Pharmaceutical Coatings and Tablet Types
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Questions and Answers

What is a primary advantage of film coating compared to sugar coating?

  • It improves the structural integrity of the tablet.
  • It requires a shorter time period for the coating operation. (correct)
  • It is more cost-effective.
  • It provides better taste masking.
  • What is the purpose of enteric coating on tablets?

  • To ensure disintegration occurs in the stomach.
  • To protect drug substances from gastric fluid. (correct)
  • To enhance the flavor of the medication.
  • To increase the tablet's shelf life.
  • Which type of tablet is created through repeated compression cycles to form multiple layers?

  • Controlled-Release Tablets
  • Enteric-Coated Tablets
  • Multiple Compressed Tablets (correct)
  • Press-Coated Tablets
  • What is a key benefit of press-coated tablets?

    <p>They can separate incompatible drug substances. (C)</p> Signup and view all the answers

    What characterizes controlled-release tablets?

    <p>Release of the drug slowly over an extended time period. (C)</p> Signup and view all the answers

    Which granulation method is primarily used for producing granules that can melt into a liquid form?

    <p>Melt granulation method (B)</p> Signup and view all the answers

    What is one of the primary uses of effervescent granules in pharmaceuticals?

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

    What does micromeritics study in pharmaceuticals?

    <p>Particle size and its effects (B)</p> Signup and view all the answers

    How does particle size affect drug release from dosage forms?

    <p>Smaller particle sizes can enhance surface area and release rates. (D)</p> Signup and view all the answers

    Which of the following is NOT an application of micromeritics in pharmaceuticals?

    <p>Chemical stability of reactive substances (C)</p> Signup and view all the answers

    What property of powders can impact the consistency and quality of tablet manufacturing?

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

    Which method is NOT commonly used for determining particle size?

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

    What is the significance of Carr’s Index in powder characterization?

    <p>It assesses the flowability of powders. (D)</p> Signup and view all the answers

    What is the primary purpose of sodium starch glycolate in tablet formulation?

    <p>To serve as a disintegrating agent (B)</p> Signup and view all the answers

    Which method involves dividing the starch used as a disintegrant into two portions?

    <p>Intra-extra granular incorporation (C)</p> Signup and view all the answers

    Which factor does NOT influence the disintegration time of compressed tablets?

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

    What is a common issue that can occur during the tableting process?

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

    Which type of colors and dyes is typically applied as dry powders?

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

    What characteristic of aspartame poses a challenge in tablet formulations?

    <p>Instability in moisture (C)</p> Signup and view all the answers

    What is the main role of lubricants in tablet preparation?

    <p>To prevent adhesion to manufacturing surfaces (C)</p> Signup and view all the answers

    Which of the following statements about flavour oils is TRUE?

    <p>They have better stability than water-soluble flavors. (C)</p> Signup and view all the answers

    Which ingredient is commonly used as a disintegrant in tablet formulation?

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

    What is the function of adsorbents in tablet formulation?

    <p>To hold fluid in a dry state (C)</p> Signup and view all the answers

    What concentration of talc is commonly used when it is the only lubricant in a formulation?

    <p>5% (B)</p> Signup and view all the answers

    What happens when excessive amounts of lubricant are used in tablet formulation?

    <p>Poor disintegration and delayed dissolution (B)</p> Signup and view all the answers

    Which property is vital for a binder used in direct-compression tablet preparation?

    <p>Free-flowing but also cohesive (A)</p> Signup and view all the answers

    What is the suggested percentage of starch to achieve normal disintegration time in tablets?

    <p>5% (B)</p> Signup and view all the answers

    Which of the following materials is NOT typically classified as a disintegrant?

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

    Which class of materials is known for having an affinity for water and promotes tablet disintegration?

    <p>Starch-based disintegrants (C)</p> Signup and view all the answers

    What effect does uneven powder flow have on powder transfer?

    <p>Increases dust contamination risks (D)</p> Signup and view all the answers

    Which of the following factors does NOT affect the flow properties of powders?

    <p>Temperature change during storage (D)</p> Signup and view all the answers

    What defines a tablet according to the European Pharmacopoeia (EP)?

    <p>A compressed mass containing a single dose of one or more active substances (B)</p> Signup and view all the answers

    What characterizes sugar-coated tablets (SCT)?

    <p>They have a sugar coating that may be coloured (C)</p> Signup and view all the answers

    What type of tablet is characterized by having a thin layer of water-soluble material?

