Excipients in Drug Formulations

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Questions and Answers

Which of the following describes the primary role of adsorbents in pharmaceutical formulations?

  • Keeping powders dry by adsorbing moisture. (correct)
  • Preventing foam formation in liquid preparations.
  • Maintaining a stable pH in the preparation.
  • Preventing oxidation of active pharmaceutical ingredients.

What is the main function of anti-foaming agents in liquid pharmaceutical formulations?

  • To improve the solubility of the drug.
  • To increase the viscosity of the liquid.
  • To prevent the formation of foam. (correct)
  • To protect active ingredients from oxidation.

Why are antioxidants included in some pharmaceutical formulations?

  • To maintain a stable pH.
  • To improve the taste of the medication.
  • To prevent microbial growth.
  • To prevent oxidation of active pharmaceutical ingredients. (correct)

What is the purpose of anti-adherents and lubricants in tablet manufacturing?

<p>To prevent particles from sticking and improve powder flow. (C)</p> Signup and view all the answers

A pharmaceutical scientist is formulating a new oral solution and needs to ensure the pH remains constant. Which type of excipient is most suitable for this purpose?

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

Which of the following describes the primary function of chelating agents in pharmaceutical formulations?

<p>To bind metal ions and prevent oxidation catalysis. (A)</p> Signup and view all the answers

What is the main reason for using coatings on tablets?

<p>To protect from light, oxygen, and moisture and mask unpleasant taste. (A)</p> Signup and view all the answers

Why are diluents or fillers used in the manufacturing of tablets and capsules?

<p>To increase the volume or size of the dosage form. (C)</p> Signup and view all the answers

What is the role of disintegrants in solid dosage forms like tablets and capsules?

<p>To help the dosage form break up in the body. (D)</p> Signup and view all the answers

A pharmacist is compounding a topical ointment and needs an excipient to soften and soothe the skin. Which type of excipient is most appropriate?

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

What is the primary purpose of enteric coatings on tablets?

<p>To protect the drug from being destroyed by stomach acid. (C)</p> Signup and view all the answers

A formulation scientist is trying to increase the viscosity and provide physical stability to a suspension. What type of excipient should they consider using?

<p>Gelling/thickening agent/ stabilizer (D)</p> Signup and view all the answers

Which property of powders is improved by glidants?

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

What is the primary purpose of humectants in pharmaceutical creams and ointments?

<p>To prevent drying and brittleness. (C)</p> Signup and view all the answers

A pharmacist needs to dissolve a water-soluble solute in a formulation. Which type of solvent is most appropriate?

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

Which type of solvent is best suited for dissolving lipophilic substances?

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

What is the primary function of levigating or wetting agents in pharmaceutical compounding?

<p>To reduce particle size and improve dispersion. (D)</p> Signup and view all the answers

Why are opaquing agents included in some pharmaceutical formulations?

<p>To protect the formulation from light. (C)</p> Signup and view all the answers

What is the purpose of preservatives in pharmaceutical formulations?

<p>To prevent microbial growth. (D)</p> Signup and view all the answers

Which best describes the use for suppository bases?

<p>The material which forms the main body of the suppository and carries the drug. (B)</p> Signup and view all the answers

Flashcards

What are Adsorbents?

Substances used to keep powders dry by adsorbing moisture.

What are Anti-Foaming Agents?

A compound that breaks and prevents foam formation in liquid preparations.

What are Antioxidants?

Substances that prevent the oxidation of active pharmaceutical ingredients (APIs), improving product stability.

What are Anti-Adherents / Lubricants?

Excipients that prevent particles from sticking to each other or equipment, reduce friction, and improve powder flowability.

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What are Buffering Agents?

Substances that maintain a stable pH in a preparation.

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What are Chelating Agents?

Substances that bind metal ions to prevent the catalysis of oxidation reactions.

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What are Coatings (in drug formulations)?

Coatings protect from light, oxygen, moisture, and mask unpleasant taste.

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What are Diluents / Fillers?

Substances used to increase the volume or size of tablets or capsules for easier handling.

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What are Disintegrants?

Substances that help break up tablets/capsules in the body by absorbing water and swelling.

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What are Emollients?

Substances that soothe and soften skin and can act as a topical drug vehicle.

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What are Enteric Coating Agents?

Coatings that protect drugs from being destroyed by stomach acid by delaying release until the intestine.

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What are Gelling / Thickening Agents / Stabilizers?

Agents that increase viscosity and provide physical stability to suspensions or gels.

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What are Glidants?

Substances that improve the flow properties of powders by reducing interparticle friction.

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What are Humectants?

Substances that prevent drying and brittleness in formulations.

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What are Hydrophilic Solvents?

Solvents used to dissolve solutes that are water-soluble.

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What are Hydrophobic Solvents?

Solvents used to dissolve lipophilic substances (not miscible with water).

