First FDA Approved 3D Printed Drug Paved New Path for Increased Precision in Patient Care

Author(s): C. Venkateswara Reddy*, Balamuralidhara V., M.P. Venkatesh, T.M. Pramod Kumar

Journal Name: Applied Clinical Research, Clinical Trials and Regulatory Affairs (Discontinued)
Continued as Applied Drug Research, Clinical Trials and Regulatory Affairs

Volume 7 , Issue 2 , 2020


DOI : 10.2174/2213476X07666191226145027

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Graphical Abstract:


Abstract:

The pharmaceutical industry is developed every year with the aim of public health, safety, and financial growth. Keeping public safety in mind, the industry is mostly concentrated on novel plans in the drug development process and plans on how to increase the curing rate of a disorder and building up the accuracy in patient care. The increase in the number of diseases has led to the generic and branded drug competition by which the pressure on the market has increased. The pharmaceutical manufacturers are attempting to find the needs of patients in different ways. The industries were manufacturing the drugs in unique ways which help to increase their productivity and also to increase the patient experience. Due to this, all pharmaceutical manufacturers are trying to manufacture drugs using 3D printing. In 2015, the industries succeeded by manufacturing the drug Spritam using 3D printing and it was the first prescribed drug manufactured by using 3D printing (3DP). 3DP is the process of depositing powder in a layer upon layer that was opposite to subtractive manufacturing and it is perfect for pharmaceuticals because it provides enhanced accuracy in the development and formulation of dosage forms. The 3DP has different advantages to companies and patients like an increase in dissolution rate, absorption, adherence, efficacy, and long life of branded drugs along with the decrease in pill burden. This process leads to a break in the manufacturing method of drugs but helps to overcome several problems and also helps in better patient outcomes in the solid dose markets.

Keywords: Spritam, 3D printing, additive manufacturing, pill burden, solid dose market, pharmaceutical industry.

