibrate or cinnarizine
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