    <p>Film-coated tablets (D)</p> Signup and view all the answers

    Which of the following statements is true about compressed tablets (CT)?

    <p>They are formed by compression and contain no special coating (B)</p> Signup and view all the answers

    What issue can arise from the separation of a small quantity of powder just before production?

    <p>Weight uniformity of the dose may be affected (D)</p> Signup and view all the answers

    Which component is typically NOT included in the formulation of compressed tablets?

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

    What is the primary objective of mixing when trying to achieve a uniform product?

    <p>To promote a chemical reaction for uniform products (A)</p> Signup and view all the answers

    Which type of mixture occurs when two immiscible liquids are mixed?

    <p>Negative mixture (C)</p> Signup and view all the answers

    What happens to very small particles during the elutriation segregation process?

    <p>They are blown upwards and remain suspended in air (A)</p> Signup and view all the answers

    In a positive mixture, what is the nature of the mixtures formed?

    <p>They mix easily and irreversibly (C)</p> Signup and view all the answers

    What is a key characteristic of negative mixtures?

    <p>They require energy for effective mixing (D)</p> Signup and view all the answers

    Why is mixing particularly important when formulating potent materials?

    <p>To combine them with bulking agents for better formulation (D)</p> Signup and view all the answers

    Which of the following best describes the potential behavior of larger particles during trajectory segregation?

    <p>They tend to move greater distances than smaller particles (A)</p> Signup and view all the answers

    What effect does stopping a mixer have on small particles in a dusting out scenario?

    <p>They settle to form a layer on coarser particles (A)</p> Signup and view all the answers

    Flashcards

    Enteric-Coated Tablets (ECT)

    Tablets coated with substances that dissolve in the intestines but not the stomach, allowing drugs to be released where they are most effective.

    Multiple Compressed Tablets (MCT)

    Tablets made by compressing multiple layers of different granulations, often used for prolonged release or to separate incompatible drugs.

    Press-Coated Tablets

    Tablets prepared by compressing a new layer of granulation around pre-formed tablets, offering advantages of both compressed and sugar-coated tablets.

    Controlled-Release Tablets

    Tablets designed to release the drug slowly over an extended time, achieving sustained therapeutic effects.

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    Sustained-Release Dosage Forms

    A type of controlled-release tablet that releases the drug gradually over a longer period.

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    Wet Granulation

    This method involves mixing drug powder with a liquid binder, forming wet granules, drying, and sieving to get the desired size.

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    Dry Granulation

    This method involves compressing the powder mixture directly without adding a liquid binder, resulting in granules.

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    Melt Granulation

    This method involves melting a suitable material (usually a waxy substance) and mixing with the drug powder. The mixture is then allowed to solidify and is subsequently broken down into granules.

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    Micromeritics

    The science and technology of small particles. It studies their properties, behavior, and applications.

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    Powder Flowability

    A measure of how well a powder flows, influencing how it moves through equipment and how it mixes with other ingredients.

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    Sieving

    A technique used to determine the size of particles. It involves passing the powder through a series of sieves with decreasing pore sizes.

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    Sedimentation

    A method for determining particle size. It involves allowing particles to settle in a liquid medium, with the settling rate depending on the particle size.

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    Particle Volume Measurement

    This method involves measuring the volume of particles, which can be used to determine their size. It uses a specialized instrument that measures the displacement of a liquid by a particle.

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    Binder

    A substance that helps tablet formation by holding powder particles together. It can be added in solution or dry.

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    Lubricant

    A substance that ensures smooth flow of powder or granules during tablet compression. Reduces friction and helps tablets eject easily.

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    Lubricants: Function

    Lubricants prevent sticking of materials to the tablet press. They reduce friction between particles and improve flow.

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    Disintegrant

    A substance that helps the tablet dissolve quickly in the body. Commonly used are starches, clays, celluloses, gums, and polymers.

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    Swelling Disintegrant

    A type of disintegrant that works by swelling when exposed to water, causing the tablet to disintegrate.

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    Capillary Disintegrant

    A type of disintegrant that works by capillary action. It draws water in between tablet particles causing the tablet to break apart.

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    Super disintegrants

    A type of disintegrant that breaks down the tablet quickly. Examples include Croscarmellose, Crospovidone, and Sodium Starch Glycolate.

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    Anti-adherant

    Reduces sticking of granules or powder to the tablet press. Prevents sticking to the die walls and punches.

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    Powder Flow and Friction

    Uneven powder flow can cause friction between particles and the die wall, leading to lubrication issues and increased dust contamination during powder transfer.

