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?

It has a high contact angle. Signup and view all the answers

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

It is not as effective as magnesium stearate. Signup and view all the answers

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

They should be used only after granulation. Signup and view all the answers

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

Granules promote better binding. Signup and view all the answers

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

They enhance flow properties. Signup and view all the answers

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

To facilitate the production, administration, and identification of the drug Signup and view all the answers

Which property is NOT desirable for an ideal excipient?

Costly to produce. Signup and view all the answers

What potential effect can excipients have on drug formulations?

They can affect the bioavailability of the drug Signup and view all the answers

Which of the following statements about excipients is incorrect?

Excipients are always chemically reactive with drugs Signup and view all the answers

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

Adding volume to the dosage form to facilitate handling Signup and view all the answers

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

Protecting the drug against degradation Signup and view all the answers

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

Ensuring the safety and quality of excipients Signup and view all the answers

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

It assures the quality and safety of excipients for pharmaceutical use Signup and view all the answers

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

To dissolve other ingredients effectively Signup and view all the answers

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

Polyethylene glycol Signup and view all the answers

What is the primary role of buffers in liquid preparations?

To control microbial growth Signup and view all the answers

Which statement regarding antimicrobial agents in liquid formulations is incorrect?

They enhance the dissolution of drugs. Signup and view all the answers

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

It supports microbiological growth. Signup and view all the answers

What is the function of antioxidants in liquid formulations?

To protect against oxidation Signup and view all the answers

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

To decrease interfacial tension Signup and view all the answers

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

It swells slowly in the presence of water Signup and view all the answers

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

They aid in the processing of the drug delivery system. Signup and view all the answers

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

It increased the mean serum concentration of phenytoin. Signup and view all the answers

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

It led to nephrotoxic and hepatotoxic effects. Signup and view all the answers

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

It acted as a matrix for the drug. Signup and view all the answers

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

They can be responsible for some side effects. Signup and view all the answers

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

They assist in stabilizing the drug formulation. Signup and view all the answers

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

Ensuring excipients do not adversely affect drug bioavailability. Signup and view all the answers

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

It increases the speed of drug release. Signup and view all the answers

What is the primary function of disintegrating agents in tablets?

To facilitate rapid disintegration and increase surface area Signup and view all the answers

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

Generate carbon dioxide upon dissolution Signup and view all the answers

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

Cellulose acetate phthalate Signup and view all the answers

What role do glidants serve in granulation?

To improve the flow of powders and reduce friction Signup and view all the answers

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

Croscarmellose sodium Signup and view all the answers

Which of the following statements about coatings is FALSE?

Coatings are exclusively used for aesthetic reasons. Signup and view all the answers

What effect does colloidal silica have in granulation?

Fills surface irregularities to enhance flow Signup and view all the answers

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

Polyvinylpyrrolidone (PVP) in solution Signup and view all the answers

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

Obesity and tooth decay Signup and view all the answers

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

Polyoxyl castor oils Signup and view all the answers

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

Benzyl alcohol Signup and view all the answers

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

To increase tablet size for handling Signup and view all the answers

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

Aspartame Signup and view all the answers

What characteristic makes spray dried lactose suitable for direct compression?

Special porosity Signup and view all the answers

Which excipient is noted for its consistent inert properties?

Lactose Signup and view all the answers

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

Microcrystalline cellulose Signup and view all the answers

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

Hypersensitivity and behavioral disturbances Signup and view all the answers

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

Direct compression lactose Signup and view all the answers

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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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.