Workshop 2: Pharmaceutical Forms 2024/2025
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Questions and Answers

What is an advantage of using capsules as a dosage form?

  • They are the only form suitable for all patients.
  • They require no manufacturing process.
  • They have a shorter expiration date.
  • They mask unpleasant tastes effectively. (correct)
  • Which dosage form is described as a process of particle size enlargement?

  • Compression
  • Granulation (correct)
  • Dissolution
  • Capsulation
  • What type of capsule is specifically designed for oils?

  • Hard capsules
  • Controlled-release capsules
  • Soft capsules (correct)
  • Gastro-resistant capsules
  • Which of the following is NOT a solid dosage form?

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

    Which of the following statements is true about tablets as a dosage form?

    <p>They offer precision dosing for medications. (C)</p> Signup and view all the answers

    Which type of powder is primarily intended for external use?

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

    What defines a gastro-resistant capsule?

    <p>It protects the medication from stomach acid. (C)</p> Signup and view all the answers

    Which of the following is considered a limitation of using tablets?

    <p>Limited use in individuals who cannot swallow. (B)</p> Signup and view all the answers

    What is primarily compared to determine if two drugs are bioequivalent?

    <p>The pharmacokinetic profiles, specifically rate and extent of absorption (C)</p> Signup and view all the answers

    Which of the following routes of administration is classified as local?

    <p>Intranasal (D)</p> Signup and view all the answers

    Which aspect of a generic drug might differ from its reference product?

    <p>Inactive ingredients (D)</p> Signup and view all the answers

    What does the term 'INN' refer to in the context of generic drugs?

    <p>International Nonproprietary Name (A)</p> Signup and view all the answers

    What is a primary disadvantage of the oral route of drug administration?

    <p>Inactivation by digestive enzymes (B)</p> Signup and view all the answers

    Which of the following statements about generic drugs is true?

    <p>They must be clinically bioequivalent to the reference product. (B)</p> Signup and view all the answers

    Which route of administration avoids the first-pass effect?

    <p>Sublingual (D)</p> Signup and view all the answers

    For which situation should oral drug administration be avoided?

    <p>The patient is unconscious (B)</p> Signup and view all the answers

    What does AUC stand for in pharmacokinetic profiling?

    <p>Area Under the Curve (C)</p> Signup and view all the answers

    What characterizes the onset of action for the sublingual route of administration?

    <p>Minutes to onset (C)</p> Signup and view all the answers

    Generic drugs can differ slightly in which aspect related to their formulation?

    <p>Inactive ingredients and their excipients (B)</p> Signup and view all the answers

    Which factor is NOT typically considered in choosing a route of administration?

    <p>Policies of the administering facility (A)</p> Signup and view all the answers

    Which of the following is NOT a characteristic of a reference product?

    <p>Identical to all generic forms (B)</p> Signup and view all the answers

    Which dosage form is appropriate for sublingual administration?

    <p>Tablet (D)</p> Signup and view all the answers

    Why is it important to know the inactive ingredients in generic drugs?

    <p>They could cause allergic reactions in some patients. (A)</p> Signup and view all the answers

    What is a common characteristic of systemic routes of administration?

    <p>Effects are distributed throughout the body (B)</p> Signup and view all the answers

    Which statement accurately describes the purpose of coated tablets?

    <p>They mask unpleasant tastes and protect active ingredients. (C)</p> Signup and view all the answers

    What is a characteristic of delayed-release tablets?

    <p>They are designed to release the drug over extended time periods. (D)</p> Signup and view all the answers

    Why are sublingual and buccal tablets favored for certain medications?

    <p>They bypass the first-pass metabolism and increase absorption speed. (C)</p> Signup and view all the answers

    What distinguishes effervescent tablets from other uncoated tablets?

    <p>They release carbon dioxide when dissolved in water. (A)</p> Signup and view all the answers

    What is the primary use for multilayer tablets?

    <p>They allow for the mixing of incompatible substances. (B)</p> Signup and view all the answers

    What is a significant advantage of rectal suppositories?

    <p>They can be used to avoid gastrointestinal irritation. (C)</p> Signup and view all the answers

    Chewable tablets are primarily designed for which of the following reasons?

    <p>To improve administration for children and those with swallowing difficulties. (A)</p> Signup and view all the answers

    How do lozenges work to provide relief for irritated throat tissues?

    <p>They are designed to dissolve slowly in the mouth. (D)</p> Signup and view all the answers

    What is the primary purpose of vaginal suppositories?

