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 Packaging of pharmaceuticals and healthcare products-Springer US (1996)

Packaging of pharmaceuticals and healthcare products-Springer US (1996)

As was the case with Charles Ross's Packaging of  Pharmaceuticals published by the UK Institute of Packaging in 1975 it is assumed that the reader of this book already has a broad understanding of the basics of packaging. If not the Packaging  Users Handbook  and the Handbook  of Food Packaging are recommended.

The packaging needs of pharmaceuticals are different in degree only from those of other perishable products such as processed foods. Because the required action of a medication can be nullified by any deterioration in its active principles the protection required from its packaging is at least an order of magnitude greater than that needed by foods for example. Functional efficiency is therefore of prime importance.

Conversely the need for the packaging to 'sell' the medication is much less, hence the graphics required need only provide the right 'image' for the product  when presented for use in hospital or surgery . Even when on sale at the pharmacy the 'appeal ' required is that of providing hygiene and confidence more than anything else. Thus, the textual requirements are paramount including traceability (batch numbers, date-coding etc) in case of recall; while striking appearance to attract customer attention is in lower key. And with the increase in malicious tampering nowadays recall is more frequent.

Much of the  contents of  this book (Chapters 2, 3, 6 and parts of Chapters 1 and 4) update and revise Charles Ross's work but Chapters 5 and 7 are completely new as is the latter part of Chapter 1 and the Appendix to Chapter 4. We are indebted to Mike Robertston, Roy Evans and John Garbett respectively for their contributions.

Chapter 8 on child resistant packaging reflects the considerable changes over the last decade or so in the public attitude  to  the  problems  of medicines getting into the hands of very young children. It  should  be stressed that the child resistance of a package is defined as being such that 4 out of every 5 children of the test age group will be unable to open the package and get at the contents.  Hence  the  packaging  can only be a last line of defence and medicines should always be locked up out  of  reach of the young investigator.

Since the Tylenol case in 1982 the development of the (older, so-called) pilfer proof package (to discourage petty theft) into a packaging system which requires more sophisticated tools to interfere with the contents than previously needed has progressed rapidly but is still not satisfactory.  To educate the general public to recognise when someone has tampered with a package is very difficult. Chapter 9 gives the present state of the art.

The final Chapter on healthcare products is largely devoted to the advances that have been made in the development and packaging of items used in hospitals and surgeries which achieve their purpose by other than pharmacological means. Items like syringes and gloves may be disposable while tubing, sutures and implants for use in joint replacements etc are more or less permanent. In nearly all instances sterility is paramount and the package must therefore not only maintain that sterility before use but must also be capable of being opened and the item used without any non-sterile contact being made. Many modern developments in the packaging scene have been employed in this developing market.

The book is primarily designed as an introduction to a very specialised area of packaging which is developing rapidly in many sectors . Our thanks are due to the many colleagues with whom we have discussed specific areas and to the many authors who have contributed to the technical literature. It may be that some readers will ask why there is nothing on package recycling. We would reply that in our opinion recycled materials should never be used in the primary packaging or pharmaceuticals and the prime objectives of hygiene and the avoidance of any possible contamination take precedence over such considerations.

Introduction

Pharmaceuticals require more detailed packaging than do other sensitive products, such as foods, although there are several similarities in their requirements. Almost every type of modern packaging is used for the wide range of medications and devices now available, but the quantities involved are usually smaller than with foods. Security and integrity of the package are, however, more important and are controlled by licensing arrangements.

Definition

One of the best general definitions of pharmaceutical packaging was proposed by Dean [1]: an economical means of providing protection, presentation, identifica­ tion, information and convenience  for a pharmaceutical product  from the moment of production until it is used or administered.

Probably the most important function of pharmaceutical packaging is protection of the product. Physical damage and chemical deterioration from mechanical and climatic hazards, as well as changes caused by microorganisms must be prevented. The product and packaging materials must be compatible.

Additionally, modern packaging needs to be child resistant and tamper­ evident. Advances in packaging technology have led to more complex testing requirements and hence a greater in-depth knowledge is required of traditional as well as newer packaging methods and materials. Convenience and ease of use, hygiene, package integrity, and new dispensing methods must now also be provided for patients.

Drugs need more care in their packaging than do most other products, because any failure in their packaging could result in changes in  the  drug that lead either to a failure to cure, to illness, to  injury or even  to death of the patient. A drug must be efficacious, for if it is only palliative then the drug and/or the package is a failure. Potency and bio-availability must both be demonstrated. Requirements in respect of Good Manufacturing

Practice (GMP), improved microbiological standards and better ways of reducing possible contamination all play a part in the package  design process.

Types of product

There are two major  types of  pharmaceutical  product: ethical medicines and proprietary medicines (also called over-the-counter [OTC] drugs), and they require different treatment in respect of their packaging.

ETHICAL MEDICINES

Ethical medicines are sold to the public only on a prescription basis. In the USA, mainland Europe and the UK their sale in any other way is prohibited by law. There are some countries where such drugs can be obtained without prescription, but these are few. The principal users of packaging for ethical medicines are doctors, dentists, nurses, pharmacists and medical technicians. However, with the introduction of original pack dispensing (OPD), some ethical drugs are now dispensed to the patient in the same type of package as is used for over-the-counter products.

