3-D PRINTING- AT A GLANCE

International Research Journal of Engineering and Technology (IRJET) e ISSN: 2395 0056

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3-D PRINTING- AT A GLANCE

Address:K.K Wagh college of pharmacy,hirabai haridas vidyanagari,amruthdham,panchavati,Nashik 422003 ***

Abstract: The3DPRINTINGinnovationhasgrabbedtheeye of clinical gadgets industry and drug industry because of its applications on different stage in medical services industry. Despite the fact that this innovation exists for quite a while it is of public interest exceptionally now because of the endorsement of three dimensional printed tablet and other clinicalgadgets andfurthermore with the comingofUSFDA's directiononspecializedcontemplations intendedfor gadgets utilizingaddedsubstanceproducingwhichincludes3 layered (3D)printinghas setoffnumerouscontemplationsaboutthis innovation which should be considered for effective conveyance of expected item. This paper presents administrative offices assumptions, constraints, issues in laying out such arrangements for creation of medication items, benefits, drawbacks, applications, techniques and related takes a chance with engaged with assembling. It likewise gives the far reaching audit of the flow status of innovative work on this stage.

Keywords: Three dimensional printing, personalized medicine

1.INTRODUCTION

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Drug delivery is the technique of formulation development to efficiently transport a pharmacologicallyactivecompoundinthebodyto achievetherapeuticefficiencyinasafemanner.The efficiency and safety of a pharmaceutical product canbeimprovedbycontrollingthereleaseprofile which in turn affects the pharmacokinetics of a drug.Inclinicalscenario,theinterspeciesvariability isanobstaclewhichfacedfrequently.Personalized medicineanddosingreceivesincreasingattention because of the high chances of undesirable side effectsandpropermedication.(1,2)

sequencing multiple layers.The rapid prototyping involvestheconstructionofphysicalmodelsusing computer aideddesigninthreedimension(3).

2. HISTORY

3D Printing acted like a potential stage for customizedmedicationduringthe1990s.Thereare significantaccomplishmentsin3Dprintedclinical gadget, FDA's Center for Device and Radiological Health (CDRH) has assessed and cleared 3DP clinical gadgets. The guideline of 3D "added substanceprocesses"isinthisinteractionbylaying out the progressive layer of material an article is created. Folio material is put layer by layer on powder bed in inkjet printer heads. This cycle permits to deliver complex shapes with the assistance of utilizing less material than conventionalassemblingstrategies.

The first 3D printing strategy utilized in quite a while was accomplished by inkjet printing a fastener arrangement onto a powder bed, restrictingalongtheselinestheparticlestogether. Theinteractionwasrehasheduntilthelastwanted structurewasgotten. 

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3D printing technology play a significant role in multipleactiveingredientdosageforms,wherethe formulationcanbeasasingleblendormultilayer printed tablets with sustained release properties. Thisresultsinreductionoffrequencyandnumber ofdosageformunitsconsumedbythepatientona daily routine. 3D printing technology has high potential in personalized dosage form concept called the polypill concept. This brings about the possibilityofallthedrugsrequiredforthetherapy into a single dosage form unit. Three layered printing innovation is a clever fast prototyping procedureinwhichsolidobjectsaredevelopedby

This previously occurred in the mid 90's at the Massachuset Institute Technology created and protected by Sachs et al . In 1989, Scott Crump, documented a patent on another 3D printing innovation:combinedtestimonydisplaying,where expelled polymer fibers warmed into a semi fluid state were expelled through a warmed spout and saved onto a form stage layer by layer to solidify. Inkjet printing was the strategy used to produce Spritam (levetiracetam) tablets for oral use, the primary3DprinteddrugendorsedbytheFoodand Drug Administration (FDA) in 2016 by Aprecia Pharmaceuticals.3Dprintingisfurtherdeveloped in the fields of vehicle, aviation, biomedical and tissuedesigningthaninthedrugbusinesswhereit is in its underlying stage. FDA energizes the improvement of cutting edge fabricating innovations, including 3Dprinting, utilizing risk basedapproaches.

