Packaging of medicines Flashcards
What is the most common form of packaging?
Blister packs / Blister cavities
How are blister cavities formed?
- Thermoforming - flims are heated to 120-145 degrees to improve ductility (stretchiness) for moulding the blisters
- Cold moulded: The alumminium films are moulded into shape, and to avoid any pin holes, the foil needs to be >20microns thick
- cannot print on the alumminium foil
Alternative to the aluminium foil in blister packs, what is the other possible foil?
Push-through blister foil. These are a strong seal, and are a one-step removal. CAn be printed on with stove lacquer.
What is the child-resistant form of foil?
Peelable foil - not push through making it child-resistant.
It has a two-step process to open - remove individual blister and then peel the foil.
What are Moisture proof foils?
These are often used if a drug is unstable in any moisture.
They use an OPA laminate and ordered Polyamine, and are impermeable to water vapour.
Very expensive to buy therefore only used if required.
Product Protection: Human altering:
Adulteration
Counterfiting
Tampering
What is Adulteration?
This is the dilution of an acitve raw material with another material or the substitution for someting that looks the same.
A problem with herbal medicines
Detected using: Pharmacognosy which is a process of detecting plant material that should and should not be in the formulation.
What is the difference between Falsified and Counterfit medications?
Falsified: Fake meds designed to mimic real meds
Counterfit: meds that don’t comply with intellectual property rights or that violate trademark law.
What do we know is a barrier in stopping Falsified meds from getting onto market?
The distribution chain is very complex - drug manufactured in one country, printed somewhere else, distributed to whole slaer who then sells to buisnesses. It is difficult to spot them as they look so similar to the originals. They are dangerous to patients.
WHat are the saftey features to reduce Falsified Meds on market?
1) saftey features e.g. bar codes, anti-tampering devices
2) Supply cahin and good distribution practice - new responsibilities for whole salers and good-distribution-practice guidelines.
3) Active ingredients and excipients regulations: All active substances and excipients manufactured from outside the EU must be accompanied by a written conformation from the authoroties of the exporting countries. Ensures GMP standards form outside EU are maintained.
4) Internet sales: any websites that are legally operating pharmacies and approved EU retailers will have a logo not on other un-approved websites.
Counterfit medications in more detail:
These are the correct medicine, but from an unothourised source used to mislead customer. The packaging will be very similar to original, with similar letters and numbers on the tablets, same shape etc.
They are very dangerous and can kill patients.
What is being done to protect against counterfit drugs?
More complex shape and apparence of tablets, more elaborate printing.
Packs can have expensive tags and biological markers
SOme have Radio-frequency indentification tags (RFID) to folow the journey of the durgs.
WHat is tampering with medication?
WHen medication has been tampered with, then put back on the shelf, or sold on black market as the real medication. Thsi is not from manufacturer or wholeslaer, but from members of the public or in the pharmacy.
What are the features to avoid tampering?
Film wrappers, foils, breakable caps, sealed metal tubes etc.
What is the patient adivce on tampering?
DOn’t take if:
medication looks different than usual,
tablets/capsuels are not all the same size or thickness,
different odour or taste,
Why is packaging so important for some products more than others?
SOme products will not exist without packaging i.e. will not survive the environment, or delicate material that cannot be handled without breakage, or formulations of volatile (easily evaporated) components.
What are the saftey features on bottles?
Child proof caps
Tamper-evidence caps - know if it has been opened beofre or not.
What is the protocol for testing child-proof caps?
Must be difficult for children <5 to open.
“normal” adults must be able to open , and also not too difficult for seniors to open (tests 100 50-70 year olds to check)
WHat are the issues with child-resisetet caps and how are these resolved?
Geriatric, arthritis patients: If requested at time of dispensing, can exemt the use of a child proof cap.
What is a Primay container?
Container in contact with the medicine
What is a secondary container?
Designed to protect the primary container
To improve handling, or a source of additional information e.g. box outside medicine bottle
What is a container?
An article that contains a medicinal substance and may or may not be in contact with it.
Provides a suitable degree of protection.
Minimises loss of contents
Should not interact chemically or physically with the content
maintains product stability
What must a COntainer have:
- Have a COST in keeping with usage
- Provide PROTECTION against climate, bilogical, physical, and chemical hazards
- Have acceptable PRESENTATION for clinical usage
4, Maintain adequate IDENTIFICATION info - contribute to patient COMPLIANCE and CONVENIENCE
What are the different types of containers?
Single-dose
Multi-dose
Well-closed
Airtight
What are the different extras to the types of containers?
Sealed containers
Tamper-proof
Child-proof
What are well-closed containers?
Protects content from contamination and loss under ordinary condition of handling, transport and storage
What is an airtight container?
Immperpeable to solids, liquids or gases under ordinary conditions. It is for multiple use, designed to be airtight after re-closure.
What is the feature of a sealed container?
Closed by fusion of container material.
Exept for powders for incjections.
What si the feature of a tamper-proof container?
Device on closed container reveals irreversibly that container has been opened if it has been opened.
what is the feature of a child proof container?
Fitted with closure that prevents opening by children
What are some mechanical hazards that product in container may come accross?
1. shock or impact damage compression vibration abrasion puncture
What are the environmental hazards?
Moisture temperature pressure light atmospheric gasses particulate airborne contamination
How are actives that are unstable in light protected?
- product design - dyes, pigments
- opaque primary container - brown bottles, metal foils for blisters
- Place promary container in an opaquesecondary container
What are packages made form?
plastics glass paper metals rubber
What are the requirements of plastic containers?
Not absorb too much ingredents onto surface and migrate through the plastic
What are the tests for parenteral containers?
1 resistance to centrifugation 2 . resistance to stretching 3. leakage 4. vapour permeability 5. emptying under pressure 6. speed of filling 7. resistance to temp variations 8. transparency 9. extractable matter.
How are plastic conainers produced?
Dlow Fill Seal Packs: 1Heat the plastic granules to 170-220 degrees to form a parison 2. blow sterile air to fill the mould 3. sterile fill liquid 4. hermeically eal
GLASS; benefits
Transparent, easy to clean, good appearance, easy to make good closures, handles well on automatic high speed.
Glass - negatives
afture manufacute, need to keep clean before filling
bulky and heavy
fragile (breakable)
types of glass containers:
ampuoles
bottles, vials, syringes
Whay are paper conainers based on?
Based on cellulpse fibres
Benefits of paper containers
cheap
easy to print on
good secondary container
negatives of paper container
not suitable as a primary container
