Dosage form Design I — Summer 2021

What is the importance of preformulation study? Discuss oxidation reaction in detail and different means to arrest it as a part of preformulation study.

Write a note on prodrug approach.

What do you mean by drug-excipient compatibility study? Which are the different methods to determine it?

What is the importance of an adjuvant in pharmaceutical products? Enlist cellulose derivatives polymers and write a note on HPMC.

Write a note on biodegradable polymers,

Which different categories of excipients are utilized in a tablet dosage form? Discuss anyone in detail.

How can one maintain the shelf life by means of overages? What is its limit of addition? Discuss in detail method to calculate overages.

What do you mean by order of reaction? Which are the different methods to determine order of reaction?

What do you mean by reduced and full design in stability testing? Write a note on matrixing design.

Compare and contrast passive and facilitated diffusion process.

Explain plasma protein binding in detail.

Discuss physiological barriers to drug distribution in body.

Define bioavailability. Discuss methods to enhance the bioavailability.

Discuss the merits and demerits of using healthy volunteers and patients for bioavailability study.

Draw a layout of latin square crossover design for 12 subjects to compare three different formulations A, Band C. Discuss the advantages and limitations of this design. Q. 6 (a) Enlist factors affecting dissolution. Discuss factors related to drug product formulation in detail.

Give full form of BDDCS. What is its importance and applications in drug discovery and development?

Classify methods for dissolution profile comparison and discuss model independent method in brief.

Enumerate theories of dissolution. Explain in brief ‘Film Theory’

What are the various non-renal routes of drug excretion?

Discuss the regulatory requirements for conduction of bio-equivalence studies