### **1.

Tablet Design and Formulation**

- **Purpose**: Tablets are designed to deliver the correct drug dose in the proper form, at the
right time, and to the desired location.
- **Components**:
- **Active Pharmaceutical Ingredients (APIs)**: The drug(s) in the tablet.
- **Excipients**: Non-drug components that ensure the tablet's quality, stability, and
performance. These include:
- **Diluents/Fillers**: Add bulk to the tablet (e.g., lactose, starch, microcrystalline cellulose).
- **Binders**: Promote cohesion and granulation (e.g., PVP, HPMC).
- **Disintegrants**: Aid in tablet breakup in the gastrointestinal tract (e.g., starch,
croscarmellose sodium).
- **Lubricants**: Reduce friction during compression (e.g., magnesium stearate, talc).
- **Glidants**: Improve powder flow (e.g., talc, colloidal silica).
- **Colors, Flavors, and Sweeteners**: Enhance appearance and taste.

### **2. Tablet Manufacturing**

- **Methods**:
- **Compression**: The most common method, involving powder compression in a die using
punches.
- **Moulding, Freeze-Drying, and 3D Printing**: Alternative methods for specific tablet types.
- **Compression Process**:
- **Stages**: Die filling, tablet formation, and tablet ejection.
- **Equipment**: Single-punch press (for small batches) and rotary tablet presses (for large-
scale production).
- **Direct Compression**: A simplified process where powders are compressed directly without
granulation, reducing production time and cost.

### **3. Quality Control Tests**

- **General Appearance**: Evaluates color, odor, taste, size, shape, and surface texture.
- **Hardness**: Measures the force required to break a tablet, affecting durability and
dissolution.
- **Friability**: Tests tablet durability by measuring weight loss after tumbling.
- **Weight Variation**: Ensures uniformity in tablet weight.
- **Content Uniformity**: Ensures each tablet contains the correct drug amount.
- **Disintegration**: Measures the time for a tablet to break down in a liquid medium.
- **Dissolution**: Evaluates the rate at which the drug is released from the tablet.
The document provide
- **Dissolution**: Evaluates the rate at which the drug is released from the tablet.

### **4. Key Considerations**

- **Excipient Selection**: Must be inert, stable, non-toxic, and compatible with the
drug.
- **Formulation Challenges**: Include drug-excipient interactions, flow properties,
and bioavailability.
- **Manufacturing Challenges**: Stratification, content uniformity, and tablet size for
high/low-dose drugs.

### **5. Regulatory Standards**

- **USP Guidelines**: Define acceptable limits for weight variation, content
uniformity, disintegration, and dissolution.
- **In-Process Testing**: Ensures batch-to-batch consistency and compliance with
quality standards.

This document serves as a guide for designing, formulating, and manufacturing

tablets, emphasizing the importance of excipients, manufacturing processes, and
quality control in ensuring effective and safe drug delivery.
1. **What is the primary purpose of a diluent in tablet formulation?**
a) To enhance drug absorption
b) To add bulk to the tablet when the drug dose is small
c) To improve tablet hardness
d) To act as a disintegrant
**Answer: b) To add bulk to the tablet when the drug dose is small**

2. **Which of the following is a commonly used binder in tablet formulation?**

a) Lactose
b) Magnesium stearate
c) Polyvinyl Pyrrolidone (PVP)
d) Talc
**Answer: c) Polyvinyl Pyrrolidone (PVP)**

3. **What is the role of a disintegrant in a tablet?**

a) To improve tablet hardness
b) To aid in the breakup of the tablet in the gastrointestinal tract
c) To enhance drug stability
d) To reduce friction during compression
**Answer: b) To aid in the breakup of the tablet in the gastrointestinal tract**

4. **Which excipient is commonly used as a lubricant in tablet formulation?**

a) Lactose
b) Microcrystalline cellulose
c) Magnesium stearate
d) Starch
**Answer: c) Magnesium stearate**

5. **What is the primary disadvantage of using water-insoluble lubricants?**

a) They increase tablet hardness
b) They may delay drug dissolution
c) They improve tablet disintegration
d) They reduce tablet weight variation
**Answer: b) They may delay drug dissolution**

6. **Which of the following is a superdisintegrant?**

a) Lactose
b) Croscarmellose Sodium
c) Talc
d) Hydroxypropylcellulose
**Answer: b) Croscarmellose Sodium**
True/False Questions

True or False: Excipients are active pharmaceutical ingredients in a tablet.

Answer: False (Excipients are non-drug components.)
True or False: Direct compression is a method that involves granulation
before tableting.
Answer: False (Direct compression skips granulation.)
True or False: Magnesium stearate is a water-soluble lubricant.
Answer: False (It is water-insoluble.)
True or False: The weight variation test is sufficient for ensuring content
uniformity in low-dose tablets.
Answer: False (Content uniformity testing is required for low-dose tablets.)
True or False: Disintegration is the first step toward drug dissolution.
Answer: True
Short-Answer Questions

What are the three main stages of tablet compression?

Answer: Die filling, tablet formation, and tablet ejection.
List three functions of excipients in tablet formulation.
Answer:
Provide bulk (diluents).
Promote cohesion (binders).
Aid in tablet breakup (disintegrants).
What is the difference between a binder and a disintegrant?
Answer:
Binder: Promotes cohesion and granulation.
Disintegrant: Aids in the breakup of the tablet in the gastrointestinal tract.
Why is the friability test important in tablet quality control?
Answer: It evaluates the durability of tablets by measuring weight loss after
tumbling, ensuring they can withstand handling and shipping.
What are the USP requirements for content uniformity in tablets?
Answer:
9 out of 10 tablets must contain 85% to 115% of the labeled drug content.
The 10th tablet must not contain less than 75% or more than 125% of the labeled
drug content.
Discuss the role of excipients in tablet formulation and provide examples of
each type.
Answer: Excipients are non-drug components that ensure the tablet's
quality, stability, and performance. Examples include:
Diluents: Lactose, microcrystalline cellulose.
Binders: PVP, HPMC.
Disintegrants: Starch, croscarmellose sodium.
Lubricants: Magnesium stearate, talc.
Glidants: Colloidal silica.
Colors, Flavors, and Sweeteners: Mannitol, artificial flavors.
Explain the advantages and disadvantages of direct compression in tablet
manufacturing.
Answer:
Advantages: Fewer processing steps, reduced production cost, improved
stability (no heat or water), faster drug dissolution.
Disadvantages: Risk of stratification, limited use for high/low-dose drugs,
higher cost of direct compressible excipients.
Describe the disintegration test and its importance in tablet quality control.
Answer: The disintegration test measures the time it takes for a tablet to
break down in a liquid medium (e.g., water, simulated gastric fluid). It is
important because disintegration is the first step toward drug dissolution,
which affects bioavailability. The USP specifies maximum disintegration
times for different types of tablets.