[1]
Approved drug products Based on internal research using the 2016 FDA Orange Book 2020 Available from: https://www.fda.gov/media/71474/download
[2]
World changing ideas Future pills will be personalized and 3D printed, just for you 2019 Available from: https://www.fastcompany.com/90300828/the-future-of-pills-is-personalized-and-3-d-printed-just-for-you
[3]
Lepowsky E, Tasoglu S. 3D printing for drug manufacturing: A perspective on the future of pharmaceuticals. Int J Bioprint 2018; 4(1): 119.
[4]
Agency for health care policy and research diagnosis and treatment of swallowing disorders (dysphagia) in acute-care stroke patients: Summary, evidence report/technology assessment rockville, Md: Agency for health care policy and research 8 1999 Available from: https://www.ncbi.nlm.nih.gov/books/NBK11901/
[5]
Hein T. The problem with pills 2015 Available from: http://www.pmlive.com/pharma_news/the_problem_with_pills_640133
[6]
Renganathan S. 3D printed drugs: the latest advancements 2019 Available from: https://all3DP.com/2/3D-printing-drugs-the-latest-advancements-around-the-world/
[7]
Jassim-Jaboori AH, Oyewumi MO. 3D printing technology in pharmaceutical drug delivery: prospects and challenges. J Biomol Res Ther 2015; 4(4): 1-3.
[8]
Norman J, Madurawe RD, Moore CM, Khan MA, Khairuzzaman A. A new chapter in pharmaceutical manufacturing: 3D-printed drug products. Adv Drug Deliv Rev 2017; 108(1): 39-50.
[http://dx.doi.org/10.1016/j.addr.2016.03.001] [PMID: 27001902]
[9]
Yoo JD. 3D printing of pharma dosage forms a promising new tech for discovery 2019 Available from: https://www.mastercontrol.com/gxp-lifeline/3D-printing-of-pharma-dosage-forms-is-promising-new-tech-for-discovery/
[10]
A Hard Pill to Swallow: Meeting the needs of modern consumers 2014 Available from: http://ipimediaworld.com/wpcontent/uploads/2014/12/A-hard-pill....pdf
[11]
Carnaby-mann G, Crary M. Pill swallowing by adults with dysphagia. JAMA Otolaryngol Head Neck Surg 2005; 131(11): 970-5.
[http://dx.doi.org/10.1001/archotol.131.11.970]
[12]
Gadgeppa Bhusnure D. 3D printing pharmaceutical manufacturing: opportunities and challenges. Int J Bioassays 2016; 5: 4723-38.
[13]
Jose PA. 3D printing of pharmaceuticals: a potential technology in developing personalized medicine. Asian J Pharm 2018; 6(3): 46-54.
[http://dx.doi.org/10.22270/ajprd.v6i3.375]
[14]
3D printing market by offering (printer, material,software, service), process (binder jetting, direct energy deposition, material extrusion, material jetting,powder bed fusion), application, vertical, technology,and geography - Global Forecast to 2024 Available from: https://www.marketsandmarkets.com/Market-Reports/3d-printing-market-1276.html
[15]
Sawant R, Kakade P. 3D Printing market by technology [Stereo lithography (SLA), Fused Deposition Modelling (FDM), Selective Laser Sintering (SLS),Electron Beam Melting (EBM), Digital Light Processing (DLP), and others], component (hardware,software, and services), and end user (automotive,healthcare, industrial, consumer electronics, aerospace & defense, and others): global opportunity analysis and industry forecast Available from: https:///www.alliedmarketresearch.com/3D-printing-market
[16]
3D printing and its social and organizational impacts 2014 Available from: https://www.3Ders.org/articles/20131111-3D-printing -market-worth-billion-by-2020.html
[17]
Jamróz W, Szafraniec J, Kurek M, Jachowicz R. 2018 3D Printing in pharmaceutical and medical applications – recent achievements and challenges springerPharm Res 2018; 35-176 Available from: https://link.springer.com/content/pdf/101007%2Fs11095-018-2454-x.pdf
[18]
Wu G, Wu W, Zheng Q, Li J, Zhou J, Hu Z. Experimental study of PLLA/INH slow release implant fabricated by three dimensional printing technique and drug release characteristics in vitro. Biomed Eng Online 2014; 13(97): 97.
[http://dx.doi.org/10.1186/1475-925X-13-97] [PMID: 25038793]
[19]
Lee KJ, Kang A, Delfino JJ, et al. Evaluation of critical formulation factors in the development of a rapidly dispersing captopril oral dosage form. Drug Dev Ind Pharm 2003; 29(9): 967-79.
[http://dx.doi.org/10.1081/DDC-120025454] [PMID: 14606661]
[20]
Fina F, Madla CM, Goyanes A, Zhang J, Gaisford S, Basit AW. Fabricating 3D printed orally disintegrating printlets using selective laser sintering. Int J Pharm 2018; 541(1-2): 101-7.
[http://dx.doi.org/10.1016/j.ijpharm.2018.02.015] [PMID: 29454028]
[21]
Wang J, Goyanes A, Gaisford S, Basit AW. Stereolithographic (SLA) 3D printing of oral modified-release dosage forms. Int J Pharm 2016; 503(1-2): 207-12.
[http://dx.doi.org/10.1016/j.ijpharm.2016.03.016] [PMID: 26976500]
[22]
Pere CPP, Economidou SN, Lall G, et al. 3D printed microneedles for insulin skin delivery. Int J Pharm 2018; 544(2): 425-32.
[http://dx.doi.org/10.1016/j.ijpharm.2018.03.031] [PMID: 29555437]
[23]
Clark EA, Alexander MR, Irvine DJ, et al. 3D printing of tablets using inkjet with UV photoinitiation. Int J Pharm 2017; 529(1-2): 523-30.
[http://dx.doi.org/10.1016/j.ijpharm.2017.06.085] [PMID: 28673860]
[24]
Kyobula M, Adedeji A, Alexander MR, et al. 3D inkjet printing of tablets exploiting bespoke complex geometries for controlled and tuneable drug release. J Control Release 2017; 261(3): 207-15.
[http://dx.doi.org/10.1016/j.jconrel.2017.06.025] [PMID: 28668378]
[25]
Jamróz W, Kurek M, Łyszczarz E, et al. 3D printed or dispersible films with Aripiprazole. Int J Pharm 2017; 533(2): 413-20.
[http://dx.doi.org/10.1016/j.ijpharm.2017.05.052] [PMID: 28552800]
[26]
Arafat B, Wojsz M, Isreb A, et al. Tablet fragmentation without a disintegrant: a novel design approach for accelerating disintegration and drug release from 3D printed cellulosic tablets. Eur J Pharm Sci 2018; 118: 191-9.
[http://dx.doi.org/10.1016/j.ejps.2018.03.019] [PMID: 29559404]
[27]
Acosta-Vélez GF, Wu BM. 3D pharming: direct printing of personalized pharmaceutical tablets Polym Sci 2016; 1(2): 1-10Available from: http://polymerscience.imedpub.com/3d-pharming-dir ect-printing-of-personalized-pharmaceutical-tablets.php?aid=9673
[28]
Li Q, Guan X, Cui M, et al. Preparation and investigation of novel gastro-floating tablets with 3D extrusion-based printing. Int J Pharm 2018; 535(1-2): 325-32.
[http://dx.doi.org/10.1016/j.ijpharm.2017.10.037] [PMID: 29051121]
[29]
Khaled SA, Burley JC, Alexander MR, Yang J, Roberts CJ. 3D printing of tablets containing multiple drugs with defined release profiles. Int J Pharm 2015; 494(2): 643-50.
[http://dx.doi.org/10.1016/j.ijpharm.2015.07.067] [PMID: 26235921]


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Article Details

VOLUME: 7
ISSUE: 2
Year: 2020
Published on: 26 December, 2019
Page: [93 - 103]
Pages: 11
DOI: 10.2174/2213476X07666191226145027

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