Capsule Quiz: Hard Capsules and Their Components

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Questions and Answers

Why can formaldehyde not be used with deliquescent or efflorescent materials in capsule manufacturing?

It may cause dryness of the capsule shell due to salts and potassium hydroxide (KOH).

What raw materials are used in the production of empty hard capsules?

Gelatin, colorant, and process aids

From where is gelatin sourced for making capsule shells?

Animal bones and skin

What are the reasons for using gelatin in capsule manufacturing?

It is non-toxic, readily soluble in body fluids, and a good film-forming material. Signup and view all the answers

Why was sodium lauryl sulfate used as a process aid in capsule manufacturing?

To serve as a wetting agent and ensure uniform covering of the moulds with gelatin solutions Signup and view all the answers

Why are preservatives no longer added to empty hard capsules?

They are no longer needed due to modern manufacturing practices. Signup and view all the answers

How are the capsules rejoined after repositioning the cap plate over the body one?

Using manual pressure Signup and view all the answers

What is the dosing system in dependent systems based on?

Using the capsule body to measure the powder Signup and view all the answers

How is the weight of powder filled into the capsule body controlled in dependent systems?

By controlling the speed of rotation of the plate holder Signup and view all the answers

What is placed on top of the body plate that revolves underneath it in dependent systems?

Powder hopper Signup and view all the answers

What are empty capsules fed into in dependent systems before being filled with powder?

Ring holders Signup and view all the answers

What does the capsule filing machine use to separate the caps and bodies in dependent systems?

Vacuum Signup and view all the answers

What is the main difference between Type A and Type B gelatin?

Type A is derived from animal skins while Type B is derived from bovine bones Signup and view all the answers

How is the concentrated solution of gelatin prepared for capsule production?

Using hot demineralized water and stirring until dissolved Signup and view all the answers

What is the purpose of adding dye solutions or pigment suspensions to the gelatin solution?

To give color or appearance to the capsules Signup and view all the answers

How are the films formed during the manufacture of empty capsules?

By dipping pins into the solution and slowly rotating them during transfer Signup and view all the answers

What is the final step in the manufacture of empty capsules after drying the films?

Cutting the dried films into correct lengths and joining them together Signup and view all the answers

What raw materials are often used in manufacturing pharmaceuticals, as mentioned in the text?

Raw materials obtained from animal sources such as bovine origin Signup and view all the answers

What is the maximum temperature range used for thermally bonding the two parts of a hard gelatin capsule?

40°C to 45°C Signup and view all the answers

Which of the following is NOT a limitation for materials that can be filled into hard gelatin capsules?

The material must have a high level of free moisture Signup and view all the answers

Which of the following types of materials can be filled into hard gelatin capsules?

Dry solids, semisolids, and nonaqueous liquids Signup and view all the answers

What is the first step in the process of filling hard gelatin capsules using a capsule filling machine?

Rectification Signup and view all the answers

What is the purpose of the 'rectification' step in the capsule filling process?

To orient the empty capsules to point in the same direction Signup and view all the answers

Which of the following methods is described for bench-scale filling of hard gelatin capsules with powder?

Using predrilled plastic plates to hold the capsules Signup and view all the answers

What is the relationship between the number of capsule sizes and the body volume?

The body volume decreases with increasing number of capsule sizes Signup and view all the answers

Which of the following is the simplest way to estimate the fill weight for a powder?

Multiplying the bulk tapped density by the capsule body volume Signup and view all the answers

How are filled capsules sealed to prevent them from coming apart during the filling and packaging process?

They are sealed through a heat-welding process that fuses the cap to the body Signup and view all the answers

What was the main reason for the introduction of self-locking capsules?

To prevent the filled capsules from coming apart and spilling their contents during the filling and packaging process Signup and view all the answers

What is the relationship between the specific gravity of a liquid and the fill weight of a liquid-filled capsule?

The fill weight is calculated by multiplying the specific gravity of the liquid by the capsule body volume and then multiplying by 0.8 Signup and view all the answers

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Study Notes

Formaldehyde and Deliquescent Materials

Formaldehyde cannot be used with deliquescent or efflorescent materials
Deliquescent materials (e.g. KOH, salts) may cause dryness of the capsule shell
Efflorescent materials (e.g. borax) may cause softening of the capsule shell

Hard Capsules

Manufactured empty and then filled with product
Raw materials used in empty capsules:
- Gelatin
- Colorant (water-soluble dyes or insoluble pigments)
- Process aids (e.g. sodium lauryl sulfate, not more than 0.15%)

Gelatin

Main constituent of capsule shell
Sources of gelatin: collagen of animal bones and skin
Reasons for using gelatin:
- Nontoxic and widely used in food
- Readily soluble in body fluids
- Good film-forming material
- Solutions at high concentrations are mobile at 50°C

Capsule Sizes and Filling

Capsule size and body volume:
- Size 0: 0.69 ml
- Size 1: 0.50 ml
- Size 2: 0.37 ml
- Size 3: 0.28 ml
- Size 4: 0.20 ml
Fill weight calculation:
- For powders: bulk tapped density x body volume
- For liquids: specific gravity x body volume x 0.8

Capsule Locking (Sealing)

Methods of sealing:
- Colored band of gelatin
- Heat-welding process
- Liquid wetting agent and thermal bonding

Capsule Filling Materials

Types of materials for filling:
- Dry solids
- Powders
- Pellets
- Granules
- Tablets
- Semisolids
- Thixotropic mixtures
- Pastes
- Liquids
- Nonaqueous liquids

Capsule Filling Machines

Basic operations:
- Rectification
- Separation
- Filling
- Closing
- Ejection
Types of machines:
- Bench scale filling
- Industrial scale filling
Dependent systems:
- Dosing system uses the capsule body to measure the powder
Independent systems:
- Powder is measured independently of the capsule body volume

Gelatin Types

Type A gelatin:
- Derived by acid treatment of the precursor
- Takes 7-10 days for preparation
- Mainly for animal skins
Type B gelatin:
- Obtained by alkali treatment of the precursor
- Takes 10 times as long as Type A
- Mainly for bovine bones

Manufacture of Empty Capsules

Steps:
1. Concentrated solution of gelatin (35-40%) is prepared
2. Solution is stirred until gelatin has dissolved and vacuum is applied
3. Dye solutions or pigment suspensions are added
4. Viscosity is measured and adjusted
5. Pins of machine are dipped into the solution and slowly withdrawn
6. Films are dried by blowing air over the pins
7. Dried films are removed from moulds, cut to correct length, and joined together

Hard Capsules and Their Components Quiz

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