Derek G. Chapman

Introduction

Pharmaceutical formulations must be suitably contained, protected and labelled from the time of manufacture until the patient uses them. Throughout this period, the container must maintain the quality, safety and stability of the medicine and protect the product against physical, climatic, chemical and biological hazards. The British Pharmacopoeia identifies the closure as part of the container.

To promote good patient compliance, the container must be user-friendly. Thus, containers should be easy to open and reclose, most notably for elderly or arthritic patients. Other factors must also be considered in the selection of the container used to package a pharmaceutical formulation, including the cost and the need for both child-resistant closures and tamper-evident seals.

Repackaging may be performed for dispensing purposes in the community and hospital pharmacies and in specialized production facilities (see Chs 30, 39). Bulk medicines are repackaged into smaller quantities in dispensing containers for distribution to hospital wards, clinics and general practitioners for direct supply to patients. This is mostly carried out with tablets and capsules that are transferred from bulk quantities into smaller amounts that are more suitable for patient use. In the UK, this process is performed in the hospital pharmacy where the MHRA allows the repackaging of small batches of up to 25 containers. Larger batches must be packed in licensed manufacturing premises. The facilities used for these repackaging operations are designed to maintain the quality of the medicine.

The composition of containers and closures used for the repackaging of bulk medicines must be carefully selected and must be of a quality as good as the original container. Both glass and plastic containers are used for repackaging but glass containers are often preferred due to the more inert qualities of glass.

Primary containers used for repackaging must not:

The container used in the repackaging process must protect the product from:

As the medicine has been transferred into a new container, the expiry date of the repackaged medicine must not exceed 12 months, unless the stability of the repackaged product justifies a longer shelf-life. The details of these repackaging processes must be recorded.

Each container of the repackaged batch is labelled with the:

There are some situations where the repackaging is limited, such as with glyceryl trinitrate tablets, owing to the potential loss of the volatile drug (see Ch. 39). Sterile products cannot easily be repackaged and require effective closure systems to minimize the risk of microbial contamination of the contents within the container. In addition, the pack itself must withstand sterilization procedures. Consequently, care must be applied to the selection of the container and its closure for the packaging of sterile products (see also Chs 40, 41, 44, 46).

Primary and secondary packaging

Primary packaging materials are in direct contact with the product. This also applies to the closure, which is also part of the primary pack. It is important that this container must not interact with the medicine. It must protect the medicine from damage and from extraneous chemical and microbial contamination. In addition, the primary packaging should support the use of the product by the patient. Secondary packages are additional packaging materials that improve the appearance of the product and include outer wrappers or labels that do not make direct contact with the product (Table 32.1). Secondary packages can also supply information about the product and its use. They should provide evidence of tampering with the medicine.

The following terms are used to describe containers:

An important consideration when selecting the packaging for any product is that its main objective is that the package must contribute to delivering a drug to a specific site of effective activity in the patient.

The selection of packaging for a pharmaceutical product is dependent on the following factors:

Packaging materials

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