Excipients Quiz
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Questions and Answers

What is one characteristic of mannitol when used in chewable tablets?

  • It is tastier than lactose. (correct)
  • It is less tasty than lactose.
  • It enhances tablet strength.
  • It reduces disintegration time.

What is one function of lubricants in tablet formulation?

  • To prevent powder/metal adherence. (correct)
  • To increase tablet strength.
  • To enhance disintegration.
  • To provide binding agents.

How does magnesium stearate affect disintegration time?

  • It eliminates disintegration entirely.
  • It prolongs disintegration time. (correct)
  • It enhances drug dissolution.
  • It decreases tablet porosity.

Which of the following is a disadvantage of using magnesium stearate?

<p>It has a high contact angle. (A)</p> Signup and view all the answers

Which of the following statements regarding sodium stearyl fumarate is correct?

<p>It is not as effective as magnesium stearate. (D)</p> Signup and view all the answers

What is the recommended usage of binding agents in tablet formation?

<p>They should be used only after granulation. (B)</p> Signup and view all the answers

What is a benefit of using granules over powders in tablet formulation?

<p>Granules promote better binding. (B)</p> Signup and view all the answers

What effect do lubricants have on the flow properties of tablet components?

<p>They enhance flow properties. (A)</p> Signup and view all the answers

What is the primary purpose of excipients in a dosage form?

<p>To facilitate the production, administration, and identification of the drug (D)</p> Signup and view all the answers

Which property is NOT desirable for an ideal excipient?

<p>Costly to produce. (D)</p> Signup and view all the answers

What potential effect can excipients have on drug formulations?

<p>They can affect the bioavailability of the drug (A)</p> Signup and view all the answers

Which of the following statements about excipients is incorrect?

<p>Excipients are always chemically reactive with drugs (A)</p> Signup and view all the answers

What does the term 'bulk up' refer to in the context of excipients?

<p>Adding volume to the dosage form to facilitate handling (D)</p> Signup and view all the answers

Which is an example of a role that excipients can play in drug stability?

<p>Protecting the drug against degradation (D)</p> Signup and view all the answers

What is the primary focus of Good Manufacturing Practices (GMP) in the context of excipients?

<p>Ensuring the safety and quality of excipients (A)</p> Signup and view all the answers

What is the significance of complying with BP, PhEur, and USP-NF standards for excipients?

<p>It assures the quality and safety of excipients for pharmaceutical use (D)</p> Signup and view all the answers

What is the primary function of water as an excipient in liquid preparations?

<p>To dissolve other ingredients effectively (D)</p> Signup and view all the answers

Which of the following co-solvents does NOT enhance solubility in liquid preparations?

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

What is the primary role of buffers in liquid preparations?

<p>To control microbial growth (C)</p> Signup and view all the answers

Which statement regarding antimicrobial agents in liquid formulations is incorrect?

<p>They enhance the dissolution of drugs. (A)</p> Signup and view all the answers

What is a significant drawback of using water as an excipient in liquid formulations?

<p>It supports microbiological growth. (D)</p> Signup and view all the answers

What is the function of antioxidants in liquid formulations?

<p>To protect against oxidation (B)</p> Signup and view all the answers

What is the purpose of wetting agents in a liquid formulation?

<p>To decrease interfacial tension (D)</p> Signup and view all the answers

Which property of HPMC makes it suitable for controlling drug release in formulations?

<p>It swells slowly in the presence of water (C)</p> Signup and view all the answers

What is one of the roles of excipients in drug formulation?

<p>They aid in the processing of the drug delivery system. (C)</p> Signup and view all the answers

How did changing from calcium sulfate to lactose in phenytoin capsules affect the drug's bioavailability?

<p>It increased the mean serum concentration of phenytoin. (A)</p> Signup and view all the answers

What consequence did the use of diethylene glycol instead of glycerin have in pharmaceuticals?