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What are Levigating / Wetting Agents?

Agents that reduce particle size and improve dispersion into a medium.

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What are Opaquing Agents?

Agents providing light protection and improving product appearance

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What are Preservatives?

Agents that prevent microbial growth in formulations.

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What are Suppository Bases?

The material used as the carrier for suppositories.

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Study Notes

  • Study guide covering excipients in drug formulations

Adsorbents

  • Examples: Magnesium oxide, magnesium carbonate, and kaolin.
  • Purpose: Used to keep powders dry by adsorbing moisture.

Anti-Foaming Agents

  • Example: Simethicone.
  • Purpose: Breaks and prevents foam formation in liquid preparations.

Antioxidants

  • Examples: Ascorbic acid, sodium bisulfite, and EDTA.
  • Purpose: Prevents oxidation of active pharmaceutical ingredients (APIs), improving product stability.

Anti-Adherents/Lubricants

  • Example: Magnesium stearate.
  • Purpose: Prevents particles from sticking to each other or equipment, reduces friction, and improves powder flowability.

Buffering Agents

  • Example: Sorensen's modified phosphate buffer.
  • Purpose: Maintains a stable pH in the preparation.

Chelating Agents

  • Example: EDTA.
  • Purpose: Binds metal ions to prevent catalysis of oxidation reactions.

Coatings

  • Examples: Shellac, gelatin, and gluten.
  • Purpose: Protects from light, oxygen, and moisture, and masks unpleasant taste.

Diluents/Fillers

  • Examples: Starches, calcium salts, lactose, cellulose, mannitol, and sorbitol.
  • Purpose: Used to increase volume or size of tablets or capsules for easier handling.

Disintegrants

  • Examples: Alginic acid, polacrillin potassium (Amberlite), cellulose products, starches, and compressed sugar.
  • Purpose: Helps break up tablets/capsules in the body by absorbing water and swelling.

Emollients

  • Example: Petroleum jelly.
  • Purpose: Soothes and softens skin; can act as a topical drug vehicle.

Enteric Coating Agents

  • Examples: Cellulose acetate phthalate and shellac.
  • Purpose: Protects drugs from being destroyed by stomach acid by delaying release until the intestine.

Gelling/Thickening Agents/Stabilizers

  • Examples: Gelatin, bentonite, agar, alginates, guar gum, acacia, tragacanth, carbomer, cellulose, starches, and pluronic gels.
  • Purpose: Increase viscosity and provide physical stability to suspensions or gels.

Glidants

  • Examples: Colloidal silica and magnesium stearate.
  • Purpose: Improves flow properties of powders by reducing interparticle friction.

Humectants

  • Examples: Glycerin and propylene glycol.
  • Purpose: Prevents drying and brittleness in formulations.

Hydrophilic Solvents

  • Examples: Polyethylene glycol (PEG) and alcohols.
  • Purpose: Used to dissolve solutes that are water-soluble.

Hydrophobic Solvents

  • Examples: Canola oil, coconut oil, and Omega-3 and Omega-6 fatty acids.
  • Purpose: Used to dissolve lipophilic substances (not miscible with water).

Levigating/Wetting Agents

  • Examples: Mineral oil, glycerin, polysorbate 80 (Tween 80), and propylene glycol.
  • Purpose: Reduces particle size and improves dispersion into a medium.

Opaquing Agents

  • Example: Titanium dioxide.
  • Purpose: Provides light protection and improves product appearance.

Preservatives

  • Examples: Chlorhexidine, sodium benzoate, benzoic acid, benzalkonium chloride, thimerosal, EDTA, and benzyl alcohol.
  • Purpose: Prevents microbial growth in formulations.

Suppository Bases

  • Examples: Cocoa butter (Theobroma oil), hydrogenated vegetable oils (e.g., palm, coconut oil), glycerinated gelatin, and polyethylene glycol (PEG) polymers.
  • Purpose: Used as the carrier material for suppositories.

Surfactants

  • Examples: Sodium lauryl sulfate, polysorbates (Tweens), and sorbitan esters (Spans).
  • Purpose: Reduces surface tension, improves wetting and mixing, and neutralizes static charge.

Sweeteners

  • Examples: Aspartame, saccharin, glycerin, dextrose, lactose, mannitol, sorbitol, phenylalanine, stevia, and xylitol.
  • Purpose: Adds sweetness to oral or chewable preparations.

Water Types

  • From most to least pure: Sterile water for injection (SWFI), purified water, potable water (tap or drinking water).
  • Purpose: Universal solvent in formulations.

Excipients to Avoid in Certain Patient Populations

  • Gelatin should be avoided in those avoiding pork; Hypromellose (cellulose-based capsule) can be used as an alternative.
  • Gluten should be avoided in those with celiac disease or are gluten-sensitive; Corn starch or potato starch can be used as an alternative.

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