Automated therapy preparation of isoleucine formulations using 3D printing for the treatment of MSUD: First single-centre, prospective, crossover study in patients

Goyanes, Álvaro; Madla, Christine M.; Umerji, Aysha; Duran, Goretti; Montero, Jose Maria Giraldez; Diaz, María Jesús Lamas; Barcia, Miguel González; Taherali, Farhan; Sánchez‐Pintos, Paula; Couce, María-Luz; Gaisford, Simon; Basit, Abdul W.

doi:10.1016/j.ijpharm.2019.118497

Cited by 200 publications

(115 citation statements)

References 35 publications

(34 reference statements)

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“…Three-dimensional printing (3DP) is an innovative additive manufacturing technology that has come to the fore in the preparation of personalised dose printlets (3D printed tablets) [10][11][12][13][14]. 3D printing is an umbrella term that encompasses various technologies, many of which have already been evaluated in the pharmaceutical field [15][16][17][18], including powder bed inkjet printing, fused deposition modelling (FDM) [19][20][21][22][23][24][25][26][27], semi-solid extrusion (SSE) [28][29][30][31][32][33], selective laser sintering (SLS), direct powder extrusion (DPE) [34] and stereolithography (SLA) [15,[35][36][37][38].…”

Section: Introductionmentioning

confidence: 99%

Selective Laser Sintering 3D Printing of Orally Disintegrating Printlets Containing Ondansetron

Allahham¹,

Fina

Marcuta³

et al. 2020

Pharmaceutics

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142

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The aim of this work was to explore the feasibility of using selective laser sintering (SLS) 3D printing (3DP) to fabricate orodispersable printlets (ODPs) containing ondansetron. Ondansetron was first incorporated into drug-cyclodextrin complexes and then combined with the filler mannitol. Two 3D printed formulations with different levels of mannitol were prepared and tested, and a commercial ondansetron orally disintegrating tablet (ODT) product (Vonau® Flash) was also investigated for comparison. Both 3D printed formulations disintegrated at ~15 s and released more than 90% of the drug within 5 min independent of the mannitol content; these results were comparable to those obtained with the commercial product. This work demonstrates the potential of SLS 3DP to fabricate orodispersible printlets with characteristics similar to a commercial ODT, but with the added benefit of using a manufacturing technology able to prepare medicines individualized to the patient.

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Section: Introductionmentioning

confidence: 99%

Selective Laser Sintering 3D Printing of Orally Disintegrating Printlets Containing Ondansetron

Allahham¹,

Fina

Marcuta³

et al. 2020

Pharmaceutics

Self Cite

142

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“…For instance, a study evaluating the effect of shape and size on picking and swallowing of 3D printed tablets (also known as printlets) showed that certain new designs may be better accepted than conventional shapes [45]. More recently, a study concerning paediatric patients with a rare metabolic disease (maple syrup urine disease, MSUD) [46] indicated that 3D printing provides a viable approach to fabricate tailored medicines on-demand [47], improving acceptability and efficacy of treatment.…”

Section: Introductionmentioning

confidence: 99%

3D Printed Tablets (Printlets) with Braille and Moon Patterns for Visually Impaired Patients

et al. 2020

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Visual impairment and blindness affects 285 million people worldwide, resulting in a high public health burden. This study reports, for the first time, the use of three-dimensional (3D) printing to create orally disintegrating printlets (ODPs) suited for patients with visual impairment. Printlets were designed with Braille and Moon patterns on their surface, enabling patients to identify medications when taken out of their original packaging. Printlets with different shapes were fabricated to offer additional information, such as the medication indication or its dosing regimen. Despite the presence of the patterns, the printlets retained their original mechanical properties and dissolution characteristics, wherein all the printlets disintegrated within ~5 s, avoiding the need for water and facilitating self-administration of medications. Moreover, the readability of the printlets was verified by a blind person. Overall, this novel and practical approach should reduce medication errors and improve medication adherence in patients with visual impairment.

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“…Additionally, the study showed that more than half of 3-5-year-old children liked orodispersible films very much and that almost all caregivers were willing to use the dosage form. Goyanes et al investigated the effect of flavor and color on drug acceptability of chewable printlets administered to four pediatric patients [4]. Preferences of flavor and color were individual; however, the most preferred flavors were strawberry, orange, and lemon.…”

Section: Main Findingsmentioning

confidence: 99%

“…Studies on the development of different printing technologies in drug manufacturing of oral dosage forms are comprehensively presented in the literature. Semi-solid extrusion (SSE) has, for instance, been used to print immediate release tablets of levetiracetam [2] and paracetamol [3], chewable solid dosage forms containing isoleucine [4], as well as orodispersible films containing warfarin [5,6]. Other printing technologies used for the production of oral films include inkjet printing, also referred to as 2D printing [6][7][8][9][10]; flexographic printing [11]; fused deposition modeling (FDM) [12]; and hot melt ram extrusion [13].…”

Section: Introductionmentioning

confidence: 99%

“…The pharmaceutical company would provide the compounding pharmacy with raw materials and guidance on printing, whereas the compounding pharmacy would compound personalized medicines for patients with different needs based on a prescription by a physician. To the best of the author's knowledge, there is, however, published evidence only on one printed dosage form compounded in a hospital pharmacy that has been used for children in a clinical trial [4].…”

Section: Introductionmentioning

confidence: 99%

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Benefits and Prerequisites Associated with the Adoption of Oral 3D-Printed Medicines for Pediatric Patients: A Focus Group Study among Healthcare Professionals

et al. 2020

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The utilization of three-dimensional (3D) printing technologies as innovative manufacturing methods for drug products has recently gained growing interest. From a technological viewpoint, proof-of-concept on the performance of different printing methods already exist, followed by visions about future applications in hospital or community pharmacies. The main objective of this study was to investigate the perceptions of healthcare professionals in a tertiary university hospital about oral 3D-printed medicines for pediatric patients by means of focus group discussions. In general, the healthcare professionals considered many positive aspects and opportunities in 3D printing of pharmaceuticals. A precise dose as well as personalized doses and dosage forms were some of the advantages mentioned by the participants. Especially in cases of polypharmacy, incorporating several drug substances into one product to produce a polypill, personalized regarding both the combination of drug substances and the doses, would benefit drug treatments of several medical conditions and would improve adherence to medications. In addition to the positive aspects, concerns and prerequisites for the adoption of 3D printing technologies at hospital settings were also expressed. These perspectives are suggested by the authors to be focus points for future research on personalized 3D-printed drug products.

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Automated therapy preparation of isoleucine formulations using 3D printing for the treatment of MSUD: First single-centre, prospective, crossover study in patients

Cited by 200 publications

References 35 publications

Selective Laser Sintering 3D Printing of Orally Disintegrating Printlets Containing Ondansetron

Selective Laser Sintering 3D Printing of Orally Disintegrating Printlets Containing Ondansetron

3D Printed Tablets (Printlets) with Braille and Moon Patterns for Visually Impaired Patients

Benefits and Prerequisites Associated with the Adoption of Oral 3D-Printed Medicines for Pediatric Patients: A Focus Group Study among Healthcare Professionals

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