Pharmaceutical Science: Capsules Overview
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Questions and Answers

What is a primary concern regarding the cost of capsules?

  • They have no added value.
  • They are not covered by insurance.
  • They are always cheaper than other medications.
  • They may be more expensive than tablets or liquids. (correct)

The largest size of hard gelatin capsules commonly accepted by patients is No. 000.

False (B)

What are hard gelatin capsules primarily used for in the pharmaceutical industry?

To deliver life-saving drugs and supplements.

Hard gelatin shells are primarily made from __________.

<p>gelatin</p> Signup and view all the answers

Which type of capsule is specifically designed to resist stomach acids?

<p>Gastro-Resistant Capsules (B)</p> Signup and view all the answers

Match the types of capsules with their characteristics:

<p>Hard Gelatin Capsules = Widely used for life-saving drugs Soft Gelatin Capsules = Contain liquid or oil Gastro-Resistant Capsules = Resist stomach acids Modified-Release Capsules = Release medication over time</p> Signup and view all the answers

Hard gelatin capsules can only be commercially filled and not hand-filled by pharmacists.

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

Which components form a hard gelatin capsule?

<p>Two telescoping caps and a body piece.</p> Signup and view all the answers

What is the primary material commonly used to create capsule shells?

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

Capsules release their contents slowly compared to tablets.

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

What distinguishes two-piece capsules from one-piece capsules?

<p>Two-piece capsules are made of a body and a cap, while one-piece capsules are pliable and consist of a single shell.</p> Signup and view all the answers

Capsules may contain one or more active pharmaceutical ingredients along with various ______.

<p>excipients</p> Signup and view all the answers

Match the following advantages with their descriptions:

<p>Fast Acting = Breaks down quickly to relieve symptoms Consistent Dosing = Ensures exact medication amount is delivered</p> Signup and view all the answers

Which type of capsule is known for being more pliable?

<p>Soft shell capsules (B)</p> Signup and view all the answers

Preservatives, sweeteners, and coloring agents are examples of excipients that may be found in capsule shells.

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

Name one advantage of using capsules over tablets.

<p>Fast acting or consistent dosing.</p> Signup and view all the answers

What is the ideal relative humidity for storing filled capsules?

<p>50% (B)</p> Signup and view all the answers

Capsules that fail quality control checks are typically accepted for distribution.

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

What is the primary purpose of packaging filled capsules?

<p>To protect them from extremes of humidity and temperatures.</p> Signup and view all the answers

The punch and pour method is primarily used for __________ hard gelatin capsules.

<p>manual filling</p> Signup and view all the answers

Match the following methods of manufacturing hard gelatin capsules with their descriptions:

<p>Punch and Pour Method = Manual filling for small batches Hand Operated Capsule Machine = Machine-assisted filling on a small scale Quality Control = Checks capsules for weight and defects Packaging = Protects capsules from external conditions</p> Signup and view all the answers

Which of the following is NOT a method of quality control for filled capsules?

<p>Capsule design testing (C)</p> Signup and view all the answers

The Pour Method is used for manual filling of powder mixtures only.

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

What is the maximum temperature for storing filled capsules?

<p>25 °C</p> Signup and view all the answers

What is the primary advantage of soft-shell capsules over dry-filled capsules and tablets?

<p>Greater homogeneity and accurate metering (A)</p> Signup and view all the answers

Soft-shell capsules can only be filled with liquids.

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

Name one type of soft gel that requires chewing for drug release.

<p>Chewable soft gels</p> Signup and view all the answers

Soft-shell capsules are predominantly administered _____.

<p>orally</p> Signup and view all the answers

Match the following types of soft gels with their characteristics:

<p>Chewable soft gels = Highly flavoured shell that releases liquid when chewed Suckable soft gels = Gelatin shell containing a flavoured medicament to be sucked Twist-off soft gels = Capsule designed to be twisted or snipped for access Meltable soft gels = Designed for use as pessaries or suppositories</p> Signup and view all the answers

Which process is commonly used to form soft-shell capsules?

