Pharmaceutical Formulations Quiz
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Questions and Answers

What is the primary function of the gelatin or Hydroxypropyl methylcellulose matrix in a capsule?

  • To provide a physical barrier to prevent the release of the active ingredient until it reaches the intended site of absorption. (correct)
  • To protect the active ingredient from degradation by stomach acid.
  • To enhance the absorption of the active ingredient in the gastrointestinal tract.
  • To facilitate the rapid dissolution of the active ingredient in the stomach.

What is the main difference between hard-shelled capsules and soft-shelled capsules?

  • Hard-shelled capsules are more stable and have a longer shelf life than soft-shelled capsules.
  • Hard-shelled capsules are more easily absorbed by the body than soft-shelled capsules.
  • Hard-shelled capsules are less expensive to manufacture than soft-shelled capsules.
  • Hard-shelled capsules are typically used for solid, powdered ingredients, while soft-shelled capsules are used for liquids or semi-solids. (correct)

What is the primary role of lubricants in effervescent tablets?

  • To prevent the tablet from sticking to the manufacturing equipment during production.
  • To improve the flowability of the powder mixture during tablet compression.
  • To facilitate the rapid dissolution of the tablet in water. (correct)
  • To mask the unpleasant taste of the active ingredients.

What is the main advantage of effervescent tablets over other oral dosage forms?

<p>They provide faster drug release and absorption. (B)</p> Signup and view all the answers

What is the primary mechanism by which effervescent granules release carbon dioxide when added to water?

<p>The granules contain a chemical reaction that produces carbon dioxide gas when in contact with water. (C)</p> Signup and view all the answers

What is the primary benefit of oral solutions compared to other liquid preparations?

<p>They allow for more precise dosing of the active ingredient. (A)</p> Signup and view all the answers

Which of the following factors contribute to the rapid disintegration or dissolution of fast-dissolving oral delivery formulations?

<p>All of the above. (D)</p> Signup and view all the answers

What is the primary advantage of oral emulsions over solid oral dosage forms?

<p>They mask the unpleasant taste of the active ingredients. (A)</p> Signup and view all the answers

Which of the following statements about drug properties relevant to oral bioavailability is accurate?

<p>Optimizing lipophilicity can significantly improve drug absorption. (A)</p> Signup and view all the answers

Which factor is critical in determining the dosage form suitable for a patient?

<p>Biopharmaceutical characteristics of the drug. (B)</p> Signup and view all the answers

In the context of medication, which best describes the term ‘excipient’?

<p>An inactive ingredient that aids in drug delivery. (C)</p> Signup and view all the answers

Which dosage form is typically designed to release medication directly into the bloodstream?

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

What is the significance of pH in relation to drug solubility and absorption?

<p>pH can influence the ionization of drugs which affects their solubility. (B)</p> Signup and view all the answers

Which of the following describes the relationship between drug and medicine?

<p>A drug is the active component of the medicine which includes excipients. (A)</p> Signup and view all the answers

What influences the rate and extent of drug absorption into the body?

<p>The method of drug administration. (C)</p> Signup and view all the answers

Which property must be considered for developing effective dosage forms?

<p>The desired duration of action. (A)</p> Signup and view all the answers

What was the approximate annual sales figure for Comirnaty in 2022?

<p>$37.8 billion (C)</p> Signup and view all the answers

Which company developed the blockbuster drug Keytruda?

<p>Merck &amp; Co. (B)</p> Signup and view all the answers

Which of the following diseases is treated by Humira?

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

What caused a decrease in sales for Comirnaty in 2023?

<p>Transition of pandemic into endemic stage (C)</p> Signup and view all the answers

Before COVID, how long did Humira maintain its status as the top-selling drug?

<p>9 years (B)</p> Signup and view all the answers

Which of the following was a major reason for the loss of blockbuster status of certain drugs?

<p>Market entry of generics (C)</p> Signup and view all the answers

Which company had the highest sales among these blockbusters in 2023?

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

What was the main therapy area of blockbuster drug Ozempic?

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

What does pharmacodynamics primarily focus on?

<p>The effects of the drug on the body (C)</p> Signup and view all the answers

Which process is NOT considered a part of pharmacokinetics?

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

In terms of drug distribution, what does ADME stand for?

<p>Absorption, Distribution, Metabolism, Excretion (D)</p> Signup and view all the answers

What is primarily affected by the method of drug administration, such as IV injection?