International Research Journal of Engineering and Technology (IRJET) e ISSN: 2395 0056

Table 1: Comparison between traditional manufacturing and 3 D printing .

TRADITIONAL MANUFACTURING 3D PRINTING

COST Higher cost of manufacturing and shipping.

DESIGN Less innovative design due to cost constraints.

Upto705savingsdue toprototypingcosts.

Allows for easy yet inexpensive innovationindesign.

SPEED More time to build finalproduct. Lesser time taken due to compressed designcycles.

QUALITY Createsmorewaste; subtractive process willcompromiseon precision.

3. METHODOLOGY

Inkjet Printing

Lighter and smaller amount of waste;higher precision with layer by layer manufacturing.

problem.Burdensincorporatelow resolutionandexpensive maintenance(18)

3.1.3 Drop on Demand Inkjet Printer

In these printers, drops of fluid are ejected out from the printheadbecauseofatriggersign,justwhenitisvitaland thedropsaredepositedontoasubstrate.Thissortofprinter commonly contains numerous spouts (100 1000, yet particularprintheadsmakeoutofonlyone).Differentiating the continuous inkjet printer where ejection of drops is because of the outside pressure, drop on demand inkjet printers have the drops kinetic energy obtained from sources near every spout and situated inside the printhead(19). This innovation is moderately basic, offers highaccuracyandisminimalexpense.Itcanpossiblystore little drops of controllable sizes and furthermore delivers themwithgreatarrangementprecision.Itadditionallylimits thewastageofmedications.Henceforth,itispreferredover continuous inkjet printing for printing applications(20,21),Drop on demandinkjetprintercanbe further classified, based on the type of printhead, into thermalinkjetandpiezoelectricinkjetprinter(22)

3.1.4 Thermal Inkjet Printer (TIJ)

Laser Based Writing System

Powder Based 3D Printing

Nozzle Based Deposition Systems

Extrusion based method

3.1 Inkjet Printing

Iinkjet printing depicts frameworks which use design creating gadgets to carefully control and spot little fluid drops on a substrate. In pharmaceuticals, suitable combinationsofmedication,alongsidereasonableexcipients (knownasink)arekeptaslittledropsinalayerwisestyle onasuitablesubstrate.Continuousinkjetprinting(CIJ)and drop on demand (DoD) are the two fundamental inkjet printingstages(16,17)

3.1.1 Continuous Inkjet Printer

As the name recommends, continuous inkjet printers deliversstreamoffluidbeadsonasubstratepersistently,in any event, when the drops are excessive. Here, a tension waveiscreatedintotheinkstream,whichseparatestheink intouniformestimatedbeadsthroughvibrationofthenozzle andafterwarddeliversthedropsoutofthenozzle.Sinceit ejects beads consistently, this innovation prompts the wastage of ink. The benefits of this printing innovation incorporatehighvelocityconsistentbeadformation,because of which the nozzle doesn't get stopped up without any

Here,thermalenergyisthetriggersystemusedtorelease drops, which then leave the spout. The printheads have resistors inserted in them which are in prompt exposure with the liquid (ink) and endless supply of electric flow produceheat.Thisheatthenoutcomesinthedevelopmentof anairpocketinsidetheunstableliquid,whichthen,atthat point,growsanddischargesalittlevolumeofliquidoutof the spout framing a bead (Fig. 1a). The limitation of this procedure is the utilization of high temperatures (200 300°C)oftheresistor,whichcouldpromptthedegradation ofthermolabileactiveingredients(18,23)

3.1.5 Piezoelectric inkjet printer (PIJ)

Thisinnovationmakesoutofapiezoelectriccomponentor actuator which changes its shape because of an electric voltage. This produces a strain, which prompts the liquid (ink) being ejected out of the spout. After the component returnstoitsoriginalshape,thespoutisreloadedwiththe liquid and is fit to be initiated once more(21,24). The principle benefits of this procedure incorporate its operabilityatroomtemperaturesutilizinglessvolatileand morebiocompatiblefluids(23)

3.2 Laser Based Writing System

Itdependsontheprincipleofphotopolymerization,wherein freeradicalsaredeliveredaftertheinteractionbetweenthe photoinitiatorandUVlight.