<p>Rotary die process (B)</p> Signup and view all the answers

The size of empty gelatin capsules is determined only by the fill-material used.

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

What type of formulation technology do liquid-filled capsules involve?

<p>Similar formulation technology as soft-shell capsules</p> Signup and view all the answers

What is the primary purpose of the dosator device method in capsule filling?

<p>To dip into a powder bed (B)</p> Signup and view all the answers

The tamping device method forms the plug by pulling powder into the capsule.

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

What component is mixed with gelatin and water to form the gelatin solution for soft gelatin capsules?

<p>Plasticizers</p> Signup and view all the answers

What is the primary advantage of soft gelatin capsules over traditional tablets?

<p>They provide greater content uniformity between dosage units. (B)</p> Signup and view all the answers

The process of removing air bubbles from the gelatin mixture is called __________.

<p>deaeration</p> Signup and view all the answers

Soft gelatin capsules can only be used to encapsulate solid drugs.

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

Match the dosing devices with their respective methods:

<p>Dosator Device Method = Forms plugs using a tube Tamping Device Method = Compresses powder with a punch Auger Device Method = Dispenses powder using a rotating screw</p> Signup and view all the answers

What is a common suspending agent used in soft gelatin capsules?

<p>Lecithin</p> Signup and view all the answers

At what speed can large scale manufacturing of hard gelatin capsules operate?

<p>1,65,000 capsules per hour (D)</p> Signup and view all the answers

The filling process starts with placing the powder on the unit.

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

Soft gelatin capsules provide a neat appearance and convenient __________.

<p>ingestion</p> Signup and view all the answers

What is used to help obtain a homogenous gelatin mass in capsule preparation?

<p>Heat</p> Signup and view all the answers

Which of the following is NOT a disadvantage of soft gelatin capsules?

<p>Ability to encapsulate solid forms easily. (B)</p> Signup and view all the answers

Match the following aspects of soft gelatin capsules with their descriptions:

<p>Hermetically sealed = Ideal for liquids and volatile drugs Patient-friendly = Eases ingestion of unpleasant contents Higher reproducibility = More consistent filling compared to powders Manufacturing equipment = Requires specialized machinery</p> Signup and view all the answers

Soft gelatin capsules can be printed on for easy identification.

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

What is one of the primary components of the shell of a soft gelatin capsule?

<p>Gelatin</p> Signup and view all the answers

Flashcards

Capsule

A solid dosage form where medicinal agents and excipients are enclosed in a small shell, usually made of gelatin.

Hard shell capsule

Consist of two pieces: a body and a cap, offering greater flexibility in size and content.

Soft shell capsule

A single-piece capsule made from more pliable material allowing for liquid or paste-like contents.

Gastro-resistant capsule

Capsules designed to resist stomach acid and release their contents in the small intestine.

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Modified release capsule

Capsules that release medication over a specific time period.

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Ease of Consumption

Capsules are often preferred because they offer a convenient and efficient way to take medication.

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Fast-acting

Capsules can break down faster than tablets, leading to quicker symptom relief.

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Consistent dosing

Capsules ensure a consistent dose, guaranteeing every capsule delivers the exact amount of medication prescribed.

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Bubble process

A manufacturing process for soft-shell capsules that forms spherical capsules without seams.

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Chewable soft gel

A type of soft-shell capsule designed to be chewed, releasing the liquid filling and its flavor.

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Suckable soft gel

A type of soft-shell capsule designed to be sucked, releasing the medication and flavor.

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Twist-off soft gel

A type of soft-shell capsule designed to be opened by twisting or snipping, allowing access to the filling.

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Meltable soft gel

A type of soft-shell capsule designed to melt and be used as a pessary or suppository.

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Fill material capacity

The capacity of a capsule shell is determined by the amount of fill material and its density and compressibility.

