Questions and Answers
Which of the following methods is involved in comminution?
What is a solution?
A solute dissolved in a solvent.
What defines a suspension?
What is the purpose of an emulsifier in an emulsion?
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What happens during precipitation/sedimentation?
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Which factor affects the dissolution rate of a solute?
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What are the two methods to prepare emulsions mentioned?
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What is the primary purpose of glidants in powders?
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What is the maximum Beyond Use Date (BUD) for oral solutions prepared with water?
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What do the terms 'hand molding,' 'fusion molding,' and 'compression molding' refer to?
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The high-risk sterile compounding uses only sterile ingredients and equipment.
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Which of the following is not classified as a low-risk sterile compounding?
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Study Notes
Compounding Definitions and Techniques
- Comminution: Reducing particle size through grinding, crushing, or milling.
- Trituration: Thorough mixing and grinding, often used for tablets in a mortar and pestle.
- Levigation: Similar to trituration but includes a levigating agent to assist grinding; performed in a mortar and pestle.
- Spatulation: Mixing powders on an ointment slab with a spatula.
- Pulverization by intervention: Dissolves crystalline powders in a solvent, resulting in finer particles upon evaporation.
Solution Preparation
- A solution consists of a solute in a solvent, resulting in a homogeneous mixture such as syrups or elixirs.
- Solubility depends on temperature; Fick's First Law calculates dissolution rates.
- Increasing surface area, stirring, and applying heat can enhance dissolution.
- Solutions may require a buffer for pH stability and preservatives to inhibit microbial growth.
Suspension Characteristics
- A suspension is a heterogeneous mixture of solid particles in a liquid.
- Wetting agents help disperse the solid within the liquid; the mixture should be shaken to re-dispersed easily.
- Stability is key; good suspensions do not rapidly precipitate.
Emulsions and their Preparation
- Emulsions are formed by dispersing one liquid in another, often requiring an emulsifier to lower surface tension.
- The Continental method (dry gum) involves mixing oil, water, and an emulsifier in a specific ratio, trituration until creamy.
- The English method (wet gum) begins with emulsifier and water to form a mucilage before oil is added.
Powders and Excipients
- Excipients enhance powder flowability; glidants like magnesium stearate are commonly used.
- The concept of eutectic mixtures allows components to melt at lower temperatures.
- Adsorbents maintain powder dryness and stability.
Capsule Formulation
- Capsules can be made from gelatin or hypromellose, filled with active compounds and excipients.
- Plasticizers like glycerol ensure capsules are flexible rather than brittle.
Tablets Overview
- Compounded tablets are typically molded, while manufactured tablets are generally compressed.
- Tablets consist of active drugs and additional excipients for stability and usability.
Lozenges and Usage
- Lozenges are designed for local oral medication delivery, featuring various ingredients based on texture.
Ointment Preparation
- Ointments require thorough trituration of powders with an appropriate levigating agent.
- Ingredients are mixed using geometric dilution and, when necessary, heated via the fusion method.
Gels for Drug Administration
- PLO gel incorporates lecithin and poloxamer polymers for transdermal drug delivery, acting as a thermoresponsive gel.
Suppositories Composition and Preparation
- Bases for suppositories can be oil-soluble or water-soluble.
- Manufacturing techniques include hand molding, fusion molding, and compression molding.
Beyond-Use Dates (BUD) Guidelines
- Nonaqueous formulations are to be used before the expiration of the API or 6 months.
- Water-containing oral solutions have a BUD of 14 days under refrigeration.
- Topical preparations have a BUD of 30 days at room temperature.
Sterile Compounding Risk Levels
- Low-risk sterile compounding typically involves 1-3 sterile additives, done in a cleanroom setting.
- Medium-risk sterile compounding introduces more than three sterile additives, increasing contamination risk.
- High-risk sterile compounding involves non-sterile ingredients, requiring subsequent sterilization before use.
BUD for IV Compounding
- Compounded sterile preparations have specific BUDs based on risk; for low-risk products, BUDs at room temperature is 48 hours, while refrigerated conditions allow for 14 days.
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Description
Explore key concepts in the documentation and preparation of compounded medications through this set of flashcards. Learn about critical processes such as comminution, trituration, levigation, and spatulation, which are vital in achieving the desired particle size and consistency in pharmaceutical preparations.
