L34 Pharmaceutical Packaging TJ and GT Flashcards
Why is Pharmaceutical pagaging is important, what is the purpose and function of packaging
A product cannot exist as a product without a suitable container.
The purpose and function of packaging is to:
- contain the product
- provide information about the product
- make the product identifiable and presentational
- advertising
- protect the drug
What are the types of packaging available?
There are three types of packaging:
- Primary - in contact with actual drug
- Secondary - the outer box
- Tertiary - crates cardboard for delivering
what new things are we seeing with packaging?
Dose effectiveness can be improved through sophisticated packaging (e.g MDIs, where the product is insite the package and the package is involved in the delivery system)
In some cases, increase in compliance (e.g Rheumatoid Arthritis Patients)
there are now two general forms of packaging, these are
Traditional and Contemporary
what is traditional packaging
The original needs of containment of the pharmaceutical dosage form; such that at any point before expiration date, a single, efficacious dosage form was available.
- There must be no interactions with package and drug
- Protection from external factors
how do we define contemporary packaging
the combination of components necessary to contain, preserve and protect and deliver a safe efficacious product. more influence on the effect of delievery as the packaging itself can affect the way a drug is delivered.
Aims of primary packaging
- provide containment
- shouldnt interact with drug
- should be easy to access and use
- protected from hazards
- biologicaly, chemically, and environmentally protected (light and humidity and oxygen)
Aims of secondary packaging
- Protect the primary package form.
- Mechanical and eironmental hazard proctection
- All provide containers for the patient information leaflet (PIL) and dispensing devices such as spoons and cups
- there is also a legal need to provide information about the product via a label: Dx name, strength, expiry, Batch N0, storage conditions
- POM or P or OTC needs to be indicated
according the cGMP, the product container should NOT
shouldnt be reactive, additive or absorptive to alter the drug safety, identity, quantity.
what evidence must be provided that will show consistency of a stable product and compatible container?
shelf tests - must support the expiry date and the specifications needed to ensure consistency.
in a Package evaluation
- dosage is tested in its pack (to support a shelf life)
- ideally aim to minimise the number of tests
- a clear report is required together with proposed specification for all components
Within the packing developmental process, what should the pack provide
the pack must provide adequate protection for clinical trial supplies so that the quality is maintained throughout the duration of the studies. duration can vary from weeks to months.
Why is packaging more complicated for global markets?
- Differences in local availability of packaging materials
- Local availability of packaging machines may be poor
- local preferences for different types of packaging
Five key technical factors that need to be considered when packaging a product
- compatibility of drug with packaging
- protection of drug from environment
- the ease of use by patients (elderly secifically)
- child resistant
- make criminal tampering evident by broken seal
what materials do we use for packaging liquid
glass bottles with metal tops
