Capsules: An Overview of Types and Benefits
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Questions and Answers

What is the primary composition of soft gelatin capsules?

  • Plasticizers and preservatives
  • Colorants and emulsifiers
  • Water and alcohol
  • Gelatin and a filling material (correct)

Which type of gelatin capsule is characterized by its one-piece design?

  • Hard gelatin capsules
  • Liquid capsules
  • Non-gelatin capsules
  • Soft gelatin capsules (correct)

What is a benefit of using soft gelatin capsules?

  • Improved shelf stability
  • Better drug absorption (correct)
  • Lower production costs
  • Longer duration of action

Which component is often added to the shell of soft gelatin capsules to enhance flexibility?

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

What types of liquids can be used as filling materials in soft gelatin capsules?

<p>Both hydrophilic and lipophilic liquids (D)</p> Signup and view all the answers

Which shape is NOT commonly associated with soft gelatin capsules?

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

What is a key disadvantage of soft gelatin capsules compared to tablets?

<p>They require specialized equipment for production. (C)</p> Signup and view all the answers

How do soft gelatin capsules help with the taste of medications?

<p>They mask the bitter and unpleasant taste (A)</p> Signup and view all the answers

What is one advantage of regular conventional softgels?

<p>They release their contents rapidly in the stomach. (C)</p> Signup and view all the answers

What is typically NOT included in the composition of soft gelatin capsule shells?

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

What is a characteristic of chewable softgels?

<p>They release liquid drug fill when chewed. (D)</p> Signup and view all the answers

Which type of softgel is designed for topical medication dosing?

<p>Twist-off softgels (C)</p> Signup and view all the answers

Why are enteric coated capsules used?

<p>They are designed to prevent drug release until reaching the intestine. (C)</p> Signup and view all the answers

What is a drawback of softgel capsules regarding their interaction with contents?

<p>They have intimate contact with their liquid contents, increasing interaction. (A)</p> Signup and view all the answers

What is a unique feature of meltable softgels?

<p>They can be used as suppositories or pessaries. (C)</p> Signup and view all the answers

Which of the following is not a form of softgel mentioned?

<p>Enteric coated softgels (D)</p> Signup and view all the answers

What is the first step in the drug encapsulation process for soft-gel capsules?

<p>Gelatin passes through sol-gel transition to form gel ribbons (D)</p> Signup and view all the answers

How thick can the gel ribbons be controlled during the casting process?

<p>± 0.1 mm (B)</p> Signup and view all the answers

What happens to the gelatin sheets that are not used in forming softgels?

<p>They are recycled for reuse (D)</p> Signup and view all the answers

What method is used to seal the two softgel capsule halves together?

<p>Application of heat pressure (B)</p> Signup and view all the answers

What is injected into the space between the gelatin ribbons during the encapsulation process?

<p>Liquid fill matrix (A)</p> Signup and view all the answers

What allows for the creation of bicoloured softgels?

<p>Different colors of gel ribbons (C)</p> Signup and view all the answers

What is the purpose of the rotary die encapsulation tool?

<p>To encapsulate the drug within gel ribbons (D)</p> Signup and view all the answers

During which process do the two gel ribbons get carried through rollers?

<p>Casting process (C)</p> Signup and view all the answers

What is a key reason for a high local concentration of the drug in the intestine instead of the stomach?

<p>To maximize effectiveness against intestinal parasites (D)</p> Signup and view all the answers

Which process occurs simultaneously with the formation of the gel mass in soft gelatin capsule preparation?

<p>Manufacturing the liquid fill matrix (A)</p> Signup and view all the answers

What is added to the gelatin during the formulation of the outer gel mass for the soft-gel shell?

<p>Plasticizer and opacifiers (A)</p> Signup and view all the answers

What method is used to remove air before forming the soft-gel capsule shells?

<p>Vacuum removal (A)</p> Signup and view all the answers

What is the significance of controlling the thickness of the gel ribbons to ± 0.1 mm?

<p>To maintain dosage accuracy and predictability (B)</p> Signup and view all the answers

Which component is formed by dispersing or dissolving the drug in a liquid vehicle?

<p>Liquid fill matrix (B)</p> Signup and view all the answers

During the encapsulation process, what transformation does gelatin undergo?