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

What does the term 'Cmax' refer to in the pharmacokinetic profile of a drug?

<p>Maximum plasma concentration (C)</p> Signup and view all the answers

Which of the following represents the point at which the drug concentration is sufficiently high to be effective?

<p>Minimum effective concentration (MEC) (B)</p> Signup and view all the answers

What is lag time in drug administration?

<p>The delay before drug action begins (C)</p> Signup and view all the answers

What does 'AUC' stand for in the context of drug plasma concentration over time?

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

What is the primary barrier to hydrophilic drugs in the cornea?

<p>50-100 µm thick hydrophobic layer (C)</p> Signup and view all the answers

Which ocular condition requires intraocular delivery for effective treatment?

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

Which route is considered the major pathway for ocular drug absorption?

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

What is the main limitation of the conjunctival route for drug delivery?

<p>Rapid systemic circulation loss (C)</p> Signup and view all the answers

Which of the following conditions affects the major absorption pathway for lipophilic drugs in the eye?

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

What is the main function of the nasal cavity?

<p>To filter, humidify and warm inhaled air. (D)</p> Signup and view all the answers

Which factor influences drug absorption through the nasal epithelium most significantly?

<p>The size of the drug molecule. (D)</p> Signup and view all the answers

Which of the following correctly describes the impact of the protective mucus layer on drug absorption through the nasal epithelium?

<p>It hinders drug absorption by acting as a physical and chemical barrier. (A)</p> Signup and view all the answers

What is the primary reason for the high bioavailability of small, lipophilic drugs administered nasally?

<p>They easily diffuse through the lipophilic nasal epithelium. (D)</p> Signup and view all the answers

Which aspect of nasal physiology is most relevant to the deposition of nasal drug delivery systems?

<p>The high air turbulence within the cavity. (C)</p> Signup and view all the answers

What advantage does nasal drug administration offer over oral administration for peptides?

<p>Nasal administration avoids the first-pass metabolism in the liver, leading to higher bioavailability. (A)</p> Signup and view all the answers

Which factor contributes MOST to the high rate of mucus clearance in the nasal cavity?

<p>The continuous movement of cilia in the nasal epithelium. (D)</p> Signup and view all the answers

What is the main reason why the nasal delivery of aerosols or powders is dependent on particle size?

<p>Larger particles are more likely to be deposited in the nasal cavity. (A)</p> Signup and view all the answers

Flashcards

Pharmacokinetics (PK)

The study of how the body affects a drug, including absorption, distribution, metabolism, and excretion.

Pharmacodynamics (PD)

The study of how a drug affects the body, including its mechanism of action and its effects on various tissues and organs.

Liberation

The process by which a drug is released from its dosage form and becomes available for absorption.

Absorption

The process by which a drug enters the bloodstream from the site of administration.

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Distribution

The process by which a drug is distributed throughout the body to different tissues and organs.

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Metabolism

The process by which a drug is broken down into inactive metabolites by enzymes in the body.

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Excretion

The process by which a drug and its metabolites are eliminated from the body.

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Plasma concentration vs time

The concentration of a drug in plasma over time, visualized as a graph.

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Lipophilicity

The tendency of a molecule to dissolve in lipids or fats.

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Partition Coefficient

A measure of the relative solubility of a compound in two immiscible phases, typically water and octanol. It shows how readily a drug moves from water to a lipid environment.

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Acid-Base Theory

The branch of chemistry that deals with the properties and reactions of acids and bases.

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pH

A measure of the hydrogen ion concentration in a solution. It indicates the acidity or alkalinity of the solution.

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pKa

The negative logarithm of the acid dissociation constant (Ka). It indicates the strength of an acid. A lower pKa means a stronger acid.

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Electrolytes

Substances that can conduct electricity when dissolved in a solvent. They often dissociate into ions in solution.

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Buffers

Solutions that resist changes in pH. They contain a weak acid and its conjugate base or a weak base and its conjugate acid.

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Chemical Kinetics and Stability of Dosage Forms

The chemical reactions that occur in a drug formulation. The rate and extent of these changes affect the stability and effectiveness of the medication.

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Conjunctiva

The outermost layer of the eye, responsible for protecting the eye and providing a transparent window for light to enter.

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Keratitis

A disease of the cornea, the transparent front part of the eye, that can cause clouding or scarring.

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Ocular drug absorption

The process by which a drug is absorbed from the site of administration into the bloodstream.

