DIGITALISATION AND AUTOMATION IN PHARMACEUTICALS FROM DRUG DISCOVERY TO DRUG ADMINISTRATION

Authors

  • Abdul Mannan Department of Pharmaceutics, Deccan School of Pharmacy, 500001, Hyderabad, India
  • Hajera Mubeen Department of Pharmaceutics, Deccan School of Pharmacy, 500001, Hyderabad, India

DOI:

https://doi.org/10.22159/ijpps.2018v10i6.24757

Keywords:

Nil, Digitalization, Automation, Pharmaceutical Industry, Drug Products and Computer Aided Design

Abstract

The rapid progress in the pharmaceutical industry is due to the advancement in the digitalization and automation starting from the invention to the administration of the drug. Every advancement in the development of the pharmaceutical product is associated with progress in digitalization. A drug or a drug product to be administered safely and to provide efficacy it has to undergo a long journey from its discovery, including pre-clinical and clinical trials to further product development in the research and development. The production and manufacturing systems with appropriate digitalization and automation compile the drug formulation after the servitude of the research and development (RandD) department. Later, the quality control and quality assurance systems utilize digitalization to maintain the quality and standard of the drug product. Subsequently, packaging and labeling of the drug product are carried out with effective automation. Further, the marketing and supply of the drug products are digitally monitored and dispatched to the distributors and the pharmacies. Finally, the drug product will be dispensed to the patient for its administration with a concordance of digitally monitoring for enhanced efficacy and safety. Therefore, in this review article, various strategies for digitalization and automation in the pharmaceuticals from drug discovery to drug administration are briefly discussed.

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References

Petrova E, Ding M, Eliashberg J, Stremersch S. Innovation and marketing in the pharmaceutical industry. [S. l.]: Springer-Verlag New York 2014;7:19-81.

Bansal P, Gill S, Christopher A, Gupta V. Emerging role of bioinformatics tools and software in evolution of clinical research. Perspect Clin Res 2016;7:115-22.

Leuenberger H, Leuenberger MN. Implementing virtual R and D reality in industry: In silico design and testing of solid dosage forms. Virtual R and D reality/proof of concept. Swiss Pharm 2009;31:18-21.

Markarian J. Using robotics in pharmaceutical manufacturing, equipment and processing report, [Internet]. Pharmtech.com. Available from: 2014. Available from: http://www. pharmtech.com/ using-robotics-pharmaceutical-manufacturing.[Last accessed on 25 Mar 2018]

Ranganathan S, Bellani V. Digital marketing in the indian pharmaceutical industry: a study to assess views of pharmaceutical marketing professionals in using digital marketing as a brand promotional lever. World J Pharm Pharm Sci 1970;89:5, 2278–4351.

Mahnaz S, Ahmadi M, Sadoughi F, Garavand A. A copmarative review of electronic prescription systems: lessons learned from developed countries. J Res Pharm Pract 2017;6:3-11.

Acemoglu D, Linn J. Market size in innovation: theory and evidence from the pharmaceutical industry. Quart J Econ 2004;119:1049–90.

Cassiman B, Ueda M. Optimal project rejection and new firm start-ups. Manag Sci 2006;52:262–75.

High-Throughput Screening and Compound Screening Service | Medicilon Inc. Medicilon.com; 2017. Available from: http://www.medicilon.com/high-throughput-screening-service/. [Last accessed on 22 Apr 2018]

Saurav R. NMR (Nuclear Magnetic Resonance) [Internet]. Slideshare.net; 2014. Available from: https://www. slideshare.net/RawatDAGreatt/nmr-40157983. [Last accessed on 25 Mar 2018]

Devi B, Rajagopal K, Elizabeth E. Pharmacophoric screening of various endophytic fungal metabolites. Asian J Pharm Clin Res 2017;10:140-6.

Saxena S, Devi P, Soni V, Yogeeswari P, Sriram D. Identification of novel inhibitors against Mycobacterium tuberculosis L-alanine dehydrogenase (MTB-AlaDH) through structure-based virtual screening. J Mol Graph Model 2014;47:37-43.

Zerhouni EA. Clinical research at a crossroads: the NIH roadmap. J Investig Med 2006;54:171–3.