    <p>Local action within the vagina (D)</p> Signup and view all the answers

    Which of the following describes a characteristic of ointments?

    <p>Greasy and meant for application to the skin (C)</p> Signup and view all the answers

    What distinguishes creams from other semi-solid dosage forms?

    <p>They are a mixture of oil and water (C)</p> Signup and view all the answers

    Which type of cream contains small droplets of oil in a continuous aqueous phase?

    <p>Oil-in-water cream (D)</p> Signup and view all the answers

    What is a defining feature of gels compared to other semi-solid forms?

    <p>Structured by a polymeric matrix (C)</p> Signup and view all the answers

    Which semi-solid dosage form serves as a good protective barrier over the skin?

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

    Which of the following is NOT commonly included in vaginal pessaries?

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

    What type of dosage form is triacetonide dental paste categorized as?

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

    What is a significant advantage of rectal administration compared to the oral route?

    <p>Can be used on unconscious patients (B)</p> Signup and view all the answers

    Which of the following is a disadvantage of rectal administration?

    <p>Absorption can be erratic and unpredictable (A)</p> Signup and view all the answers

    Which type of medication is commonly administered rectally for treatment of status epilepticus in children?

    <p>Microenemas of Diazepam (B)</p> Signup and view all the answers

    What is the primary characteristic of parenterally administered drugs compared to enteral routes?

    <p>Higher bioavailability and faster onset (A)</p> Signup and view all the answers

    Which route of administration allows for immediate drug action?

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

    Why are drugs administered via the subcutaneous route generally absorbed more slowly than those given intramuscularly?

    <p>The tissue is less vascularized (D)</p> Signup and view all the answers

    Which of the following routes can administer the largest volume of medication at one site?

    <p>Intramuscular injection (D)</p> Signup and view all the answers

    What is true about the absorption of drugs through the rectal route?

    <p>Absorption is often erratic and unpredictable (C)</p> Signup and view all the answers

    Flashcards

    Powder

    A solid dosage form that consists of a mixture of dry, finely divided drugs.

    Granulation

    The process of particle size enlargement of homogeneously mixed powder ingredients.

    Capsule

    A solid dosage form that contains medication enclosed in a gelatin container.

    Tablet

    A solid dosage form that is a hard, compressed medication in round, oval, or square shape. It allows for precise dosing and extended shelf life.

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    Dosage Forms

    They are classified according to the route of administration (oral, topical, etc.) and the physical form (solid, semisolid, liquid).

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    Bioavailability

    A key factor in the approval of generic drugs, ensuring they perform similarly to the original reference product.

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    Route of Administration

    The way a drug is administered into the body, e.g., oral, topical, rectal, etc.

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    Specific Types of Capsules

    Different types of capsules, including hard, soft, gastro-resistant, controlled-release, and modified-release.

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    Generic Drug

    A medication that has the same active ingredient, dosage form, strength, and intended use as the original brand-name drug. It's essentially a copy of the original, but often costs less.

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    Reference Product

    A medication that's the original version of a drug, marketed under a brand name, and typically protected by a patent.

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    International Nonproprietary Name (INN)

    The name given to a drug that's not owned by a specific company, and is publicly recognized worldwide. It's often used for generic drugs.

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    Bioequivalence

    When two drugs have similar absorption rates and reach the same concentration levels in the bloodstream, they are considered bioequivalent. This ensures they have the same effectiveness.

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    Cmax

    The maximum concentration of a drug in the bloodstream after administration. It's used to measure how quickly a drug is absorbed.

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    Area Under the Curve (AUC)

    The total amount of drug absorbed into the bloodstream. It is measured by AUC and shows how much drug is in the body over time.

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    Pharmacokinetic Profile

    The characteristics of how a drug is absorbed, distributed, metabolized, and eliminated in the body.

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    Inactive Ingredients

    Inactive ingredients that add necessary features like color, shape, and stability to a medication. Though they don't impact the main effect, they may be what makes generics differ from brand-name drugs.

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    Coated tablets- Protection

    Tablets with a coating that prevents the active ingredient from being destroyed by air, moisture, or light.

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    Sublingual tablets

    Tablets that dissolve quickly under the tongue, bypassing the stomach and liver, for faster absorption and action.

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    Delayed-release tablets

    Tablets designed to release their medication over a period of time, often bypassing the stomach and delaying release in the intestines.

