Pharmaceutical packaging technology
By D. A. Dean, Roy EvansPharmaceutical products generally requires a standard of packaging which is superior to that of most other products in order to support and comply with their main requirements, i.e. proven efficacy, safety, uniformity, reproducibility, integrity, purity with limited impurities, minimum side-effects coupled to minimum product liability risks, and a good shelf-life stability profile.
Uniformity applies within and between batches and usually referes to the quantification of active ingredients, excipients and impurities/degradation.
Some facors that may influence the pharmaceutical pack
1. the type of dosage form: primarily related to the pysical state, e.g. solid, liquid or gas, and whether its is sterile, non-sterile, unit dose or multi-dose
a. Solids may be regular, irregular, free-flowing, cohesive, i.e. powders, tablets, capsules, suppositories, etc
b. Liquid or semi-liquid products may be based on water, alcohol, solvents, oils, gels, etc, i.e. emulsions, suspensions, creams, ointments, solutions, etc.
c. Gases may be liquefied, pressurised, volatile, inert, i.e. vapours, inhalations, aerosols
2. the route or mode of administration or use: may make certain packaging features desirable or necessary
a. Oral: dispensing, dosing, with absorption/mode of action occuring between mouth and colon
b. Local: topical applications to the skin, hair
c. Parenteral: sterile products administered intravenously, intramuscularly, intrathecally, subcutaneously, etc., in single or multi-dose packs.
d. Orifice introduction: ear, nose, eye, rectal, vaginal, etc.
e. Inhalation: via mouth or nose uing a face mask, breathing tube or direct inhalation into mouth or lungs.
Packs may provide single (non-reclosable) use, or multi-use (reclosable). Both groups have influence on the product and have to be considered in terms of the materials characteristics and the total packaging concept involving such factors as product compatibility, functional and aesthetic design, production performance, material costs, produce costs and user convenience.
4. the mode of sale/marketing area: The 'sale' of a pharmaceutical product may be by retail (community pharmacy), wholesale, health centre, hospital, dental, health care centres, special homes, home trade or export, etc. These may be further broken down into ethical or over the ounter (OTC) sales.
5. the mode of dispensing via a combined device/pack
6. administration by a device separate to the pack
Protection: The most important and frequently the most complex factor of packaging
Protection against the following primary hazards:
1. climatic, i.e. those associated witht he surrounding atmosphere
2. biological - these involve microbiological (bacteria, moulds and yeasts) and biological factors (insects, rodents, human pilferage, etc.)
3. mechanical, i.e. physical hazards associated with storage, carriage, etc. - general handling
4. chemical - aspects of interaction and exchange betweenproduct and pack, i.e. compatibility, ingress and egress, and combinations of these and the factors above
5. use - professional and patient, including any possibilities of misuse or abuse.
To assist memory recall and provide a check list, the individual factors are presented in a mnemonic form (SCRAP CART MIST MARD)
S - shock
C - compression
R - rattle (vibration)
A - abrasion
P - puncture
C - contamination/compatibility between pack and product
A - ageing (certain combinations involving several sources)
R - rodents or similar animal sources of contamination
T - theft
M - moisture (relative humidity (RH), rain, sea water)
I - insects
S - sunlight or any light sources
T - temperature (extremes)
M - microbiological
A - atmospheric - gases, pressure differentials, dirt, dust, oxygen, carbon dioxide, etc.
R - reuse/recycling/recovery/reduce, i.e. 'the four Rs'
D - disposal - indirect hazards associated with ultimate disposal of pack-product including any pollution risks