Chang J, Zhu X. Bioinformatics databases: Intellectual property protection strategy. J Intellect Property Rights 2010;15:447–54.

Liu Y, Hu B, Fu C, Chen X. DCDB: Drug combination database. Bioinformatics 2009;26:587-8.

Liu X, Wang S, Meng F, Wang J, Zhang Y, Dai E, et al. SM2miR: a database of the experimentally validated small molecules’ effects on microRNA expression. Bioinformatics 2013;29:409–11.

Raviteja M, Gupta N. A review on electronic data management in pharmaceutical industry. Asian J Pharm Clin Res 2013;6:38-42.

Richard C, Bairu M. Global clinical trials: effective implementation and management. Elsevier Academic Press; 2011. p. 471-522.

Edwards R, Edwards S. A computer-assisted data collection system for use in a multicenter study of American Indians and Alaska Natives: SCAPES. Computer Methods Programs Biomed 2008;90:38–55.

Pavlović I, Kern T, Miklavcic D. Comparison of paper-based and electronic data collection process in clinical trials: costs simulation study. Contemporary Clinical Trials. Elsevier 2009;30:300-16.

Collada A, Fazi P, Luzi D, Ricci F, Serbanati L, Vignetti M. Toward a model of clinical trials. Proceedings of the 5th international symposium ISBMDA; 2004. p. 299–312.

Barrett T, Suzek TO, Troup DB, Wilhite SE, Ngau WC, Ledoux P, et al. NCBI GEO: Mining millions of expression profiles–database and tools. Nucleic Acids Res 2005;33:562–6.

Brylinski M, Skolnick J. A threading-based method (FINDSITE) for ligand-binding site prediction and functional annotation. Proc Natl Acad Sci U S A 2008;105:129–34.

Huang L, Li F, Sheng J, Xia X, Ma J, Zhan M, et al. Drug combo ranker: Drug combination discovery based on target network analysis. Bioinformatics 2014;30:228–36.

Electronic Data Capture (EDC) During Clinical Trials [Internet]. Clinnovo. blogspot.in; 2015. Available from: http://clinnovo.blogspot.in/2015/01/electronic-data-capture-edc-during.html. [Last accessed on 25 Mar 2018]

Guidelines, Guidance for industry; Providing regulatory submissions in electronic format [Internet]. Justia Regulation Tracker; 2014. p. 7463-4.

Maurer L, Leuenberger H. Application of near infrared spectroscopy in the full-scale manufacturing of pharmaceutical solid dosage forms, Pharm Indian 2009;71:672–8.

Maurer L, Leuenberger H. Terahertz pulsed imaging and near infrared imaging to monitor the coating process of pharmaceutical tablets, Int J Pharm 2009;370:8–16.

Kabra MP, Kabra D, Somani G. A review on role of robot in pharmaceutical industry. Int J Instl Pharm Life Sci 2011;1:220-37.

Leuenberger H, Bonny J, Kolb M. Percolation effects in matrix-type controlled drug release systems. Int J Pharm 1995;115:217-24.

Krausbauer E, Puchkov M, Betz G, Leuenberger H. Rational estimation of the optimum amount of non-fibrous disintegrant applying percolation theory for binary fast disintegrating formulation. J Pharm Sci 2008;97:529–41.

Maulvi FA, Shah MJ, Solanki BS, Patel AS, Soni TG. Application of 3D printing technology in the development of novel drug delivery systems. Int J Drug Dev Res 2017;9:44-9.

Gbureck U, Vorndran E, Muller F, Barralet J. Low temperature direct 3D printed bioceramics and biocomposites as drug release matrices. J Controlled Release 2007;122:173-80.

Goyanes A, Buanz AB, Basit AW, Gaisford S. Fused-filament 3D printing (3DP) for fabrication of tablets. Int J Pharm 2014;476:88-92.

Lee BK, Yun YH, Choi JS, Choi YC, Kim JD. Fabrication of drug-loaded polymer microparticles with arbitrary geometries using a piezoelectric inkjet printing system. Int J Pharm 2012;427:305-10.

Pardeike J, Strohmeier DM, Schrodl N, Voura C, Gruber M. Nano suspensions as advanced printing ink for accurate dosing of poorly soluble drugs in personalized medicines. Int J Pharm 2011;420:93-100.

