Multimechanism oral dosage forms fabricated by three dimensional printing™

Abstract Objectives The traditional manufacturing methods of solid oral dosage forms (SODFs) are reported to be time-consuming, highly expensive and not tailored to the patient’s needs. Three-dimensional printing (3DP) is an innovative emerging technology that can help to overcome these issues. The aim of this review is to describe the most employed 3DP technologies, materials and the state of the art on 3DP SODFs. Characterization techniques of 3DP SODFs, challenges and regulatory issues are also discussed. Key findings The interest in the investigation of the suitability of 3DP as an alternative strategy for the fabrication of SODFs is growing. Different 3DP technologies and starting materials have been investigated for the development of SODFs. Numerous SODFs with complex geometries and composition, and with different release patterns, have been successfully manufactured via 3DP. Despite that, just one 3DP SODF has reached the market. Summary 3DP can be a promising alternative to the classical SODFs manufacturing methods. However, numerous technically and regulatory challenges still need to be addressed in order 3DP to be extensively used in the pharmaceutical sector.

Download Full-text

Current formulation approaches in design and development of solid oral dosage forms through three-dimensional printing

Progress in Additive Manufacturing ◽

10.1007/s40964-020-00127-5 ◽

2020 ◽

Vol 5 (2) ◽

pp. 111-123

Author(s):

Carlo Curti ◽

Daniel J. Kirby ◽

Craig A. Russell

Keyword(s):

Three Dimensional ◽

Dosage Forms ◽

Oral Dosage ◽

Design And Development ◽

Three Dimensional Printing ◽

Current Formulation ◽

Solid Oral Dosage Forms ◽

Oral Dosage Forms ◽

Dimensional Printing

Download Full-text

Oral dosage forms fabricated by Three Dimensional Printing™

Journal of Controlled Release ◽

10.1016/s0168-3659(99)00225-4 ◽

2000 ◽

Vol 66 (1) ◽

pp. 1-9 ◽

Cited By ~ 173

Author(s):

W.E Katstra ◽

R.D Palazzolo ◽

C.W Rowe ◽

B Giritlioglu ◽

P Teung ◽

...

Keyword(s):

Three Dimensional ◽

Dosage Forms ◽

Oral Dosage ◽

Three Dimensional Printing ◽

Oral Dosage Forms ◽

Dimensional Printing

Download Full-text

Development of Near Zero-Order Release Dosage Forms Using Three-Dimensional Printing (3-DP™) Technology

Drug Development and Industrial Pharmacy ◽

10.1080/03639040500519300 ◽

2006 ◽

Vol 32 (3) ◽

pp. 367-376 ◽

Cited By ~ 54

Author(s):

Chen-Chao Wang ◽

Monica R. Tejwani (Motwani) ◽

Willie J. Roach ◽

Jennifer L. Kay ◽

Jaedeok Yoo ◽

...

Keyword(s):

Three Dimensional ◽

Dosage Forms ◽

Zero Order ◽

Three Dimensional Printing ◽

Order Release ◽

Zero Order Release ◽

Dimensional Printing

Download Full-text

Additive Manufacturing of Personalized Pharmaceutical Dosage Forms via Stereolithography

Pharmaceutics ◽

10.3390/pharmaceutics11120645 ◽

2019 ◽

Vol 11 (12) ◽

pp. 645 ◽

Cited By ~ 12

Author(s):

Andrew V. Healy ◽

Evert Fuenmayor ◽

Patrick Doran ◽

Luke M. Geever ◽

Clement L. Higginbotham ◽

...

