On-Demand Manufacturing of Direct Compressible Tablets: Can Formulation Be Simplified?

Azad, Mohammad; Osorio, Juan G.; Wang, Allison; Klee, David; Eccles, Mary E.; Grela, Erin; Sloan, Richard G.; Hammersmith, Gregory; Rapp, Kersten; Brancazio, David; Myerson, Allan S.

doi:10.1007/s11095-019-2716-2

Cited by 14 publications

(15 citation statements)

References 27 publications

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“…A comparison of processing steps required for traditional pharmaceutical manufacturing direct compressions (DC) vs. 3D printing (FDM and PAM) is shown in Figure 4. DC is considered the simplest manufacturing process for pharmaceutical tablets [66,67]. Both FDM and PAM require the same number of processing steps to manufacture deliverable finished products from raw materials (API and excipients).…”

Section: Extrusion-based 3d Printingmentioning

confidence: 99%

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Polymers for Extrusion-Based 3D Printing of Pharmaceuticals: A Holistic Materials–Process Perspective

et al. 2020

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Three dimensional (3D) printing as an advanced manufacturing technology is progressing to be established in the pharmaceutical industry to overcome the traditional manufacturing regime of 'one size fits for all'. Using 3D printing, it is possible to design and develop complex dosage forms that can be suitable for tuning drug release. Polymers are the key materials that are necessary for 3D printing. Among all 3D printing processes, extrusion-based (both fused deposition modeling (FDM) and pressure-assisted microsyringe (PAM)) 3D printing is well researched for pharmaceutical manufacturing. It is important to understand which polymers are suitable for extrusion-based 3D printing of pharmaceuticals and how their properties, as well as the behavior of polymer–active pharmaceutical ingredient (API) combinations, impact the printing process. Especially, understanding the rheology of the polymer and API–polymer mixtures is necessary for successful 3D printing of dosage forms or printed structures. This review has summarized a holistic materials–process perspective for polymers on extrusion-based 3D printing. The main focus herein will be both FDM and PAM 3D printing processes. It elaborates the discussion on the comparison of 3D printing with the traditional direct compression process, the necessity of rheology, and the characterization techniques required for the printed structure, drug, and excipients. The current technological challenges, regulatory aspects, and the direction toward which the technology is moving, especially for personalized pharmaceuticals and multi-drug printing, are also briefly discussed.

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Section: Extrusion-based 3d Printingmentioning

confidence: 99%

“…However, the dosage should have some short period of stability at least for one or two weeks. Tablet properties such as assay, tensile strength, and dissolution after a short period of stability need to be checked to ensure that the drug does not degrade [67].…”

Section: Dosage Shape Size Complexitymentioning

confidence: 99%

Polymers for Extrusion-Based 3D Printing of Pharmaceuticals: A Holistic Materials–Process Perspective

et al. 2020

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“…However, for this Demo phase, we added the ability to manufacture solid oral dosage forms. An additional module was designed and built to allow for this increase in functionality. , …”

Section: Technologymentioning

confidence: 99%

“…The powder is then dispensed in the required amount depending on dosage size into a tablet press die where the blend is compressed into a tablet before ejection and weighing. Additional details can be found in prior publications. , …”

Section: Technologymentioning

confidence: 99%

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Continuous Production of Five Active Pharmaceutical Ingredients in Flexible Plug-and-Play Modules: A Demonstration Campaign

Rogers

Briggs

Achermann

et al. 2020

Org. Process Res. Dev.

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Traditional pharmaceutical manufacturing is based on a complex supply chain that is vulnerable to spikes in demand and interruptions. Continuous pharmaceutical production in compact modules is a potential solution that allows for drug manufacturing when and where it is needed with significantly shorter lead times. As part of the Pharmacy on Demand (PoD) initiative, we demonstrate the potential for end-to-end manufacturing of multiple drug substances in reconfigurable devices, under common industrial constraints, and within a challenging manufacturing time frame. A new set of refrigerator-sized modules was constructed for the synthesis, isolation, and formulation of several drugs, with focus on achieving high manufacturing throughputs, and allowing for the production of pharmaceutical tablets. Their operation is demonstrated with the synthesis and formulation of USP-compliant tablets of diazepam, diphenhydramine hydrochloride, and ciprofloxacin hydrochloride, as well as liquid formulations of lidocaine hydrochloride and atropine sulfate.

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Quality by Design (QbD) Concept for Formulation of Oral Formulations for Tablets

Ansari,

Alahmed,

Sami

2024

Introduction to Quality by Design (QbD)

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On-Demand Manufacturing of Direct Compressible Tablets: Can Formulation Be Simplified?

Abstract: On-demand manufacturing of direct compressible tablets: can formulation be simplified?Cite this article as: Mohammad A. Azad, On-demand manufacturing of direct compressible tablets: can formulation be simplified?, Pharmaceutical Research,

Cited by 14 publications

References 27 publications

Polymers for Extrusion-Based 3D Printing of Pharmaceuticals: A Holistic Materials–Process Perspective

Polymers for Extrusion-Based 3D Printing of Pharmaceuticals: A Holistic Materials–Process Perspective

Continuous Production of Five Active Pharmaceutical Ingredients in Flexible Plug-and-Play Modules: A Demonstration Campaign

Quality by Design (QbD) Concept for Formulation of Oral Formulations for Tablets

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