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    Powder Caking

    Powder caking is a phenomenon where powder particles clump together, often due to prolonged storage or shipping. This can occur in vials or bags, affecting powder flow and homogeneity.

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    Powder Separation

    Separation of small quantities of powder from the bulk material can occur during the production process, particularly when preparing individual doses. This can result in inaccurate weight uniformity and inconsistent dosages.

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    Particle Size and Distribution

    The size and distribution of particles significantly influence powder flow. Fine powders tend to flow poorly, while larger and uniformly sized particles flow more readily.

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    Particle Shape and Texture

    The shape and texture of particles affect their flowability. Irregular shapes and rough surfaces can reduce powder flow, while smooth, spherical particles flow better.

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    Surface Forces in Powder Flow

    Surface forces, like electrostatic charges, van der Waals forces, and surface tension, can influence powder flow. These forces can cause particles to stick together, hindering flow.

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    Formulation Additives

    Formulating additives, such as lubricants and anti-caking agents, can be used to improve powder flow properties. They reduce friction and prevent clumping.

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    What are Tablets?

    Solid preparations containing a single dose of one or more active substances. They are typically circular, flat or bi-convex, and may include excipients for manufacturing, disintegration, or appearance.

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    Intra-extra Granular Incorporation

    The method of adding a disintegrant to the tablet during two different stages: before and after granulation.

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    Capping

    The process of separating the top or bottom of a tablet from the main body.

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    Tablet Hardness

    A factor that impacts how quickly a tablet breaks down, with harder tablets disintegrating slower.

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    Adsorbent

    A substance that absorbs liquids and appears dry.

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    Artificial Sweeteners for Tablets

    Artificial sweeteners are often used in tablets meant to dissolve in the mouth to provide a pleasant taste.

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    Trajectory segregation

    This occurs when particles of different sizes move at different speeds, causing them to separate because of their kinetic energy.

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    Elutriation segregation

    When a mix is discharged, small particles can be 'blown' upwards by air currents, staying suspended until they settle on top of the coarser particles.

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    What is mixing?

    The process of combining two or more substances, ensuring they are uniformly distributed.

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    Simple physical mixing

    This involves mixing materials to create a homogeneous mixture, like dissolving sugar in water to make a solution.

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    Mixing for chemical reaction

    Mixing to facilitate a chemical reaction to produce uniform products.

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    Dispersion of solid in liquid

    Involves dispersing a solid in a liquid to form a suspension or paste.

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    Dispersion of immiscible liquids

    This involves combining two immiscible liquids (liquids that don't mix) to form an emulsion, like mixing oil and water.

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    What are negative mixtures?

    These occur when two immiscible liquids are mixed, like oil and water, or when an insoluble solid is mixed with water, like magnesium silicate and water.

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    Study Notes

    Pharmaceutical Powders

    • Pharmaceutical powders are solid dosage forms of medicament.
    • They contain one or more drugs in a finely divided state, potentially with excipients.
    • Powders can be crystalline or amorphous.
    • They are a type of solid dosage form distinct from granules, tablets, and capsules.
    • Powders have solid particles, all with a diameter less than 1000 µm.

    Pharmaceutical Granules

    • Granules are powder agglomerates creating free-flowing particles, typically ranging from 4 to 10 mesh.
    • Granules are irregularly shaped, though they can be made spherical.
    • Granulation is useful as an intermediate in capsule and tablet preparation, allowing for smoother, more predictable flow compared to small powder particles.

    Advantages of Powders and Granules

    • Easier to prescribe specific amounts for a physician.
    • Faster onset of action due to ease of dissolution in body fluids.
    • Easier to administer (orally).
    • Easy to carry.
    • More stable than liquid dosage forms.
    • Used internally and externally.

    Disadvantages of Powders and Granules

    • Bitterness or unpleasant tastes are difficult to mask.
    • Some drugs causing nausea are difficult to administer.
    • Drugs affected by atmospheric conditions are not appropriate for powder form. These need special packaging.
    • Quantities less than 100mg are difficult to weigh accurately
    • Inaccurate dosing possible for bulk powders.
    • Inconvenient to carry, particularly in bulk form.