This strategy was the first industrially introduced SFF (strongfreestylecreation)methodsandcreatedin1986.In

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International Research Journal of Engineering and Technology (IRJET) e ISSN: 2395 0056

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thefieldofbioengineering,theyarevigorouslyutilizedand evaluated [24]. To make a model, models, examples, and creationpartsutilizingaphotochemicalinteractionwiththe assistanceofprintinginnovationasStereolithography[SLA] [31].Нisresearchcameduringthe1970s,yetthetermwas coinedbyChuckHullin1984whenhelicensedhisprocess, whichwasallowedin1986.

3.2 Stereolithographic 3D Printing

Stereolithographydependsonthesolidifyingofliquidresin byphotopolymerizationutilizingUVlight.Thesetupofthe printer can either be bottom up, where the UV source is situatedunderneaththeprinterandthemovingstageabove, ortop down,wheretheUVsourceisaboveandthestageis beneath. Themainlayer,subsequenttobeingfollowed by the laser in the x and y axis coordinated by examining mirrors, gets photograph relieved and connects to the structurestage.Thestagethen,atthatpoint,getsacrossthe z axistoadegreewhichreliesuponthewidthofeachlayer (droppeddownifthereshouldbeanoccurrenceofbottom up approach and raised in the event of top down methodology).Followingthis,theliquidresinisrearranged overtherecentlysolidifiedlayerforitssolidifyingandthe cycle is kept on building the 3D article. The item is then purgedwithliquortodisposeoftheabundanceresin.Post restoring can be employed utilizing an UV broiler to strengthenthearticle(22,99)

3.3 Selective Laser Sintering (SLS)

SLS, a laser based innovation, as the name recommends works by causing combination in the powder bed by a controlled examining laser beam[19]. During the printing system,thelaseriscoordinatedtodrawaparticularpattern ontotheouterlayerofthepowderbed.Whentheprimary layer is finished, a roller appropriates another layer of powderontopofthepreviousone.Theitemisconstructed layer by layer, which is then recovered from under the powderbed.SLShasforthemostpartbeenutilizedinthe arrangementofframeworksinbioengineeringwithproper biocompatible materials. There are not many definitions concentratedoninvolvingSLSas3Dprintinginnovation.

In 2017, quick delivery and changed discharge details of paracetamol as a model medication and Kollicoat® IR or Eudragit®L100 55aspolymerswereprintedutilizingSLS innovation[20].SLSutilizeslaserstosolidifythepolymers by expanding the temperature of the polymer above dissolving temperature. In any case, there should be interactionbetweenthelaserbeamandthepowderparticles for the process to occour. As of late, in 2018, orally deteriorating tablets (ODTs) with paracetamol as a model medicationandhydroxypropylmethylcellulose(HPMC)and kollidon® VA 64 as polymers alongside Candurin® gold sheenwaseffectivelyplannedutilizingSLSinnovation[21].

SLShasadvantagesofhigh resolutionprintingandprinting ofmedicinewithouttheneedofthesolvent.Inanycase,high energylasersmightcausedegradationofmedicationsand polymers utilized. With appropriate investigation of this innovationforthedifferentdosageformandtheaccessibility of polymers ready to assimilate laser light might give an alternative technique of printing medications utilizing 3D innovation. This strategy utilizes powder streaming or powder bed to extended far layers of powder and all the whileapplyingfluidcoverdropswiththeassistanceofinkjet printers (35). The ink (covers and APIs or folio arrangements) is sprinkled over a powder bed in two layered style to make the eventual outcome in a layer by layer design. The adaption of this procedure into drug fabricatingissimplerthandifferentstrategiesaspowderand cover arrangements are generally utilized in the pharmaceutical industry. This strategy has its own drawbacks too. Extra drying is expected to eliminate dissolvablebuildups.Overabundancepowdergathersduring printing prompting wastage. Additionally the mechanical strengthofthemedicationconveyanceframeworkispoor becauseofthepermeabledesignofthepowder(4,35).