<p>Sol-gel transition (B)</p> Signup and view all the answers

What is the purpose of adding colors and preservatives to the gel mass?

<p>To improve the appearance and stability (B)</p> Signup and view all the answers

Flashcards

Soft gelatin capsules: One-step production

Soft gelatin capsules are formed, filled, and sealed in one process.

Soft gelatin capsules: Large scale production

Soft gelatin capsules are not feasible for small-scale production, requiring specialized equipment and large batches.

Soft gelatin capsules: Expensive

Soft gelatin capsules are more expensive compared to direct compression tablets or hard gelatin capsules.

Soft gelatin capsules: Increased interaction risk

Soft gelatin capsules have closer contact between the shell and liquid contents, increasing the risk of interactions.

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Soft gelatin capsules: Limited fill types

Soft gelatin capsules are not suitable for multiple drug formulations within one capsule, unlike hard shell capsules.

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Chewable softgels: Release in the mouth

Chewable softgels have a flavored shell that is chewed to release the liquid medication in the mouth.

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Suckable softgels: Pediatric dosing

Suckable softgels are designed for children and contain flavored medication to be sucked for oral dosing.

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Twist-off softgels: Topical/Inhalation use

Twist-off softgels have a tag that can be twisted or snipped off to access the medication for topical or inhalation use.

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Soft Gelatin Capsule

A type of capsule made from gelatin that is flexible and can hold liquid or semisolid medications.

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Plasticizer

A key ingredient in soft gelatin capsules that makes them pliable and easy to swallow.

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Gel Mass

A component of soft gelatin capsules that forms the outer shell, containing gelatin, plasticizers, and other ingredients like colorants.

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Filling Material

The substance enclosed within a soft gelatin capsule which can be a liquid, semisolid, or suspension.

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Advantages of Soft Gelatin Capsules

Advantages of soft gelatin capsules include better absorption and bioavailability, masking unpleasant tastes, and ease of swallowing.

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Gelatin

One of the main components of a capsule shell, a protein derived from animal collagen.

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Hard Gelatin Capsule

A type of capsule made from a rigid, hard material like gelatin, typically holding solid or powdered medications.

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Excipients

Substances added to capsules to enhance their appearance or stability.

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Sol to Gel Transition

This stage involves transforming a gelatin solution (sol) into a solid gel, which forms strips called gel ribbons.

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Gel Ribbon Thickness Control

The thickness of these gelatin strips is precisely controlled to ensure consistent capsule size and shape.

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Roller Transport of Gel Ribbons

The gel ribbons are carefully guided through special rollers, preparing them for the encapsulation process.

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Drug Encapsulation within Gel Ribbons

The core drug material is encapsulated within the gelatin ribbons to form the body of the softgel capsule.

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Liquid Fill Matrix Injection

Accurate amounts of the liquid fill matrix are injected into the gap between the gel ribbons, ensuring consistent dosage.

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Heat Sealing of Softgel Capsules

Two softgel capsule halves, made from the gel ribbons, are joined together under heat and pressure, forming a sealed capsule.

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Cooling and Recycling

Newly formed softgels are moved to cool down and harden; excess gelatin material is collected for reuse.

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Bicoloured Softgels

Softgels can be made in two distinct colors by using gel ribbons of different shades, creating a visually appealing capsule.

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Softgel Capsule Preparation Stages

The process of creating a softgel capsule involves two key stages: preparing the fill matrix and the gel mass. This is followed by encapsulating the fill matrix into the gel mass shell.

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Fill Matrix Preparation

The fill matrix is a liquid mixture containing the active drug substance. It's created by dissolving or dispersing the drug in a non-aqueous liquid vehicle using mixers or homogenizers.

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Gel Mass Formation

The gel mass forms the outer shell of the softgel. It's made by dissolving gelatin in water, adding a plasticizer like glycerol, and then incorporating other components such as colors, opacifiers, flavors, and preservatives.

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Air Removal from Gel Mass

Air bubbles are removed from the gel mass before encapsulating to prevent defects in the capsule. Air removal is done using a vacuum.

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Gel Mass Transfer and Cooling

The hot gel mass is transferred through heated pipes and then poured onto a cooling drum in the encapsulation machine. This forms two separate gelatin ribbons.