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Corneal route

The main route for ocular drug absorption, where the drug passes through the cornea into the bloodstream.

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Conjunctival route

A route of ocular drug absorption where the drug passes through the conjunctiva and sclera, but much of it is lost into the blood stream.

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What is a blockbuster drug?

The annual revenue of a drug exceeding $1 billion. It's a significant milestone for pharmaceutical companies.

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What causes a drug to lose its blockbuster status?

When a drug loses its blockbuster status, its annual revenue falls below $1 billion. This could happen due to several factors.

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What is pricing power?

The ability of a drug to maintain its price and stay competitive in the market. It's essential for long-term profitability.

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What is the impact of generic drugs on blockbuster drugs?

When a drug's patent expires, generic versions can enter the market, increasing competition and lowering prices.

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How can competitors impact blockbuster drugs?

A competitor might introduce a similar drug with better efficacy or a lower price, impacting the original drug's sales.

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What is drug adoption?

The process by which a drug becomes widely used, typically driven by strong marketing and clinical evidence. It's crucial for gaining market share.

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What is unique about the sales figures of Comirnaty?

Comirnaty (Pfizer and BioNTech's COVID-19 vaccine) reached unprecedented sales figures, surpassing $36.8 billion in 2021.

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How does the transition from pandemic to endemic affect blockbuster drugs?

The transition of the pandemic into an endemic stage leads to a decrease in demand for COVID-19 vaccines and treatments, impacting their sales figures.

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What are effervescent tablets?

Uncoated tablets that react with water to release carbon dioxide, creating a fizzy drink.

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What's a capsule?

Dosage form where an ingredient is enclosed in a gelatin or Hydroxypropyl methylcellulose shell.

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What are oral granules?

Solid, dry particles of medication often packed in sachets, dissolved in water before taking.

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What are fast dissolving oral delivery forms?

Dosage form that dissolves or disintegrates quickly in the mouth without needing water, making it convenient for quick absorption.

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What are oral solutions?

Clear liquid preparations for oral use, containing dissolved active ingredients.

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What are oral emulsions?

Stable mixtures of oil droplets dispersed in water, where either phase might contain dissolved solids.

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How do fast dissolving oral delivery forms work?

Tablets designed to rapidly dissolve or disintegrate in saliva, potentially increasing drug absorption.

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What makes fast dissolving oral delivery forms challenging?

These tablets are often difficult to handle and therefore require a special packaging, often a peel-off blister pack.

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Nasal Cavity Volume & Surface Area

The nasal cavity is a complex structure with a total volume of approximately 20 ml and a large surface area of around 150 cm2, lined with a dense network of blood vessels to facilitate air conditioning and drug absorption.

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Nasal Air Conditioning

The nasal cavity is designed to condition incoming air by adjusting its temperature to within 10 degrees Celsius of body temperature and humidity to 97-98%.

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Nasal Epithelium & Its Functions

The nasal epithelium, lining the nasal cavity, is a protective barrier composed of pseudo-stratified columnar cells. It also has cilia to facilitate mucus clearance and microvilli to increase surface area.

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Drug Absorption in the Nasal Cavity

Drug absorption through the nasal cavity depends on factors like lipophilicity (ability to dissolve in lipids), ionization (charge), and size. These factors affect how efficiently the drug can cross the epithelial barrier.

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Nasal Mucus & its Role in Drug Absorption

Mucus is a sticky barrier that lines the nasal cavity and traps foreign particles. This barrier acts like a physical and chemical barrier, limiting drug absorption. It gets cleared by the cilia.

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Nasal Blood Supply & Drug Absorption

The nasal cavity's rich blood supply delivers around 40 mL/min/100 g of tissue, contributing to the rapid absorption of drugs. This efficient blood flow aids in distributing the drug throughout the body.

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Nasal Air Turbulence & Drug Delivery

The nasal cavity is a highly turbulent environment, causing air to swirl and mix. This turbulence helps distribute airborne particles, playing a role in drug deposition.

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Inter-Patient Variability in Nasal Anatomy

Individual variation in the internal anatomy of the nasal cavity significantly affects drug deposition and absorption. This variability makes it difficult to predict how a drug will be absorbed from one person to another.