3.4 Nozzle Based Deposition Systems

New innovations have been created to overcome the limitations of the past innovation. Nozzle based system comprisetheblendingofmedications,polymersandother strong components before 3D printing. The blend is gone through a spout that certainly begins, layer by layer, the three layeredproduct. Therearetwosortsofprintings as indicated by the kind of material utilized: FDM (Fused Deposition Modeling), which utilizations dissolved parts, and,PAM(Pressure AssistedMicrosyringes),whichdoesn't needtheutilizationofliquefiedmaterials[4].

3.5 Fused Deposition Modelling 3D Printing

This is the expelling a thermoplastic fiber through high temperaturespoutintosemi solidfused statefiberinlayer by layer style. The article is framed by layers of dissolved thermoplastic fiber expelled from the printer's head at specific directions as directed by PC programming. The material is warmed to simply over its conditioning point whichisthenexpelledthroughaspout,anddepositedlayer bylayer,solidifyinginamoment.Tothisenditislikewise calledFusedFilamentFabricationDrugstackinginthefiber is typically accomplished through incubation in natural solventsandpoordrugloadingmayrestrictitsutilizationto lowdoseddrugs(36)

Xuyu Chai et al (37) utilized combination statement demonstrating3Dprintingtogetreadyintragastric floating sustainedrelease tabletsofdomperidone.Themedication wasstackedintohydroxypropylcellulosefiberutilizinghot softenexpulsion.Thefibers werethen printedintoempty organizedtabletsthroughchangingtheshellnumbersand theinfillrates.

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A benefit of FDM over powder bed printing is its higher resolution, which permits it to create more complicated platforms, and to accomplish a superior dosing precision. Other than this, FDM additionally offers great mechanical strengthandthechoicetoacquiredifferentdeliveryprofiles oftheprinteddosestructuresbyadjustingtheinfillrate,the modelplan,orthesurfaceregionofthedetailing.

Some drawbacks are the limited thermophiles materials options with good melt viscosity properties for extrusion, and the inability to use some APIs due to the high temperaturesoftheprocess[5].

Overallitisthemostcommonlyused3Dprintingtechnique underresearchbecauseofitsabilitytocreatecomplexdrugs with difficult geometrics, but the quality and speed of manufacture should be improved to make it effective in clinicalpractice.

3.6 Pressure-Assisted Microsyringe technology

This innovation depends on the utilization of a needle extruder that stores a viscous and semi liquid material, throughacompressedaircylinder,layerbylayer,asperthe designed geometry. Consistency, viscoelasticity, and the evidentflexiblelimitarethekeyboundariesthatdecidethe reproducibilityofthisstrategy.Ithasadvantagesoverother processes,asithasthepossibilitytoworkwithaconstant stream and at room temperature. It has additional impediments,similartotheutilizationofsolvents,whichare frequentlyharmfultowellbeingandcausealossofstability inspecificAPIs.Itsmosthelpfulapplicationsareconnected with tissue printing substitutes or frameworks of delicate tissues, as well as manufacture of complex drug delivery systems[4,22]

3.7 Extrusion based method

Inthedruginnovationregion,hot meltextrusion(HME)and expulsionofsemisolidmaterialsarewellknownprocesses [55].Thisspecializedtechniqueisconnectedwithprogress probabilityofsomewhatreasonablehardwareandcompact size,andexpandingfameofprintingstrategy.Twodifferent waysofprintingstrategyarenotable[56].1.Extrusioncycle ofsemi liquidmaterialsorsemi solid(gels,glues)atroom temperatureorraisedtemperature.