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Capsule size selection

The process of choosing the right size capsule for the amount of fill material.

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Capsule Dosage Form

Capsules are a type of oral medication that are enclosed in a gelatin shell.

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Hard Gelatin Capsules

They are the most common types of capsules used in the pharmaceutical industry. They're essentially small gelatin containers that hold medication.

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Hard Gelatin Capsule Material

They are made from gelatin, which is a protein derived from animal collagen. However, they can also be made from starch or other suitable substances.

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Hard Capsule Identification

Hard capsules are often colored to identify the manufacturer or the medication inside. They can also be printed with additional information like strengths or product codes.

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Hard Capsule Structure

Hard gelatin capsules consist of two parts: a cap and a body. These parts fit together to form a closed container.

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Hard Capsule Closure

They provide a secure closure to prevent the capsule from opening accidentally during shipping and handling.

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Capsule Grooves

The grooves or indentations on the capsule help ensure the cap and body stay together firmly, preventing the capsule from coming apart.

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Hard Capsules in Clinical Trials

They are used in clinical drug trials to compare the effects of a new drug with another drug or a placebo.

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Weight Variation Check

A quality control check that ensures capsules have the correct weight and are filled consistently.

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Visual Inspection

A quality control check where capsules are inspected for visible flaws such as cracks or uneven filling.

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Disintegration Test

A test that measures how quickly a capsule dissolves in a simulated stomach environment.

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Punch and Pour Method

A method of filling capsules by hand, often used for research or small batches.

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Hand Operated Capsule Machine

A manual capsule filling machine used for small-scale production. It allows for filling capsules by directly introducing powder into the capsule shell.

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Ideal Relative Humidity for Capsule Storage

The ideal relative humidity range for storing filled capsules, ensuring proper preservation.

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Ideal Temperature for Capsule Storage

The ideal temperature range for storing filled capsules, maintaining their quality over time.

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Pour Method

A manual method of filling capsules with granular materials, where the material is poured into the capsule shell.

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Dosator Device Method

A method to fill hard gelatin capsules by using a tube that dips into a powder bed, forming a plug which is then transferred into the capsule body.

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Tamping Device Method

A method to fill hard gelatin capsules by compressing powder in cavities of a dosing disk, similar to tablet manufacturing.

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Auger Device Method

A method to fill hard gelatin capsules by using a rotating screw (auger) to push powder or granules into the capsule body.

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Plasticizer

A substance that makes gelatin more flexible and prevents it from becoming brittle.

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Deaeration

Removing air bubbles from the gelatin solution to prevent defects in the final capsules. It's crucial for quality.

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Dipping

The process of forming the capsule shell by dipping stainless-steel pins into a gelatin solution.

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Caps and Bodies

The two parts of a hard gelatin capsule: the top and the bottom.

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Large Scale Manufacturing

Machines that automate the process of filling hard gelatin capsules, capable of producing up to 1,65,000 capsules per hour.

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Capsule Printing

Capsules are printed before filling for ease of handling, typically using high-speed rotary presses. They can be printed axially along the length or radially around the circumference.

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Softgel Composition

Soft gelatin capsules are primarily made of gelatin, water, plasticizers, colors, and flavors. They contain an oil-based fill that may include suspending agents like lecithin.

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Softgel Advantages

Softgel capsules offer several advantages, including ease of administration for unpleasant liquids, rapid drug release, high reproducibility, and hermetic sealing that protects sensitive drugs.

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Softgels for Lipid-Soluble Drugs

Softgel capsules are particularly useful for encapsulating lipid-soluble drugs at low doses, ensuring greater consistency between capsules.

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Softgels for Water-Insoluble Drugs

Softgel capsules are also preferred for encapsulating liquid, water-insoluble drugs, offering a more suitable alternative to tablets.

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Softgel Manufacturing Cost

Softgel capsules require specialized manufacturing equipment, which can contribute to higher costs compared to tablet production.

