3D printing of unique water-soluble polymer-based suppository shell for controlled drug release

Tagami, Tatsuaki; Hayashi, Naomi; Sakai, Norihito; Ozeki, Tetsuya

doi:10.1016/j.ijpharm.2019.118494

Cited by 60 publications

(23 citation statements)

References 31 publications

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“…Further, 3D printing of rectal formulations may allow researchers to further optimise the properties of suppositories and develop formulations with predictable release profiles. Indeed, 3D printing of a watersoluble polymer suppository shell has been successfully developed to offer desirable drug release using progesterone as a model drug [43]. Research into the potential application of 3D printing for antimicrobial suppositories is justified.…”

Section: Preliminary Stability Studiesmentioning

confidence: 99%

Characterisation of rectal amoxicillin (RAMOX) for the treatment of pneumonia in children

Hanning

Matiz

Krasser

et al. 2020

Drug Deliv. and Transl. Res.

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Access to medicines, including their availability and affordability, is a major public health challenge worldwide. This research aimed to characterise rectal formulations containing amoxicillin for the treatment of pneumonia in children under five, as an accessible alternative to existing formulations. Lipophilic Suppocire (S-NA15) and hydrophilic polyethylene glycol (PEG; 80% PEG 1500 and 20% PEG 4000, w/w) suppositories containing 250 mg amoxicillin were prepared. Hardness, apparent viscosity, uniformity of mass, uniformity of content, disintegration and dissolution time were determined. Irritation potential was screened using a slug mucosal assay and antibacterial efficacy against Staphylococcus aureus determined by isothermal microcalorimetry. Both lipophilic and hydrophilic formulations met the European Pharmacopoeia standards for suppositories when tested in vitro. They disintegrated within 30 min with rapid amoxicillin release profiles (98.6 ± 0.9%, 94.9 ± 1.2% over 30 min, respectively). Over-encapsulation of S-NA15 suppositories with hydroxypropyl methylcellulose shells slowed drug release and improved stability over 2 months. S-NA15 suppositories were classified as non-irritant and PEG suppositories only mildly irritant. Antibacterial efficacy of formulations was equivalent to amoxicillin alone. Both PEG and over-encapsulated S-NA15 rectal formulations developed in the present work have shown promise based on pre-clinical screening, and further development is justified to develop a product with commercial potential.

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Section: Preliminary Stability Studiesmentioning

confidence: 99%

Characterisation of rectal amoxicillin (RAMOX) for the treatment of pneumonia in children

Hanning

Matiz

Krasser

et al. 2020

Drug Deliv. and Transl. Res.

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“…This is especially useful in the case of narrow therapeutic index drugs, such as tacrolimus. Previous work has described the fabrication of suppository moulds and shells with different shapes and geometries [40] , [41] , [42] , but to date no study has directly printed the suppositories without the need for moulds or covers. Enabling the direct preparation of self-supporting suppositories would obviate the need for moulds, reducing both time and material costs required to prepare the suppositories.…”

Section: Introductionmentioning

confidence: 99%

3D printed tacrolimus suppositories for the treatment of ulcerative colitis

Seoane-Viaño

Ong

Luzardo-Álvarez

et al. 2021

Asian Journal of Pharmaceutical Sciences

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Ulcerative colitis is a global health problem, affecting millions of individuals worldwide. As an inflammatory condition localised in the large intestine, rectal delivery of immunosuppressive therapies such as tacrolimus is a promising strategy to maximise drug concentration at the site of action whilst minimising systemic side effects. Here, for the first time, self-supporting 3D-printed tacrolimus suppositories were prepared without the aid of moulds using a pharmaceutical semi-solid extrusion (SSE) 3D printer. The suppositories were printed vertically in three different sizes using combinations of two lipid pharmaceutical excipients (Gelucire 44/14 or Gelucire 48/16) and coconut oil. Although both suppository formulations had the appropriate viscosity characteristics for printing, the Gel 44 formulation required less energy and force for extrusion compared to the Gel 48 system. The Gel 44 disintegrated more rapidly but released tacrolimus more slowly than the Gel 48 suppositories. Although the tacrolimus release profiles were significantly different, both suppository systems released more than 80% drug within 120 min. DSC and XRD analysis was inconclusive in determining the solid-state properties of the drug in the suppositories. In summary, this article reports on the fabrication of 3D printed self-supporting suppositories to deliver personalised doses of a narrow therapeutic index drug, with potential benefits for patients with ulcerative colitis.

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“…Multicompartmental devices, loaded with SNEDDS [12], drugloaded hot melt extrudates [13] or bulk APIs [14,15], and suppository dosage forms [16], were also fabricated. Moreover, regular tablet and capsule shapes have been investigated as potential carriers that provide the targeted drug delivery of alginate beads [17] and hydrogels [18].…”

Section: Filled Formulationsmentioning

confidence: 99%

“…Separate inner compartments providing predictable drug release profiles [15] PVA commercial progesterone 3D printed suppository molds for filling with different suppository formulations [16] PLA commercial Eudragit L100-55 Eudragit S100 patient-specific dose of the second API, was produced. Thus, the mass production capabilities of IM were exploited and combined with the patient-centric orientation of FFF.…”

Section: Other Systemsmentioning

confidence: 99%

Manufacturing of hybrid drug delivery systems by utilizing the fused filament fabrication (FFF) technology

Eleftheriadis

Katsiotis

Genina

et al. 2020

Expert Opinion on Drug Delivery

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The potential of fused filament fabrication (FFF) for the administration of active pharmaceutical compounds is a recent approach to develop complex and custom-made drug delivery systems (DDSs). However, the FFF technology is characterized by certain limitations, which are associated with the nature of the process, i.e., the required mechanical properties of the feedstock, as well as the thermal stability of the incorporated polymers, excipients and active compounds. Thus, hybrid DDSs have been recently introduced, to overcome these boundaries. The concept of these systems is defined by the effective coupling of FFF with conventional manufacturing technologies, as a novel pathway to expand the available pool of raw materials and pharmaceutical applications of FFF.

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3D printing of unique water-soluble polymer-based suppository shell for controlled drug release

Cited by 60 publications

References 31 publications

Characterisation of rectal amoxicillin (RAMOX) for the treatment of pneumonia in children

Characterisation of rectal amoxicillin (RAMOX) for the treatment of pneumonia in children

3D printed tacrolimus suppositories for the treatment of ulcerative colitis

Manufacturing of hybrid drug delivery systems by utilizing the fused filament fabrication (FFF) technology

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