Brainscape's Knowledge GenomeTM

Browse over 1 million classes created by top students, professors, publishers, and experts.


See full index

PCT 411 > Capsules > Flashcards

Capsules Flashcards

Based on the AOC.

1
Q

What are the stages of the manufacturing process of hard gelatin capsules?

A
  1. Production of the hard gelatin shell
  2. Preparation of the formulation for the filling.
  3. Capsule filling
  4. Capsule sealing
  5. Capsule finishing
  6. Capsule storage
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
2
Q

Briefly discuss the production of hard gelatin shells.

A
  • Dissolve gelatin in demineralised water heated to 60-70°C to form a 30-40%w/v solution.
  • Apply vacuum to remove air bubbles.
  • Add coulourants and pigments to achieve final appearance.
  • Dip stainless steel mold pins in gelatin solution
  • Spin to ensure a uniform layer of gelatin
  • Dry mold
  • Strip capsules from pins
  • Trim caps and bodies
  • Join caps and bodies together.
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
3
Q

What are the raw materials used in gelatin preparation?

A

i. Demineralised water
ii. Gelatin
iii. Colourants
iv. Optional materials e.g flavour

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
4
Q

Mention 5 properties of gelatin that make it suitable for the manufacture of capsules.

A
  1. It is non-toxic
  2. it is soluble in biological fluids at body temperature
  3. It is a good film-forming material
  4. Solutions of high conc (40%w/v) are mobile at 50°C
  5. Undergoes a reversible change from gel to sol at slightly above room temperature.
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
5
Q

What are the properties of gelatin that are most important to capsule manufacturers

A

Bloom strength and viscosity

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
6
Q

What is bloom strength and how is it determined?

A

Bloom strength is a measure of gel rigidity. It is defined as the load (in grams) required to push a standard plunger 4mm into the gel.

It is determined by preparing a standard gel (6.66%w/v) and maturing it to 10°C

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
7
Q

What are the bloom strengths of gelatin used in hard capsules and in soft capsules?

A

Hard capsule: 200-250g
Soft capsule: 150g

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
8
Q

What are the types of dyes used in hard gelatin capsules?

A
  1. Water-soluble dyes
    a. Azo dyes:
    b. Non-azo dyes:
    erythrosine(E127),
    indigo carmine (E132), Quinoline yellow (E104).

2 Insoluble pigments: black, red, yellow iron oxides (E172), titanium oxide (171)

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
9
Q

What is the function of sodium lauryl sulfate in hard capsules?

A

It is a wetting agent.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
10
Q

What are the 3 methods of filling hard capsule?

A
  1. Punch method
  2. Non-automated machine (Felton filling machine)
  3. Automated machine
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
11
Q

Briefly describe the punch method.

A

i. Triturate the ingredients to the same particle size
ii. Mix by geometric dilution
iii. Place powder on ointment slab and smoothen to about half the height of the capsule body
iv. Hold the base of the capsule between the thumb, index and forefinger and repeatedly punch the open end of the capsule body into the powder until the capsule is filled.
v. Weigh each filled capsule using an empty capsule as counter balance
vi. Adjust the content of each capsule accordingly
v. Tap the capsule to remove air spaces.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
12
Q

Briefly discuss the Felton filling machine.

A

Each plate consists of predrilled holes.
i. Empty capsules are fed into the holes.
ii. The bodies are locked in their plate and the caps are removed along with the top plate.
iii. The bodies are released and they drop below their plate surface
iv. Powders are placed on the surface and spread with a spatula to fill the bodies
v. The cap plate is then repositioned over the body plate and the capsules are rejoined by manual pressure.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
13
Q

What are 4 types of seals used in the production of hard gelatin capsules?

A
  1. Gelatin banded seals: involves the use of a coloured band of gelatin.
  2. Heat-welded seals: involves a heat-welding process that fuses the capsule cap to the body through the double wall thickness at their juncture. This results in a distinctive ring around the capsule where heat was applied.
  3. Thermally coupled seals: involves the used of a liquid wetting agent that lowers the melting point in the contact areas of the capsule’s cap and body and thermally bonds the parts using low temperatures. (40-45°)
  4. Industrial capsule seals: produces 60,000-150,000 sealed capsules per hour.
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
14
Q

Cleaning and polishing of hard capsules is done using the _______.

A

Accela-Cota apparatus

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
15
Q

How are hard capsules stored?

A

In well closed containers not exceeding 30°C.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
16
Q

What are soft gel capsules?

