How Is a Tablet Manufactured? A Step-by-Step Guide to Pharmaceutical Tablet Production

Tablet manufacturing is a precise, regulated process that converts raw materials (powders, granules, or active ingredients) into uniform, solid dosage forms—critical for pharmaceuticals, nutraceuticals, and functional foods. The process requires strict quality control, compliance with global standards (GMP, FDA, CE), and specialized equipment to ensure consistency, potency, and safety. YANGZHOU NUOYA MACHINERY CO.,LTD., a leading provider of pharmaceutical manufacturing solutions, offers a full line of equipment tailored to each stage of tablet production—from mixing and granulation to compression, coating, and packaging. Below is a detailed breakdown of the tablet manufacturing process, highlighting key steps, equipment, and quality considerations.

1. Raw Material Preparation & Pre-Formulation

• Ingredients: Core components include active pharmaceutical ingredients (APIs), fillers (e.g., lactose, microcrystalline cellulose), binders (e.g., starch, PVP), disintegrants (e.g., croscarmellose sodium), lubricants (e.g., magnesium stearate), and colorants/flavorants (for consumer-centric products).

• Testing: Raw materials are inspected for purity, particle size, moisture content, and flowability—critical for downstream processing. For example, APIs must meet potency specifications, while fillers need uniform particle size to ensure even mixing.

• Equipment: YANGZHOU NUOYA’s precision weighing scales and material handling systems (e.g., vacuum conveyors) ensure accurate ingredient dosing and prevent contamination during transfer.

2. Mixing (Blending)

• Process: Ingredients are loaded into a blender and mixed for a predefined time to achieve homogeneity. The type of blender depends on material properties (e.g., flowability, density).

• Equipment: YANGZHOU NUOYA offers industrial blenders (e.g., V-blenders, ribbon blenders, high-shear mixers) designed for pharmaceutical use:

• High-shear mixers: Ideal for wet granulation (see Step 3), combining mixing and binder incorporation in one step.

• V-blenders: Suitable for dry mixing of free-flowing powders, ensuring gentle blending without damaging particles.

• Quality Check: Post-mixing, samples are tested for API uniformity (content uniformity test) to confirm consistency.

3. Granulation (Optional but Critical for Most Tablets)

A. Wet Granulation (Most Common for Pharmaceuticals)

• Process:

1. A liquid binder (e.g., water, ethanol, or polymer solutions) is added to the mixed powders.

2. The mixture is agitated (via high-shear mixer) to form wet granules.

3. Granules are dried to remove moisture (critical for stability and compression).

• Equipment: YANGZHOU NUOYA’s high-shear granulators and fluid bed dryers work seamlessly together:

• High-shear granulators ensure uniform binder distribution and granule formation.

• Fluid bed dryers use controlled air flow to dry granules gently, preserving API potency and preventing caking.

B. Dry Granulation (For Moisture-Sensitive Materials)

• Process: Powders are compressed into dense sheets (slugging) or rolls (roller compaction) without binders, then crushed into granules.

• Equipment: YANGZHOU NUOYA’s dry granulators (roller compaction models) are ideal for moisture-sensitive APIs or formulations where wet granulation could degrade ingredients.

4. Milling & Sizing (Granule Conditioning)

• Process: Granules are passed through a mill (e.g., oscillating granulator) to break down oversized lumps and create a consistent particle size distribution (typically 100–500 μm).

• Equipment: YANGZHOU NUOYA’s oscillating granulators feature adjustable screens to control granule size, with stainless steel construction for easy cleaning and GMP compliance.

• Quality Check: Sieved granules are tested for flow rate and bulk density to ensure they perform well in compression.

5. Lubrication (Final Mixing)

• Process: Lubricants (e.g., magnesium stearate, stearic acid) are added in small quantities (0.5–2% of total weight) and mixed gently to avoid over-lubrication (which can reduce tablet hardness or dissolution rate).

• Equipment: YANGZHOU NUOYA’s blenders (e.g., tumble blenders) are used for gentle lubricant mixing, preserving granule structure while ensuring even lubricant distribution.

6. Tablet Compression (Tablet Pressing)

• Process:

1. Granules are fed into a hopper and distributed into die cavities (defined by die size/shape).

2. Upper and lower punches apply high pressure (5–50 MPa) to compress granules into tablets.

3. Compressed tablets are ejected from the die and collected for further processing.

• Equipment: YANGZHOU NUOYA’s tablet compression machines (lab-scale, semi-automatic, fully automatic) are engineered for pharmaceutical precision:

• Fully automatic models: Offer high throughput (50,000–200,000+ tablets/hour), in-line weight checks, and PLC control for batch data logging (GMP-compliant).

• Lab-scale models: Ideal for R&D or small-batch production, with adjustable pressure and die sets for testing formulations.

• Quality Checks: In-line inspections include weight variation (±1% for pharmaceuticals), hardness testing (10–40 N), and thickness uniformity. Defective tablets are automatically rejected.

7. Coating (Optional)

• Process:

1. Tablets are loaded into a coating pan or fluid bed coater.

2. A coating solution (polymer, colorant, plasticizer) is sprayed onto the rotating tablets.

3. Warm air dries the coating to form a thin, uniform layer.

• Equipment: YANGZHOU NUOYA’s film coating machines and fluid bed coaters are designed for pharmaceutical use:

• Fluid bed coaters offer uniform coating and faster drying, ideal for large-scale production.

• Coating pans are suitable for small-batch or specialty coatings (e.g., sugar coating for pediatric tablets).

• Quality Check: Coated tablets are tested for coating thickness, uniformity, and dissolution rate (critical for enteric-coated tablets).

8. Packaging

• Process:

1. Tablets are counted and packaged into blister packs, bottles, or sachets.

2. Packages are labeled with product name, dosage, expiration date, lot number, and regulatory information.

• Equipment: YANGZHOU NUOYA’s blister packing machines and bottle filling lines are tailored to pharmaceutical packaging needs:

• Blister packing machines: Seal tablets in individual, tamper-proof blisters (PVC/PET/aluminum film), with in-line inspection for empty blisters or incomplete seals.

• Bottle filling lines: Automate counting, filling, capping, and labeling for bottle packaging, ensuring accuracy and efficiency.

• Compliance: Packaging equipment meets GMP and FDA standards, with batch traceability for recall management.

9. Quality Control (Throughout the Process)

• Incoming Raw Materials: Purity, potency, and particle size testing.

• In-Process QC: Mix uniformity, granule moisture content, tablet weight/hardness/disintegration.

• Finished Product Testing: API potency, dissolution rate, stability (shelf-life testing), and microbial contamination (for sterile tablets).

• Equipment: YANGZHOU NUOYA’s machines integrate in-line QC features (e.g., weight checks, hardness monitors) and are compatible with third-party QC tools for comprehensive testing.

Why Choose YANGZHOU NUOYA for Tablet Manufacturing Equipment?

• GMP Compliance: All equipment is designed with stainless steel 304/316L construction, smooth surfaces, and data logging for regulatory compliance.

• Precision & Consistency: Machines deliver uniform mixing, granulation, compression, and coating—reducing defects and ensuring batch-to-batch consistency.

• Scalability: Solutions range from lab-scale R&D equipment to high-speed industrial lines, growing with your production needs.

• Efficiency: Automated processes reduce labor costs and material waste, while energy-efficient designs lower operational expenses.

• Global Support: Comprehensive after-sales service, including installation, training, and technical support, ensures smooth operation worldwide.

Conclusion