<p>It led to nephrotoxic and hepatotoxic effects. (D)</p> Signup and view all the answers

What characteristic of calcium sulfate contributed to its prolonged release of phenytoin?

<p>It acted as a matrix for the drug. (A)</p> Signup and view all the answers

What is a potential adverse effect of excipients in medicinal formulations?

<p>They can be responsible for some side effects. (D)</p> Signup and view all the answers

What role do excipients play in maintaining drug integrity during storage?

<p>They assist in stabilizing the drug formulation. (C)</p> Signup and view all the answers

Which of the following interventions is crucial when selecting excipients for drugs with a narrow therapeutic index?

<p>Ensuring excipients do not adversely affect drug bioavailability. (C)</p> Signup and view all the answers

What main benefit does lactose provide over calcium sulfate in drug formulations?

<p>It increases the speed of drug release. (C)</p> Signup and view all the answers

What is the primary function of disintegrating agents in tablets?

<p>To facilitate rapid disintegration and increase surface area (A)</p> Signup and view all the answers

Which of the following is NOT a method by which disintegrating agents can function?

<p>Generate carbon dioxide upon dissolution (D)</p> Signup and view all the answers

Which polymer is used for enteric coating and is known for its acid resistance?

<p>Cellulose acetate phthalate (C)</p> Signup and view all the answers

What role do glidants serve in granulation?

<p>To improve the flow of powders and reduce friction (B)</p> Signup and view all the answers

What is an example of a superdisintegrant used in tablet formulations?

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

Which of the following statements about coatings is FALSE?

<p>Coatings are exclusively used for aesthetic reasons. (D)</p> Signup and view all the answers

What effect does colloidal silica have in granulation?

<p>Fills surface irregularities to enhance flow (D)</p> Signup and view all the answers

Which of the following materials is typically associated with wet granulation technology?

<p>Polyvinylpyrrolidone (PVP) in solution (D)</p> Signup and view all the answers

What is a potential consequence of using glucose and sucrose as excipients?

<p>Obesity and tooth decay (C)</p> Signup and view all the answers

Which of the following excipients is associated with severe allergic reactions?

<p>Polyoxyl castor oils (C)</p> Signup and view all the answers

Which excipient may lead to Central Nervous System effects, particularly in neonates?

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

What is the primary role of diluents or bulking agents in tablets?

<p>To increase tablet size for handling (C)</p> Signup and view all the answers

Which of the following excipients can be toxic in phenylketonuria patients?

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

What characteristic makes spray dried lactose suitable for direct compression?

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

Which excipient is noted for its consistent inert properties?

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

Which of these diluents is commonly associated with good flow characteristics?

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

What is the main concern regarding the use of colourants like tartrazine?

<p>Hypersensitivity and behavioral disturbances (A)</p> Signup and view all the answers

Which excipient allows for powder free flow and does not require granulation during tablet production?

<p>Direct compression lactose (B)</p> Signup and view all the answers

Flashcards

What are excipients?

Substances added to a dosage form that are not therapeutically active.

How can excipients impact drug absorption?

Excipients can affect how well a drug is absorbed into the bloodstream.

What are some practical applications of excipients?

Excipients are used to make tablets easier to manufacture, administer, and identify.

How can excipients control drug release?

Specific examples of excipients controlling drug release include coatings that slow down the release of the drug.

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What role do excipients play in drug stability?

Excipients can protect the drug from degradation and help preserve its stability.

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What are some ideal properties of an excipient?

Ideally, excipients should be stable, non-reactive with the drug, inert in the body, and cost-effective.

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What are the quality standards for excipients?

Excipients must be pharmaceutically safe and meet quality standards, often conforming to regulations like the British Pharmacopoeia.

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How are excipients manufactured?

Good Manufacturing Practices (GMP) are followed to ensure the safe and consistent production of pharmaceutical products, including excipients.

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Excipients: What are they?

Substances added to a drug formulation to aid in its manufacture, stability, bioavailability, or patient acceptability.

