1. What is a Tablet?
A tablet is a solid oral dosage form produced by compressing a mixture of Active Pharmaceutical Ingredients (APIs) and excipients under high pressure.
2. What is an API?
API stands for Active Pharmaceutical Ingredient—the component responsible for producing the intended pharmacological or therapeutic action.
3. What is an Excipient?
Excipients are pharmaceutically inactive substances added to formulations to support processing, stability, and performance of the dosage form without providing any therapeutic effect.
Common Excipients Used in Solid Dosage Forms
- Diluents
- Binders
- Disintegrants
- Glidents
- Lubricants
- Colourants
- Flavouring agents
4. What Tests Are Performed on Tablets?
- Weight variation
- Thickness
- Hardness
- Friability
- Disintegration
- Dissolution
- Assay
- Content uniformity
5. Common Tablet Defects
- Capping
- Lamination
- Sticking
- Picking
- Weight variation
6. What is disintegration?
Disintegration refers to the time required for a tablet or capsule to break apart into smaller particles that pass through a #10 mesh, leaving no solid residue.
7. Disintegration Time Limits
- Capsules: Not more than 30 minutes
- Uncoated tablets: Not more than 15 minutes
- Film-coated tablets: Not more than 30 minutes
- Sugar-coated tablets: Not more than 60 minutes
8. Disintegration Time for Enteric-Coated Tablets
Enteric-coated tablets should remain intact in acidic medium for 2 hours, and must disintegrate in an alkaline medium within 1 hour.
9. Friability Limit
Friability must be not more than 1%.
10. Types of Coating & Common Coating Defects
Types of Coating
- Film coating
- Enteric coating
- Sugar coating
Coating Defects
- Sticking
- Colour variation
- Orange-peel effect
- Logo filling
- Chipping
11. What is an HVAC System?
HVAC stands for Heating, Ventilation, and Air Conditioning.
Functions
- Prevent cross-contamination
- Control temperature
- Control humidity
- Maintain differential pressure
- Provide required air changes
12. Types of Capsules
Hard gelatin capsules
Soft gelatin capsules
13. Friability Test Revolution Speed
The friabilator operates at 25 rpm for 4 minutes.
14. Examples of Natural Binders
Starch
Cellulose
Gelatin
15. Example of Synthetic Binder
PVP K-30 (Povidone, Kollidon)
16. Why Are Granules Prepared Before Tableting?
Granulation is performed to:
- Improve flow properties
- Minimize weight variation
- Reduce dust formation
- Prevent segregation of ingredients
- Enhance content uniformity
- Improve compressibility
- Reduce tablet capping due to elastic properties of powders
17. What is a Rathole?
A flow defect where powder adheres to hopper or blender walls, creating an empty channel in the center that causes inconsistent flow, weight variation, and weak tablets.
18. Why is an opacifier used in tablet coating?
To make the coating opaque, improve appearance, and enhance heat-insulation properties.
19. Commonly Used Opacifiers
Titanium dioxide
Aluminum hydroxide
Aluminum silicate
20. Excipients Used in Enteric-Coated Tablets
CAP (Cellulose Acetate Phthalate)
PVAP
Kollicoat
Eudragit polymers
21. Is Enteric Coating pH-Dependent?
Yes, enteric coating dissolves only at higher pH values.
22. What is Kollicoat?
A Methacrylic Acid–Ethyl Acrylate Copolymer (1:1).
23. Types of Kollicoat Used in Coating
Kollicoat IR
Kollicoat SR 30D
Kollicoat MAE 100P
Kollicoat 30DP
24. Common Tableting Problems
Capping
Lamination
Cracking
Low hardness
High disintegration time
Low dissolution
25. How to Improve Low Tablet Hardness?
Increase binder concentration
Change the type of diluent
Optimize compression force
26. Why Are Plasticizers Used in Coating?
Improve flexibility and elasticity
Lower the glass-transition temperature of polymers
27. Common Plasticizers
Castor oil
Glycerin
PEG 1000 / 1450 / 3350
28. Why Is Magnesium Stearate Added Last?
To avoid negative effects on compressibility and dissolution.
29. Precautions for Hygroscopic Materials
Maintain RH below 45%
Avoid wet granulation
30. Preferred RH for Clavulanic Acid Products
Relative Humidity should be not more than 30%.
31. Parameters Checked After Granulation
Assay
Granule size distribution
Flow properties
32. Mechanism of Sodium Perborate as Preservative
Releases hydrogen peroxide upon hydrolysis, providing oxidative antimicrobial action.
33. Why Are Methylparaben and Propylparaben Used Together (9:1)?
Because they exhibit synergistic preservative activity.
34. Why Must Ophthalmic Preparations Be Sterile?
To avoid microbial contamination that could harm the eye.
35. Difference Between RMG and Mass Mixer
RMG mixes rapidly and efficiently, while mass mixers operate slower and less uniformly.
36. What is Compression Force in Tableting?
The force applied during tableting to compact granules into a solid tablet.
37. Why Is Lubrication Important in Tableting?
To reduce friction between the tablet and die walls, preventing sticking.
38. What Is Pre-Compression?
A light compression step before final compression to remove air and improve tablet integrity.
39. What Is Flow Property Measurement Tool?
Angle of repose, Carr’s index, and Hausner ratio are commonly used.
40. What Does Dissolution Test Measure?
The rate and extent to which API is released from the dosage form in a given medium.
41. What Is Tapping Density?
The density of powder after mechanical tapping, used to evaluate compressibility.
42. What Is Bulk Density?
The mass of powder divided by its volume before tapping.
43. What Is Punch Binding?
Adhesion of formulation material to punches during compression.
44. What Is Over-Lubrication?
Using excessive lubricant causing soft tablets and poor dissolution.
45. What Is a Glidant?
An excipient that improves powder flow by reducing inter-particle friction.
46. What Is a Lubricant?
An excipient that minimizes friction between tooling surfaces.
47. What Is Tablet Erosion?
Gradual wearing away of tablet surface during dissolution.
48. What Is Moisture Sensitivity in Tablets?
When tablets degrade or soften due to moisture absorption.
49. What Is Bloom Strength in Gelatin?
A measure of gelatin's firmness and gel strength used for capsules.
50. Why Use Disintegrants?
To ensure tablets break apart in the GI tract for proper drug absorption.
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