Goyanes A, Det-Amornrat U, Wang J, Basit A, Gaisford S. 3D scanning and 3D printing as innovative technologies for fabricating personalized topical drug delivery systems. J Controlled Release 2016;234:41-8.

Brugger J. Inkjet printing | LMIS1 [Internet]. Lmis1.epfl.ch; 2018. Available from: https://lmis1.epfl.ch/page-34709.html. [Last accessed on 25 Mar 2018]

Popovic D. Automation and control in production processes, Control systems, robotics and automation. Industrial Appl Control System 2009;19:1-10.

Markarian J. Using robotics in pharmaceutical manufacturing, equipment and processing report, [Internet]. Pharmtech.com. 2014. Available from: http://www.pharmtech.com/using-robotics-pharmaceutical-manufacturing. [Last accessed on 25 Mar 2018]

Invetech and Argos Therapeutics Announce Agreement [Internet]. Invetech. 2014. Available from: https://www.invetechgroup.com/news/2014/11/invetech-and-argos-therapeutics-announce-agreement/. [Last accessed on 30 Mar 2018]

Twig L. Paperless manufacturing system, siemens product lifestyle management software, camstar enterprise [Internet]. 2018. Available from: http://camstar.industrysoftware. automation.siemens. com/en/products-services/enterprise-platform/camstar-manufacturing-execution-system/. [Last accessed on 26 Mar 2018]

Guidelines, Process performance and product quality monitoring system, Corrective action and preventive action (CAPA) system, FDA, ICH; 2009. p. 8-14.

Guidelines, Guidance for Industry Q10 Pharmaceutical Quality System, FDA, ICH; 2009. p. 1-19.

Gary Warren, Quality by Design (QbD); 2015. Available from: https://www.pda.org/docs/default-source/website-document-library/chapters/presentations/australia/quality-by-design-(qbd)-overview.pdf?sfvrsn=6 [Last accessed on 25 Mar 2018]

Godambe R, Disouza J, Jamkhandi C, Kumbhar P. Development of spectrophotometric and fluorometric methods for estimation of darunavir using QbD approach. Int J Curr Pharm Res 2018;10:13-9.

Nishendu P, Nadpara, Rakshit V, Thumar, Vidhi N, Kalola, et al. Quality by design (QbD): a complete review. Int J Pharm Sci Rev Res 2012;17:20-8.

Peraman R, Bhadraya K, Reddy Y. Analytical quality by design: a tool for regulatory flexibility and robust. Anal Int J Anal Chem 2015;1:1-9.

Ghante M, Shelar R, Sawant S, Kadam M. Development and validation UV-spectrophotometric method for estimation of darunavir ethanolate in bulk and tablet dosage form. Int J Pharma Pharm Sci 2014;6:240-2.

Balamuralikrishna K. Development and validation of analytical procedure for the simultaneous estimation of efavirenz, lamivudine and zidovudine through new RP-HPLC method. J Pharm Res 2011;4:3766-8.

Kamble R, Sharma S, Varghese V, Mahadik K. Process analytical technology (pat) in pharmaceutical development and its application. Int J Pharm Sci Rev Res 2013;23:212-23.

Amit S, Anil P. Quality by design (QbD): a new concept for development of quality pharmaceuticals. Int J Pharm Quality Assurance 2017;4:13-9.

Mahalik N. Advances in packaging methods, processes and systems. Challenges 2014;5:374-89.

Bansal D, Malla S, Gudala K, Tiwari P. Anti-counterfeit technologies: a pharmaceutical industry perspective. Sci Pharm 2013;81:1–13.

