Process Development and Scale Up

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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?

Decarboxylation (C) Signup and view all the answers

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

Contamination by organisms producing penicillinase (C) Signup and view all the answers

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

To denature the enzymes in the gum (A) Signup and view all the answers

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

Phase separation of the polymer (D) Signup and view all the answers

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

To wash away the butadiene (D) Signup and view all the answers

What is the role of ethylcellulose in the microencapsulation process?

As a coating material (C) Signup and view all the answers

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

2:1 (C) Signup and view all the answers

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

As a solvent for polybutadiene (B) Signup and view all the answers

What is the purpose of microencapsulation?

To control the release of the core material (C) Signup and view all the answers

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

All of the above (D) Signup and view all the answers

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

To facilitate production by unskilled labor (A) Signup and view all the answers

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

To identify potential problems in large-scale production (B) Signup and view all the answers

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

To evaporate the solvent for the polymer (B) Signup and view all the answers

What can influence the size of a product during manufacturing?

Physical properties of the new drug (C) Signup and view all the answers

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

Their shape (C) Signup and view all the answers

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

To form microcapsules of the appropriate size (C) Signup and view all the answers

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

A matrix-type microcapsule is formed (B) Signup and view all the answers

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

All of the above (D) Signup and view all the answers

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

Liquid-liquid, liquid-gas, solid-liquid, or solid-gas interface (A) Signup and view all the answers

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

The polymer shrinks around the core (A) Signup and view all the answers

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

The microcapsule is formed (C) Signup and view all the answers

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

The rate constant (D) Signup and view all the answers

What is the purpose of Nelson's equation?

To determine the amount of drug required to maintain a therapeutic level (C) Signup and view all the answers

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

It is used to calculate the rate constant of the drug (D) Signup and view all the answers

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

The plot is a straight line (A) Signup and view all the answers

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

The sum of initial dose and maintenance dose (B) Signup and view all the answers

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

It is the product of initial dose and the fraction of blood level (D) Signup and view all the answers