1. What is formulation development?
It’s the process of designing and optimizing a dosage form to ensure safety, efficacy, and stability of the drug product.
2. Why is preformulation study important?
It helps understand physicochemical properties of API to select proper excipients and dosage form.
3. What are common preformulation parameters?
Solubility, pH, hygroscopicity, particle size, polymorphism, and compatibility.
4. What is the difference between API and excipient?
API provides therapeutic effect, excipients support formulation stability, manufacturability, and performance.
5. What is the purpose of excipient compatibility study?
To ensure no chemical or physical interaction between API and excipients.
6. What are the stages of formulation development?
Preformulation → Prototype → Optimization → Scale-up → Validation.
7. What factors affect tablet formulation?
Flow properties, compressibility, moisture content, binder concentration, and lubricant amount.
8. What is wet granulation?
A process where powders are mixed with a binder solution to form granules before compression.
9. Why dry granulation is preferred sometimes?
It’s suitable for moisture or heat-sensitive drugs.
10. What is the role of binder in tablet formulation?
To provide cohesion and improve tablet strength.
11. What is bioavailability?
The fraction of administered drug that reaches systemic circulation.
12. What is the difference between dissolution and disintegration?
Disintegration is tablet breakup; dissolution is drug release into solution.
13. What is QbD?
Quality by Design — systematic approach focusing on understanding processes and controlling variability.
14. What is DoE in formulation?
Design of Experiment — statistical tool to optimize formulation parameters efficiently.
15. What is stability study?
Testing the product under various conditions to determine shelf life and storage requirements.
16. What is the purpose of accelerated stability study?
To predict product stability in shorter time.
17. What is the role of surfactant in formulation?
To improve wetting and solubility of poorly soluble drugs.
18. What is the difference between prototype and pilot batch?
Prototype is for R&D trials; pilot batch simulates production scale.
19. What is scale-up?
Transition of a formulation from lab scale to commercial scale while maintaining quality.
20. What are critical quality attributes ?
Physical, chemical, or biological properties that affect product quality (e.g., hardness, assay).
21. What are critical process parameters ?
Variables that directly impact CQAs (e.g., mixing time, compression force).
22. What is the purpose of coating tablets?
To protect from moisture/light, mask taste, or control drug release.
23. What is in-vitro vs in-vivo correlation ?
Relationship between in-vitro dissolution and in-vivo absorption data.
24. What are key documents in R&D formulation?
Formulation development report, batch manufacturing record, and stability protocol.