Ingredients, Formulations & Finishing

Customised packaging solutions are designed for thoseapplications where standardised processes areinsufficient for realising a specific packaging need;instead, they require the development of newtechnologies according to their use. In the growthmarkets of pharmaceuticals and medical engineering,packaging solutions that extend beyond commercialavailability are increasingly being sought after. Certainpharmaceutical applications require individualhandling, which has implications for themanufacturing and packaging processes.

The level of demand for a particular packaging design inany target market is closely dependent on social andpolitical factors, which differ significantly across theworld. In Europe, for example, painkillers such asparacetamol are sold in packs of 10, 20 or even 50. Inthe countries of Africa, South America and South EastAsia, on the other hand, it is standard practice to offer

these common medications in the smallest possiblequantities. The tablets are frequently sold singly andunpackaged by street traders or retailers; noconsideration is given to drug safety in this context, asthe origin of the goods can no longer be traced andcritical consumer information is missing. This meansthat counterfeits can enter circulation, some of whichwill have disastrous consequences for the health of theconsumer. Due to a lack of controls, counterfeitpharmaceuticals are a fundamental problem in (rapidly)developing countries, and the problem is being foughton a number of different levels.

At Romaco Siebler, a brand of the Romaco Group, weprovide innovative systems for the production, handlingand packaging of pharmaceuticals based on heat-sealingtechnologies. This article reviews two examples of howpackaging systems have been developed to meet theneeds of specific pharmaceutical applications: CatchCovers and Strip Tablets.

ALL-INCLUSIVE CATCH COVERS

In Indonesia, the inclusion of patient information in thesale of pharmaceuticals has been a legal requirement forseveral years. This measure is intended to encourageconsumer awareness of correct procedures when dealingwith drugs. Catch Cover packaging was developed inorder to harmonise this obligatory requirement with ahigh demand for individual tablets. With this design, thepackage insert is directly integrated into the primarypackaging (see Figure 1). The drug itself is put in strippackaging made from elastic aluminium foil, produced indifferent sizes and shapes. The four-side seal packagingproduced using a heat-seal process is ideal for thesesmallest possible sale units. With the Catch Cover design,the strip is additionally enclosed in a laminated bookletwith the relevant product information printed on theinside; this cover replaces the classic folding cardboardbox that normally contains the package insert. The stripcover is fastened on the front and rear of the package

Sometimes, a pharmaceutical product might require a novel packagingsystem that has been geared specifically to the way in which it is used; in such situations, the design of user-friendly packaging can be crucial to the commercial success of a product.

78 Innovations in Pharmaceutical Technology

By Martin Grau atRomaco PharmatechnikGmbH

Customised Packaging for Special Applications

Figure 1: CatchCover packagingwith integratedpatient information

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using a sealed seam, and there is a perforated seam on thefront of the package for opening the booklet. This type ofpackaging is ideal for pharmaceuticals in solid forms –such as tablets – as well as hard and soft gelatine capsules.In Indonesia, this speciality design has been usedsuccessfully for several years.

Catch Cover packaging is one way of linking traditionaltrade forms with the modern safety standards of thepharmaceutical industry. The fully automatedproduction of Catch Cover strips uses the heat-sealprocess with an integrated booklet-feed system and anassociated sealing and cutting machine (see Figure 2). Inthe first step, the pharmaceutical products are fed to theheat seal process where they are moved from the dose-controlled storage container, through a suction device, tothe sorting plate. From here, the products enter a verticalseparating system, where they are positioned accuratelyin the individual cells of the foil sheet. Meanwhile, theprimary foil packaging material is unrolled by two rollholders, and fed to the heart of the machine – the sealingsystem; here, the formulations are fed between the foilsheets by an indexing unit and sealed in their pouches.

The seal parameters of time, pressure and temperature areset using special software and controlled through anoperator panel. In order to keep the speed of the processuniform, a constant tension must be maintained duringthe unrolling by the foil feed. The seal pressure can beadjusted from the operator interface; in addition,calibrated temperature gauges monitor the high-performance cartridge heaters of the seal station. Aftersealing, the strips are cut to the appropriate packaging sizeand fed directly to a downstream unit that was developedby Romaco specifically for handling the Catch Covers.The engineering was carried out in co-operation with asystem manufacturer that specialises in paper-folding andbrochure-feeding processes. This joint research activityresulted in a method by which the Catch Covers could beplaced precisely around the strip packaging prior to beingsealed. In the subsequent cutting process, the CatchCover strips are cut to their correct size and then passedto a counting, grouping and stacking unit for their outerpackaging. In the case of a fully automated operation, thecustomised packaging line can reach a maximum outputof 1,200 Catch Cover packs per minute.

