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Packaging the pharmaceuticals
P V Narayanan | Thursday, November 13, 2003, 08:00 Hrs  [IST]

Packaging has a direct link to the standards of living. It reduces the spending in DPI and food and pharma packagings are specific examples. In the case of food, particularly processed foods, two aspects are to be considered, viz. Premade, ready-to-consume foods versus expenditure on shopping, preparing preparation inputs, utility of energy and time. The latter groups are not invariably considered when observing that the former is costlier.

Pharmaceuticals and appropriate packaging have dramatic influence in bringing down diseases and a clear and transparent contribution to health and hygiene resulting in considerable savings to exchequer. Their role in the country's healthcare is significant and cannot be undermined. In this context, increasing product mix and new product launch is of extreme importance. Launching a product should ensure many aspects, viz. pricing strategy, appropriate product formulation, market focus and right packaging.

Adequate and scientific packaging is a good tool for market entry, dosage dispersibility, product identity, health consciousness etc. These factors with packaging as an aid help to develop brand identity. Lack of hygiene and literacy has caused many diseases. Increased literacy level with more awareness- general and medical, should help to improve living conditions and curtail diseases. Packaging has a contribution in this direction.

Some of the developments in the field of pharma packaging are discussed in the following paragraphs.

Tablets & Capsules

The most common means of packaging are the strip packs, blister packs and bottles.

Strip pack is the traditional type of convenience pack and is still in vogue, though a good percentage of share is conceded to blister pack. The strip substrate more commonly and essentially, is foil based poly laminated or VMCH coated. The substrate type and caliper is determined through the product nature and its sensitivity, shelf-life etc. For lesser sensitive products, even a paper laminate is in practice. The strip width and pocket size are influenced by tablet/capsule size (diameter and thickness).

With the availability of a wide cross section of packaging media, the primary need is to analyse their adaptability with cost advantage. Most of these would be aimed at either replacing thicker aluminium foil or introduction of alternate substrates, such as:
- Metallised paper
- Lower thickness Al-foil with polypropylene
- Metallised plastic film based laminates
- Metallised paper with improved plastic film barriers.

In the existing range of srip materials, invariably LDPE film constitutes the inner heat seal medium. Quite a few alternatives are now available with EVA,EAA,VMCH and LLDPE. Some of these with lower heat seal range should help in improved productivity and reduced energy consumption.

Blister system probably is a very fast growing concept. This is supported by some specific advantages notably- tamper evident, affords protection against cross-contamination. Positive contribution against child safety, abrasion resistance, improved product stability, built up barrier protection savings in storage space and reduced volume of made-up packs etc. Generally a UPVC with aluminium foil base or glassine poly base is used. However quite a few developments are witnessed in this specific area.

The thermoformable blister material can be UPVC, PVDC coated PVC, PVD/PVC laminated or UPVC/PVDC/PE, a triple laminate. It is observed that the moisture barrier of the triple laminate 200 u UPVC/25 U PVDC/40 U PE 0.5 gms/sq meter compared to 3.5 gms/sq meter of 200 u UPVC. For a seven times improved barrier, the cost is about 4 times. Cold-formed aluminium laminate give an impervious barrier to moisture, gases and light.

Some new combinations are:

Base web-plastic support film/PET or PP/Adh/Al-foil/Adh/UPVC and Barex film or co-polyester film.

Lid material - plastic support film/Adh/Al-foil/heat seal lacquer.250 u PVC is mostly commonly used as the blister medium. The trend is to provide a cost of PVDC corresponding to 4-6- gm/sq metre of dry PVDC. To obtain best results, the PVC at the blending stage itself is mixed with ultraviolet components, which act as a filter. Studies are in progress to assess the feasibility of replacing PVC and introduce PVDC.

The other mode of packaging tablets and capsules are bottles, particularly as institutional and OTC products. A variety of bottles are used in varying capacities. Primarily, a colourless and amber coloured bottle is used with ROPP caps. Considering the Indian scene, the scope for variety reduction and standardization is enormous. The second interesting feature is the ROPP caps now with side and top champering with savings in materials.

The move is towards the "child resistant" normally plastic based caps. Screw caps of various designs are also used. The competitive packaging media are the tinplate containers and plastic and leak proof composites. These are also fitted with diaphragms and taggers.

Liquids

The general inertness, coupled with excellent liquid resistance glass has provided an ideal solution.

Though glass has the predominance in liquid pharma packaging, plastics have also made inroads in standard ranges, particularly for OTC products. Plastics offer the benefits of lightweight and non-fragile nature. The developments in plastics field include stretch-blow moulded PVC and PET bottles, co-extruded bottles, PVDC and other similar barrier coated bottles. However, in the area of plastics, considerable developments are yet to be seen that could enable them heat sterilisable.

Creams & Ointments

Because of specific advantages aluminium collapsible tubes offer, they are widely used for creams and ointments. Plastic or lamitubes do not seem to enter such application areas yet more commercially. The other modes of packaging, however, are metal, glass, plastic jars and bottles.

