Stability Considerations in Dosage Form Design

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Questions and Answers

What is stability in the context of dosage form design?

  • The ability of a product to withstand extreme temperatures
  • The ability of a product to maintain its color and appearance over time
  • The resistance of a product to external forces like pressure and impact
  • The extent to which a product retains its properties throughout its period of storage and use (correct)

Which of the following is not a factor contributing to the decomposition of drug substances?

  • Alkaline pH (correct)
  • Heat
  • Oxygen
  • Moisture

How can drugs be classified based on their sensitivity to breakdown?

  • Based on their taste
  • Based on their color
  • Based on their stability in different conditions (correct)
  • Based on their route of administration

What is checked during the design of formulations to ensure drug safety?

<p>Interactions between drugs and added excipients (D)</p> Signup and view all the answers

Which thermal analysis technique is particularly useful for identifying possible drug-additive and drug-drug interactions?

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

What has thermal analysis revealed about magnesium stearate and aspirin?

<p>Magnesium stearate interacts with aspirin and should be avoided in formulations containing this drug (D)</p> Signup and view all the answers

Which type of stability concern is related to the retention of antimicrobial agents' effectiveness within specified limits?

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

What is the most frequently encountered destructive process chemically?

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

Which chemical group is most susceptible to the hydrolytic process?

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

What type of stability ensures that the original physical properties of a drug are retained?

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

Which type of stability concerns the retention of the therapeutic effect of a drug?

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

What is the example given for ester hydrolysis in the text?

<p>Formation of salicylic acid and acetic acid (A)</p> Signup and view all the answers

What catalyzes the hydrolysis of amides?

<p>Acids or bases (B)</p> Signup and view all the answers

Which type of drug is too unstable to be formulated as solutions?

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

What enhances the stability of drug products through the reduction or elimination of water from the pharmaceutical system?

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

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