Requirements for the packaging of ethical medicines . Special attention is required, because both the container and closure  must  protect  the medication from light, water vapour and oxygen, under the conditions of distribution and storage, which are  often for longer periods than in the case of OTC products. Both the drug and the  packaging  must  be approved  by the regulating authority. While this is also true for OTCs, it is important to remember that OTCs often  come in smaller  quantities  per  pack  and, as they have to meet the retail selling (marketing) challenge, they will require some display and convenience factors, e.g. transparency and easy opening, not required for ethical packages.  A further  difference  is that OTCs often use more packaging per  dose, in order  to deliver the  message and to get shelf space.

With certain exceptions, all ethical medicines, in whatever form  (unit dose, prescription tablets, capsules, oral liquids, some ointments and some creams) were, until the introduction of OPD, always supplied to the pharmacist in bulk packages and repacked for dispensing according to the doctors' instructions.  Fifty years ago, almost all drugs were in liquid form and were contained in stoppered  glass  bottles.  The great  majority  were also administered in hospitals. Currently, there is great emphasis on solid dosage forms, a decrease in liquid forms and the appearance of many new forms such as inhalers and transdermal patches. The development of new forms presents sophisticated challenges for packing developers .

Unit dose packaging. The  most significant advance in the packaging of drugs used in hospitals was the introduction of unit  doses  for  oral medicines. Although strip packaging for an aspirin-based product (Aspro) started in 1927, some 20 years elapsed before the concept was widely used . During the early 1950s, some tablets and capsules were available packaged individually into pockets in a continuous tube , the pockets being separated from each other by perforations in the foil strip. From this concept , the hospital unit dose evolved. The advantages are obvious: this form of packaging controls the dispensing and administering of a prescribed single dose of the correct drug at the right time , and it significantly  reduced hospital errors, especially when  prefilled disposable syringes came into use in the USA in the 1960s.

Blister packaging (Figure 1.1), first introduced in American hospitals, was an even greater improvement in safe dispensing. The tablet or capsule is visible through the 'blister' and the product can thus be recognised before the  package is opened. In the USA this packaging is also considered to be cost-effective, mainly because its use can reduce wastage by avoiding the wrong package being opened.

Today, both strip packs and blister packs are widely used all over the wo rld. They are more popular  in Japan and Europe than in the UK and USA. The advantages of the unit dose concept are even more clearly

Figure 1.1 Blister packaging. A push-through vinyl blister with foil back. Either vinyl or foil can be print ed.

4 PACKAGING OF PHARMACEUTICALS AND HEALTHCARE PRODUCTS

demonstrated in medicaments for the eyes, ears and nose, as well as for enemas, where the accuracy of dosage and simpler formulation  plus the much reduced risk of cross infection are even more relevant.

The main plastics used for blister packaging  are  PVC,  PVDC coated PVC, and PCTFE/PVC laminates. These  have  some  differences  in moisture resistance, the last being 10 times as good as PVC which is three times less effective than the coated material. Many blister packs are backed with 18-20 micron aluminium foil with a heat-seal coating.

Unit-of-use packages. While unit dose packs are particularly valuable for hospital in-patients the unit-of-use package is devised for out-patients and prescription customers. The pack contains sufficient drug to provide the patient with his needs for a particular time (usually up to 30 days). It is dispensed and labelled by the pharmacist, indicating the doctor's instruc­ tions and other necessary information.

PROPRIETARY  MEDICINES OTCs

Unlike ethical medicines which are provided to professional healthcare personnel for dispensing to the patient, proprietary medicines (OTCs) are designed and produced for self-medication purposes to the actual consumer, and are available not only through prescription outlets but also in supermarkets, department stores, corner shops and even from vending machines. Structural and graphic design are both required to appeal to the consumer and to assist in selling the product. In the USA, the UK and some other countries there are different safety regulations concerning the use of child-resistant and tamper-evident packaging for certain drugs. For example, in the USA the law permits the sale of one size of package without the use of a child-resistant closure, while in the UK the purchaser may request that a plain closure is used.

Unit dose packaging is used extensively for OTC medications as blister packaging in particular  has the further advantage of  providing more space for instructions and even a diagram of how to take the dose .

Other classifications

There are other possible classifications for medicines than ethical prepara­ tions and OTCs. For example, products may be classified  by their use - health care, eye care, oral hygiene, etc. They may  also  be  grouped according to the manner in which they are administered - local or topical products (those applied externally to the body, such as creams, ointments, lotions, talcum powder), oral products (entering by mouth) and parenterals (this is the medical term for 'outside of the intestine' and usually refers to sterile products entering the body by injection or infusion into veins (IV), arteries or muscles (IM)). Parenterals can be further sub-divided into large and small volume parenterals (LVPs and SVPs). The former include intravenous (IV) solutions and irrigation fluids, which involve volumes between 500 millilitres and 3 litres and the latter (the SVPs) single and multi-dose injections usually with volumes below 100 millilitres. Origin­ ally, parenteral products were invariably packed into glass containers (ampoules, rubber-stoppered or sealed vials, and rubber-stoppered bottles). The rubber compounds have always had to be  specially  made , often compounded specifically for one or a narrow class of product. By their method of use IV solutions can be considered as a form of unit dose. Although used for years , glass is not completely inert even when the surface is specially treated . It is also, of course, heavy and fragile and containers may require rubber stoppers, from which there is the risk of extractives and other contaminantion. Hence, the plastic package for IV solutions was developed and has been approved. These are made preformed from PE, PP or PVC and of the form-fill-seal type from PE or PP,   although   preformed   PVC  containers   are   generally   preferred.

Currently, plastic ampoules, vials and bottles are appearing for other types of parenteral product.

Packaging of pharmaceuticals


Table 1.1 illustrates the wide range of complaints for which Ethicals and OTC products are available.


  

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