Pharmaceutical Capsule Filling and Sealing Quiz

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Questions and Answers

What is the purpose of using excipients in powder formulation?

  • To improve powder stability
  • To bulk up the powder and form a plug (correct)
  • To enhance powder bioavailability
  • To reduce powder cohesion

Why is it important for powders to be non-adhesive?

  • To increase powder bioavailability
  • To improve powder appearance
  • To reduce powder cohesion
  • To prevent clumping and facilitate production (correct)

What is the role of disintegrants in tablet formulation?

  • To aid in tablet disintegration under high pressure (correct)
  • To reduce powder cohesion
  • To enhance powder bioavailability
  • To improve powder stability

Why is uniform power mix needed in tablet formulation?

<p>To ensure accurate dosing (A)</p> Signup and view all the answers

What happens to gelatin shell in a higher pH environment?

<p>It can cause cross-linking of gelatin molecules, making the shell harder to dissolve (A)</p> Signup and view all the answers

What is the function of a self-emulsifying system for drug delivery?

<p>To ensure the oil containing drug and surfactant mixes in GI fluid (C)</p> Signup and view all the answers

What is the purpose of using a suspension for drug delivery?

<p>For drugs not soluble in solvents (D)</p> Signup and view all the answers

How does a higher pH environment affect gelatin hydrolysis?

<p>It inhibits gelatin hydrolysis (B)</p> Signup and view all the answers

What are the key quality control tests for softgel capsules?

<p>Uniformity of weight, uniformity of content, disintegration, and dissolution tests (C)</p> Signup and view all the answers

What does the dissolution test measure?

<p>How much drug dissolves from the capsule at specific time points (A)</p> Signup and view all the answers

What is the purpose of opacifiers in softgel capsules?

<p>To block out light and protect the drug from photodegradation (C)</p> Signup and view all the answers

What is a disadvantage of softgel capsules?

<p>Higher cost and slower production (C)</p> Signup and view all the answers

What is the composition of softgel capsules?

<p>Gelatin, plasticizer, filling (liquid), colorants, opacifiers, flavors, and enteric coating (B)</p> Signup and view all the answers

What does the disintegration test for softgel capsules involve?

<p>Placing capsules in a disintegration well, moving them in specified liquid, and checking the time for disintegration (C)</p> Signup and view all the answers

What is the role of flavors in softgel capsules?

<p>To provide taste to the capsule shell (C)</p> Signup and view all the answers

What is the purpose of the polymer shell in softgel capsules?

<p>It is pH-sensitive and does not require an enteric coating (B)</p> Signup and view all the answers

What is the significance of the ratio of dry plasticizer to dry gelatin in softgel capsules?

<p>It is crucial for the flexibility and pliability of the shell (B)</p> Signup and view all the answers

What type of drug delivery are softgel capsules suitable for?

<p>Liquids or suspensions as a single solid dose (B)</p> Signup and view all the answers

What are the advantages of softgel capsules?

<p>High bioavailability, consumer preference, good appearance, and protection of the drug from oxidation and moisture (A)</p> Signup and view all the answers

What is the role of enteric coating in softgel capsules?

<p>It protects the drug from gastric acid and facilitates release in the intestines (C)</p> Signup and view all the answers

What excipients can enhance the solubility of poorly soluble drugs?

<p>Wetting agents and sugars (B)</p> Signup and view all the answers

What is the purpose of disintegrants in capsules?

<p>To push particles apart by swelling when wet (C)</p> Signup and view all the answers

What method can be used to reduce powder sticking to machine surfaces?

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

What affects the release of the drug after swallowing?

<p>Shell disintegration, polymer dissolution, and powder form (A)</p> Signup and view all the answers

Which type of polymers can be used in the capsule material to create enteric capsules?

<p>pH-sensitive polymers (B)</p> Signup and view all the answers

What is the purpose of surfactants like sodium lauryl sulfate in capsule formulation?

<p>To aid in wetting for hydrophobic drugs (C)</p> Signup and view all the answers

What is the purpose of using a tamping system in industrial scale capsule filling?

<p>To ensure proper compaction of the powder blend (C)</p> Signup and view all the answers

What can be used to create a tamper-proof seal for capsules?

<p>Creating a band using a polymer (D)</p> Signup and view all the answers

What can be used to enhance the solubility of poorly soluble drugs?

<p>Wetting agents and sugars (C)</p> Signup and view all the answers

What can reduce the dissolution rate of powders?

<p>Powders that aggregate (D)</p> Signup and view all the answers

What is the purpose of using magnesium stearate in capsule formulation?

<p>To reduce powder sticking to machine surfaces (D)</p> Signup and view all the answers

What affects the dissolution rate of powders?

<p>Particle size and aggregation (A)</p> Signup and view all the answers

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Study Notes

Capsule Filling and Sealing Process Overview

  • Capsules may need to break easily, especially for powders, and may require microcrystalline cellulose, sodium starch glycolate, and crospovidone for disintegration.
  • Disintegrants work by swelling when wet, pushing particles apart, and the need for disintegrants depends on the powder's compression and space between particles.
  • Starch is suitable for tablets but not for capsules due to its strength, and surfactants like sodium lauryl sulfate are used for hydrophobic drugs to aid in wetting.
  • The release of the drug after swallowing depends on the shell disintegration, polymer dissolution at body temperature, and the powder's loose or plug form affecting the speed of drug release.
  • Particle size affects dissolution rate, and powders that aggregate reduce the dissolution rate, necessitating a formulation where powders disperse effectively in the gastrointestinal tract.
  • Excipients like wetting agents and sugars can enhance the solubility of poorly soluble drugs and draw water into the powder mass.
  • Magnesium stearate can reduce powder sticking to machine surfaces, but excessive use can decrease drug release, and lubricants impact the cohesion and adhesion of powders.
  • Bench scale filling involves manually filling empty caps with a powder blend, pushing the powder into the cap, and industrial scale filling can handle 5000-150,000 capsules per hour using various systems like the auger, dosing tube, and dising disc with a tamping system.
  • Capsule sealing methods include creating a band using a polymer for extra security, tamper-proof seals, and using heat, color, or solvent to seal the capsule.
  • Cleaning and coating processes involve dedusting and polishing the capsules, spraying coating solutions, and applying film or functional coatings based on the purpose.
  • Enteric capsules can be made through enteric coating or by using pH-sensitive polymers in the capsule material.

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