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Ceutics Exam 2, Part 1
Powders and Granules, Capsules
46
Pharmacology
Professional
02/13/2012

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Cards

Term
Are powders often used as a dosage form?
Definition
No. Powders are usually part of other dosage forms, such as tablets or suspensions
Term
Define excipient
Definition
The majority of a powder, used to dilute the drug, make it measurable, and provide desired qualities
Term
Define comminution
Definition
Reducing particle size
Term
List three small-scale ways to reduce particle size
Definition
1. Mortar and pestle
2. Levigation (if semi-solid)
3. Ball milling
Term
List three large-scale ways to reduce particle size
Definition
1. Hammer Mill
2. Fitzmill
3. Airjet mill (attrition)
Term
Define levigation
Definition
Mixing powder into a little liquid to make a paste for easier addition with an ointment base
Term
How does the ball milling process work?
Definition
A large rotating cylinder filled with ceramic/steel balls and as much as 100g powder crush powder size as small as 50μm depending on milling time
Term
How does a Hammer Mill work?
Definition
Powder is fed into a mill with a hammer inside. Powder can be reduced as small as 50μm depending on feed rate, mill speed, and the size of the screen at the bottom for powder to fall out.
Term
How does a Fitzmill work?
Definition
Similar to a hammer mill, but instead of a hammer there are blades.

The blades can make different particle shapes and sizes.
Term
How does rotor speed in a mill affect particle size?
Definition
Higher rotor speeds lead to smaller particles
Term
How do Air Jet (attrition) Mills work?
Definition
It's a continuous process where opposing air jets (operating at 100psig) and a cyclone separator direct products to a filter and a collector.

A cyclone separator acts as the mesh once the size is small enough.

Particle size 1-5μm (very small!)
Term
What four qualities affect what blending procedure you should use?
Definition
1. Amount of powder
2. Powder properties
3. Time of blending
4. Procedure of blending

(How much? What? How long? How?)
Term
What are some limits of tumbling mixing?
Definition
1. Powder segregation
2. Sifting or percolation
3. Air entrapment (fluidization)
4. Particle entrapment (dusting)
Term
What are the three types of blends?
Definition
1. Segregated
2. Perfect
3. Random
Term
If a powder is mixed for a very, very long time, does this guarantee a perfect mixture blend?
Definition
No, it could end up as a random blend. Some powders, if tumbled too long, start to segregate.
Term
List three types of tumbling mixers
Definition
1. V-mixer
2. Double cone
3. Rotating cube

All have the same principle, the shape rotates around an axis
Term
What is a ribbon blender? What are its advantages?
Definition
It is like other shape tumblers, but have helical ribbons running through it that help prevent air pockets
Term
List the groups of powders that are given in powder dosage form
Definition
1. Bulk powders (laxatives, antacids, douce, external)

2. Divided (individual doses in paper)

3. Powders for inhalation
Term
What four types of paper can divided powders be put into?
Definition
1. Simple bond
2. Vegetable parchment
3. Glassine ("the best one")
4. Waxed
Term
What is usually the blend ingredients and blend proportion for inhalation powders?
Definition
<5μm active drug to >40μm of carrier (usually lactose)
Term
What are some reasons why aggregation would be favorable for powder dosage forms?
Definition
1. More free flowing
2. Mixtures don't separate
3. Easier to dose by volume
4. Reduces "dust"
5. Improves compression characteristics
6. Improves appearance
Term
Define granulation
Definition
Process of size enlargement where small particles are gathered together into larger permanent aggregates to render them into a free-flowing state
Term
List the steps of wet granulation extrusion
Definition
1. Moisten powder
2. Extrude through a mesh
3. Dry
Term
How does spray drying granulate powder?
Definition
Based on the Venturi/Nernoulli principle, compressed gas is blown through the powder in solution to make droplets of powder
Term
List the steps of dry dense sheet granulation
Definition
1. A roller compactor (chilsonator) presses powder into dense sheets
2. A mechanical granulator mills it to the correct size
Term
List the steps of dry slugging granulation
Definition
1. Coarse tablets or slugs are laid flat
2. Slugs are granulated to desired particle size
Term
List some examples of commercial granules
Definition
1. Antibiotics or oral suspension
2. Antacids
3. Electrolyte flavor packs
Term
Define effervescent granulated salts
Definition
Coarser powders containing active ingredient in a dry mixture containing a "bubbling agent" such as sodium bicarbonate