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Roles of Excipients

Excipients can help in mixing, protecting the drug, enhancing its stability, improving how it's absorbed, and making it more palatable.

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Excipients & Bioavailability

The excipient's properties can influence drug release and absorption, potentially impacting its effectiveness.

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Excipient Change Example: Phenytoin

A change in the excipient can dramatically alter a drug's release rate and circulating levels in the body.

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Excipient Safety: Diethylene Glycol Case

Diethylene glycol, a toxic substance, was mistakenly used in place of glycerin in a cough syrup, resulting in serious health consequences.

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Excipients & Side Effects

Excipients can sometimes cause side effects, although this is relatively uncommon.

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Excipient Importance in Drug Development

Careful selection and control of excipients are crucial for drug development and ensuring patient safety.

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Excipients: Hidden Heroes

Excipients are often overlooked but play a vital role in drug formulation, impacting a drug's effectiveness, safety, and delivery.

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Mannitol

A type of sugar alcohol that is used as a sweetener in chewable tablets. It's often preferred over lactose because it tastes better.

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Tablet excipients

Ingredients added to tablets that help with the process of making them, such as binding, disintegrating, lubricating, etc.

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Binding agents

Materials that help hold the tablet together and make it strong. These are usually added after granulation.

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Post-mixing lubricant

Adding lubricant after mixing can cause the tablet to stick to the pressing equipment.

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Lubricants in tablet making

Lubricants help prevent the powdered tablet from sticking to the metal parts of the tablet press, allowing for smooth ejection.

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Effects of Lubricants

Lubricants can affect the disintegration time, dissolution of the drug, and the strength of the tablet.

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Magnesium Stearate

A common lubricant that is hydrophobic. It's highly effective at promoting the flow of powders.

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Sodium Stearyl Fumarate

A lubricant that is hydrophilic. It's not as effective as magnesium stearate in promoting powder flow.

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Granulating Agents (Binders)

Substances that help bind particles together during granulation, forming a solid mass. They can be added dry or as a solution.

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Starch (Binder)

Starch, a natural polymer, often used as a binder in dry granulation, helping particles stick together.

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Polyvinylpyrrolidone (PVP) (Binder)

Polyvinylpyrrolidone (PVP) is a synthetic polymer used as a binder, especially in wet granulation, providing a strong bond.

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Glidants

Substances that improve the flowability of powder and granules by reducing friction between particles. Think of lubricant in a car!

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Colloidal Silica (Glidant)

Colloidal silica, a fine powder, fills up the space between rough surfaces of particles, making the powder flow more easily.

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Disintegrating Agents

Substances that cause tablets to break down into smaller pieces when exposed to liquid, increasing the surface area for faster dissolution.

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Superdisintegrants (Starch, Croscarmellose Sodium)

Starches and croscarmellose sodium are examples of superdisintegrants that swell in water, creating pressure for rapid tablet disintegration.

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Pregelatinised Starch (Disintegrant)

Pregelatinised starch is a disintegrant that works through capillary action drawing liquid inside the tablet, disrupting bonds and causing it to break apart.

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HPMC and xanthan gum

These excipients are used for their ability to slowly swell, gradually releasing the drug over time, making them ideal for controlled drug release.

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Water as an Excipient

Water is the most widely used excipient, as it's safe and dissolves many ingredients. However, it's vulnerable to microbial growth and can break down certain drugs.

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Water-miscible co-solvents

These are added to enhance a drug's solubility, making it dissolve faster. This can improve the medication's taste and stability.

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Buffers in liquid formulations

Buffers are used to control the acidity or alkalinity of the liquid. This helps ensure that the drug stays stable and doesn't get destroyed by changes in pH.

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Antimicrobial agents

These excipients act like tiny soldiers fighting off harmful microbes in the liquid medicine, preventing them from spoiling.

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Antioxidants

Antioxidants are like heroes who sacrifice themselves to protect the rest of the medicine. They prevent other ingredients from being damaged by oxygen.

