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Rationale for modified dosage forms
Less under-medicated problems (Below MEC)
Less over-medication problems (Above MTC)
Increase compliance and acceptance
Why do IR products exist?
When precision of control of release is important
Potential for overdose
Constraints on types of drugs that are suitable for MR formulations
Cost

What are the types of sterilisation?
Moist-Heat sterilisation
Dry-Heat sterilisation
Filtration sterilisation
Gas sterilisation
Sterilisation with exposure to ionising radiation
What equipment does Moist-sterilisation use and how does it work?
Autoclave, uses steam under pressure

How does moist-heat sterilisation work?
Denaturation of microbial proteins
How does dry-heat sterilisation work?
Cellular dehydration and pyrolysis/oxidation
What equipment is used for dry-heat sterilisation and what’s the pressure in it.
Oven, pressure is increased to increase temperature
How does moist-heat sterilisation compare to dry-heat sterilisation?
Moist-heat sterilisation can sterilise at lower temperatures due to presence of moisture
Dry-heat sterilisation can be used if the product is moisture sensitive.
How does filtration sterilisation work?
Filtering the product through filters, physically removes microbial contaminants
When is filtration sterilisation used?
When products are easily damaged by heat.
What are the advantages of filtration sterilisation?
Efficient and low cost
How to maximise the lifetime of a filter?
Pass the solution through bigger to smaller diameters (1 micrometer, 0.45 and then 0.22)
How does sterilisation by exposing to ionising radiation work?
disrupts microbial DNA → causing deadly mutations or breaks in DNA strands
What is sterilisation by exposing to ionising radiation used for?
Therapeutic agents/excipients
Production of formulations that are manufactured and packaged under aseptic conditions, are not sterilized by filtration
How does gas sterilisation work?
Exposing products to mixtures of ethylene oxide or propylene oxide and an inert gas (eg. carbon dioxide) → Alkylates proteins, DNA and RNA in microorganisms, disrupting metabolic functions and leading to cell death
What is gas sterilisation used for?
Medical devices and porous surgical accessories
Why is gas sterilisation used?
Highly penetrative nature of gas medium