Hard Capsules Manufacturing and Filling Process
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Questions and Answers

What is the purpose of sodium lauryl sulfate in the manufacturing of hard capsules?

  • To serve as a colorant
  • To function as a wetting agent (correct)
  • To harden the capsule shell
  • To act as a preservative

Why are preservatives no longer added to empty capsule shells?

  • Because they make the capsules hard to swallow
  • To prevent reactions with gelatin
  • Preservatives were formerly used but are not added now (correct)
  • Due to their bitter taste in the capsule shell

Which type of colorant can be used in the manufacturing of empty hard capsules?

  • Insoluble pigments
  • Water-soluble dyes (correct)
  • Water-insoluble dyes
  • Soluble pigments

Why is gelatin a preferred material for capsule shells?

<p>Because it is a good film-forming material (A)</p> Signup and view all the answers

What is the role of gelatin in the manufacturing of capsule shells?

<p>To ensure even covering of the moulds (D)</p> Signup and view all the answers

From where is gelatin obtained for making capsule shells?

<p>Hydrolysis of animal bones and skin (D)</p> Signup and view all the answers

How is Type A gelatin derived?

<p>By acid treatment of the precursor (D)</p> Signup and view all the answers

What is the main source for Type B gelatin production?

<p>Bovine bones (D)</p> Signup and view all the answers

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

<p>To prepare capsules (A)</p> Signup and view all the answers

What role does viscosity play in capsule production?

<p>Controlling the thickness of the capsule shell (D)</p> Signup and view all the answers

How are films of uniform thickness formed in capsule production?

<p>By dipping pins in the gelatin solution and rotating them during transfer (C)</p> Signup and view all the answers

From which type of gelatin are capsules usually produced?

<p>Both Type A and Type B (A)</p> Signup and view all the answers

What is the purpose of using a liquid wetting agent in the process described?

<p>To accelerate the bonding process (A)</p> Signup and view all the answers

What is an important limitation that needs to be considered when filling hard gelatin capsules?

<p>The material must not react with gelatin (C)</p> Signup and view all the answers

Which of the following is NOT a type of material used for filling hard gelatin capsules?

<p>Gels (B)</p> Signup and view all the answers

What operation involves orienting empty capsules so that they all point in the same direction?

<p>Rectification (B)</p> Signup and view all the answers

How is bench scale filling of powder typically carried out?

<p>By spreading powder onto the surface of the body plate and filling it into the bodies (B)</p> Signup and view all the answers

Which of the following is NOT a step in the filling process of capsule filing machines?

<p>Dispensing (D)</p> Signup and view all the answers

What are Quali-V capsules made of?

<p>HPMC with carrageenan and potassium chloride (D)</p> Signup and view all the answers

What is the standard moisture content for hard gelatin capsules?

<p>13-16% (A)</p> Signup and view all the answers

How do gelatin capsules behave at low humidity levels?

<p>They lose moisture and become brittle (B)</p> Signup and view all the answers

What makes gelatin capsules readily soluble in water at 37°C?

<p>High moisture content (A)</p> Signup and view all the answers

What is one advantage of HPMC-based capsules over gelatin capsules?

<p>Less moisture content (C)</p> Signup and view all the answers

In which range are hard capsules manufactured in terms of size?

<p>Various sizes depending on the manufacturer (B)</p> Signup and view all the answers

What is the purpose of the cap plate in the capsule filling process?

<p>To rejoin the capsules (D)</p> Signup and view all the answers

How are empty capsules initially separated in dependent dosing systems?

<p>By feeding them into a pair of ring holders (D)</p> Signup and view all the answers

What distinguishes independent dosing systems from dependent dosing systems in capsule filling?

<p>Dependent systems measure the powder independently, while independent systems use the capsule body for measurement (D)</p> Signup and view all the answers

What component is responsible for forcing powder down to the capsules bodies in capsule filling machines?

