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802 > Lecture 12 > Flashcards

Lecture 12 Flashcards

Capsules

1
Q

Capsules

A
  • Solid dosage forms containing drug/excipients in a “shell”
  • Shells can be made of gelatin, cellulose, or other suitable substances
  • Shells can be hard or soft
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2
Q

Capsule Uses (3)

A
  1. Oral - swallowed whole (most common)
  2. Sprinkle on food - good for those with trouble swallowing (Ex: Theo-dur, Feverall sprinkles)
  3. Inhalation - Ventolin Rotocaps, Intal capsules
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3
Q

Gelatin Physiochemical Properties

A
  • Obtain from partial hydrolysis of collagen (retrieved from skin, connective tissue, or bones of cows and pigs)
  • Stable in dry air, microbial decomposition when moist or in solution
  • Insoluble (swellable) in cold water
  • Soluble in hot water and gastric fluid
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4
Q

Hard Gelatin Capsules

A
  • Basic formulation - gelatin, sugar, water (13-16%)
  • Optional additions - colorants and opacifiers (opacity)
  • 2 piece design - capsule body and shorter cap, “locking mechanism”
  • Purchased as empty capsules
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5
Q

Manufacturing of Hard Gelatin Capsules

A
  • Dipping metal pins into gelatin solution
  • Defects - sizing/joining, external grease, bubbles, uneven cuts
  • Must control levels of humidity (too dry or too sticky) and water sources (clean or purified) in manufacturing process
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6
Q

Advantages of Hard Gelatin Capsules (5)

A
  1. Rapid dissolution in stomach and lack of powder compaction (good bioavailability)
  2. Flexibility of contents (powder, liquid, pellets)
  3. Protection against light (if opaque) and oxygen (if sealed)
  4. No taste. Non direct contact with tongue
  5. Good patient compliance
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7
Q

Disadvantages of Hard Gelatin Capsules (6)

A
  1. Potential adhesion to esophagus
  2. Not suitable for hydrolytic, deliquescent, or hydroscopic drug (absorbs water out of shell)
  3. Cost (drug + shell)
  4. Filling equipment - slower than tablets (adds to cost)
  5. Not suitable for vegetarian patients and patients with religious restrictions
    * *6. Problems with powder blending (homogeneity) and flow)
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8
Q

HGC Appearance Variations

A
  • Color
  • Opacity
  • Size (4-00) - 4 is smallest and 00 is largest
  • Printing
  • Flavors
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9
Q

HGC Shape Variations (4)

A
  1. Conventional - rounded at the ends
  2. Pulvule - tapered at one end
  3. Spansule - tapered at both ends
  4. DB Capsule - used in overencapsulation, larger diameters and capsule cap
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10
Q

Types of Fills for HGC

A
  • Solids - powders, granules, pellets, tablets, capsules
  • Semisolids - thixotropic mixtures, thermosoftening mixtures, pastes
  • Liquids - oily, suspensions, solutions
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11
Q

Amount of Fill Dilemma

A

More you put into the capsule, the great risk of non homogeneous mixture and the longer it takes to make up.

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12
Q

Band-Seals

A
  • Gelatin used to seal around the cap/body joint
  • Necessary for liquid-filled products (prevents leaking)
  • Optional for solid filled. Ex: Benadryl “Kapseal”
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13
Q

Use of Inactive Ingredients in HGC

A
  • Only use when necessary

- Use filler/diluent, disintegrant, glidant, lubricant to fill capsules in addition to API

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14
Q

HGC Blending & Filling Process

A
  • Add ingredients and mix well
  • Add lubricant and don’t mix as vigorously
  • Add powder blend to empty capsules
  • Goes through deduster
  • Inspected and weighed
  • Rejects separated out and approved, finished capsules are packaged
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15
Q

Mechanisms of Filling HGC (4)

A
  1. “Punch” filling powders in HGC for a small number of capsules
  2. Hand operated capsule filling machines - larger quantities than punch filling
  3. Semi-automatic Machines
  4. Automatic Machines
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16
Q

Do you need tap density or bulk density for calculating minimum capsule sizes?

