Topic 5: Labelling and packaging

Question 1

Parts 1,2 and 3 in important aspects of labelling pharmaceutical products

Answer 1

Part 2: Mandatory requirements for specific medicine types: covers various types of packaging, routes of administration, specific medicine types.
Part 3: Best practice principles; non-mandatory but included to improve safety and quality of the product i.e. use of braille, website addresses.
Part 4: Tabulated display of critical health information (CHI) which is important for the safe use of non-prescription medicine.

Question 2

Issues which can arise from the improper use of packaging

Answer 2

• Migration of container ingredients into the formulation (leaching)
• Change in pH of the formulation
• Change in colour, odour, taste of the formulation
• Formation of particulate matter in the formulation

Question 3

Types of glass used in packaging

Answer 3

Type Description Uses
1* Highly resistant, borosilicate Buffered/unbuffered aqueous solution
2** Treated soda lime Buffered solutions with pH < 7, dry powders, oleaginous gels
3 Soda lime Dry powders, oleaginous solutions
4 General purpose soda lime / NP glass Not for parenteral formulations, oral solutions, emulsions etc

treated with boric oxide to remove alkalinity by neutrilizing the oxide of potassium and sodium
** treated with sulphur to remove surface alkali rendering the glass more chemically resistant. Used for alkali sensitive products including infusion fluid, plasma and blood.

Question 4

Extractable’s and leachables

Answer 4

Extractables are chemicals that will extract from components of a container closure system device into solvents under controlled conditions. Used to identify and qualify certain leachables

Leachables are chemicals that migrate from components of a container closure system or device into a drug product over its shelf life. Usually present in drug product matrices at trace levels.

Question 5

Conducting an extractable study

Answer 5

Extractable studies are conducted under controlled conditions. 2-3 solvents of varying solvating power are used (I,e, water, ethanol), solvents of overly strong solvating power should be avoided as everything will extract, for liquid formulations a solvent closest to the formulation should be used. The study is conducted under exaggerated time and temperature conditions i.e. 37ºC for 24 hours, 37ºC for 72 hours, 50ºC for 72 hours, 70ºC for 24 hours, and 121ºC for 1 hour. GC/LC-MS techniques are used to attain results.

Leachables study
• conducted to monitor any entities that leach out of a material into the final drug product in its commercial packaging
• commonly conducted as part of a regulatory stability study
• substances of concern identified via toxicological consideration of the extractables data