A

They are one-piece hermetically-sealed capsules.

17
Q

Mention 5 advantages of soft gels.

A
  1. Improved drug absorption
  2. Pharmaceutical elegance
  3. Easy to swallow
  4. Dose uniformity for low-dose drugs
  5. Good product stability
17
Q

Mention 3 disadvantages of soft gels

A
  1. They are not easily prepared.
  2. They are an expensive dosage form
  3. Increased possibility of interactions due to contact between shell and liquid contents
18
Q

What are the stages of the manufacturing process of soft gels?

A
  1. Gelatin preparation
  2. Fill preparation
  3. Encapsulation
  4. Drying
  5. Inspection, polishing and packaging
19
Q

How is gelatin prepared in soft gel production?

A

Gelatin is dissolved in water at 80°C under a vacuum, followed by addition of a plasticizer, colourant, opacifier and flavours as needed.

20
Q

Give 2 examples of plasticizers used in soft gel preparation.

A
  1. Sorbitol
  2. Glycerol
21
Q

Give an example of opacifier used in soft gel preparation.

A

Titanium dioxide
Conc may be up to 0.5%

22
Q

List 3 methods of encapsulation.

A
  1. Plate process
  2. Rotary die press
  3. Reciprocating die press
23
Q

Briefly describe the rotary die press.

A

Liquid gelatin from an overhead tank forms two ribbons which are brought together between twin rotary dies. At the same time, a well-timed and metered injector injects fill material between ribbons right before they are brought together by the rotary twin dies. They are then sealed by heat and pressure.

24
Q

What 3 parameters require careful control in the rotary die press?

A

Time
Pressure
Temperature

25
Q

Stern machine is an example of ________.

A

A reciprocating die press

26
Q

Describe the drying process of soft gels.

A

They are tumble dried then spread unto trays in a tunnel drier that supplies air at 2% relative humidity.

This process takes 2-3 days or 2 weeks.

27
Q

Give 3 advantages of rotary die process.

A
  1. Capsules come in various shapes and sizes
  2. Different colours on both sides
  3. Wide variety of fills
28
Q

Give 2 disadvantages of rotary die process.

A
  1. Longer drying process
  2. More shell waste material
29
Q

What are the 3 basic morphologies of microcapsules?

A
  1. Mononuclear: shell around a single core
  2. Polynuclear: shell around multiple cores
  3. Matrix encapsulation: core material is distributed homogeneously in the shell material.
30
Q

Mention 5 coating materials used for microencapsulation.

A
  1. Gums: gum arabic, sodium alginate
  2. Carbohydrates: starch, sucrose
  3. Celluloses: carboxymethylcellulose, methylcellulose
  4. Lipids: beeswax, phospholipids
  5. Proteins: gelatin, albumin
31
Q

Mention 5 physical microencapsulation techniques.

A
  1. Spray drying
  2. Spray congealing
  3. Fluidized bed technology
  4. Pan coating
  5. Co-extrusions
32
Q

Mention 5 chemical microencapsulation techniques.

A
  1. Polymerization
  2. Coacervation
  3. Phase separation
  4. Solvent evaporation
  5. Hydrogel microspheres
33
Q

Define Microencapsulation.

A

It is the process by which individual particles or droplets of solids or liquids are coated in a continuous polymeric materials to produce capsules in the micometer to millimetre range called microcapsules.

34
Q

Mention 5 properties of microencapsulation coating material.

A
  1. Inert to active ingredients
  2. Stability
  3. Tasteless
  4. Pliable
  5. Film-forming
  6. Economical
  7. Non-hygroscopic
  8. Soluble in aqueous media
  9. Controlled release under certain conditions
35
Q

Mention 5 applications of microencapsulation.

A
  1. To mask bitter taste of drugs
  2. To reduce GI irritation
  3. To reduce odour and volatility
  4. For hygroscopic materials
  5. To separate incompatible materials
  6. To improve handling and storage
36
Q

Mention 4 advantages of microencapsulation.

A
  1. Targeted delivery at site of action
  2. Controlled release
  3. Targeting of anticancer drugs directly at tumour
  4. Important in determing rate of particles in vivo
37
Q

What is a capsule?

A

A capsule is an edible package made from gelatin or other suitable materials (e.g. HPMC, starch, polyvinyl copolymer) which is filled with medicines to produce a unit dosage form, mainly for oral use.

PCT 411 (3 decks)

Brainscape helps you reach your goals faster, through stronger study habits.
© 2024 Bold Learning Solutions. Terms and Conditions