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Questions and Answers
What is the primary purpose of making a powder triturate?
What is the primary purpose of making a powder triturate?
Which container is most commonly used for bulk topical powders?
Which container is most commonly used for bulk topical powders?
Why is it important to calculate for one extra chart when preparing divided powders?
Why is it important to calculate for one extra chart when preparing divided powders?
What is the ideal total amount of powder per chart when preparing divided powders?
What is the ideal total amount of powder per chart when preparing divided powders?
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What is called the method used for minimal comminution of powders on ointment paper?
What is called the method used for minimal comminution of powders on ointment paper?
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What may happen if the amount of powder prepared for a divided powder is too small?
What may happen if the amount of powder prepared for a divided powder is too small?
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Which of the following methods is NOT one of the recommended blending methods for powder mixtures?
Which of the following methods is NOT one of the recommended blending methods for powder mixtures?
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What is the common outcome during the processing of powders that needs to be factored into calculations?
What is the common outcome during the processing of powders that needs to be factored into calculations?
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What is the primary purpose of overfilling the mold cavities during the double casting technique?
What is the primary purpose of overfilling the mold cavities during the double casting technique?
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Why is it crucial to avoid overheating the suppository base?
Why is it crucial to avoid overheating the suppository base?
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What is the first step in the double casting technique?
What is the first step in the double casting technique?
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What method can be used to ensure the powder does not agglomerate when mixing with the melted base?
What method can be used to ensure the powder does not agglomerate when mixing with the melted base?
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How should suppositories made with fatty-acid bases be stored?
How should suppositories made with fatty-acid bases be stored?
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What is recommended when dispensing individual suppositories?
What is recommended when dispensing individual suppositories?
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What temperature should the water bath be maintained at when preparing the suppository base?
What temperature should the water bath be maintained at when preparing the suppository base?
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What happens if suppositories are frozen during cooling?
What happens if suppositories are frozen during cooling?
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What is included on the label when dispensing suppositories?
What is included on the label when dispensing suppositories?
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What is the USP beyond-use date for suppositories stored at controlled room temperature?
What is the USP beyond-use date for suppositories stored at controlled room temperature?
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What is the purpose of grinding coarse particles when mixing with smaller particles?
What is the purpose of grinding coarse particles when mixing with smaller particles?
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Which method is recommended for comminuting and mixing powders simultaneously?
Which method is recommended for comminuting and mixing powders simultaneously?
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What characteristic of the mortar is important when using a porcelain mortar?
What characteristic of the mortar is important when using a porcelain mortar?
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What mixing technique is used to help prevent the powder from embedding in the mortar?
What mixing technique is used to help prevent the powder from embedding in the mortar?
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What is geometric dilution primarily used for?
What is geometric dilution primarily used for?
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Which of the following is a downside of using folded powder paper?
Which of the following is a downside of using folded powder paper?
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What should be considered when determining the beyond-use date for powders?
What should be considered when determining the beyond-use date for powders?
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What is a significant characteristic of hygroscopic ingredients regarding packaging?
What is a significant characteristic of hygroscopic ingredients regarding packaging?
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Which risk is associated with using a glass mortar that has a coarse interior?
Which risk is associated with using a glass mortar that has a coarse interior?
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Which hazard is NOT recognized by NIOSH for hazardous drugs?
Which hazard is NOT recognized by NIOSH for hazardous drugs?
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What is the most recent USP dating for dry powders at controlled room temperature?
What is the most recent USP dating for dry powders at controlled room temperature?
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When performing geometric dilution, what is critical at each addition stage?
When performing geometric dilution, what is critical at each addition stage?
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Which mixing motion is recommended for achieving better homogeneity?
Which mixing motion is recommended for achieving better homogeneity?
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Why is it important to calculate for extra volume when preparing oral solutions?
Why is it important to calculate for extra volume when preparing oral solutions?
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What technique is used to increase the surface area of powders for faster dissolution?
What technique is used to increase the surface area of powders for faster dissolution?
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What is a potential effect of using excess levigating agent when preparing solutions?
What is a potential effect of using excess levigating agent when preparing solutions?
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When preparing elixirs, how should the components be combined?
When preparing elixirs, how should the components be combined?
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What should be done when using viscous vehicles during solution preparation?
What should be done when using viscous vehicles during solution preparation?
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What is the purpose of washing the mortar with the vehicle?
What is the purpose of washing the mortar with the vehicle?
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What kind of vehicle is recommended for use in oral suspensions?
What kind of vehicle is recommended for use in oral suspensions?
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What is the recommended beyond-use date for oral liquids stored in controlled cold temperatures?
What is the recommended beyond-use date for oral liquids stored in controlled cold temperatures?
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When making suspensions, what should be noted about thixotropic liquids?
When making suspensions, what should be noted about thixotropic liquids?
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What is critical to check before dispensing a suspension?
What is critical to check before dispensing a suspension?
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What should be considered when choosing a mold for suppositories?
What should be considered when choosing a mold for suppositories?
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What is the significance of calibrating molds for suppositories?