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Gelatin Sol-Gel Transition

During the cooling process, the gelatin undergoes a transition from a liquid (sol) to a solid (gel) state, forming the desired ribbon shape. The thickness of these ribbons is precisely controlled.

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Encapsulation Process

The fill matrix is encapsulated into the gel mass ribbons using a rotary die encapsulation machine. The process is continuous and efficient, ensuring consistent softgel capsules.

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Rotary Die Encapsulation

Rotary die encapsulation is a continuous manufacturing process that produces softgel capsules efficiently and consistently. It uses a rotating machine with dies to encapsulate the fill matrix into the gel mass ribbons.

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Study Notes

Capsules

  • Capsules are a common oral dosage form
  • Two main types: hard gelatin and soft gelatin (softgels)

Types of Capsules

  • Hard gelatin capsules
    • Composed of a hard, shell-like casing.
    • Often used for dry or powdered medications
  • Soft gelatin capsules (softgels)
    • Composed of a soft, flexible shell
    • Often used for liquid or semi-solid medications

Soft Gelatin Capsules (Softgels)

  • Composition:
    • Gelatin shell
    • Water
    • Plasticizers (glycerol, sorbitol, PG)
    • Colorants
    • Excipients (processing aids)
  • Filling:
    • Liquid (excluding water)
    • Oil
    • Lipophilic liquids (e.g., vegetable oils)
    • Hydrophilic liquids (e.g., PEG400)
    • Emulsions, microemulsions, nanoemulsions
    • Suspensions (up to 30% solids)
    • The active drugs are usually incorporated throughout the entire filling matrix or into the capsule shell, or outer gel mass.

Advantages of Soft Gelatin Capsules (Softgels)

  • Ease of swallowing
  • Masking of unpleasant tastes
  • Accurate dosage
  • Improved drug absorption (rapid onset)
  • Suitable for liquid formulations

Disadvantages of Soft Gelatin Capsules (Softgels)

  • Small-scale production is typically not possible
  • More expensive compared to direct compression tablets or hard gelatin capsules.
  • Increased possibility of interactions between the liquid contents and the shell.
  • Not suitable for incorporating multiple types of fillings within the same capsule.

Different Forms of Softgels

  • Regular conventional softgels: easy to swallow, contain oils, solutions, or suspensions; rapidly release in the stomach.
  • Chewable softgels: highly flavored shell, chewed to release liquid fill.
  • Suckable softgels: flavored gelatin shell; suitable for pediatric products when sucked.
  • Twist-off softgels: softgel has a tag to be twisted or snipped off to access the fill; useful for topical meds (skin/hair, inhalations)
  • Meltable softgels: designed for use as suppositories or pessaries

Advanced Forms of Softgels:

  • Enteric-coated capsules:
    • Coated with a gastric-resistant polymer
    • Resists dissolution in low stomach pH, dissolves in higher pH of the intestine.
    • Used when the drug is destroyed in the stomach, irritating the stomach lining, or for high local drug concentration in the intestine.

Preparation of Soft Gelatin Capsules

  • Rotary soft capsule machine:

    • Subprocesses simultaneously produce fill matrix - Gel mass forming the capsule shell,
    • Encapsulation of the mixture into the softgel shell, within one machine.

  • Liquid Fill Matrix Formation (a): The active drug substance is mixed with non-aqueous solvents using mixers/homogenizers

  • Soft-Gel Shell Formation (b):

    • Gelatin and water form gel mass; plasticizers added
    • Other capsule shell components (colors, opacifiers, flavors, preservatives) are added
    • Removed air bubbles.
    • Gel mass formed into ribbons.

  • Drug Encapsulation (c):

    • Fill matrix injected between wet gelatin ribbons.
    • Molded into capsules, sealed, and cooled.
    • Excess gelatin sheets are recycled

Limitations for Capsule Filling Materials

  • Avoid materials that dissolve gelatin, contain high moisture, or are deliquescent/hygroscopic.
  • Avoid materials that react with gelatin (like formaldehyde)
  • The addition of adsorbents ( e.g., magnesium carbonate) can help overcome certain problems.

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Description

This quiz covers the essential aspects of capsules, focusing on the two main types: hard gelatin and soft gelatin capsules (softgels). Explore their composition, filling methods, and advantages in medication delivery. Perfect for those studying pharmaceutical sciences or pharmacy courses.

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