Introduction to Capsules

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Questions and Answers

What is the primary purpose of lubricating stainless-steel molds before dipping into the gelatin solution?

  • To enhance the flavor of the gelatin
  • To accelerate the cooling process
  • To reduce surface tension and improve wetting (correct)
  • To prevent the molds from rusting

What is crucial for achieving a uniformly filled capsule with powder filling?

  • Using multiple colors in the filling
  • The flow characteristics of the powder (correct)
  • The taste of the powder filling
  • The temperature of the filling process

Which of the following is NOT a permitted liquid filler for hard gelatin capsules?

  • Polyethylene glycols
  • Vegetable oils
  • Water (correct)
  • Water-miscible liquids

What characteristic do granules and pellets need to possess for uniform filling in capsules?

<p>They should be near spherical and free-flowing (A)</p> Signup and view all the answers

What type of agents are included in powder filling to enhance drug release?

<p>Wetting and disintegrating agents (B)</p> Signup and view all the answers

What material is primarily used to create cachets?

<p>Rice flour (A)</p> Signup and view all the answers

Which of the following is an advantage of cachets?

<p>They can disintegrate quickly in the stomach. (A)</p> Signup and view all the answers

What is a disadvantage of using cachets?

<p>They can be easily damaged. (B)</p> Signup and view all the answers

How are cachets typically prepared?

<p>By molding rice flour mixed with water. (C)</p> Signup and view all the answers

What characteristic makes swallowing cachets difficult for some patients?

<p>They need to be softened first. (C)</p> Signup and view all the answers

Which of the following characteristics of cachets contributes to the need for them to be softened before swallowing?

<p>Their hard texture. (C)</p> Signup and view all the answers

Which of the following statements about cachets is true?

<p>They are rarely used in modern practice. (B)</p> Signup and view all the answers

What is the main reason cachets might not be suitable for filling drugs on a large scale?

<p>Their fragile shell can lead to compression of their content. (A)</p> Signup and view all the answers

What is a characteristic feature of hard gelatin capsules?

<p>The shells are clear, colourless, and tasteless. (A)</p> Signup and view all the answers

What sizes do hard gelatin capsules range from?

<p>000 (largest) to 5 (smallest) (A)</p> Signup and view all the answers

What is the main purpose of soft gelatin capsules?

<p>To improve bioavailability of drugs. (D)</p> Signup and view all the answers

How are soft gelatin capsules typically manufactured?

<p>Manufactured and filled in one operation. (D)</p> Signup and view all the answers

What is typically added to hard gelatin capsules for protection?

<p>Colourings and markings. (B)</p> Signup and view all the answers

Which type of medication can NOT be filled in hard gelatin capsules?

<p>Non-aqueous liquids (B)</p> Signup and view all the answers

What is the primary advantage of using soft gelatin capsules over powders?

<p>They allow for precise liquid dosage. (A)</p> Signup and view all the answers

What happens to soft gelatin capsules when filled?

<p>They appear swollen. (A)</p> Signup and view all the answers

What is a key characteristic that differentiates hard gelatin capsules from soft gelatin capsules?

<p>Soft gelatin capsules are more flexible. (D)</p> Signup and view all the answers

Which of the following is a common advantage of using capsules for medication?

<p>They mask the odor and taste effectively. (D)</p> Signup and view all the answers

What type of medication do soft gelatin capsules typically contain?

<p>Non-aqueous dispersions or oils. (D)</p> Signup and view all the answers

What is a notable disadvantage of using capsules for medication delivery?

<p>Specialized manufacturing equipment is necessary. (A)</p> Signup and view all the answers

Capsules are not suitable for certain drugs. Which of the following drugs would be inappropriate to encapsulate?

<p>Very soluble salts. (C)</p> Signup and view all the answers

What manufacturing characteristic is true about hard gelatin capsules?

<p>They are rigid and composed of two separate pieces. (D)</p> Signup and view all the answers

What is the primary source for the preparation of gelatin?

<p>Animal collagen (C)</p> Signup and view all the answers

Which of the following statements is true regarding the formulation of capsules?

<p>Fewer excipients are typically required for capsules. (D)</p> Signup and view all the answers

What is a common shape of soft gelatin capsules?

<p>Spherical or ovoid. (B)</p> Signup and view all the answers

Which type of gelatin is produced through acid hydrolysis?

