Process Development and Scale Up
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Questions and Answers

What is the purpose of adding chelating agents to a liquid?

  • To prevent decomposition of the liquid (correct)
  • To remove trace elements from the liquid
  • To increase the pH of the liquid
  • To change the color of the liquid

    • Which of the following antioxidants is commonly used in oily preparations?

  • Sodium sulphite
  • Ascorbic acid
  • Sodium thiosulphate
  • Ascorbyl palmitate (correct)

    • What is the result of racemization of l-hyoscyamine?

  • Formation of epinephrine
  • Formation of dopamine
  • Formation of depinephrine
  • Formation of atropine (correct)

    • What is the process by which an organic compound loses a molecule of carbon dioxide and becomes inactivated?

    <p>Decarboxylation</p> Signup and view all the answers

    What can cause the degradation of antibiotic activity in penicillin solutions?

    <p>Contamination by organisms producing penicillinase</p> Signup and view all the answers

    What is the purpose of heating gums like acacia to 80-100°C?

    <p>To denature the enzymes in the gum</p> Signup and view all the answers

    What is the effect of adding a nonsolvent to a polymer solution?

    <p>Phase separation of the polymer</p> Signup and view all the answers

    What is the purpose of adding hexane to the polybutadiene toluene solution?

    <p>To wash away the butadiene</p> Signup and view all the answers

    What is the role of ethylcellulose in the microencapsulation process?

    <p>As a coating material</p> Signup and view all the answers

    What is the ratio of core material to coating material in the microencapsulation of methylscopolamine hydrobromide?

    <p>2:1</p> Signup and view all the answers

    What is the purpose of using toluene in the microencapsulation process?

    <p>As a solvent for polybutadiene</p> Signup and view all the answers

    What is the purpose of microencapsulation?

    <p>To control the release of the core material</p> Signup and view all the answers

    What is the main challenge in scaling up a small-scale formula to large production?

    <p>All of the above</p> Signup and view all the answers

    Why is it necessary to draw up a complete product specification with accurate manufacturing directions?

    <p>To facilitate production by unskilled labor</p> Signup and view all the answers

    What is the purpose of conducting trials on a pilot plant?

    <p>To identify potential problems in large-scale production</p> Signup and view all the answers

    What is the purpose of heating the mixture in the microencapsulation process?

    <p>To evaporate the solvent for the polymer</p> Signup and view all the answers

    What can influence the size of a product during manufacturing?

    <p>Physical properties of the new drug</p> Signup and view all the answers

    What is the main difference between amorphous and crystalline forms of therapeutic materials?

    <p>Their shape</p> Signup and view all the answers

    What is the purpose of reducing the temperature of the liquid vehicle?

    <p>To form microcapsules of the appropriate size</p> Signup and view all the answers

    What is the result of the core material being dissolved in the coating polymer solution?

    <p>A matrix-type microcapsule is formed</p> Signup and view all the answers

    Why is it necessary to consider the physical properties of a new drug during manufacturing?

    <p>All of the above</p> Signup and view all the answers

    What type of interface exists between the core material and the continuous phase in the polymerization method?

    <p>Liquid-liquid, liquid-gas, solid-liquid, or solid-gas interface</p> Signup and view all the answers

    What happens to the polymer when the core material is dispersed in the coating polymer solution?

    <p>The polymer shrinks around the core</p> Signup and view all the answers

    What is the result of the solvent for the polymer being evaporated?

    <p>The microcapsule is formed</p> Signup and view all the answers

    What is the value of k in the equation k = 0.693/ t1/2?

    <p>The rate constant</p> Signup and view all the answers

    What is the purpose of Nelson's equation?

    <p>To determine the amount of drug required to maintain a therapeutic level</p> Signup and view all the answers

    What is the significance of the equation k = 0.693/ t1/2?

    <p>It is used to calculate the rate constant of the drug</p> Signup and view all the answers

    What is the relationship between the cumulative amount released from a sustained release dosage form and time?

    <p>The plot is a straight line</p> Signup and view all the answers

    What is the total amount of the drug to be incorporated in a sustained-release preparation?

    <p>The sum of initial dose and maintenance dose</p> Signup and view all the answers

    What is the significance of the variable b in Nelson's equation?

    <p>It is the product of initial dose and the fraction of blood level</p> Signup and view all the answers

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