2. Extrusion cycle of liquid celluloid or thermoplastic rod shape(fiber)materials.

In the two strategies, the materials are extruded from the nozzleandarespreadinresultinglayersontheformstage surface[57].Thedistanceofprintheadtofabricateplateis madeonacharacterizedprintingwayanditisaffectedbyte nozzleorificediameter.Thenatureoftheprintedobjectis impacted by two boundary nozzle hole measurement and print speed [58]. Another layer is applied when the print head or print plate moves along z axis at the distance of

layer level [59]. Three dimensional printers and the mechanicalarrangementdependonprintingmaterials.For themostpartoverallextrusionbasedstrategyisutilizedin 3Dprintingmethod

4. ADVANTAGES

High drug loading ability when compared to conventionaldosageforms

Accurateandprecisedosingofpotentdrugswhich areadministeredatsmalldoses

Reducescostofproduction duetolessermaterial wastage

Reasonablemedication forchallengingtoformulate dynamic fixings like unfortunate water dissolvability,drugsWiththintherapeuticwindow

Medication can be prescribed to a patient in particular based on genetic variations, ethnic differences,age,genderandenvironment.

Intheeventofmultidrugtreatmentwithnumerous dosingroutine,treatmentcanbealteredtoworkon understandingadherence.

Aspromptandcontrolleddischargelayerscanbe incorporated because of the adaptable plan and productionofthismeasurementstructure,ithelps inpickingthebestremedialsystemforaperson

Avoids batch to batch varieties found in mass assemblingofordinarymeasurementsstructures.

3D printers occupy minimal space and are affordable.

Theabilitytocreatetabletsofanyshapeandsize.

The ability to set the dosageindividuallyfor each patient.

The ability to regulate the number of active substancesinthecompositionofthetablet,remove or replace individual components. This will assist manyindividualswithtakingmedicationregardless of whether there are contraindications to an individualsubstance.

Thecapacitytosupplantcountlessmedicationswith onetablet,whichlikewisedecreasestherecurrence ofdrug.

Theabilitytocontroltheprocessofreleaseofactive substancesallows toslow down or accelerate the

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effect of the drug, which will increase the effectivenessoftablets.

Thelargeravailabilityofdrugsthatcanbeobtained atanypharmacywitha3Dprinterifapatienthasa doctor’sprescription.

differentcycles,whethertoprevent obstructingor advanceitemconsistency. 

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Eco friendly production in the process of manufacturingtabletswitha3Dprinter,nowaste pollutestheenvironment.

3D printers used in pharmaceutical formulation preparation do not meet good manufacturing practice (GMP) standard and thus need to be validatedto ensure they meetthe requiredsafety standards. 

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Theabilityto printsmall batchesofdrugs,saving money on the production and testing of drugs in comparisonwiththetraditionalmethod

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The manufacture of tablets on a 3D printer eliminates the possibility to mix up drugs or take otherpatient’stabletsbymistake.

Forthemanufactureofdrugs,a3Dprinteristheonlypiece of required equipment. Therefore, mini factories for the production of tablets can be in each local region. Such printerscanevenbeinstalledinmilitaryhospitalsandtaken on space expeditions. This could help patients to get appropriate medications even during a pandemic, natural disasterorotherevents.

5. DISADVANTAGES

Minimumjobopportunity

Therearedifferentelementsthatcanimpactitem properties with 3D assembling, from nozzle fineness and glue thickness to drying techniques and temperature. To ensure the mechanical propertiesaresuitable,theequipmentandcontrol programmes must be enhanced, adhesive nozzles refinedandprintingprocessparametersoptimised. 

Therearesomeregulatorychallengesinthequality of3Dprinteddrugdelivery

7. APPLICATIONS

The use of 3D printing in drug delivery is to compoundandprintpersonalizeddosageforms.

Personalizedmedicinesaregenerallyrequiredfor paediatric populations, geriatrics or patients exhibiting allergy to certain formulation components.