Masks taste and dissolves faster
Term
How are effervescent granulated salts manufactured?
Definition
Either as a wet method (but using alcohol as the wetting agent) or a normal dry method to remove crystallizing water (results in spongy powders)
Term
Define capsules
Definition
Solid dosage forms in which the drug substance is enclosed in either hard or soft, soluble container or shell of a suitable form of gelatin
Term
What are some advantages of capsules?
Definition
-Easier to swallow than tablets
-Can be prepared "extemporaneously"
-Dosage form of choice in clinical trials (easy to double-blind)
Term
What makes up the outer coating of capsules?
Definition
-Gelatin (hard or soft)
-Sometimes methylcellulose, calcium alginate, or DRcaps Gastro Resistant Capsules
Term
How is gelatin manufactured?
Definition
1. Derived from skin or bone
2. Acid or alkali treatment
3. Filtered
4. Vacuum conentration
5. Cooled to solidify
6. Air dry
7. Mill to size
Term
How is gelatin formed into hard capsule shapes?
Definition
Mechanical dipping of metal (bronze) pins and pegs of desired shapes into the gelatin solution, then the pegs are dried and trimmed

1. Initial shells dried
2. Bodies and caps fitted
3. Final caps and bodies
4. NB colorant for color and titanium oxide for opacity
Term
In a hard gelatin capsule shell, what gives color? What gives opacity?
Definition
Dye- NB colorant
Opacity/shine- titanium oxide
Term
List some excipients that can be added to capsules
Definition
1. Glidant (eg silicon dioxide)
2. Lubricant (eg magnesium stearate)
3. Bulking agent (eg lactose)
4. Surfactant (eg sodium dodecyl sulfate)
5. Diluent/Absorbent (Kaolin)

-Not all of these are necessary in every capsule
Term
What is the role of an absorbent in a capsule?
Definition
To absorb water, capsule shells aren't very good at preventing water
Term
What three things can influence the needed capsule size?
Definition
1. Quantity of formulation required
2. Bulk density
3. Compressibility

-No strict rules apply, individual needs can be addressed
Term
How does capsule number correspond to capsule size?
Definition
From largest to smallest:

000, 00, 0, 1, 2, 3, 4, 5
Term
What are the steps of a machine filling a capsule?
Definition
1. Put capsules in machine
2. Rectification (put them vertically)
3. Separate capsules
4. Fill capsules
5. Join capsules
6. Discharge
Term
Describe four methods for a machine to fill capsules
Definition
1. Reservoir: pegs press powder into capsules

2. Auger: a drill pushes powder in for uniformity

3. Tamping: like reservoir, but multiple taps

4. Compression: ?
Term
List four ways for capsules to be sealed
Definition
1. Spot welded with heated metal pin

2. Bonded with molten gelatin

3. Snap fit

4. Coni-snap
Term
Are hard shell or soft shell capsules more common?
Definition
About 80% of capsules are hard shell
Term
What ingredients do soft gelatin capsules contain?
Definition
Shells of gelatin, glycerin, or sorbitol

(to induce plasticity)
Term
List two methods to manufacture soft capsules
Definition
1. Die process: (Rotary/Reciprocating) presses medicine into a capsule

2. Plate molds
Term
What is the range of quality control for weight of a capsule?
Definition
Each capsule must be within 85-115% of goal
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