Data-Enriched Edible Pharmaceuticals (DEEP) with Bespoke Design, Dose and Drug Release

Data-enriched edible pharmaceuticals (DEEP) is an approach to obtain personalized medicine, in terms of flexible and precise drug doses, while at the same time containing data, embedded in quick response (QR) codes at a single dosage unit level. The aim of this study was to fabricate DEEP with a patient-tailored dose, modify drug release and design to meet patients’ preferences. It also aimed to investigate physical stability in terms of the readability of QR code patterns of DEEP during storage. Cannabinoids, namely, cannabidiol (CBD) and delta-9-tetrahydrocannabinol (THC), were used as the model active pharmaceutical ingredients (APIs). Three different substrates and two colorants for the ink were tested for their suitability to fabricate DEEP by desktop inkjet printing. Flexible doses and customizable designs of DEEP were obtained by manipulating the digital design of the QR code, particularly, by exploring different pattern types, embedded images and the physical size of the QR code pattern. Modification of the release of both APIs from DEEP was achieved by applying a hydroxypropyl cellulose (HPC) polymer coating. The appearance and readability of uncoated and polymer-coated DEEP did not change on storage in cold and dry conditions; however, the HPC polymer layer was insufficient in preserving the readability of the QR code pattern in the extreme storage condition (40 °C and 75% relative humidity). To sum up, the DEEP concept provides opportunities for the personalization of medicines, considering also patients’ preferences.

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2.1. Materials
The drug-containing ink for inkjet printing was formulated based on the oromucosal drug product Sativex®, containing 27 mg/mL delta-9-tetrahydrocannabinol (THC) and 25 mg/mL cannabidiol (CBD) that was obtained from 2care4 (Esbjerg, Denmark). The coloring agents, erythrosine B (90% dye content) and brilliant black BN (60% dye content), were purchased from Sigma-Aldrich (St. Louis, MO, USA). The placebo ink was based on ethanol (96%) from VWR (Fontenay-sous-Bois Cedex, France) and propylene glycol (PG) from Sigma-Aldrich (99.5%, Sigma-Aldrich, St. Louis, MO, USA). For the preparation of the orodispersible substrates (solid foam), hydroxypropyl methylcellulose
(HPMC) (Metolose 60SH-4000) (Shin-Etsu, Tokyo, Japan), poloxamer 188 (Lutrol® F68) (Sigma-Aldrich, Steinheim, Germany), polyethylene glycol 4000 (PEG 4000), Merck KGaA, Darmstadt, Germany), polysorbate 20 (Tween® 20) (Merck KGaA, Fontenay-sous-Bois Cedex, France) and glycerol (99%, Sigma-Aldrich, Petaling Jaya, Malaysia) were used.

The transparent laser paper (type A paperbacked laser/copier transparencies) used for Pharmaceutics 2021, 13, 1866 3 of 12 casting polymer dispersion was from Xerox (Norwalk, CT, USA). Potato starch substrate (wafer paper) (AB Marketing GmbH, Ebern, Germany), fondant paper (A4, AB Marketing GmbH, Ebern, Germany) and normal copy paper (A4. 80 g/m2, Plano® Universal, EU) were used as the commercially available substrates for printing. Hydroxypropyl cellulose (HPC) (150–400 mPa s for 2% aqueous solution) (Tokyo Chemical Industry Co., Ltd, Toshima, Kita-Ku, Tokio, Japan) was used as the polymer for coating. For the analyses with ultra-high-performance liquid chromatography (UHPLC), acetonitrile was purchased from VWR Chemicals (Fontenay-sous-Bois Cedex, France), and Milli-Q water was freshly prepared with Ultrapure (Type 1) Water (Merck KGaA, Darmstadt, Germany). For the artificial saliva, sodium chloride, potassium dihydrogen phosphate, and disodium hydrogen phosphate (Merck KGaA, Darmstadt, Germany) were used.

Chao, M.; Öblom, H.; Cornett, C.; Bøtker, J.; Rantanen, J.; Sporrong, S.K.; Genina, N. Data-Enriched Edible Pharmaceuticals (DEEP) with Bespoke Design, Dose and Drug Release. Pharmaceutics 2021, 13, 1866. https://doi.org/10.3390/pharmaceutics13111866