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    Multilayer tablets

    Tablets that release their medication in multiple stages, allowing different components to be released at different times.

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    Effervescent tablets

    Tablets that contain acid and carbonates, which fizz when dissolved in water, creating carbon dioxide.

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    Rectal suppositories

    Solid dosage forms inserted into the rectum where they melt, soften, or dissolve at body temperature.

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    Chewable tablets

    Tablets designed to be chewed, often for easier administration, especially to children or those with swallowing difficulties.

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    Lozenge

    A small medicated candy that dissolves slowly in the mouth, intended to soothe irritated tissues in the throat.

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    Vaginal suppositories

    Vaginal suppositories are solid dosage forms inserted into the vagina for local treatment. They contain various ingredients like antiseptics, contraceptives, local anesthetics, and therapeutic agents for treating infections.

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    Molded Pessary

    A type of vaginal suppository, typically molded into a specific shape, for introducing medication locally.

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    Compressed Pessary

    A form of vaginal suppository, often molded into a round shape, for local action. Also known as vaginal tablets.

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    Vaginal Capsule

    A type of vaginal suppository, often enclosed in a capsule. It is designed for local treatment in the vagina. Also known as Ovule.

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    Ointment

    Ointment is a semi-solid, greasy preparation applied to skin, rectum, or nasal mucosa. It's usually anhydrous and immiscible with skin secretions.

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    Paste

    A semi-solid preparation similar to an ointment, with a high percentage of insoluble solid added. It forms a thick, stiff barrier over the skin.

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    Cream

    A semi-solid emulsion system containing mixtures of oil and water. It's miscible with skin secretions and comes in oil-in-water or water-in-oil forms.

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    Gel

    A semi-solid system where a liquid phase is constrained within a 3-D polymeric matrix containing a high portion of water. Used for medications and lubrication.

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    Parenteral Route

    Medication delivered directly to the bloodstream, avoiding the digestive tract, resulting in faster action.

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    Enteral Route

    Medication administered through the digestive tract, often slower absorption with potential first-pass metabolism.

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    Oral Route (PO)

    Medication taken by mouth, the most common and convenient route, but can be affected by food and gastric enzymes.

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    Sublingual Route

    Medication placed under the tongue, bypassing the stomach, allowing faster absorption and avoiding first-pass metabolism.

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    Intravenous Injection (IV)

    Medication administered directly into a vein, providing immediate action and high bioavailability.

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    Intramuscular Injection (IM)

    Medication injected into a muscle, allowing slow and sustained release, suitable for larger volumes and some vaccines.

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    Topical Route

    Medication applied to the skin or mucous membranes, for localized effects, avoiding systemic circulation.

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    Rectal Administration

    A route of drug administration where medication is inserted into the rectum, bypassing the first-pass metabolism in the liver, leading to faster onset and higher bioavailability.

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    Enema

    A liquid drug formulation used in rectal administration, particularly for laxatives or systemic absorption.

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    Enema Uses

    Local action: Crohn's disease treatment. Systemic action: Status epilepticus treatment in children.

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    Intravenous (IV)

    Administration of medication directly into the bloodstream, bypassing the digestive system, leading to rapid absorption and immediate action.

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    Subcutaneous (SC)

    Administration of medication into the subcutaneous tissue, usually via injection, leading to slower absorption than intramuscular injections.

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    Intramuscular (IM)

    Administration of medication into skeletal muscle, allowing for larger volumes and generally faster absorption than subcutaneous injections.

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    Intrathecal (IT)

    A method of drug administration that involves injecting medication into the space surrounding the spinal cord, bypassing the blood-brain barrier.

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    Epidural

    A route of drug administration where medication is injected into the epidural space, located between the outer covering of the spinal cord and the vertebral bone, providing targeted pain relief.

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    Study Notes

    Workshop 2: Pharmaceutical Forms

    • Topic is pharmaceutical forms, in III Medicine, academic year 2024/2025, presented by Vittoria Carrabs PhD.
    • Key topics include generic drugs, dosage forms, routes of administration, and symbols/abbreviations.