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Wetting agents

These excipients reduce the surface tension between the liquid and a hydrophobic drug, allowing it to get wet and dissolve evenly.

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Excipients

Substances added to a drug formulation to aid in its manufacture, stability, or administration. They are inactive ingredients that do not possess any therapeutic effect.

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Diluents or Bulking Agents

A type of excipient that increases the bulk of the tablet to make it a suitable size for handling and swallowing.

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Lactose (α-lactose monohydrate)

A common diluent known for its pleasant taste, good solubility, and low moisture absorption properties.

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Spray Dried Lactose

A special type of lactose designed for direct compression, meaning it can be compressed into tablets without the need for granulation.

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Microcrystalline Cellulose

A common diluent known for its good flowability and ability to be directly compressed into tablets.

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Disintegrants

A type of excipient that influences how quickly a tablet dissolves in the body.

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Binders

A type of excipient that helps to bind the ingredients together and maintain the tablet's shape.

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Lubricants

A type of excipient that reduces friction between tablet ingredients during compression, improving the flowability of powders.

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Colorants

A type of excipient used to color tablets, often used for identification or aesthetic purposes.

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Study Notes

MPharm Programme - Excipients

  • Excipients are minor components of dosage forms, often present in very small quantities (e.g., 1 in 1000).
  • They are not therapeutically active but serve a purpose, such as bulking up the drug.
  • Excipients are crucial in controlling the behaviour of dosage forms, impacting bioavailability (e.g., how much drug reaches the blood).
  • Excipients influence drug release and stability, potentially affecting the rate of drug absorption.
  • Example excipients include tablets, facilitating manufacture, administration, and identification of drugs, regulating consistent release and promoting stability or protecting drugs.

Excipient – Ideal Properties

  • Ideal excipients are stable and reproducible.
  • They should have no unintended interactions with the drug (no chemical reactions).
  • Excipients are pharmacologically inert, meaning they do not affect the drug's activity.
  • They must deliver the desired function.
  • Cost-effectiveness is a key factor.
  • They must comply with pharmaceutical standards (e.g. BP PhEur, USP-NF, manufactured under GMP).

Excipients – Role

  • Excipients aid in the processing of drug delivery systems during manufacturing.
  • They protect, support, or enhance stability, bioavailability, and patient acceptability.
  • They assist in product identification and improving the drug's safety profile.
  • They facilitate drug effectiveness and/or delivery, and maintain the drug product's integrity during storage

Excipients – Safety

  • In the 1960s, replacing calcium sulfate with lactose in phenytoin capsules affected bioavailability, increasing the mean serum phenytoin concentration by 4.5-fold. Lactose is soluble in water, while calcium sulfate is less soluble, thus influencing drug release. Lactose gave an immediate, large release, while calcium gave a prolonged release.
  • Diethylene glycol (antifreeze) was used as a cough syrup ingredient in 2007, leading to health problems (e.g., nephrotoxicity, hepatotoxicity).

Excipients – Adverse Effects

  • Some excipients can cause side effects.
  • Examples include glucose/sucrose (linked to obesity and tooth decay), benzyl alcohol (gassing syndrome in neonates), ethanol (CNS effects), aspartame (phenylketonuria), polyoxyl castor oils (anaphylactoid reactions).
  • Propylene glycol (CNS effects in infants and young children), and colourants (hypersensitivity and behavioural disturbances), can negatively affect patient health.

Tablet Compression/Compaction

  • Tablet compression involves precise positioning of granules or powders.
  • Granules flow into a die cavity and are compressed into a tablet.
  • Movements of punches and hopper shoes shape and form the tablet, ensuring smooth ejection.