    Pharmaceutical Applications of Powders and Granules

    • Raw materials for other solid dosage forms (e.g. tablets, capsules)
    • Granulation and Tablet production
    • Masking bitter tastes in capsules.
    • Treatment of local infections.
    • Treatment of asthma and other respiratory diseases.
    • Counter-irritant, e.g. camphor starch dusting powder (used in infections)
    • Used in dyspepsia, e.g. rhubarb powder
    • Antimicrobial, e.g. chlorhexidine dusting powder
    • Anti-emetic/anti-pyretic, e.g. Dover's powder (containing ipecacuanha, opium)
    • Antacids/anti-flatulent, e.g. magnesium trisilicate powder
    • Antiseptics, e.g. dusting powders for microbial control
    • Used in cosmetics (e.g., face powders), treatment of skin burns, and baby rash protection.

    Micromeritics

    • Study of small particles (e.g., powders).
    • Focuses on particle size, shape, and distribution.
    • Key characteristics: particle size (and range), shape, surface area, and related physical/chemical/pharmacological properties of drugs.
    • These are important for determining the drug's release from dosage forms, especially those taken orally, parenterally, rectally, and topically.

    Relationship Between Angle of Repose, Carr's Index, Hausner Ratio and Powder Flowability

    Data to determine powder flow characteristics.

    Tablet Properties and Considerations for Manufacture

    • Tablets are small, compressed masses containing one or more medicinal agents.
    • They may be circular with flat or convex surfaces.
    • Tablets are made by either compression or molding.
    • Divided into categories dependent on the manufacturing method (e.g., compressed tablets, sugar-coated tablets, film-coated tablets, enteric-coated tablets, multiple compressed tablets, and press-coated tablets).

    Tablet Excipients

    • Inert materials that aid in the tablet's proper use.
    • Used for processing, compaction, and physical characteristics in the final product
    • Used to improve flowability, compressibility, and dissolution of the tablet. Types include diluents, binders, disintegrants, colors, flavours, etc.

    Tablet Coating (processes, materials, equipment)

    • Coating involves applying a material to a tablet's surface to modify its properties (e.g., taste masking, protecting from degradation). Kinds of coatings exist, both by process (sugar coating, film coating, etc.) and by function (e.g., enteric coated tablets for targeting drug delivery to intestines).
    • Coating materials have characteristics for effectiveness, ease of processing, stability, and cost and include polymers, plasticizers, and solvents.
    • Coating machines vary in types (e.g., coating pans, spray coating equipment for film coating).

    Capsules

    • Capsules are another dosage form for drugs, encapsulating medicinal agents within a small shell or container.
    • They can be made of gelatin or other comparable materials with varied shapes and sizes.
    • These are generally swallowed, used primarily for oral administration
    • Types include hard capsules (two-piece) and soft capsules (one-piece), which depend on the drug and/or desired form of adminstration.

    Capsules: Advantages and Disadvantages

    • Advantages:
      • Easy to swallow.
      • Can mask flavors and odors, improving palatability for patients.
      • Easy to handle and carry.
      • Suitable for drugs that are difficult to compress into tablets.
      • Higher bioavailability relative to tablets.
    • Disadvantages:
      • More expensive to produce than tablets and/or have an inability to withstand moisture or humidity.
      • Shorter shelf life.
      • Not suitable for all drugs (e.g., hygroscopic).
      • Not suitable for all delivery methods (e.g., intravenous).

    Capsule Manufacturing

    • Manufacturing steps for hard capsules (e.g., dipping, spinning, drying, stripping, trimming, joining, polishing). Specific machines can be used for processing.
    • Manufacturing steps for soft capsules (e.g., preparation of gel, encapsulation, drying, inspection & packaging). Specific machines can be used for processing materials.

    Mixing

    • Mixing is the process of combining two or more substances to create a homogenous mixture.
    • It is widely used for creating a uniform product, promoting chemical reactions, dispersing solids into liquids, or combining immiscible liquids.

    Homogenization

    • A process used to produce fine emulsions and suspensions by breaking down larger particles into smaller ones.
    • Processes include passing substances through high-pressure narrow orifices using homogenizers.

    Drying (of materials)

    • Drying materials by removal of moisture (or other solvent) through evaporation to end in a solid state.
    • Reasons include removing moisture for stability, allowing for easier transportation or use, or as a final processing step.
    • Methods include freeze-drying (lyophilization), oven-drying or tray drying, and other specific types.

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    Description

    This quiz covers various aspects of pharmaceutical coatings, focusing on the advantages of film coating over sugar coating, the purpose of enteric coatings, and characteristics of different tablet types. Test your knowledge on press-coated and controlled-release tablets to better understand their manufacturing and functionality.

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