Lecture 4: Packaging, formulation drug delivery Flashcards
Why use the parenteral route?
- To ENSURE adequate delivery (sustained??)
- To TARGET delivery e.g. to organ or malignancy
- Oral route unavailable…unconscious, elderly
- Low or NO oral bioavailability
- Unstable drug (pH)
- To give a LOCAL effect (anaesthesia)
- To give a rapid effect
- To give sustained effect (depot injection, implants)
- To assure compliance – administered by trained personnel
Parenteral routes
Intradermal (diagnostic tests)
Subcutaneous S/C (e.g. insulin)
Intramuscular I/M (e.g. vaccines)
Intravenous I/V (e.g. infusions, drugs, EMERGENCIES)
Intra-arterial I/A(EMERGENCY)
Spinal injections
Epidural (anaesthesia)
Intrathecal (into CSF)
Joints
Intrasynovial (e.g. anti-inflammatory, steroids)
Potential issues - parenteral route
- Dosage forms MUST be sterile
- Costs - drug prep & administration
- Effects (adverse) are almost immediate – no way back!
- Fear & pain of injections.
Formulation of Parenteral Products
Factors to consider:
1) Route
2) Volume of injection
3) Vehicle
4) Osmotic pressure (isotonic: 0.9% w/v NaCl)
5) Use of preservative
6) pH – transfer across biol. membranes
7) Stability of components
PHARMACEUTICAL CLOSURES
Essential part of primary and secondary packaging
types:
1. Physical compression
- plug-in e.g. rubber closure for injections
- push-over or “snap-fit”
- screw cap
- roll-on aluminium alloy caps
2. Heat sealing
Three Primary Modes of Drug
Delivery
- To provide for the insertion of a drug into one of the bodies orifices
- To provide for drug entry into the blood stream
- To provide for inhalation of drugs into the lungs
Medicine labels and what they must contain
Tell you what you are buying, what the medicine can do for you, and how to use it…
Active Ingredient
Uses of the medicine and Directions for Use
Warnings
Declarations (possible allergens etc)
Storage conditions
Expiry date
Batch number and company address
Australian Register of Therapeutic Goods (ARGT) number
What are ARTG numbers
The ARTG number not only identifies the product, but is a guide to how much examination the product has received before going on sale, including whether the TGA has
assessed the medicine for efficacy.
Medicines sold in Australia will have either an AUST R, an AUST L or an AUST L(A) number
“AUST R” numbers
registered medicines
are assessed for quality, safety and effectiveness before they can be sold.
include all prescription-only medicines, and many over-the counter medicines
An AUST R number means the medicine is tightly controlled and highly regulated.
“AUST L” numbers
listed medicines
are lower risk self-medication products
used for minor health problems
and are less regulated than AUST R
AUST L medicines include fish oils,
multivitamins, as well as herbal and
homoeopathic products
AUST L(A)
If AUST L are assessed for efficacy complimentary medicines are referred to as AUST L(A)
Purpose of medicinal packaging
- Provides protection against climatic, biological, physical and chemical hazards
- Provides product identification and information
- Assists patient compliance and convenient use of medication
etc
Metered dose inhalers (MDIs)
“sophisticated” pharmaceutical packaging
like puffers - they release a metered dose at a time obvi
Primary & Secondary Packaging
PRIMARY packaging:
Directly contains and comes into contact with the pharmaceutical e.g. bottle or closure.
SECONDARY packaging:
Provides additional physical protection to ensure safe warehousing and delivery to point where bulk quantities are broken down into individual units.
Physical or mechanical hazards
Shock or impact damage
Risk reduced by - use of cushioning
- restriction of pack movement
- careful handling
Vibration/abrasion during transport
Puncture due to sharp objects