<p>The revolving auger (C)</p> Signup and view all the answers

Which part of the capsule filling machine revolves underneath the powder hopper?

<p>The variable speed turntable (A)</p> Signup and view all the answers

Flashcards

Wetting Agent

A substance that reduces surface tension and allows liquids to spread more easily, used in capsule production to help the gelatin evenly coat the molds.

Preservatives

A substance that prevents the growth of microorganisms, formerly used in empty capsule shells but no longer added.

Water-soluble Dyes

Colors that dissolve in water, used to color empty hard capsules.

Gelatin

A protein derived from animal sources, used to make capsule shells because it forms a strong, flexible film.

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Even Covering of Moulds

The process of coating the molds with gelatin to create capsule shells.

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Hydrolysis of Animal Bones and Skin

The process of breaking down animal bones and skin to obtain gelatin.

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Acid Treatment of Precursor

The process of treating the precursor (animal collagen) with acid to obtain a specific type of gelatin.

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Bovine Bones

The main source for producing Type B gelatin, usually from cows.

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Adding Dye Solutions or Pigment Suspensions

The process of adding color to the gelatin solution, resulting in colored capsules.

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Viscosity

The measurement of a liquid's resistance to flow, important in capsule production for controlling capsule shell thickness.

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Films of Uniform Thickness

The process of creating evenly thick films by dipping pins in the gelatin solution and rotating them during transfer.

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Type A and Type B Gelatin

Both Type A and Type B gelatin can be used to make capsules.

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Liquid Wetting Agent

A liquid used to speed up the bonding process between the gelatin layers in capsule production.

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Material Reactivity with Gelatin

The filling material must not react with the gelatin capsule shell, potentially causing changes in the capsule's properties or even breaking it down.

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Gels as Capsule Filling Material

Gels are not typically used as a filling material for hard gelatin capsules. Instead, powders, granules, or liquids are commonly used.

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Rectification

The process of aligning empty capsules so that they all point in the same direction, making them ready for filling.

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Bench Scale Filling

The process of manually filling powder into capsules using a simple technique.

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Powder Filling into Capsule Bodies

The process of distributing powder onto the surface of the body plate and then filling it into the capsule bodies.

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Dispensing in Capsule Filling

Dispensing is not a step in the filling process. The capsule filling process typically involves steps like feeding, measurement, filling, and sealing.

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Quali-V Capsules

A type of capsule made from hypromellose (HPMC), carrageenan, and potassium chloride, providing an alternative to traditional gelatin capsules.

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Standard Moisture Content

The typical range of moisture content for hard gelatin capsules, affecting their stability and solubility.

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Gelatin Capsules at Low Humidity

At low humidity, gelatin capsules can lose moisture, becoming fragile and breakable.

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Dissolving in Water at 37°C

Due to their high moisture content, gelatin capsules dissolve readily in water at body temperature (37°C).

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HPMC-based Capsules

HPMC-based capsules contain less moisture than gelatin capsules, making them more stable and less susceptible to environmental factors.

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Capsule Size Range

Various sizes of hard capsules are produced, depending on the manufacturer and the amount of medication to be filled.

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Cap Plate

The top part of the capsule that seals the capsule body, used to ensure the filled capsules are closed properly.

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Empty Capsule Separation

In dependent dosing systems, capsules are separated by a mechanism that feeds them into a pair of ring holders, ensuring each capsule is filled individually.

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Dependent vs. Independent Dosing Systems

The key difference is that dependent systems use a separate mechanism to measure the powder for each capsule, while independent systems rely on the capsule body to hold a specific amount of powder.

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Revolving Auger

This component inside the capsule filling machine is responsible for pushing the powder down into the capsule bodies, ensuring each capsule is properly filled.

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Variable Speed Turntable

This part of the capsule filling machine rotates below the hopper containing the powder, ensuring the powder flows smoothly and consistently to the filling mechanism.

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