3D printed multi-drug-loaded suppositories for acute severe ulcerative colitis

Awad, Atheer; Hollis, Eleanor; Goyanes, Álvaro; Orlu, Mine; Gaisford, Simon; Basit, Abdul W.

doi:10.1016/j.ijpx.2023.100165

Cited by 8 publications

(10 citation statements)

References 49 publications

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“…Results of the characterisation of the 3D printed suppositories, including weight, drug loading, binding capacity and disintegration time (mean ± SD). (Awad et al, 2023b), where the effect of changing the lipid component or drugs' content on the release properties was studied. On this basis, the current formulation was adapted and developed to allow the incorporation of larger drug molecules including biopharmaceuticals.…”

Section: Tablementioning

confidence: 99%

“…Unlike analogous 3D printing technologies that necessitate the use of elevated temperatures, SSE 3D printing utilises low temperatures, making it well suited for use with thermosensitive active pharmaceutical ingredients (APIs) (Evans et al, 2021;Rodríguez-Pombo et al, 2022). Building on our previous work where we have shown that SSE 3D printed suppositories can be used for delivering small drug molecules (e.g., tacrolimus (Seoane-Viaño et al, 2020;Seoane-Viaño et al, 2021a), tofacitinib citrate and budesonide (Awad et al, 2023b)), herein we demonstrate that this flexible platform can be expanded for the delivery of biopharmaceuticals which are more challenging to produce.…”

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

3D printed infliximab suppositories for rectal biologic delivery

Awad¹,

Goyanes²,

Orlu³

et al. 2023

International Journal of Pharmaceutics: X

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Section: Tablementioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

3D printed infliximab suppositories for rectal biologic delivery

Awad¹,

Goyanes²,

Orlu³

et al. 2023

International Journal of Pharmaceutics: X

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Section: Figurementioning

confidence: 99%

3D Printing Technology as a Promising Tool to Design Nanomedicine-Based Solid Dosage Forms: Contemporary Research and Future Scope

et al. 2023

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3D printing technology in medicine is gaining great attention from researchers since the FDA approved the first 3D-printed tablet (Spritam®) on the market. This technique permits the fabrication of various types of dosage forms with different geometries and designs. Its feasibility in the design of different types of pharmaceutical dosage forms is very promising for making quick prototypes because it is flexible and does not require expensive equipment or molds. However, the development of multi-functional drug delivery systems, specifically as solid dosage forms loaded with nanopharmaceuticals, has received attention in recent years, although it is challenging for formulators to convert them into a successful solid dosage form. The combination of nanotechnology with the 3D printing technique in the field of medicine has provided a platform to overcome the challenges associated with the fabrication of nanomedicine-based solid dosage forms. Therefore, the major focus of the present manuscript is to review the recent research developments that involved the formulation design of nanomedicine-based solid dosage forms utilizing 3D printing technology. Utilization of 3D printing techniques in the field of nanopharmaceuticals achieved the successful transformation of liquid polymeric nanocapsules and liquid self-nanoemulsifying drug delivery systems (SNEDDS) to solid dosage forms such as tablets and suppositories easily with customized doses as per the needs of the individual patient (personalized medicine). Furthermore, the present review also highlights the utility of extrusion-based 3D printing techniques (Pressure-Assisted Microsyringe—PAM; Fused Deposition Modeling—FDM) to produce tablets and suppositories containing polymeric nanocapsule systems and SNEDDS for oral and rectal administration. The manuscript critically analyzes contemporary research related to the impact of various process parameters on the performance of 3D-printed solid dosage forms.

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“…12,13 Other strategies were considered specifically for gastrointestinal (GI) conditions, including oral formulations to release drugs at defined locations in the GI tract, 14 prodrugs, 15 and preparations designed for direct application at diseased sites. 16 As an alternative strategy, medicinal chemistry campaigns have produced JAK inhibitors that achieved high colonic exposures and lower contemporaneous plasma exposures after oral dosing in mice. 17,18 We and other investigators have hypothesized that such enteric-selective drugs would exhibit efficacy for GI tract disorders driven by local JAKs, with improved patient safety derived from the limited systemic exposure.…”

mentioning

confidence: 99%

“…One strategy was to increase compound selectivity within the JAK family, emphasizing JAK1 as the main target while reducing activity vs. other isoforms 12,13 . Other strategies were considered specifically for gastrointestinal (GI) conditions, including oral formulations to release drugs at defined locations in the GI tract, 14 prodrugs, 15 and preparations designed for direct application at diseased sites 16 . As an alternative strategy, medicinal chemistry campaigns have produced JAK inhibitors that achieved high colonic exposures and lower contemporaneous plasma exposures after oral dosing in mice 17,18 .…”

mentioning

confidence: 99%

A Phase I, Randomized, Multi‐Dose Study to Evaluate the Enteric Selectivity and Safety of JAK Inhibitor, Lorpucitinib, in Healthy Participants

Ma,

Borzillo,

Kothe

et al. 2024

Clin Pharma and Therapeutics

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Janus kinase (JAK) signaling has been implicated in human inflammatory diseases, including psoriasis, rheumatoid arthritis, and inflammatory bowel disease. Lorpucitinib (JNJ‐64251330) is an oral, small molecule, pan‐JAK inhibitor. Unlike systemic JAK antagonists, lorpucitinib was found to have enteric (gut)‐selective properties, providing possible applications in diseases of the human gastrointestinal tract. Here, lorpucitinib was evaluated in a phase 1, 2‐part, dosing study (NCT04552197) to assess pharmacokinetics (PK), pharmacodynamic biomarkers, and safety in healthy participants. In Part 1, 24 participants were randomized to one of four treatment arms receiving either lorpucitinib (30 mg daily, 30 mg every 12 hours [Q12H], or 75 mg Q12H) or tofacitinib (5 mg Q12H) for 5 days. Part 2 was a food‐effect study in which 12 participants received a single 75‐mg dose of lorpucitinib under either fasting or fed conditions. In Part 1, plasma and gut tissue concentrations of lorpucitinib showed approximately dose‐proportional increases. At all doses, lorpucitinib concentrations were significantly higher (392‐ to 1928‐fold) in the gut mucosal biopsies versus the corresponding plasma samples, demonstrating high enteric selectivity and significantly exceeding both the tissue concentrations (>200‐fold) and tissue/plasma ratios observed with tofacitinib. JAK inhibition in biopsies was confirmed via reduction in pSTAT‐3 levels. In Part 2, lorpucitinib plasma concentrations were detectable but at low levels, with no statistical differences in PK parameters between the fed and fasted groups. Lorpucitinib was safe and well tolerated, and the data may be useful in designing studies to evaluate lorpucitinib in patients with JAK/STAT‐driven gastrointestinal diseases.

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3D printed multi-drug-loaded suppositories for acute severe ulcerative colitis

Cited by 8 publications

References 49 publications

3D printed infliximab suppositories for rectal biologic delivery

3D printed infliximab suppositories for rectal biologic delivery

3D Printing Technology as a Promising Tool to Design Nanomedicine-Based Solid Dosage Forms: Contemporary Research and Future Scope

A Phase I, Randomized, Multi‐Dose Study to Evaluate the Enteric Selectivity and Safety of JAK Inhibitor, Lorpucitinib, in Healthy Participants

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