Keyword(s):

Three Dimensional ◽

Dosage Forms ◽

Oral Dosage ◽

Pharmaceutical Dosage Forms ◽

Glycol Diacrylate ◽

Drug Concentrations ◽

Poly Ethylene ◽

Print Process ◽

Oral Dosage Forms ◽

Poly Caprolactone

The introduction of three-dimensional printing (3DP) has created exciting possibilities for the fabrication of dosage forms, paving the way for personalized medicine. In this study, oral dosage forms of two drug concentrations, namely 2.50% and 5.00%, were fabricated via stereolithography (SLA) using a novel photopolymerizable resin formulation based on a monomer mixture that, to date, has not been reported in the literature, with paracetamol and aspirin selected as model drugs. In order to produce the dosage forms, the ratio of poly(ethylene glycol) diacrylate (PEGDA) to poly(caprolactone) triol was varied with diphenyl(2,4,6-trimethylbenzoyl)phosphine oxide (Irgacure TPO) utilized as the photoinitiator. The fabrication of 28 dosages in one print process was possible and the printed dosage forms were characterized for their drug release properties. It was established that both drugs displayed a sustained release over a 24-h period. The physical properties were also investigated, illustrating that SLA affords accurate printing of dosages with some statistically significant differences observed from the targeted dimensional range, indicating an area for future process improvement. The work presented in this paper demonstrates that SLA has the ability to produce small, individualized batches which may be tailored to meet patients’ specific needs or provide for the localized production of pharmaceutical dosage forms.

Download Full-text

Analysis of Coating Structures and Interfaces in Solid Oral Dosage Forms by Three Dimensional Terahertz Pulsed Imaging

Journal of Pharmaceutical Sciences ◽

10.1002/jps.20789 ◽

2007 ◽

Vol 96 (2) ◽

pp. 330-340 ◽

Cited By ~ 145

Author(s):

J.Axel Zeitler ◽

Yaochun Shen ◽

Colin Baker ◽

Philip F. Taday ◽

Michael Pepper ◽

...

Keyword(s):

Three Dimensional ◽

Dosage Forms ◽

Oral Dosage ◽

Terahertz Pulsed Imaging ◽

Solid Oral Dosage Forms ◽

Oral Dosage Forms

Download Full-text

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

Pharmaceutics ◽

10.3390/pharmaceutics13091401 ◽

2021 ◽

Vol 13 (9) ◽

pp. 1401

Author(s):

Danae Karalia ◽

Angeliki Siamidi ◽

Vangelis Karalis ◽

Marilena Vlachou

Keyword(s):

Mechanical Properties ◽

3D Printing ◽

Computational Methods ◽

Structural Integrity ◽

Three Dimensional ◽

Drug Distribution ◽

Dosage Forms ◽

Oral Dosage ◽

3D Printed ◽

Oral Dosage Forms

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.

Download Full-text

3D Printed Pellets (Miniprintlets): A Novel, Multi-Drug, Controlled Release Platform Technology

Pharmaceutics ◽

10.3390/pharmaceutics11040148 ◽

2019 ◽

Vol 11 (4) ◽

pp. 148 ◽

Cited By ~ 43

Author(s):

Atheer Awad ◽

Fabrizio Fina ◽

Sarah Trenfield ◽

Pavanesh Patel ◽

Alvaro Goyanes ◽

...

Keyword(s):

Drug Release ◽

Ethyl Cellulose ◽

Selective Laser Sintering ◽

Three Dimensional ◽

Single Step ◽

Oral Dosage ◽

Three Dimensional Printing ◽

Pharmaceutical Ingredients ◽

3D Printed ◽

Oral Dosage Forms

Selective laser sintering (SLS) is a single-step three-dimensional printing (3DP) process that can be leveraged to engineer a wide array of drug delivery systems. The aim of this work was to utilise SLS 3DP, for the first time, to produce small oral dosage forms with modified release properties. As such, paracetamol-loaded 3D printed multiparticulates, termed miniprintlets, were fabricated in 1 mm and 2 mm diameters. Despite their large surface area compared with a conventional monolithic tablet, the ethyl cellulose-based miniprintlets exhibited prolonged drug release patterns. The possibility of producing miniprintlets combining two drugs, namely paracetamol and ibuprofen, was also investigated. By varying the polymer, the dual miniprintlets were programmed to achieve customised drug release patterns, whereby one drug was released immediately from a Kollicoat Instant Release matrix, whilst the effect of the second drug was sustained over an extended time span using ethyl cellulose. Herein, this work has highlighted the versatility of SLS 3DP to fabricate small and intricate formulations containing multiple active pharmaceutical ingredients with distinct release properties.

Download Full-text