What is the significance of calibrating molds for suppositories?
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Why is it essential to record the physical and chemical properties of the drug?
Why is it essential to record the physical and chemical properties of the drug?
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What is a primary engineering control in the handling of hazardous drugs?
What is a primary engineering control in the handling of hazardous drugs?
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What must be true about the rooms that house primary engineering controls?
What must be true about the rooms that house primary engineering controls?
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What is the purpose of calculating enough formulation for two extra capsules?
What is the purpose of calculating enough formulation for two extra capsules?
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How should capsule bodies and caps be handled when using a capsule-filling machine?
How should capsule bodies and caps be handled when using a capsule-filling machine?
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What should be done to ensure capsule weight falls within the desired range?
What should be done to ensure capsule weight falls within the desired range?
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What is the maximum beyond-use date for capsules under USP guidelines at controlled room temperature?
What is the maximum beyond-use date for capsules under USP guidelines at controlled room temperature?
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Which factor affects the selection of the capsule size and color for a patient?
Which factor affects the selection of the capsule size and color for a patient?
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What is a common vehicle for oral liquids?
What is a common vehicle for oral liquids?
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Why is weight accuracy important in capsule preparations?
Why is weight accuracy important in capsule preparations?
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How is stability information relevant to the beyond-use date of capsules?
How is stability information relevant to the beyond-use date of capsules?
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To avoid degradation, which form of a drug should be preferably used in oral solutions?
To avoid degradation, which form of a drug should be preferably used in oral solutions?
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What is one way to clean finished capsules?
What is one way to clean finished capsules?
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What should be done after determining the fill weight of a capsule?
What should be done after determining the fill weight of a capsule?
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Why should the solubility information be checked for the correct drug form?
Why should the solubility information be checked for the correct drug form?
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Study Notes
Powder Triturate
- A powder triturate is a mixture of a small amount of dye and a large amount of lactose.
- It's used as a starting point for other preparations like powders and capsules.
- The purpose is to practice mixing powders effectively.
Powder Preparations
Bulk Powder
- Sifter cans are common containers for bulk topical powders.
- Topical powders are usually labeled as percent weight per weight.
Divided Powders
- Divided powders are sometimes called "charts" (an older term).
Preparing Divided Powders
- Calculate for one extra chart to account for potential loss during processing.
- Processing loss is common, especially for topical products.
- Ideal powder per chart is 200-500 mg.
- This range prevents excessively small or large doses, aiding handling and minimizing taste issues.
Preparing Powder Mixtures
- After calculation, prepare powder mixtures, including powder triturate.
- Comminute (grind) powders if needed; this is done in a mortar.
- Blend powders using:
- Spatulation: - Use ointment paper (parchment paper). - This method is less effective for comminuting coarse particles. - Mix ingredients of similar size for optimal flow. - Keep powders in a confined area to prevent loss. - Mix from side to side, pressing with spatula.
- Trituration in mortar: - Ideal for comminution and mixing. - Use a high-quality, crack-free mortar, ensuring the porcelain interior isn't excessively smooth (glass should be smooth and shiny). - Geometric dilution can be used if mixing unequal quantities, adding the larger amount to the smaller amount in equal increments and mixing thoroughly each time. - Use circular motions, keeping powder low in the mortar and applying light pressure. (Use more force for comminution). Avoid embedding powders by using diluents with powders.
Important Points About Mixing Powders
- Achieving complete homogeneity is often challenging in powder mixtures.
- Minimize stratification by reducing all ingredients to similar particle sizes.
- Geometric dilution is crucial for mixing powders of similar colors.
- Thoroughly mix at each stage of geometric dilution to ensure even mixing.
- Geometric dilution is especially important when combining powders in unequal quantities.
- For complete mixing, mix in all dimensions (up and down).
Packaging Divided Powders
- Weigh each dose of divided powder individually.
- Packaging methods include:
- Folded powder paper: Traditional, but less moisture-resistant than other methods.
- Plastic Ziploc bags: More practical, creating a moisture barrier by sealing bags in vials.
Beyond-Use Dating for Powders
- Beyond-Use dates for powders are based on stability information for each ingredient (e.g. drug).
- Be mindful of factors like photo-oxidation, hydrolysis, and hygroscopicity.
- Use the latest USP dating (180 days at controlled room temperature) if stable or a shorter date if necessary. (Use the shortest stability date of the ingredients and excipients, including containers.)
Working Safely with Hazardous Powders
- USP Chapter 800 covers safe handling of hazardous drugs (NIOSH list).
- Hazardous drugs have potential hazards including various types of toxicity.
- NIOSH list should be checked for updates.
Compounding Capsule Preparations
Capsule Selection
- Choose appropriate capsule size and color for the patient.
- Record the size and color in the records.
Determine Fill Weight
- Fill weight is based on capsule volume and powder density.
Packing Capsules
- Use capsule-filling machines or hand-packing.
Procedures for Filling Capsules
- Calculate for 2 extra capsules for loss.
- Record capsule size/color in the record.
- Separate caps and bodies.
