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Shah, Vinod P.; Yamamoto, Lawrence A.; Schuirman, Donald; Elkins, Jerome; Skelly, Jerome P.

doi:10.1023/a:1016442514205

Cited by 21 publications

(2 citation statements)

References 2 publications

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“…Tablets are divided manually using hands, knives, or tablet splitters, which leads to uneven weight distribution after division [8] and drug release problems (e.g., premature drug release, breakage of coating system, etc.) [9,10]. 3D printing, on the other hand, can effectively solve these problems by moving away from the "one-size-fits-all" approach and mass production toward personalized pharmacotherapy.…”

Section: Introductionmentioning

confidence: 99%

3D-Printed Oral Dosage Forms: Mechanical Properties, Computational Approaches and Applications

et al. 2021

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The aim of this review is to present the factors influencing the mechanical properties of 3D-printed oral dosage forms. It also explores how it is possible to use specific excipients and printing parameters to maintain the structural integrity of printed drug products while meeting the needs of patients. Three-dimensional (3D) printing is an emerging manufacturing technology that is gaining acceptance in the pharmaceutical industry to overcome traditional mass production and move toward personalized pharmacotherapy. After continuous research over the last thirty years, 3D printing now offers numerous opportunities to personalize oral dosage forms in terms of size, shape, release profile, or dose modification. However, there is still a long way to go before 3D printing is integrated into clinical practice. 3D printing techniques follow a different process than traditional oral dosage from manufacturing methods. Currently, there are no specific guidelines for the hardness and friability of 3D printed solid oral dosage forms. Therefore, new regulatory frameworks for 3D-printed oral dosage forms should be established to ensure that they meet all appropriate quality standards. The evaluation of mechanical properties of solid dosage forms is an integral part of quality control, as tablets must withstand mechanical stresses during manufacturing processes, transportation, and drug distribution as well as rough handling by the end user. Until now, this has been achieved through extensive pre- and post-processing testing, which is often time-consuming. However, computational methods combined with 3D printing technology can open up a new avenue for the design and construction of 3D tablets, enabling the fabrication of structures with complex microstructures and desired mechanical properties. In this context, the emerging role of computational methods and artificial intelligence techniques is highlighted.

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Section: Introductionmentioning

confidence: 99%

3D-Printed Oral Dosage Forms: Mechanical Properties, Computational Approaches and Applications

et al. 2021

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“…controlled-release tablets comparing with whole tablets (66). Zhao found more weight variation after split metoprolol extended release tablets compared with intact one because of the uneven distribution of metoprolol beads in tablet surface (67).…”

Section: Shah and Col Shown A Fast Dissolution Profile Of Halves Thementioning

confidence: 99%

Avaliação da influência de múltiplos fatores envolvidos na partição de comprimidos

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Comprimidos redondos exibiram perda de peso (2,59% ± 0,23) e variação de área (17,57% ± 0,95) maiores que os obtidos pelos comprimidos oblongos (0,66% ± 0,78, e 5,47% ± 0,52; p=0,000 para ambos). Comprimidos revestidos apresentaram menores perdas de peso (p=0,000), variações de dureza (p=0,022) e área (p=0,009), com valores de 1,4% ± 0,2, 51,5% ± 1,2 e 13,0% ± 1,2, comparados com comprimidos não revestidos que apresentaram 2,8% ± 0,3, 54,4% ± 1,3, e 16,6% ± 1,1. Finalmente, comprimidos sulcados obtiveram menor perda de peso (p=0,000) e variação de área (p=0,000; 8,63% ± 0,7 e 13,44% ± 1,01) comparados aos comprimidos não sulcados (12,63% ± 0,72 e 18,57% ± 1,32). Conclusão: Há a necessidade de mais estudos e de uma regulamentação sanitária mais consistente que possam nortear os pacientes e os profissionais de saúde acerca da partição de comprimidos. Palavras-chave: partição de comprimidos; regulação sanitária; método de partição; ensaios mecânicos e físicos.

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