PHARMACEUTICAL STRIP TABLETS

Sometimes customisation can involve the developmentof a completely new product type, as in the case ofpharmaceutical Strip Tablets (see Figure 3). TheseStripTabs® are produced using a procedure thatintegrates manufacturing, dosing and packagingprocesses in one line, using three machine systems.

In the oral hygiene area, thin fresh-breath strips havebeen on sale in different flavours for a few years now, butthese oral formulations are also ideal as a carrier for activepharmaceutical ingredients. Absorption of these stripsunder the tongue avoids the alimentary canal, leading torapid circulation of the active ingredient in the body.StripTabs®, with a thickness of about 60 to 100micrometres (µm), dissolve within a few seconds andreach the central nervous system directly throughreceptors under the tongue. Due to their immediate

80 Innovations in Pharmaceutical Technology

Figure 3: StripTabs– absorption ofthese strips underthe tongue avoidsthe alimentarycanal, leading torapid circulation of the activeingredient in the body

Figure 2: Fully automated packagingline for Catch Cover production

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effect, these new formulations are ideal forapplications such as hormone therapy andpain relief; the system has also drawninterest from manufacturers for theformulation of medicines for the treatmentof migraine, impotence and diseases of themouth and throat.

StripTabs® are produced in aninterconnected procedure that includes thepharmaceutical production process and allproduct handling, as well as the primary and secondarypackaging processes (see Figure 4). Processing of the activepharmaceutical ingredients (API) takes place in the firstproduction stage, the homogenisation and mixing process;here a homogeneous and bubble-free basic mass isproduced from dry and liquid ingredients. The liquidsolution is, to a large extent, made from pea or maizestarch, enriched with solvents and added flavours, whichforms the carrier for the active ingredient. Continuouscirculation, recirculation and heating of the basicpharmaceutical mass provide an even distribution of theactive ingredient with a desired viscosity. This is essentialfor dosing accuracy and also makes processing easier in thecoating procedure.

The next stage in the production process involvespreparing the basic mass for manufacturing the finalproduct in the form of an ultra-thin strip, the size of athumb. With a thickness tolerance of one micrometer,the liquid is applied to a highly precise plastic carrier foil.To this end, the medicinal solution is collected in theheated trough of a coating plant and routed through aprecisely dimensioned gap onto the carrier foil. Theliquid is evenly distributed to a predefined thicknessusing an adjustable blade. The foil, coated withmedication, passes through several drying units until thematerial has a residual moisture of below 15 per cent. Inthis state, the foil can be rolled up for processing. It isimportant to note that the elasticity of the roll materialdecreases after 24 to 36 hours, and so productionquantities must be accurately adjusted to the capacity ofthe packaging plant. This requires accurate mechanicalhandling, as material properties must be taken intoaccount in determining the production speed.

The coated roll material is fed to a heat-seal machine andunrolled for cutting. The product sheets are perforatedinto small rectangles measuring 20 to 30 millimetres inan integrated precision scoring station with almost zerotolerance. The roller cutters are set up so that there is nowaste material, apart from correction at the sheet edges.After the perforation procedure, the StripTabs® are

peeled from the carrier foil in a delamination process;they are then spread out to the packaging size using ashuttle system and applied to the primary packaging foil.The product strips with their individual applications arepassed to a multi-track heat-seal process and sealed tightin their soft aluminium foil packaging. Various solutionsfor opening aids can be provided to make it easier to peeloff the packaging and remove the medication directly bytongue. The use of peelable material guarantees that theproduct is not damaged when the package is torn open.

IT’S WORTH CUSTOMISING

A differentiation can be made between customisedprojects, depending on their degree of innovation. Inmany cases, a small, individual adjustment to the plantmay be sufficient to deal with a particular feature of aproduct. Now and again, however, a particular applicationrequires a completely new form of packaging technology.The success of a customised packaging project can beabsolutely crucial to the success of the product for whichthe new packaging was developed. In terms of businessmanagement, large investments in research anddevelopment are only worthwhile if a new product can bepermanently established in the marketplace as meetingpatient needs. Customised packaging projects are generallycharacterised by a special relationship between themachine construction specialist and the customer: bothare investing a great deal of capital in realising a newproduct idea and stand to profit equally from its success.

Innovations in Pharmaceutical Technology

Martin Grau is Product Manager of the internationalRomaco Group. In this function he is responsible for the brand Siebler as specialist for CustomisedPackaging Solutions. He has been with RomacoSiebler for over 25 years. Starting in sales, he movedon to be area manager and later became salesdirector Asia/Pacific. Martin is in charge of the

implementation of specialised projects in the areas heat sealingprocesses and strip packaging. The realisation of tailor-made solutionsfor the pharmaceutical, diagnostic and medical engineering industrydemands competent consulting as well as individual supervision and support. Email: martin.grau@romaco.com

Figure 4:Interconnectedprocedure for the production of StripTabs

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