🔹 Tablet Manufacturing Process: An Overview

Tablets are solid dosage forms containing one or more active pharmaceutical ingredients (APIs) with suitable excipients. The manufacturing process must ensure uniformity, stability, safety, and efficacy.

1. Pre-Formulation Studies

Study of API properties: solubility, stability, particle size, flow, compressibility.
Selection of excipients: diluents, binders, disintegrants, lubricants, glidants, coating materials.
Goal: Identify a suitable formulation strategy (direct compression, wet granulation, or dry granulation).

2. Formulation Approaches

There are three main manufacturing methods:

a) Direct Compression

Blend API + excipients → directly compressed into tablets.
Advantages: Simple, fast, cost-effective, fewer steps.
Limitations: Requires API with good flow and compressibility.

b) Wet Granulation

API + excipients mixed → binder solution added → wet mass formed → granulated → dried → sized → lubricated → compressed.
Advantages: Improves flow, compressibility, and content uniformity.
Limitations: Moisture/heat-sensitive drugs not suitable.

c) Dry Granulation (Slugging or Roller Compaction)

API + excipients compacted into slugs/compacts → milled → blended with lubricant → compressed.
Advantages: Suitable for moisture/heat-sensitive drugs.
Limitations: Higher cost, may have lower tablet strength than wet granulation.

3. Unit Operations in Tablet Manufacturing

Step 1: Weighing and Dispensing

Accurate weighing of API and excipients in dispensing booth (to prevent cross-contamination).

Step 2: Blending / Mixing

Ensures uniform distribution of API with excipients.
Performed in V-blenders, double-cone mixers, or bin blenders.

Step 3: Granulation (if applicable)

Wet granulation: Uses fluid bed granulator or high-shear granulator.
Dry granulation: Uses roller compactor.

Step 4: Drying

Removes moisture from wet granules (fluid bed dryer, tray dryer).
Aim: Achieve optimal residual moisture for flow and compressibility.

Step 5: Milling / Sizing

Break down oversized granules, ensure uniform particle size.

Step 6: Final Blending / Lubrication

Add lubricants (e.g., magnesium stearate), glidants (colloidal silica), disintegrants.

Step 7: Compression

Granules or blends compressed into tablets using rotary or single-punch tablet press.
Parameters: hardness, thickness, weight, friability.

Step 8: Tablet Coating (optional)

Film coating: Thin polymeric layer for protection, taste masking, controlled release.
Sugar coating: Traditional, thicker, less common now.
Enteric coating: Protects drug from stomach acid.

Step 9: Packaging

Blister packs, bottles, or strips under controlled conditions.
Ensures stability, patient compliance, tamper resistance.

4. In-Process & Quality Control

Blend uniformity
Granule flow, bulk/tapped density
Tablet weight variation, hardness, friability, disintegration, dissolution
Content uniformity, assay, microbial limits
Visual inspection for defects (chipping, capping, picking, lamination).

5. Key Considerations

Compliance with GMP, ICH, and pharmacopeial standards (USP, EP, IP).
Critical Process Parameters (CPPs) must be controlled to achieve desired Critical Quality Attributes (CQAs).
Process Analytical Technology (PAT) and Quality by Design (QbD) approaches increasingly applied.

✅ Summary

The tablet manufacturing process involves:

Pre-formulation & formulation development
Blending, granulation, drying, sizing, and lubrication (depending on method)
Compression and coating
Packaging & QC testing

The chosen method (direct compression, wet granulation, dry granulation) depends on the API properties and product requirements.

🎓 Discover one of the best Complete Pharmaceutical Production Course available —click below to explore the course that’s shaping future Production Course skills.

https://trcjw.on-app.in/app/oc/338669/trcjw

Tablet Manufacturing Process: An Overview