Tablet Manufacturing Process – A Detailed Guide for B. Pharma Students

💊 Tablet Manufacturing Process – A Detailed Guide for B. Pharma Students

📌 What is a Tablet?

A tablet is a solid dosage form containing one or more active pharmaceutical ingredients (APIs) and excipients, compressed into a definite shape.

Tablets are the most common oral dosage form due to their ease of administration, dose accuracy, stability, and low cost.

🏭 Major Steps in Tablet Manufacturing

Tablet manufacturing typically follows these steps:

1. Dispensing (Weighing)

  • First step in any formulation.

  • All raw materials (API + excipients) are weighed accurately as per the master formula record (MFR).

  • Requires clean, calibrated balances and proper documentation.

2. Milling / Sieving

  • Ensures uniform particle size for better mixing and compression.

  • Materials are passed through sieves (commonly #40 or #60) using a multi-mill, hammer mill, or oscillating granulator.

💡 Tablet Manufacturing Methods

There are three main techniques:

⚙️ A. Wet Granulation Method (Most Common)

➤ Steps:

1. Mixing / Blending:

  • API + diluents (e.g., lactose, MCC) mixed in a double cone blender or ribbon blender.

2. Preparation of Binder Solution:

  • Binders (like starch paste, PVP, or HPMC) dissolved in water or other solvents.

3. Wet Massing:

  • Binder is added to the dry mix to form a dough-like mass.

4. Granulation:

  • Wet mass is passed through granulators (e.g., oscillating granulator) to form granules.

5. Drying:

  • Granules are dried in a tray dryer or fluidized bed dryer (FBD) to a moisture content of ~1–2%.

6. Sifting:

  • Dried granules are passed through a sieve (#16 or #20) to ensure uniform size.

7. Lubrication:

  • Lubricants (e.g., magnesium stearate), glidants (e.g., talc), and disintegrants are added and mixed gently.

8. Compression:

  • Granules are compressed into tablets using rotary tablet press machines.

⚙️ B. Dry Granulation

Used when API is moisture or heat sensitive.

➤ Steps:

  1. Dry mixing of ingredients.

  2. Compression into slugs (slugging) or use of roller compactor.

  3. Milling of slugs into granules.

  4. Lubrication.

  5. Compression.

No water or heat is used.

⚙️ C. Direct Compression

Used for APIs and excipients that flow and compress well.

➤ Steps:

  1. Mix API with direct compressible excipients (like MCC, dicalcium phosphate).

  2. Add lubricant.

  3. Compress into tablets.

Fastest and simplest method, but not suitable for all APIs.

🏗️ Equipment Used

StageEquipment
Weighing
Balances

Mixing
Ribbon blender, Double cone blender

Granulation
Oscillating granulator

DryingTray dryer, Fluidized bed dryer

Compression
Rotary tablet press

Coating (optional)
Coating pan, Fluid bed coater

Quality Testing
Hardness tester, Disintegration tester

🧪 In-Process & Final Quality Control Tests

TestPurpose
Weight. variation       

  Uniformity of dose


Hardness test  Mechanical strength
Friability test 

Resistance to crumbling (using Roche tester)

Disintegration testTime taken to break down in GI fluid
Dissolution test
Drug release rate

Assay (by HPLC/UV)
API content


Content uniformityAPI variation in different tablets

🎨 Optional: Tablet Coating

Coating is done for:

  • Masking taste or odor

  • Protection from light/moisture

  • Controlled release

  • Better appearance

Types of coatings:

  • Sugar coating

  • Film coating (e.g., HPMC-based)

  • Enteric coating (resistant to stomach acid)

🧾 Excipients Used in Tablets

FunctionExample
DiluentsLactose, MCC, Dicalcium phosphate
BindersStarch paste, PVP, HPMC
DisintegrantsSodium starch glycolate, crospovidone
LubricantsMagnesium stearate, stearic acid
GlidantsTalc, colloidal silicon dioxide
Coating agentsHPMC, PEG, titanium dioxide (color)


✅ Advantages of Tablets

  • Stable and long shelf life

  • Easy to handle and transport

  • Accurate dosing

  • Patient compliance

❌ Disadvantages

  • Not suitable for all APIs (e.g., high-dose or poorly compressible drugs)

  • Some APIs degrade during granulation/drying

  • Slow onset compared to liquid forms

🧠 Quick Mnemonic: "We Make Great Dry Lubricated Tablets Carefully"

W – Weighing
M – Mixing
G – Granulation
D – Drying
L – Lubrication
T – Tablet compression
C – Coating

📌 Final Thoughts for Students

As a B. Pharma student:

  • Focus on understanding each unit operation and why it is done

  • Know differences between wet, dry, and direct compression

  • Learn equipment and quality control tests

  • Visit a formulation plant (if possible) during your industrial training.


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