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

What is the significance of bloom strength in gelatin?

<p>It measures the rigidity of the gel. (D)</p> Signup and view all the answers

What is the typical water content in hard gelatin capsule shells during formation?

<p>14-16% (C)</p> Signup and view all the answers

Which property of gelatin helps control the thickness of films or sheets?

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

What happens to a gelatin solution when it undergoes a phase change?

<p>It changes from a mobile liquid to a gel. (B)</p> Signup and view all the answers

The main raw materials for gelatin manufacturing are?

<p>Animal bone and skin (A)</p> Signup and view all the answers

What final water content is targeted after drying gelatin capsules filled with a drug?

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

What percentage of water content do soft gelatin capsules typically maintain?

<p>5-14% w/w (C)</p> Signup and view all the answers

What is the purpose of adding plasticisers to soft gelatin capsules?

<p>To increase pliability and flexibility (C)</p> Signup and view all the answers

Which of the following is NOT a common preservative added to capsule gelatin?

<p>Sodium lauryl sulphate (C)</p> Signup and view all the answers

What is the typical ratio of plasticiser to gelatin in soft gelatin capsules?

<p>0.8:1 (C)</p> Signup and view all the answers

What kind of agents are sometimes added to soft gelatin capsules to prevent surface growth during storage?

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

What is the primary function of using colorants in soft gelatin capsules?

<p>To enhance aesthetic appeal (B)</p> Signup and view all the answers

Which of the following is an example of a plasticiser?

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

What is the purpose of incorporating wetting agents during the preparation of gelatin solutions?

<p>To aid in the dissolution of gelatin (A)</p> Signup and view all the answers

Flashcards

Cachet Definition

A solid dosage form of drugs, also known as wafer capsules, typically made from rice paper.

Cachet Construction

Two plate-shaped rice paper pieces hold the dry powder medicine (up to 2g).

Cachet Material

Cachets are made from rice flour.

Cachet Preparation

Mixing rice flour and water, then molding it between heated cylinders. The water evaporates, forming the wafer.

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Cachet Swallowing

Cachets require dipping in water and swallowing with a lot of water to prevent tasting the medicine.

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Cachet Advantages

Easy to make; Disintegrates quickly in the stomach; Can handle large doses.

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Cachet Disadvantages

Easily damaged; Needs softening before swallowing; Not protected from light/moisture; Not suitable for large-scale production.

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Cachet Usage

Rarely used now.

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Capsule

A solid dosage form containing medication, enclosed in a soluble shell (gelatin).

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Hard Gelatin Capsule

A capsule shell made of gelatin, typically filled with powders or granules.

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Soft Gelatin Capsule

A flexible capsule shell, containing liquids, solutions, or suspensions.

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Capsule Size

Capsule sizes are numbered (000 largest to 5 smallest) based on their capacity for granules.

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Hard Gelatin Capsule Parts

A hard gelatin capsule consists of a cap (shorter) and a base (longer) portion that fit together.

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Capsule Filling

Hard gelatin capsules are filled with powders or pellets, while soft gelatin capsules can contain liquids or solutions.

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Capsule Properties

Capsules are made of materials like gelatin that are tasteless, colorless, and often clear.

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Capsule Purpose

Capsules offer a way to package, deliver, and protect medicines efficiently, by administering the compounds and preventing drug degradation.

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Hard vs Soft Capsules

Capsules are classified into Hard and Soft based on their flexibility and construction. Hard capsules have two parts (body and cap) and are less flexible, while Soft capsules are one piece, more flexible, and often used for liquids.

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Soft Capsule Advantages

Soft capsules offer advantages like ease of swallowing, taste masking, rapid drug release, and fewer excipients needed.

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Soft Capsule Applications

Soft capsules are typically used for oral medications, especially liquids, dispersions, oils, and pastes.

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Soft Capsule Disadvantages

Challenges with Soft capsules include specialized manufacturing, limited excipient choices, potential stability issues, uneven fill weight, and inability to divide doses.

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Soft Capsule Not Suitable For

Soft capsules are not suitable for strongly efflorescent drugs (losing moisture), strongly deliquescent powders (absorbing moisture), or very soluble salts, due to potential capsule shell changes.

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Capsule Components

Capsules are typically made from gelatin, a protein derived from animal collagen, and other materials to achieve the desired properties.