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Largestructureischallengingforproduction. 

Limitednumberofingredientsarecompatiblewith thistechnology 

Themisuseofthistechnologyiseasilydone. 

Thecopyrightisanotherproblemrisinginprinting replicafromoriginalproduct. 

Productliability.

6. LIMITATIONS AND CHALLENGES

The excipients for 3D printing dosage form is limitedasofconventionalmanufacturingprocessin case of process that uses heat. Biodegradable, biocompatibleandstableexcipientsarerequired. 

As the complexity of structure of dosage form is increases, the software used for production is should be continuously required to updated. The mechanical equipment, working strategies and control framework should likewise be refreshed and streamlined to address the issues of the

SLS can be utilized in manufacturing particular measurements structures, for example, orally disintegrating (ODT), supported, broadened discharge,doubledeliveryprofiles,misuseobstacle detailsandundefinedstrongscattering.

The 3DP innovation can deliver exceptionally permeabledesignswhichcandisintegrateshortly and meet breaking down time prerequisites of under30sec.

Customaryassemblingincludesdifferentadvances, forexample,planningASDbyspraydryingorhot liquefy expulsion followed by container filling or tabletpressure.SLScancreateASDmeasurement structuresinasolitaryadvancewithextremelylow crystalline part, which can be additionally constrained by formulation parameters. The compliancetodosingregimencanbeincreasedand accordinglyunfavorableimpactsmightbereduced. 

The 3D printing is used for both mono and multidrugformulatios.

Theinnovationoffersoneofakindcapacitieswhich arechallengingtoconventionalmanufacturing

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International Research Journal of Engineering and Technology (IRJET) e ISSN: 2395 0056

8. CONCLUSION

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3DPrintingtechnologyisemergingasanewfield for advanced drug delivery with development of personalized medication. 3D Printing technology will revolutionize the pharmaceutical manufacturing style and formulation techniques and hasbecomeausefulandpotentialtoolforthe pharmaceutical sector, leading to personalized medicinefocusedonthepatients’needs

tabletswith3Dextrusion basedprinting”Jan,2018,pp.325 332

7.S.T.Mule,O.GBhusnure,S.SWaghmare,MamtaRMali” RecentTrends,OpportunitiesandChallengesin3DPrinting TechnologyforPersonalizeMedicine”Vol10July,2020,pp. 242 243

8.V.M.Vaz1andL.Kumar“3DPrintingasaPromisingTool inPersonalizedMedicine”,Jan,2021,22:49

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However,thereisstillasignificantbarriertoensure that3Dprintedmedicineshavethesameefficacy, safety,andstabilityasthepharmaceuticalswhich conventionallymanufacturedbythePharmaceutical Industry.Regardingtheestablishmentofguidelines, laws, quality systems and safety of use and consumptionof3Dprintedmedicines,itisagreat challenge for the regulatory authorities involving various obstructions, given the conventional prerequisitesbythedrugarea.

9.J.Goole,K.Amighi“3Dprintinginpharmaceutics:anew tool for designing customized drug delivery systems” Feb,2016,499(1 2),pp.376 94.

10.S.Kotta,A.Nair,N.Alsabeelah”3Dprintingtechnologyin drug delivery: recent progress and application”2018, 24(42),pp.5039 48.

11.MachekposhtiS.Azizi,S.Mohaved. R.J.Narayan“Inkjet dispensing technologies: recent advances for novel drug discovery”Feb,2019,14(2),pp.101 113.

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In future 3D printing approach will be utilized to fabricateandengineervariousnoveldosageforms. As the commercial production of novel dosage forms is still difficult to formulate; creating customized medicine, enhanced drug discharge from measurements structure, compacting or keepingawayfromdrugincompatibility,insurance ofbiomoleculesduringmanufacture,construction ofmultipledrugdosageformandmultiplerelease dosageformswillbetakentoanewerathrough3D printingtechnology.

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