PPA 510 & 512: Hard Gelatin Capsules Quiz
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Questions and Answers

What is the meaning of capsula in Latin?

A small box

What are the two main types of capsules?

  • Hard and Soft (correct)
  • Solid and Liquid
  • Two-piece and One-piece (correct)
  • Large and Small

    • What is the most important property of gelatin for capsule manufacturers?

    Bloom strength and viscosity

    The basic process of making gelatin from bovine bones takes about 10 times as long as the acid process for porcine skins.

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

    Hypromellose capsules have a standard moisture content of 13%-16% w/W.

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

    Gelatin capsules are readily soluble in water at 37 °C.

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

    What is the simplest way to estimate the fill weight for a powder capsule?

    <p>Multiply the body volume by its tapped bulk density</p> Signup and view all the answers

    The shape of the capsule has remained virtually unchanged since its invention, except for the development of the self-locking capsule.

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

    What are the three main factors in powder capsule formulation?

    <p>Good flow, No adhesion, Cohesion</p> Signup and view all the answers

    Formulating a capsule to give modified-release patterns is often achieved using granules or coated pellets.

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

    What is the most commonly used lubricant for both encapsulation and tableting?

    <p>Magnesium stearate</p> Signup and view all the answers

    Superdisintegrants are used to improve dissolution properties of capsules by increasing the cohesiveness of the powder mass.

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

    What is the main factor governing whether swelling or wicking is the primary disruptive force of a disintegrant in capsule formulation?

    <p>The solubility of the active ingredient and the diluent</p> Signup and view all the answers

    Why is it necessary to optimize capsule formulations during development?

    <p>To ensure the product meets the product specifications for optimal performance</p> Signup and view all the answers

    What are the main factors in powder capsule release?

    <p>Active ingredient, particle size, hydrophilic mass, dissolution aids, formulation for filling and release (A)</p> Signup and view all the answers

    Capsules are always formulated to release their contents in the stomach.

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

    The capsule shape is a good design for swallowing because the tongue automatically aligns it with its long axis pointing towards the throat.

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

    Patients with difficulty swallowing should be instructed to swallow capsules while lying down to aid gravity.

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

    Floating capsules utilize hydrophilic polymers that swell on contact with water, forming a mass that floats on the gastric liquids.

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

    Gastro-resistant capsules are typically formulated by coating the filled capsule with an enteric film or by coating pellets with an enteric polymer.

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

    The current consensus suggests that monolithic prolonged-release dosage forms are better than multi-particulate systems.

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

    Colpermin is an example of a capsule formulated to give a prolonged release.

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

    Flashcards

    Hard Gelatin Capsule

    A two-piece capsule made of gelatin, used for oral medications.

    Gelatin

    A natural protein used to make capsule shells.

    Gelatin Properties (Oral)

    Non-toxic, soluble at body temp, good film former, creates flexible & strong capsule.

    Acid Hydrolysis (Gelatin)

    Gelatin production method using acid to break down collagen.

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    Basic Hydrolysis (Gelatin)

    Gelatin production method using alkali to break down collagen.

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    Capsule Size (Hard)

    Capsule sizes (0-4), different filled volumes.

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    Capsule Filling (Powders)

    Method of filling hard capsules with powders for oral use.

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    Capsule Filling Machines

    Machines used in mass production of filled hard capsules.

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    Capsule Filling (Pellets)

    Process of filling capsules with granules or pellets for controlled release.

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    Capsule Filling (Liquids)

    Filling capsules with liquids, often involving formulation modifications or sealing to avoid leakage.

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    Formulation (Capsule)

    Mixing drug and excipients for optimal capsule properties and drug release.

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    Excipients

    Inert substances added to formulations to modify properties like flow.

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    Capsule Disintegration

    The process of the capsule dissolving in the digestive system.

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    Dissolution (Drug)

    The process of the active ingredient dissolving in the body fluids.

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    Particle Size (Drug Release)

    Smaller particles generally lead to faster drug release.

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    Moisture Content (Gelatin)

    Standard range for moisture in gelatin capsules.

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    Hypromellose

    Alternative cellulose-based polymer to gelatin in capsule manufacture.

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    Water Activity

    Measure of available water in a material, impacting microbial growth.

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    BSE Risk

    Classification of geographic regions based on prevalence of bovine spongiform encephalopathy.

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    Colorants (Capsule)

    Pigments and dyes used to color capsule shells.

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    Process Aids

    Substances used to improve the manufacturing process, not usually within the final product.