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Capsule's Role

Capsules act as a protective shell for medications, ensuring controlled release and masking unpleasant taste or odor.

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Capsule's Advantage

Capsules are a popular dosage form due to their ease of administration, versatility in filling, and ability to mask unpleasant characteristics of medications.

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What is Gelatin?

Gelatin is a natural protein derived from collagen, mainly found in animal bones and skin. It's used in a variety of applications like food and medicine.

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Types of Gelatin

There are two main types of gelatin: Type A, produced by acid hydrolysis (from animal skins), and Type B, produced by basic hydrolysis (from bones).

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Bloom Strength

The Bloom strength of gelatin is a measure of how rigid its gel is. It indicates how strong and firm the gel will be.

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Viscosity of Gelatin Solution

Viscosity refers to the thickness or resistance to flow of a gelatin solution. It's important for controlling the thickness of films, sheets, and capsules.

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Hard Gelatin Capsule Manufacturing

Hard gelatin capsules are made by dipping molds into a gelatin solution, allowing them to set and dry. The bodies and caps are then joined to form the capsule.

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Water Content in Gelatin Capsules

Gelatin capsules typically contain 14-16% water during formation. This water content is important for the mechanical properties of the capsule.

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Water Content After Filling

After filling with drugs, gelatin capsules are dried further to a 13% water content. This ensures the capsule doesn't crack or deform.

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Soft Gelatin Capsule Moisture

Soft gelatin capsules typically contain 5-14% water by weight. This helps maintain flexibility and prevents brittleness during manufacturing and storage.

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Preservatives in Soft Gelatin Capsules

Preservatives like parabens and benzoic acid are sometimes added to soft gelatin capsules to prevent microbial contamination during manufacturing and storage.

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Plasticiser in Gelatin Capsules

Plasticisers like glycerol and sorbitol are added to gelatin to increase flexibility. Soft gelatin capsules have a higher proportion of plasticiser than hard gelatin capsules.

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Colourants in Gelatin Capsules

Colourants, often synthetic dyes or pigments, are used in gelatin capsules to enhance their appearance and help identify the product.

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Titanium Dioxide in Capsules

Titanium dioxide is a white pigment used in capsules as an opacifying agent, making them opaque and blocking light.

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Iron Oxides in Capsules

Iron oxides are pigments used in capsules to create various colours like black, red, and yellow. They are insoluble pigments, meaning they do not dissolve in the capsule shell.

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Wetting Agent in Gelatin Capsules

Wetting agents like sodium lauryl sulphate are added during the preparation of gelatin capsules to improve their ability to mix with water.

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Soft Gelatin Capsule Flexibility

Soft gelatin capsules are designed to be flexible and pliable because they contain higher levels of plasticisers.

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Powder Filling

The process of filling capsules with a mixture of active ingredients, diluents, and additives in powdered form.

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Free-Flowing Excipients

Substances like magnesium stearate that are added to powder mixtures to improve their flowability and ensure consistent filling of capsules.

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Wetting and Disintegrating Agents

Substances like starches or cellulose that help the powder mixture to break down and dissolve quickly in the body for optimal drug release.

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Non-Powder Filling

Filling capsules with substances other than powders, such as liquids, granules, pellets, or semisolids.

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Liquids for Capsules

Liquids used for filling capsules must be non-aqueous, meaning they cannot contain water. Examples include oils and polyethylene glycols.

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Study Notes

Introduction to Capsules

  • The presentation introduces capsules, a solid dosage form of medication.
  • The presenter, Nurul Alyaa Binti Ibrahim, is a pharmacist from UiTM Pulau Pinang.

Learning Outcomes

  • Students should understand cachet formulations in pharmaceutical preparations.
  • They should be able to explain the advantages and disadvantages of capsules, along with their different types and characteristics.
  • The quality standards, containers, labeling, and storage of capsules should be described.
  • The general principles of capsule manufacturing and dispensing are included.

Lecture Outline

  • The lecture covers cachets, different types of capsules, advantages and disadvantages, and capsule components.

Cachets

  • Cachets are solid dosage forms of drugs, also known as wafer capsules.
  • They consist of two plate-shaped rice paper filled with dry powder, typically up to 2 grams.
  • Cachets are molded from rice flour mixed with water, forming a wafer between two hot cylinders.
  • The powder is ingested after dipping the cachet in water. This prevents the patient from tasting the powder.