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Softgel Stability Issues

The water-soluble nature of gelatin can pose stability challenges for certain drugs that may break down quickly in water.

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Softgel Excipient Limitations

The limited range of excipients compatible with gelatin can restrict formulation options for softgel capsules.

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Study Notes

Introduction

  • Capsules are solid dosage forms.
  • The shell is typically made of gelatin or other substances.
  • The consistency can be adjusted.
  • Shells can have preservatives, opacifiers, sweeteners, coloring agents, and flavoring substances.
  • Shells can be composed of two pieces (body and cap) or one piece.
  • Two-piece capsules are called hard shell capsules.
  • One-piece capsules are called soft shell capsules.
  • Soft shell capsules are more pliable.
  • Capsule contents can be solid, liquid, or paste-like.
  • Contents may or may not include excipients like solvents, diluents, lubricants, wetting agents, preservatives, and disintegrating agents.
  • Contents do not harm the shell.
  • Digestive fluids break down the shell and release the contents.
  • Different types of capsules exist (hard gelatin, soft gelatin, gastro-resistant, and modified-release capsules).

Advantages of Capsules

  • Easy to consume due to design.
  • Fast-acting: Break down faster than tablets.
  • Consistent dosing: Pre-measured and controlled doses.
  • Customizable dosing: Can be adjusted to individual patient needs.
  • Controlled release: Slow release for consistent bloodstreams levels.
  • Reduced gastrointestinal irritation: Designed to reduce stomach irritation.
  • Tasteless: Do not require coating.
  • Easy to administer: Easy to swallow.
  • Visually engaging: Variety of available colors.
  • High drug absorption: Quick absorption.
  • Flexibility of formulation: Flexibility of formulation not possible with tablets.

Disadvantages of Capsules

  • Less durable: May crack under certain conditions.
  • Materials not encapsulated: Difficult for particular liquid substances to encapsulate
  • Difficulty in swallowing: Can be problematic for certain age groups and individuals.
  • Inability to split or crush: Cannot be adjusted to individual needs if a smaller dose is needed.
  • Limited shelf life: More susceptible to moisture than tablets.
  • Not suitable for all formulations: Not appropriate for some types of medications.
  • Risk of tampering: Susceptible to tampering as opposed to tablets.
  • Higher Cost: Can be pricier than other medication forms.

Types of Capsule Dosage Forms

  • Hard Gelatin Capsules (Dry Fill Capsules)
  • Soft Gelatin Capsules (Soft Gels)
  • Gastro-Resistant Capsules
  • Modified-Release Capsules

Manufacture of Hard Gelatin Capsule Shells

  • Hard gelatin capsule shells are manufactured in two sections: the capsule body and a shorter cap.
  • The cap fits over the open end of the capsule body.
  • Shells are produced using the dipping method on pins.
  • Then the gelatin is properly dried.
  • The finished shells are inspected and the ones that fail are rejected.
  • The finished capsules are categorized and packaged.
  • Different manufacturers use different methods.

Steps Involved in Hard Gelatin Capsule Shells Preparation

  • Preparation of Gelatin Solution
  • Deaeration of Gelatin Mass
  • Dipping
  • Spinning or Rotation
  • Drying
  • Stripping
  • Trimming and Joining
  • Polishing
  • Printing

Polishing, Printing, and Sorting

  • Polishing is done by pan, cloth, or brushing methods.
  • Capsules are printed before filling.
  • Capsules are sorted based on moisture content and defects.

Hard Gelatin Capsule Shells Sizes

  • Empty gelatin capsules are manufactured in various lengths, diameters, and capacities.
  • The size selected depends on the amount of fill material.
  • Sizes range from 000 to 5.

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Description

This quiz covers the essential aspects of capsules as solid dosage forms in pharmaceutical science. It includes details about types of capsule shells, their composition, and advantages over other dosage forms. Test your knowledge on the manufacture and purpose of different capsule varieties.

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