A

Tap Density

17
Q

Vegetable-Based Capsules

A
  • Cellulose derivative (HPMC)
  • Strength mechanism isn’t dependent on residual water
  • Less residual water in shell and absorbs less water out of atmosphere
18
Q

NCE

A

New Chemical Entity

19
Q

Methods to Minimize Contact with Incompatible Materials (3)

A
  • *When necessary**
    1. Add more diluent
    2. Put small capsule or tablet in a larger capsule with other API/excipients
    3. Produce granules from one API & mix with other API and excipients
20
Q

Soft Gelatin Capsules

A
  • Characteristically flexible - platicizer (not water) in shell
  • Wide ranges of shapes - oblong, spherical, tube-shaped, elliptical, etc.
  • Fill material, usually liquid
  • Capsules are generally prepared, filled, and sealed in continuous operation via a Rotary Die Process
  • Filling and Sealing occurs simultaneously
21
Q

SGC Applications (5)

A
  1. Oral - swallow whole, chewable, lozenges, Delayed-Release (EC)
  2. Rectal/vaginal suppositories - use moisture to dissolve
  3. Opthalmic and topical
  4. Cosmetics
  5. Other
22
Q

SGC Advantages (9)

A
  1. Good for low melting solids
  2. Good/enhanced bioavailability
  3. Tamper evident
  4. Easy to swallow
  5. Content uniformity (overcomes homogeneity issues, especially in low dosing)
  6. Taste and odor masking
  7. Fast onset of action
  8. Protects against oxygen and light (opacifier)
  9. Overcomes certain tableting problems
23
Q

SGC Disadvantages (2)

A
  • *Same disadvantages pertaining to water in shells**
    1. Specialized equipment - increases cost since you need contract manufacturers to produce this dosage form, still must control humidity and water source
    2. More intimate contact between shell and fill (liquid)
24
Q

Dynamic Nature of SGC Shell

A
  • Water can get into shell AND fill
  • Plasticizer can go in and out of shell
  • Drug can precipitate out and not be in solution
25
Q

How to deal with dynamic nature of SGC Shell

A
  • Choose plasticizer that won’t evaporate out (water)

- Pick fillant liquids that don’t evaporate out (not aqueous based)

26
Q

Composition of SGC Shell

A
  • Gelatin
  • Plasticizer - glycerin, propylene glycol, sorbitol
  • Preservatives
  • Colorants - opacifiers, dyes, lakes
  • Residual moisture - 6-10%
27
Q

Liquids Used in SGC

A
  • Water immmiscible volatile or non-volatile (can’t leave fill to enter shell) Ex: vegetable oil, hydrocarbons (mineral oil), medium triglycerides
  • Water miscible nonvolatile - PEG 400/600. Can enter shell but not atmosphere
  • Fill liquids can affect drug absorption rate
28
Q

Requirements of SGC Fills

A
  • pH - 2.5-7.5
  • Low water concentrations (<5%)
  • Drug - not soluble in water but is chemically stable
  • Use of ethanol in as a cosolvent in special packaging (aluminum blister pack)
  • DON’T use aldehydes and aqueous emulsions
29
Q

Filling Liquids in HGC

A
  • Alternative to SGC
  • Advantages - all SGC advantages and well as having possible in-house development (cost/time)
  • Disadvantages - same as SGC plus having physical/chemical stability
30
Q

Dispensing Capsules

A
  • Stored in cool, dry place
  • Bulk package - manually count desired quantity before dispensing (counting tray)
  • Unit dose packaging/strip packaging - hospitals, nursing homes, OTC allergy/cold/cough medicines
31
Q

Counting Devices (3)

A
  1. Counting Trays
  2. Electronic Sensors
  3. Baker Cell

Cleaning = important consideration

802 (14 decks)

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