Questions and Answers
What is a potential risk associated with lipophilic APIs dissolved in oleaginous vehicles?
Which of the following factors can affect the physical stability of a suspension?
What challenge is faced when using APIs with very unpleasant tastes?
Why might high dosage accuracy be problematic with potent medicines in suspension forms?
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What is a common issue related to the chemical stability of certain APIs in solution?
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What characteristic of suspensions allows for proper dosing despite sedimentation?
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Which property is typically desirable for APIs in oily solutions?
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What may lead to an unpleasant oily taste in lipophilic formulations?
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What is a significant physical stability concern for oil-in-water dispersions?
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Which factor influences the rate of hydrolysis in aqueous solutions?
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How does the presence of solid particles affect the degradation of APIs in solution?
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Which method is NOT recommended for reducing oxidation in aqueous solutions?
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Which characteristic of oral solutions can contribute to physical instability?
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Which approach is likely to enhance the palatability of an oily solution?
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What is a common issue concerning dosage accuracy in oil-in-water dispersions?
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What is the primary benefit of using APIs in suspension compared to dissolved form?
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What is the primary rate-limiting step in the absorption of active pharmaceutical ingredients (APIs) from suspensions?
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In which scenario is the partitioning of the API from the lipid phase to the aqueous phase the rate-limiting step?
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What factor primarily influences the release and absorption rate of highly lipophilic APIs?
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Which method is NOT mentioned as a way to enhance the solubility of an API in a solution?
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How does the choice of vehicle for a preparation for oral use impact the formulation?
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What is a primary concern regarding the palatability of oral liquid dosage forms?
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Which of the following is essential for achieving precise dosing in oral liquid dosage forms?
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When considering dosage form customization for different age groups, what volume is generally acceptable for younger children?
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Study Notes
Oil-in-Water (O/W) Dispersions
- Active Pharmaceutical Ingredients (APIs) can be dissolved in aqueous, oily phases, or both.
- Solid particle APIs may create suspensions within emulsions, enhancing palatability compared to oily solutions.
- Emulsion physical stability can be compromised due to issues like creaming and phase separation.
- Homogeneity in dosage forms poses risks for dosage accuracy, especially for potent medications.
- As per BP 2024, emulsions may separate but can be redispersed with shaking.
Stability Concerns
- Dissolved substances are prone to degradation through hydrolysis and oxidation; instability is often more prevalent in aqueous solutions.
- Hydrolysis rates depend on pH; oxidation can be inhibited by removing oxygen, filling bottles to reduce headspace, using chelating agents, and incorporating antioxidants.
- Oral solutions face instability risks from crystallization of dissolved solids due to insufficient chemical stability.
Lipophilic APIs
- Lipophilic APIs are often dissolved in non-polar or moderately polar oleaginous vehicles, leading to potential adverse effects like unpleasant taste and oxidation instability.
- Risks of oil aspiration can lead to lipoid pneumonia.
Suspensions
- Suspensions ideally contain APIs as solid particles, with ≤ 0.1% in solution, offering better chemical stability than solutions.
- Insufficient physical stability can result from rapid sedimentation influenced by particle size and viscosity.
- BP 2024 indicates that suspensions might display sediment that can be restored by shaking to ensure dosage accuracy.
Release and Absorption Rates
- For suspensions, the dissolution of APIs is typically the rate-limiting step, reliant on factors such as solubility, crystal form, particle size, and viscosity.
- In oily solutions and emulsions, the API's partitioning from lipid to aqueous phases defines the release rate, affected by lipid solubility and intestinal contents.
Oral Liquid Dosage Forms
- Different oral liquid formulations (solutions, suspensions, emulsions) can be tailored to meet patient needs.
- Dosage volumes vary by age: ≤ 5 mL for younger children and 5-10 mL for older children.
- Selection of the vehicle for preparations must consider active substance characteristics and desired organoleptic properties for intended use.
Dosage Accuracy and Taste Management
- High dosage accuracy is achievable when APIs are adequately soluble; alternatives include pH adjustment, co-solvents, or more soluble derivatives like salts or esters.
- It may be challenging to mask unpleasant tastes, affecting palatability.
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Description
This quiz explores the characteristics and challenges of oil-in-water dispersions in pharmaceutical applications. It covers APIs in various forms, their solubility, and the issues regarding emulsion stability and dosage accuracy. Test your understanding of formulation techniques and their impact on drug delivery.