    1. Generic Drugs

    • Active Pharmaceutical Ingredients (APIs) are the medicinal components.
    • Excipients are inactive pharmaceutical ingredients that assist with the drug's production, stability, and administration.
    • Excipients improve solubility, stabilize, preserve, thicken, dilute, emulsify, add color, and/or flavor.
    • Bioavailability (BA) measures the rate and extent of active ingredient absorption into the body.
      • Rate refers to how swiftly the drug reaches its maximum blood concentration (Cmax).
      • Extent refers to the total amount of the drug entering the bloodstream (AUC - Area under the Curve).
    • Pharmaceutical equivalents have the same active ingredients, dosage form, route of administration, and dosage.
    • Pharmaceutical alternatives have the same therapeutic moiety but different salts, esters, or complexes. They may have different dosage forms, strengths, and/or excipients.
    • Bioequivalence ensures that generic drugs have similar bioavailability and efficacy as the reference product.
    • Reference Product (INN*): A drug product which is identical or bioequivalent to a Brand/Reference drug in its active ingredients, route of administration, dosage form, and strength.
    • Reference products may be differentiated by inactive ingredients, color, and shape.
    • Almost half of the drugs in the market have Generics (E.F.G).

    2. Dosage Forms

    • Classification is based on route of administration (e.g., Oral, Topical, Rectal) and physical form (e.g., Solid, Semisolid, Liquid).
    • Solid dosage forms:
      • Powder: a mixture of dry, finely divided drugs. (External use: Dusting powders (talc, zinc stearate); Internal use: Effervescent powders, Insufflations (inhalers), dentifrice, oral powders).
      • Granule: small particles or grains.
        • Granulation is a process of particle size enlargement.
      • Capsule: medication in gelatin containers (Advantage: Masks taste, good stability, bioavailability. Disadvantage: Swallowing issues). Includes hard capsules (dry/powdered ingredients) soft capsules (used for oils).
      • Tablet: compressed medication (uncoated or coated)(coated protect from air, moisture, light.) Includes delayed-release, sublingual/buccal, multi-layer and chewable tablets. Effervescent tablets contain acids/carbonates that release CO2 when dissolved.
      • Pill: small, round solid dosage forms.
      • Suppository: solid dosage form inserted into body orifices to melt/soften/dissolve at body temperature. Includes Rectal suppositories (mechanical, local, or systemic). Vaginal suppositories (pessaries).
    • Semisolid dosage forms:
      • Ointment: semi-solid, greasy preparation. Used locally (emollient).
      • Paste: basically ointment with high percentage of insoluble solid. Acts as barrier.
      • Cream: viscous emulsion of oil and water. (A- oil-in-water, B- water-in-oil).
      • Gel: semi-solid system with liquid constrained within a 3-D matrix.
    • Liquid dosage forms:
      • Solution: one or more active ingredients completely dissolved.
      • Suspension: solid particles dispersed in a liquid.
      • Emulsion: stabilized oil-in-water dispersions.
      • Syrup: saturated sugar solution.
      • Elixir: sweetened hydroalcoholic solution. Liniments: alcoholic/oily liquid for skin application.
      • Injection: solution/emulsion/suspension in sterile and pyrogen-free vehicle for parenteral administration. (e.g., intravenous, intramuscular, subcutaneous).

    3. Routes of Administration

    • Systemic: drugs move throughout the body via bloodstream. Includes parenteral (intravenous, intramuscular, subcutaneous), enteral (oral, sublingual, rectal, inhalation), transdermal, and topical.
    • Local: drugs deliver their action directly at the site of administration. Includes intranasal, intradermal, vaginal, and topical.

    -Factors to consider when choosing a route are the drug's properties, desired onset of action, convenience, and cost.

    • Enteral Routes:
      • Oral (po): oral administration
      • Sublingual: under the tongue
      • Rectal: inserted into the rectum. Includes enemas.
    • Parenteral Routes:
      • Intravenous (IV)
      • Intramuscular (IM)
      • Subcutaneous (SC)
      • Inhalation
      • Transdermal (patch)
      • Topical
    • Topical Routes: include dermatological, ophthalmic, otic, nasal, dental and throat, and vaginal applications.

    4. Symbols and Abbreviations

    • Information on storage temperature, shelf life, prescription requirements, and special handling procedures is denoted by symbols and abbreviations. Some examples of abbreviation include: EFP, OTC, H/DH, TLD, ECM
    • symbols indicate potential hazards (e.g., warning for driving impairment, photosensitivity.)

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    Description

    This quiz focuses on pharmaceuticals, covering key areas such as generic drugs, dosage forms, routes of administration, and industry-specific symbols and abbreviations. Presented by Dr. Vittoria Carrabs, it aims to enhance your understanding of pharmaceutical components and their applications in medicine.

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