-
Capsule-filling machine methods:
- Place bodies in machine holes, followed by powder, tamping. Rejoin caps and clean the capsules.
-
Hand-packing methods:
- Mix formulation on a hard surface.
- Shape into a square pile. Wear gloves
- Insert formulation into capsule body, then flip, scrape.
- Snap caps, check weight (tare with empty), proceed.
Importance of Weighing Capsules Properly
- Two methods exist for accounting for capsule shell weight:
- Subtract empty capsule shell weight.
- Use empty shell as tare (be mindful of the balance and avoid double taring.)
Quality Control for Capsules
-
Capsule-filling machine methods:
- Accurately weigh capsules, determine if any deviate, calculate mean, standard deviation, and relative standard deviation (target < 6%).
Beyond-Use Dating for Capsules
- Beyond-use dates are based on stability data and ingredient expiration dates.
- USP recommends a beyond-use date of 180 days at controlled room temperature.
Oral Liquids
Oral Solutions
Preliminary Work
- Investigate drug solubility in the vehicle (often water).
- Confirm solubility data for correct drug form. (e.g. acid or salt form).
- Carefully review stability.
Procedures for Preparing Oral Solutions
- Calculate for 2-3 extra solutions due to loss.
- Dissolve ingredients (accelerate by trituration or levigation with a water miscible agent carefully).
- Add vehicle to a graduate, add washings to transfer the entire substance, reach final volume, and mix thoroughly with a stir rod.
- Inspect for clarity and absence of undissolved matter.
- Dispense into appropriate bottle, with labeling for refrigeration if needed.
Potentially Useful Tips
- Dissolve the ingredients in water (if viscous vehicle) first, then add the remaining solution.
- Add high-viscosity liquids to low-viscosity liquids with constant stirring.
- For elixirs, dissolve alcohol-soluble and water-soluble components separately, then combine.
- Solutions should be clear and crystal-free, with pH checked.
Oral Suspensions
Preliminary Work
- Determine the drug's solubility in the vehicle.
- Verify solubility data for the specific drug form and include potential hydrates.
- Record viscosity, particularly for suspending agents like methylcellulose.
Procedures for Preparing Oral Suspensions
- Add extra volume to account for loss (e.g. 30%).
- Mix powders and levigate if needed.
- Mix with vehicle incrementally , transferring the mortar washings.
- Bring to final volume and mix thoroughly.
- Fill an appropriate bottle, ensuring headspace for shaking if necessary.
- Label for refrigeration and shaking.
Quality Control for Suspensions
- Assure dosage uniformity.
- Visually assess viscosity (viscous or non-viscous, noting thixotropy).
- Check and record the pH.
- Make extra batches to check settling or caking if needed.
- Avoid extreme temperatures to prevent Ostwald ripening.
Beyond-Use Dating for Oral Liquids
- Beyond-use dates depend on ingredient stability and expiration dates.
- USP recommends 14 days refrigerated, or 35 days if preservatives are present.
Suppositories
Preliminary Work
- Drug powder is preferred.
- Note physical-chemical properties (solubility).
- Select the appropriate base from the prescription.
- Prepare and calibrate the mold.
Mold Choices
- Aluminum molds are commonplace (cavities around 2 mL, pediatric sizes around 1.3 mL).
Calibration of Molds
- Calibration is important for determining the amount of base required and to monitor dosage accuracy (consider the volume occupied by non-base ingredients).
- If the drug dose is small, the pharmacist can assume the volume is negligible.
- If the base and drug densities are equal, the total weight of drug can be subtracted from the total weight of the base.
Double Casting Technique
- Useful for suppositories made only once or a limited number of times without calibrating the mold
- Steps involve a two-stage melting process to result in a homogenous mix
Procedures for Making Suppositories
- Base Preparation:*
- Use a water bath at ~60°C to control heat and limit temperature overshooting for stability.
- Use the least heat possible to prevent ingredient degradation and increase the melting point. Viscosity should be manageable
- Drug/Excipient Preparation:*
- Reduce powders to uniform particle size, without agglomeration.
- Mixing:*
- Mix drug, excipients, and base thoroughly (use levigation if necessary to prevent agglomeration).
- Molding:*
- Fill cavities completely or add a slight excess for contraction.
- Pour mixture close to its solidification point.
- Cooling & Finishing:*
- Place in refrigerator (avoid freezing for brittle suppositories);
- Trim excess base (warm spatula if needed).
- Dispensing and Labeling:*
- Wrap suppositories individually as needed.
- Label packages with instructions such as moistening if needed, method (rectal, vaginal).
Storage and Beyond-Use Dating for Suppositories
- Store at controlled room temperature or refrigerated.
- Fatty-acid base suppositories are usually refrigerated.
- USP allows 180 days at controlled room temperature or refrigeration. (Pharmacies might make a decision to have a shorter date for other precautions).
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Description
This quiz covers essential concepts in powder preparations, focusing on triturates, bulk powders, and divided powders. It also emphasizes the importance of calculations and handling techniques in pharmacy practices. Test your knowledge on mixing, measuring, and preparing various powder forms.