Industrial Pharmacy I, Unit I Question Bank

2 Marks Short Answer Questions:

1. What is the main purpose of preformulation studies in pharmaceutical development?
2. Name two physicochemical characteristics of drug substances studied during preformulation.
3. What is the primary goal of studying the solubility profile of a drug substance during preformulation?
4. Name one chemical property that can lead to degradation of drug substances and discuss its impact on the stability of dosage forms.
5. Define preformulation studies in pharmaceutical development.
6. Mention one chemical property studied during preformulation and its impact on drug stability.
7. What is the goal of studying the solubility profile of a drug during preformulation?
8. Explain the concept of BCS classification and its relevance in pharmaceutical development.

5 Marks Questions:

1. Explain the significance of studying the physical properties of drug substances during preformulation. Discuss at least three physical properties and their relevance in dosage form development.
2. Describe the concept of polymorphism in relation to drug substances. How does polymorphism influence the development and stability of pharmaceutical dosage forms?
3. Explain how the physicochemical characteristics of drug substances, such as particle size, shape, and solubility profile, influence the formulation and development of different types of dosage forms, including solid, liquid oral, and parenteral formulations. Provide specific examples to illustrate your answer.

10 Marks Questions:

1. Provide a comprehensive overview of preformulation studies and their objectives in the drug development process. Elaborate on the various physicochemical characteristics of drug substances that are investigated and their relevance in designing effective dosage forms.
2. Discuss the chemical properties that can impact the stability of drug substances. Take into consideration hydrolysis, oxidation, reduction, racemisation, and polymerization reactions. How can an understanding of these properties aid in preformulation and formulation processes?
3. Explain the Biopharmaceutics Classification System (BCS) and its significance in drug development. How does the BCS classification of a drug influence its formulation and development strategy?
4. Explore the application of preformulation considerations in the development of solid, liquid oral, and parenteral dosage forms. Highlight how the physicochemical characteristics studied in preformulation impact the stability and performance of these dosage forms.