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    Capsule Manufacture

    Process of making empty capsule shells from gelatin or hypromellose.

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    Capsule Filling

    Process of placing the medication into empty hard gelatin capsule.

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    Study Notes

    PPA 510: PHARMACEUTICS V, PPA 512: ORAL SOLID DOSAGE FORMS - HARD GELATIN CAPSULES

    • Course title: Pharmaceutics V, Oral Solid Dosage Forms (PPA 510 and PPA 512)
    • Topic: Hard Gelatin Capsules
    • Presented by: Dr. Erick Kithinji Nega

    OUTLINE

    • Introduction: The word "capsule" originates from the Latin word "capsula," meaning a small box. In pharmacy, it denotes an edible package of medicine, typically made from gelatin, which holds a specific dosage.

    • Raw Materials:

      • Gelatin: The primary component, derived from collagen in animal skins and bones. Two types: Acid (Type A) and Basic (Type B) hydrolysis. Acid process (porcine skins) takes 7-10 days, while bovine bones take 10 times longer.
      • Ossein: Intermediate, sponge-like material in the bovine bone process.
      • Colourants: Water-soluble dyes (e.g., erythrosine, indigo carmine, quinoline yellow) and insoluble pigments (e.g., black, red, yellow iron oxides, titanium dioxide).
      • Processing aids: Sodium lauryl sulfate as a wetting agent, preservatives are less common currently.

    • Manufacture:

      • The process is similar to the original 1846 patent.
      • Hot gelatin solution dips metal molds, cools and dries.
      • Machine parts are mirror images (cap/body).
      • Two levels: upper/lower; 50,000 pins per machine.
      • Air-conditioned, temperature/humidity controlled rooms.
      • Drying in kilns, controlled humidity.
      • Two parts joined, cleaned, and lubricated.
      • Prelocking before filling to avoid damage.

    • Empty Capsule Properties:

      • Gelatin capsules contain significant water, acting as a plasticizer.
        • Moisture content specification: 13%-16% w/w, that can vary depending on conditions (high humidity makes the capsule soft, while low humidity makes the capsule brittle)
      • Moisture content maintained by sealed, constant-temperature storage. Hypromellose capsules maintain 3-6% moisture
      • Gelatin is soluble at 37C, its solubility in water reduces with temperatures below 26C, and swells with water at temperatures below 26C.

    • Capsule Filling:

      • Capsule sizes: Standard sizes range from 0 to 4 (and some larger sizes), volumes vary.
      • Powder formulations:
        • Filling of powders, pellets, granules, tablets, semi-solids, and liquids (including liquids and semi-solids) all using various approaches.
        • Different filling machines for various sizes and needs.
        • Important properties are the nature of capsules and the handling of materials.
        • Empty capsules are prepared in bulk.
        • Capsule orientation, loading, and rectification (making all caps point in the same direction).
        • Filling mechanisms (auger, dosator, tamping finger and disc) are available for industrial and bench-scale filling.

    • Formulation for filling properties:

      • Powders need good flow and no adhesion to fill.

    • Different excipients (e.g., diluents, lubricants, glidants) influence these properties.

    • Hydrophobic and hydrophilic mixtures.

    • Formulation for release of active ingredients:

      • First stage: disintegrating the capsule shell at body temperature (37°C) where it dissolves/breaks.
      • The time for complete disintegration varies.
      • Active release is governed by the solubility of the contents.
        • Using a soluble diluent (like lactose) for poorly soluble drugs and using less soluble diluents for readily soluble drugs.
      • Excipients affect the rate of release and dissolution.
        • Some excipients (lubricants and glidants) can affect the rate of release, and are used to improve the flow of materials and reduce friction.

    • Formulation Optimization:

      • Using statistical tools from analysis of variance experiments based on the various excipients and process operations.
      • Computer-based expert systems (like neural networks) can assist formulation optimization.

    • Formulation for position of release:

      • Many products are designed to be released in the stomach, but that may not always be ideal for absorption
      • There are various techniques, including using floating capsules. Other techniques include coating granules or pellets with enteric coatings.
        • This leads to controlled release in different parts of the GIT. Products could be designed for release in the colon to avoid gastric enzymes.

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    Hard Gelatin Capsules PDF

    Description

    Test your knowledge on Hard Gelatin Capsules in Pharmaceutics V and Oral Solid Dosage Forms. This quiz explores the raw materials, processing, and applications of gelatin capsules used in pharmacy. Ideal for students and professionals in pharmaceutical sciences.

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