Advantages and Disadvantages of Capsules

  • Advantages:*

  • Easy to make

  • Quickly disintegrates in the stomach

  • Large doses of medication can be swallowed.

  • Disadvantages:*

  • Easily damaged

  • Requires softening before swallowing

  • The enclosed material isn't protected from light and moisture.

  • Not suitable for large-scale drug filling

  • Occupies more space compared to tablets and capsules.

  • Rarely used nowadays.

Capsule Components

  • Gelatin
  • Preservatives
  • Plasticizers
  • Colourants
  • Wetting agents

Types of Capsules

  • Hard gelatin capsules: made from gelatin, clear, colorless and tasteless, filled with powders, granules or pellets.

  • Soft gelatin capsules: flexible, containing powders, liquids, solutions, emulsions, suspensions, or pastes. They are manufactured and filled in a single operation. Appear swollen and contain a large proportion of plasticizer.

Hard Gelatin Capsule Size

  • Capsule sizes range from 000 (largest) to 5 (smallest) based on granule capacity.
  • Some capsules have a ridge 'lock' at the join, a feature patented by Eli Lilly in 1963.

Manufacturing Hard Gelatin Capsules

  • Capsule molds are dipped in gelatin solution
  • The molds raise to let bodies & caps set and dry
  • Capsules stripped from pins
  • Bodies and caps are automatically joined.
  • Capsules are pushed onto a conveyor belt to be collected

Water Content in Capsule Shell

  • Hard Gelatin: Water content is 14-16% for capsule formation, and 13% after drug filling.
  • Soft Gelatin: 30-40% prior to final drying, with a final content of 5-14%.

Preservatives

  • Preservatives are sometimes added to the gelatin to prevent microbial contamination, especially during manufacturing, as finished capsules have low enough moisture to not support bacterial growth.
  • Soft gelatin capsules may include antifungal agents to prevent surface growth during storage.

Plasticizers

  • Added for flexibility; examples include glycerol, sorbitol, propylene glycol, sucrose, and acacia.
  • Soft gelatin capsules contain a higher proportion of plasticizers, leading to their flexibility.

Colourants

  • Added to enhance the aesthetic properties & for identification.
  • Common colourants include soluble dyes and insoluble pigments (e.g., titanium dioxide, iron oxides).

Wetting Agents

  • Used to reduce surface tension during the gelatin solution preparation stage. Adding wetting agents to the gelatin ensures the mold pins are uniformly wet, improving production of the uniform-thickness gelatin. An example is Sodium lauryl sulfate.

What Needs to Go Inside Capsules

  • Powder filling & Non-powder filling.

Powder Filling

  • Consists of active ingredients, diluents, and additives.
  • Proper powder flow is crucial for uniform filling
  • Free-flowing excipients (such as magnesium stearate) are used to improve flow. Fillings should be readily wetted and dispersed for proper release.

Non-Powder Filling

  • Includes liquids, granules, pellets, and semi-solids.
  • Water is not suitable for direct hard gelatin encapsulation, but sometimes used for soft gelatin..
  • Non-aqueous materials, oils, and water-miscible liquids are used for encapsulating.

Non-powder Filling #2

  • Granules and pellets should have a spherical shape and be free-flowing and regular in shape and size for uniform filling.

Non-powder Filling #3

  • Semi-solids can be incorporated into hard and soft gelatin capsules.
  • During filling, the mixture may need to be liquid but becomes solid when at room temperature—this is achievable by using thermosoftening or thixotropic materials.

Hard vs Soft Capsules

  • Hard capsules are typically made of two pieces (cap and body), while soft capsules are made of a single piece.
  • Hard gelatin capsules are typically used for solid medications, whereas soft gelatin capsules are often used for liquid or semi-solid medications.

Advantages of Capsules

  • Masking of unpleasant odors or tastes
  • Rapid and uniform drug release
  • Increased oral bioavailability of poorly soluble drugs
  • Fewer excipients may be required

Disadvantages of Capsules

  • Specific manufacturing equipment is needed
  • Limited selection of excipients
  • Stability issues with liquids
  • Problems with homogeneity of fill weight and content
  • Capsules can't be divided into individual doses

Capsule Applications

  • Primarily used for oral drugs

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