Labels

The labels used are either spot labels or wrap around labels. In India, traditional paper labels (preglued or post glued) are still used. Pressure sensitive labels which are more prominently used in other parts of the world also have entered the Indian scene as they offer a cleaner application with increased productivity. The other interesting development is the shrink sleeve label. Earlier an internally printed PVC shrink sleeve was introduced. However the recent shift is towards a PS or PP sleeve. Yet another interesting entrant in this field is a cellulose-based sleeve, which does not require any heat to shrink.

A variety of base materials are in vogue for labels which include paper, speciality papers, plastic films - plain and metallised, foil and laminates.

Caps & Closures

Caps and closures are produced from metals (tinplate and aluminium) and plastics (HIPS or MIPS, HDPE, PP). The varieties include screw caps (RS NP, ROPP, 4-lugcaps, a variety of plastic based convenience and pilfer proof caps. Notwithstanding the reasons behind, considerable developments are witnessed in respect of tamper evident and child resistant caps. The tamper evident features add to the confidence of the user-providing guarantee of the product quality, quantity, free from contamination, adulteration and spurious nature. Availability of newer resins like EVA and EVOH have helped to improve performance of caps, closures as well as plugs and inserts.

Wadding Materials

A container is only as effective as the closure. With most container the common and normal way of achieving a fair seal is by use of a resilient wad material. These substrates should have appropriate barrier properties and product compatibility. Traditional wad substrates are cork, paperboard, poly or PVC lined cork or board and centrifuged PVC resins. Recently expanded polyethylene has also made its entry. Other developments include facing materials such as saran, PVDC, Polyester, Aluminium foil, tin foil etc.

A number of waddles closures, moulded in thermoplastics primarily from PE & PP are now available. Such moulded items are commonly used as push-in, snap over, clip-on etc. Another innovation is the diaphragm type seal applied directly on to the container-sealing surface (heat seal or induction seal through the cap). The diaphragm is a combination of plastics such as LDPE, Polyester, Ionomer and foil. Yet another interesting development is the compartmental closure system. In this the drug component is kept separate from the solvent or vehicle. At the time of use the separation (eg. Diaphragm) is broken /punctured to enable intermixing of the two components.

For packaging of oral liquids, glass bottles have been used since long. Plastic bottles made from HDPE and PP started replacing glass bottles (due to the easily breakable nature and heavy weight of glass bottles), but bottles made from, these plastics lacked clarity and thus were used as opaque pigmented containers. Now, the option of using plastics has widened with the availability of OPVC,OPP and oriented and non-oriented polyester (as these bottles provide clarity and are unbreakable). Competition between OPP and PET containers is expected as these are available in various multi-layer materials and co-extrusions.

Blister Trays for Ampoules, Cartridge Tubes Etc.

Plastics are now increasingly used (apart from, being used as containers) for transit protective roles both as blister trays for ampoules, cartridge tubes, syringes etc. and also as a means of providing insulation and protection where items are sensitive to heat e.g. expanded polystyrene.

Single-Serve/Unit Dose Packages

Unit dose packages are used not only for protecting the product, but also for the convenience of patients. Repeated opening and closing of bottles (syrups, tonics and other medicines) leads to flavour loss and possibility of contamination. Unit dose packages prevent these problems. Unit dose packages are also used for oral rehydration vitalisers. These are in liquid forms and used in places where sterile water is not available for mixing with the vitalizing powders.

The Delcap Metered-Dose

It is used to dispense correct amount of cream or gel Retin- A acne medication, the Delcap allows patients to accurately dispense the prescribed dose. Each Delcap consists of two parts - a pointed over cap to puncture the foil covering on the tube's orifice and a dispenser. To use, the patient pulls the cap up and squeezes the tube. When the medication begins to emerge through the slit in the cap, the patient pushes the cap down dispensing the correct amount.

PE or PP bottles and ampoules in one operation and with one machine, under aseptic conditions can be packed without requiring a sterile production room. All pharmaceutical liquids which remain stable in PE or PP can be packed with the "bottlepack-aseptic system" Products that can be packed are infusion and intravenous solutions, blood expan-ders,enema liquids, nose-drops, injection liquids etc.

PP bottles made dfrom radiation resistant grade resins have been developed in foreign countries. The normal grades (bottles) tend to become yellow during the process of radiation sterilization. In the normal grade plastics, changes in the constituents of the plastic as well as the plastic itself may take place during sterilization.

This is called "coolest" package for burns. One mechanical and one aerosol spray nozzle combines a sterile water spray with a chilling blast to chill away pain in less than five seconds and reduce burn damage. The users have to push the red button (the mechanical sprayer) two or three times until a layer of water forms on an affected area. Then they have to push the yellow button (the aerosol) until a white "ice" layer momentarily appears.

- The author is Chair Professor & Director, SIES School of Packaging, Nerul, Navi Mumbai.

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