PHA 327 - Exam 2 - Capsules 1
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What is the final step in filling hard capsules?
Dusting off exterior powders and polishing
What three methods exist for finishing hard capsules?
- Cloth Dusting
- Pan polishing
What does it mean to “finish” a hard capsule?
Clean and polish the exterior
Describe finishing a hard capsule by Cloth Dusting:
Rub capsules with a cloth using a cloth that may or may not be impregnated with an inert oil
Describe finishing a hard capsule by brushing:
Capsules are fed into a machine with rotating brushes, accompanied with a vacuum
Describe finishing hard capsules by pan polishing:
Capsules are polished in a coating machine that is lined with either polyurethane or cheese cloth
What is an Accela-Cota?
A Coating machine for polishing hard capsules
What are soft capsules primarily made of?
- Gelatin with plasticizers like: polyols (sorbitol, propylene glycol) and glycerol
How many pieces do soft capsules have?
1 piece construction
What type of capsule is made of gelatin and plasticizers?
Name plasticizers (as presented in class) that could be added to soft capsules:
- Polyols (sorbitol or propylene glycol)
What four advantages were listed in class for Soft gelatin capsules?
- Make liquids portable
- Accuracy and uniformity of a liquid dose
- Higher bioavailability than tablets or hard capsules
- Good for oxidation prone drugs
What type of capsule would you choose for a drug that is prone to oxidation?
A soft capsule
What type of capsule would you choose for a liquid drug?
A soft capsule
What are disadvantages to Soft Gelatin Capsules?
- May stick to each other
- Greater tendency for drug/shell interactions
Which type of capsule is more expensive?
Which type of capsule has a greater chance of having a shell/drug interaction?
Soft Shell Capsules
What dosage forms can Soft gelatin capsules be used for?
- Oral dosage
- Single dose formulations of topical and ophthalmic medications
Describe how soft gelatin capsules are made:
Two sheets of gelatin are molded and sealed together after the drug has been inserted between them
How many machines are required for soft capsule production?
How many machines are needed for hard capsules production?
What variations in product exist for soft capsules?
Size, Shape and Color
What peripheral additives may be included in Soft Gelatin Capsules?
- Coloring agents
- Opacifying agents
What determines the hardness of a soft gelatin capsules?
The ratio of plasticizer weight to gelatin weight
The ratio of plasticizer weight to gelatin weight is a determinant for what?
The hardness of a soft gelatin capsule
For most soft gel capsule formulations what is the ratio of Water:Gelatin?
What is the range of Water:Gelatin used in soft gel capsules?
What determinant was discussed in class as a factor for selecting a Water:Gelatin ratio for soft gel caspules?
The viscosity of the Gelatin used
What can you adjust in your soft shell capsule formulation to account for differences in viscosity between gelatins?
Water (0.7-1.3 water :1gelatin)
What is the purpose of Methylparaben:Polybaraben (4:1) 0.2% conc. In a soft gel cap?
What preservative for soft gel caps was presented in class?
Methylparaben:Polyparaben (4:1) 0.2%
What concentration Of Methylparaben:Polyparaben 4:1 is used in soft gel caps for preservative effect?
What is the purpose of adding titanium dioxide to a soft gel cap at a conc. of 0.2-1.2%?
What opacifier for soft gel caps was presented in class?
What concentration of Titanium dioxide can be used in soft gel caps to enhance opacity?
What is the purpose of adding Ethyl Vanillin to soft gel caps at a conc. of 0.1%?
What flavoring for soft gel caps was presented in class?
What concentration of ethyl vanillin would be appropriate for flavoring soft gel caps?
What is the purpose of adding sugar (sucrose) to soft gel caps at a conc. of 5%?
What taste enhancer was presented for use in soft gel caps?
What concentration of sugar can be added to soft gel caps to enhance the taste?
What is the purpose of adding Cellulose acetate at a conc. of 4% to soft gel caps?
What component can be added at a conc. of 4% to soft gel caps to create an enteric coating?
What conc. of Cellulose acetate is useful for creating an enteric coating on soft gel caps?
What is the purpose of adding Fumaric acid, up to 1% to soft gel caps?
What would you add to soft gel caps to aid solubility?
What conc. of Fumaric acid would you add to soft gel caps to aid solubility?
Up to 1%
What would you like to do?
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