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Study Notes

Fundamentals of Pharmacy/Pharmacology: The Science of Medicines

  • This unit covers the fundamentals of pharmacy and pharmacology, focusing on the science of medicines.
  • The outline includes topics like: the science of medicines, pharmaceutics, the medicine approval process, and teaching and learning methods.
  • The first year units in Pharmacy and Pharmacology are described, including the specific modules like chemistry of drugs, science of medicines, health and disease, and preparing for professional practice.
  • The journey of a medicine from its initial discovery to its delivery to the patient is explored.
  • The process includes important aspects like drug discovery, lab testing, clinical trials, marketing authorisation, initial pricing, appraisal by NICE, and drug availability to patients.
  • The role of pharmaceutical kinetics and stability of dosage forms is highlighted, along with various dosage forms like tablets, capsules, and solutions.
  • The unit will focus on the process of making a drug into a medicine and what happens to it once it has been taken by or delivered to the patient.
  • Included in this process is the development of a drug delivery system factoring into drug properties (e.g., molecular weight, lipophilicity, ionization, and solubility), dissolution rate, and chemical stability.
  • Different dosage forms (e.g., tablets, capsules, liquids) are discussed, including the role of excipients in formulation and the quality control measures during manufacturing.

Unit overview (MPharm)

  • The schedule for the unit, including lectures, workshops, problem-based learning tutorials, and assessments, is presented.
  • Lecture topics are listed, along with relevant workshop dates and problem-based learning (PBL) schedule.
  • The assessment structure is broken down: 10% for semester 1 PBL and 30% for semester 1 exam and 60% for semester 2 exam.

Unit overview (Pharmacology)

  • The structure of this unit follows a similar schedule to MPharm, covering various concepts.
  • The schedule for the unit, including lectures, and workshops, and assessments is detailed in the provided material.
  • The assessment structure for pharmacology is also outlined by examing topics by exam period.

Semester 1 topics (MPharm and Pharmacology)

  • Overview of what is a medicine, components of a medicine, different dosage forms and roles of excipients
  • Thermodynamics
  • Physiochemical properties of small drugs, acid-base theory, pH and pKa, electrolytes and buffers
  • Chemical kinetics and stability of dosage forms
  • Optimising drug properties, and oral bioavailability in relation to the pharmaceutical formulation

Semester 2 topics (MPharm and Pharmacology)

  • Drug distribution and elimination, introduction to pharmacokinetics, and IV bolus and infusion injections
  • one-compartment model for infusions, as well as extravascular administration
  • Liquid dosage forms - solutions, suspensions and emulsions, solid dosage forms, tablet coating, drug release and capsules
  • Formulation of suppositories

Learning Outcomes

  • Demonstrate an understanding of a drug; its requirements for delivery and regulatory considerations
  • Describe the influence of physicochemical properties on drugs, including kinetics and pH
  • Demonstrate understanding of the pre-formulation and formulation procedures in relation to solid and liquid dosage forms, including their manufacture and performance
  • Demonstrate understanding of factors influencing drug release through its dosage form, subsequent absorption, and the subsequent metabolism and elimination from the body
  • Demonstrate how drugs' fate and concentration in the body are modeled using basic pharmacokinetic models
  • Student/Tutor support is available

Teaching on the unit

  • The schedule for lectures and workshops, along with resources, is presented.
  • Details about lecture recordings, workshop content (including specific questions), and additional assessment sessions for questions are detailed.

Teaching on the Unit (MPharm only)

  • The unit describes the two practical classes towards the beginning of semester two to contextualize material from semester one by gathering and analyzing experimental data.
  • The practical classes details the "road-to-market unit" of a specific medicine that is studied with support from the tutor and peers.

Problem-based learning (PBL) (MPharm only)

  • Details the approach to PBL, which encourages students to take responsibility for their learning by exploring a case study or a task.
  • The specific task for this unit involves examining the "road-to-market" of an approved medicine
  • Further details available via module Moodle page

Assessment

  • The unit presents the assessment structure for both MPharm and Pharmacology students; both exams (semester 1 &2), are explained, along with PBL requirement.
  • Aggregate mark of 40% across both exams is requirement for passing
  • MPharm students need to pass corresponding PBL module

Moodle

  • The unit has a Moodle page with relevant materials (orientation, unit overview, teaching materials, Q&A forum, lecture recordings, and library resources).
  • Support is available through this module.

Other

  • Lecture and workshop topics; content, and useful resources are detailed.

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Description

Test your knowledge on different pharmaceutical formulations including capsules, tablets, and oral solutions. This quiz covers crucial aspects such as the functions of various components, advantages of dosage forms, and factors affecting bioavailability. Perfect for students in pharmacy or related fields.

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