Podcast
Questions and Answers
What is a difficulty arising from the use of plastics in packaging?
What is a difficulty arising from the use of plastics in packaging?
What is a limitation of using a single preservative to protect preparations?
What is a limitation of using a single preservative to protect preparations?
What is a justification for using combinations of preservatives?
What is a justification for using combinations of preservatives?
What is a benefit of using methyl parabens and hexachlorophene in combination?
What is a benefit of using methyl parabens and hexachlorophene in combination?
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Why is it unrealistic to use a single preservative to protect preparations?
Why is it unrealistic to use a single preservative to protect preparations?
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What is an advantage of using preservative combinations?
What is an advantage of using preservative combinations?
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What is an example of a preservative combination designed to exert antibacterial and antifungal effects?
What is an example of a preservative combination designed to exert antibacterial and antifungal effects?
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What is a factor influencing the effectiveness of preservatives?
What is a factor influencing the effectiveness of preservatives?
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What is the purpose of preservative efficacy tests?
What is the purpose of preservative efficacy tests?
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What is measured during preservative efficacy tests?
What is measured during preservative efficacy tests?
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What is a condition for a preservative to be considered effective in a product?
What is a condition for a preservative to be considered effective in a product?
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What is the significance of the 14-day mark in preservative efficacy tests?
What is the significance of the 14-day mark in preservative efficacy tests?
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What is a potential impact of container materials on preservatives?
What is a potential impact of container materials on preservatives?
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What is the purpose of using different microorganisms in preservative efficacy tests?
What is the purpose of using different microorganisms in preservative efficacy tests?
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What is a potential consequence of inadequate preservative activity?
What is a potential consequence of inadequate preservative activity?
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What is the duration of a standard preservative efficacy test?
What is the duration of a standard preservative efficacy test?
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What is the primary effect of pH on the activity of benzoic acid as a preservative?
What is the primary effect of pH on the activity of benzoic acid as a preservative?
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Which type of preservative is more effective at high pH values?
Which type of preservative is more effective at high pH values?
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What type of formulation components can interact with preservatives and diminish their activity?
What type of formulation components can interact with preservatives and diminish their activity?
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Why are quaternary ammonium salts not used in eye drops?
Why are quaternary ammonium salts not used in eye drops?
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What is the primary concern when using traditional glass containers for preparations?
What is the primary concern when using traditional glass containers for preparations?
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What factor can affect the availability of preservatives in a formulation?
What factor can affect the availability of preservatives in a formulation?
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What type of interaction can occur between preservatives and formulation components?
What type of interaction can occur between preservatives and formulation components?
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Why is it important to consider the container material when preparing a formulation?
Why is it important to consider the container material when preparing a formulation?
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Study Notes
Difficulties in Plastic Packaging
- Interactions between phenolic preservatives and plastics or rubber containers or closures have been observed
- Permeation of preservatives through the container can occur
Preservative Combinations
- Using single preservatives to protect preparations is unrealistic due to various factors influencing effectiveness
- Combinations of preservatives are designed to have wider and more sustained powers of protection
- Justifications for using combinations of preservatives include:
- Increasing the spectrum of antimicrobial activity
- Reducing the toxic effects of high concentration levels of one preservative
- Reducing the emergence of resistant forms against one preservative
- Achieving synergism
- Economic savings
Examples of Preservative Combinations
- Methyl parabens and hexachlorophene: widen the antimicrobial spectrum and allow hexachlorophene to be used in low concentrations to minimize toxicity
- Methyl parabens and propyl parabens: designed to exert antibacterial and antifungal effects
Quaternary Ammonium Salts (Q.A.S)
- Bactericidal and fungicidal agents
- Examples: Cetrimide, Benzalkonium chloride
- Not used for eye drops due to being harmful to the eye and dissolving intracellular cement of the corneal epithelium
Factors Affecting Preservative Availability
- Effect of pH
- Interaction with other formulation components
- Effect of container
Effect of pH
- Ionizable preservatives are influenced by pH of the formulation
- Weakly acidic preservatives (e.g. benzoic acid) are only effective at low pH
- Cationic quaternary ammonium compounds are more effective at high pH values
Interaction with Other Formulation Components
- Hydrocolloids (e.g. Methylcellulose, Alginates, Tragacanth) can interact with preservatives and diminish their activity
Effect of Container
- Preparations packed in traditional glass containers can retain their preservative content if the closure is suitably airtight
Preservative Efficacy Tests (Challenge Tests)
- These tests determine whether a formulated medicine is adequately protected against microbial spoilage
- Preservative capacity is a measure of the total quantity of microorganisms a preserved formulation can inactivate
- These tests predict the activity of the preservative and how it will be influenced by the active ingredients, excipients, and container
Principle of Preservative Efficacy Tests
- Inoculate separate containers of the product with known concentrations of a variety of microorganisms
- Remove samples from each container over a period of time
- Determine the proportions of the inoculum that has survived
Interpretation of Results
- The preservative is effective in the product examined if:
- The concentration of viable bacteria is not more than 0.1% of the initial concentration by the fourteenth day
- The concentration of viable yeasts and molds remains at or below the initial concentration during the first 14 days
- The concentration of each test microorganism remains at or below designated levels during the remainder of the 28-day test period
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Description
Learn about the challenges of using plastics in food packaging, including preservative permeation and interaction. Discover how preservatives interact with containers and affect their effectiveness.