What do you understand by the term pre-formulation studies? Discuss different parameters of pre-formulation process.
[6 marks]Solid state characterization is an important criterion for product development process. Discuss.
[5 marks]How a dosage form selection is done for a particular drug? State it in terms of flowchart if possible.
[5 marks]State the difference between solubility and dissolution. Explain BCS and which category of excipients are used in improvement of dissolution rate of an API.
[6 marks]Explain in general the various Quality Attributes of an API that needs consideration during pharmaceutical product development process.
[5 marks]Describe various analytical test parameters of solid oral dosage form that are performed during product development process.
[5 marks]Which are the different types of stability testing studies and mention the storage conditions, time duration and frequency of sampling required to be done for each type?
[6 marks]What is the importance of stability studies? Elaborate various ICH guidelines for the stability study.
[5 marks]Give the types of chemical stability reactions and discuss any one in detail.
[5 marks]Classify suspending agents and state its importance. Flocculated system is better than deflocculated suspension. Comment on the given statement and give examples of flocculating agents.
[6 marks]Explain types of ointment bases with its application and examples.
[5 marks]Write a note on formulation components of a emulsion dosage form.
[5 marks]Describe the role of each class of excipients used in formulation of parenteral dosage form citing examples from each class.
[6 marks]How many types of tablet coating are there? How they are different from each other in terms of formulation components discuss?
[5 marks]Categorize the types of excipients used in formulation of TDDS giving example of each type and its use in TDDS. Q. 6 (a) Define the following terms: (Any 3) 1. QbD. 2. DoE 3. FMEA 4. QTPP
[6 marks]Enlist different types of design methodologies available under DoE and state the difference between screening design and optimization design.
[5 marks]Discuss factorial design in detail with a suitable example.
[5 marks]Classify pharmaceutical packaging system based on the materials used for their fabrication. Discuss each in brief.
[6 marks]Write a short note on anti-counterfeiting technologies used in pharmaceutical packaging system.
[5 marks]Enumerate advantages of blister pack and discuss its components.
[5 marks]