Sanjay M, Sanjeev W. Multiple strategies and technologies to combat counterfeit drugs. [Internet] Computer sciences corporation USA; 2009. Available from: https://www. slideshare.net/guest696d96/multiple-strategies-and-technologies-to combat-counterfeit-drugs. [Last accessed on 30 Mar 2018]

Guidelines, Therapeutic goods administration guideline for the Tamper-Evident packaging of medicines, complementary healthcare products and medical devices; 2000. Available from: https://www.tga.gov.au/publication/tamper-evident-packaging-guideline. [Last accessed on 30 Mar 2018]

International medical products anti-counterfeiting taskforce anticounterfeit technologies for protection of medicines. WHO; 2009. Available from: http://www.who.int/medicines/ services/counterfeit/impact/IMPACT_AntiCountMeet.pdf. [Last accessed on 30 Mar 2018]

Print and Packaging-Elanders China [Internet]. Elanders.com; 2018. Available from: https://www.elanders.com/chi/print-packaging/. [Last accessed on 25 Mar 2018]

Iyer S. RFID technology and applications, IIT Bombay, [Internet] RFID; 2005. Available from: http://www.it.iitb. ac.in/~sri/talks/rfid-05.pdf. [Last accessed on 25 Mar 2018]

Alkhateeb F, Khanfar N, Loudon D. Physicians' adoption of pharmaceutical e-detailing: application of rogers' innovation-diffusion model. Services Marketing Quarterly 2009;31:116–32.

Parekh D, Kapupara P, Shah K. Digital pharmaceutical marketing: a review. Res J Pharm Technol 2016;1:108-12.

Nelson R. Electronic Batch Record Traceability-DataNinja [Internet]. DataNinja; 2018. Available from: https://www.dataninja.com/. [Last accessed on 25 Mar 2018]

Digital marketing strategies and technology innovation in the Pharmaceutical industry [Internet]. Slideshare.net; 2014. Available from: https://www.slideshare.net/ DigiTech Strategies/ digital-marketing-strategies-and-technology-innovation-in-the-pharmaceutical-industry. [Last accessed on 30 Mar 2018]

Rx Electronic Prescribing, Centers for medicare and medicaid services, [Internet]. cms.gov; 2016. Available from: https://www.cms.gov/Medicare/E-Health/Eprescribing/index.html. [Last accessed on 25 Mar 2018].

Electronic Repeat Dispensing (eRD): Dispenser guide, Northern, Eastern and Western Devon Clinical Commissioning Group. NHS Digital [Internet]. Newdevonccg.nhs.uk; 2016. Available from: https://www.newdevonccg.nhs.uk/information-for-healthcare-professionals/electronic-repeat-dispensing-102194. [Last accessed on 25 Mar 2018]

Dermatology EMR software features–Bella Swan–Medium [Internet]. Medium; 2017. Available from: https://medium.com/@bellaa5046/dermatology-emr-software-features-65f6882c0dad. [Last accessed on 25 Mar 2018]

Callen J, Hordern A, Gibson K, Li L, Hains I, Westbrook J. Can technology change the work of nurses? Evaluation of a drug monitoring system for ambulatory chronic disease patients. Int J Med Inf 2013;82:71-6.

Goldman R, Soran C, Hayward G, Simon S. Doctors' perceptions of laboratory monitoring in office practice. J Eval Clin Pract 2010;16:1136-41.

Westbrook J, Ampt A. Design, application and testing of the work observation method by activity timing (WOMBAT) to measure clinicians’ patterns of work and communication. Int J Med Inform 2009;78:25-33.

Prescription drug monitoring programs (pdmps) [Internet]. cdc.gov; 2018. Available from: www.cdc.gov/drugoverdose/ prescribing/guideline.html. [Last accessed on 25 Mar 2018]

Schiola E. Maintain your health and mind with these 15 medical apps [Internet]. Digital trends; 2016. Available from: https://www.digitaltrends.com/mobile/best-medical-apps/3/. [Last accessed on 25 Mar 2018]

iMagazin [Internet]; 2018. Available from: http://imagazin.hu/ az-5g-mobilhalozat-alapjaiban-fogja-megvaltoztatni-vilagot/. [Last accessed on 25 Mar 2018].

Published

01-06-2018

How to Cite

Mannan, A., and H. Mubeen. “DIGITALISATION AND AUTOMATION IN PHARMACEUTICALS FROM DRUG DISCOVERY TO DRUG ADMINISTRATION”. International Journal of Pharmacy and Pharmaceutical Sciences, vol. 10, no. 6, June 2018, pp. 1-10, doi:10.22159/ijpps.2018v10i6.24757.

Issue

Section

Review Article(s)