Tablet Excipients (Diluents/Bulking Agents)

  • Diluents (fillers) are added to create the correct size for tablets, for handling, and to improve properties like taste and solubility/dissolution (e.g., lactose).
  • Lactose, a common filler, is known for its pleasant taste and low hygroscopicity (moisture absorption, preventing clumping), in addition it is inert.
  • Common diluting agents include lactose, sucrose, calcium phosphate dihydrate, glucose, calcium carbonate, mannitol, and cellulose, to name a few.
  • Spray-dried lactose is also commonly used for direct compression (DC).
  • Microcrystalline cellulose improves the direct compression process as well.
  • Mannitol is often used for chewable tablets.

Tablet Excipients (Lubricants)

  • Lubricants prevent powder/metal adherence to ensure smooth ejection from the die, improve flow properties of the drug substances, prolong disintegration time, and reduce drug dissolution.
  • Magnesium stearate, used widely up to 1% w/w, acts as a good lubricant, hydrophobic.
  • Sodium stearyl fumarate is hydrophilic, sometimes used in preference.

Tablet Excipients (Binding Agents)

  • Binding agents adhere particles together, improving tablet integrity.
  • They are commonly added during granulation as dry powder or solutions.
  • Examples include starch and polyvinylpyrrolidone (PVP).

Tablet Excipients (Glidants)

  • Glidants improve powder/granule flow, reducing interparticulate friction, and smoothing surface irregularities.
  • Examples include colloidal silica.

Tablet Excipients (Disintegrating Agents)

  • Disintegrating agents increase tablet surface area when wetted, triggering the tablet to break apart.
  • Starch, croscarmellose sodium, and pregelatinised starch function as disintegrating agents.
  • Lyophilised tablets generally disintegrate quickly in water.

Tablet Excipients (Dyes & Flavouring Agents)

  • These agents enhance tablet taste and appearance, e.g., colouring agents, flavours.
  • Film and sugar coatings, e.g., sucrose, are frequently used in tablets.

Excipients for Liquid Preparations (Water)

  • Water, a commonly used liquid excipient, is physiologically non-toxic and compatible.
  • It helps dissolve ingredients.
  • However, it can support microbial growth and be prone to hydrolysis, so careful consideration is required.
  • Water also supports chemical reactions.

Excipients for Liquid Preparations (Water Miscible Co-Solvents)

  • Water-miscible co-solvents help enhance solubility, taste, and stability.
  • Common examples include propylene glycol, glycerol, and ethanol.

Excipients for Liquid Preparations (Buffers)

  • Buffers control pH, promoting stability, and maintaining physiological compatibility within the liquid.
  • They also act to improve dissolution.

Excipients for Liquid Preparations (Antimicrobial Agents)

  • These agents prevent the growth of microbes (from excipients or the environment )within the liquid.
  • Preservatives are key examples.

Excipients for Liquid Preparations (Antioxidants)

  • Antioxidants prevent oxidation of various components in the liquid formulation, as well as components from excipients.

Excipients for Liquid Preparations (Wetting Agents)

  • Wetting agents decrease interfacial tension in liquids, allowing for better spreading, especially important with hydrophobic drugs.
  • Surface-active agents and hydrophilic colloids aid this activity.

Excipients for Liquid Preparations (Antifoaming Agents)

  • Antifoaming agents control foam formation in liquids.

Excipients for Liquid Preparations (Thickening Agents)

  • Thickening agents stabilise suspensions, improving viscosity.
  • Methylcellulose is a good example

Excipients for Liquid Preparations (Sweetening Agents)

  • Sweetening agents add sweetness to the preparations.

Excipients for Liquid Preparations (Flavouring Agents)

  • Natural and/or artificial flavouring agents enhance the taste of prepared liquids.

Excipients for Liquid Preparations (Humectants)

  • Humectants absorb moisture from the atmosphere, preventing drying of the liquid formulation, and maintaining consistency, especially for external formulations (e.g., glycerol, PEGs).

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MPharm Programme: Excipients PDF

Description

Test your knowledge about excipients in the MPharm program. This quiz covers their importance in dosage forms, ideal properties, and their role in drug stability and release. Enhance your understanding of excipients and their critical functions in pharmaceuticals.

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