Fenofibrate DC Granules –

 


Fenofibrate DC Granules – A Comprehensive Deep Blog

By Swapnroop Drugs & Pharmaceuticals – Global Manufacturer of APIs, DC Granules & Pellets

🔷 Introduction

Fenofibrate DC (Direct Compression) Granules are high-performance granules engineered for ready-to-compress tablet formulations, eliminating the need for conventional wet granulation. Fenofibrate, a widely used lipid-lowering agent, is a cornerstone therapy for hyperlipidemia and hypertriglyceridemia. Its API has extremely low aqueous solubility, which makes formulation challenging — hence the importance of advanced DC granule systems.

Swapnroop Drugs & Pharmaceuticals specializes in designing Fenofibrate DC Granules with enhanced flowability, compressibility, and dissolution performance, making it easier for pharmaceutical manufacturers to produce high-quality tablets.

💊 What is Fenofibrate?

Fenofibrate is a fibric acid derivative and a potent PPAR-α (Peroxisome Proliferator-Activated Receptor Alpha) agonist that helps reduce:

  • ✔️ LDL cholesterol
  • ✔️ Triglycerides
  • ✔️ VLDL
  • ✔️ Total cholesterol

It also helps increase:

  • ✔️ HDL cholesterol (good cholesterol)

Fenofibrate therapy is typically used in patients with:

  • Hypertriglyceridemia
  • Mixed dyslipidemia
  • Metabolic syndrome
  • Cardiovascular risk due to lipid imbalance

🧪 Challenges With Fenofibrate API

Fenofibrate has:

  • Extremely poor water solubility
  • Weak flow properties
  • Poor compressibility
  • Variable dissolution
    These properties make it unsuitable for direct tableting unless converted into specialized granules.

Swapnroop overcomes these challenges using advanced formulation techniques.

⚗️ What Are Fenofibrate DC Granules?

Fenofibrate DC Granules are pre-granulated, pre-lubricated, flow-optimized particles containing Fenofibrate API + functional excipients designed for direct compression.

Key attributes:

  • ✔️ Improved solubility & dissolution
  • ✔️ Consistent potency across granules
  • ✔️ Excellent flow for high-speed tableting
  • ✔️ Enhanced tablet uniformity
  • ✔️ Better compressibility and low friability

These granules significantly improve formulation performance and reduce manufacturing complexity.

🔬 Physicochemical Profile of Fenofibrate DC Granules

  • Appearance: Free-flowing white granular powder
  • Moisture Content (LOD): Low to ensure stability
  • Solubility: Very poorly soluble in water
  • Melting point: 80–82°C
  • Particle Morphology: Optimized for die-filling
  • Density: Improved bulk & tapped density for compressibility
  • Functional Excipients:
    • Binder
    • Superdisintegrant
    • Solubility enhancer
    • Glidant
    • Lubricant

🏭 Manufacturing Process of Fenofibrate DC Granules (Deep Explanation)

DC granules are produced using a controlled, validated, multi-step granulation process:

1️⃣ Pre-processing

  • API sieved & checked for uniformity
  • Excipients screened for quality

2️⃣ High-Shear Wet Granulation

Fenofibrate is mixed with solubilizing agents and binders to improve dispersibility.

3️⃣ Drying (Fluid Bed Drying)

Granules are dried at controlled temperatures to minimize degradation.

4️⃣ Sieving & Milling

Achieves uniform particle size distribution and prevents segregation.

5️⃣ Final Blending

Lubricants and glidants added to optimize flow & compressibility.

6️⃣ In-process QC Testing

  • Granule size
  • Density
  • Moisture
  • Flow properties

7️⃣ Packaging Under Controlled Conditions

Ensures stability and minimizes moisture uptake.

💊 Dosage Forms Produced Using Fenofibrate DC Granules

Manufacturers can directly produce:

  • 💠 Immediate-release tablets
  • 💠 Film-coated tablets
  • 💠 Combination lipid-lowering tablets (customized)
  • 💠 Capsules (granules filled directly)

The granules meet IP / BP / USP dissolution and assay specifications.

⚙️ Direct Compression Advantages for Manufacturers

Fenofibrate DC Granules drastically simplify production:

Benefits:

  • ✔️ No wet granulation or drying
  • ✔️ Reduced processing time & equipment cost
  • ✔️ Faster batch turnover
  • ✔️ Uniform tablet weight & potency
  • ✔️ Enhanced dissolution due to optimized formulation
  • ✔️ Better scalability from R&D to commercial production

🧬 Technical Advantages of Swapnroop’s Fenofibrate DC Granules

  • ⭐ Enhanced dissolution profile due to particle engineering
  • ⭐ Excellent flow properties suitable for high-speed rotary machines
  • ⭐ Superior compressibility
  • ⭐ Granule stability ensured through moisture control
  • ⭐ Uniform drug content across batches
  • ⭐ Low friability & robust mechanical strength in tablets

🧫 Quality Control Tests Performed

Every batch undergoes:

Granule Tests:

  • Assay
  • Related substances
  • Loss on drying
  • Flowability
  • Particle size distribution
  • Bulk/tapped density
  • Compressibility index
  • Hausner ratio

Tablet Tests (Post Compression):

  • Hardness
  • Disintegration time
  • Friability
  • Dissolution
  • Assay & impurities
  • Weight variation
  • Stability (ICH conditions)

📦 Packaging, Storage & Shelf Life

Storage:

  • Store below 25°C
  • Keep protected from moisture & light
  • Use original container

Packaging:

  • HDPE drums
  • Fiber/paper drums
  • Triple-layer LDPE bags

Shelf Life:

2 to 3 years, depending on stability data.

🏭 Why Choose Swapnroop Drugs & Pharmaceuticals?

  • 🌍 45+ Export Countries
  • 🏭 WHO-GMP compliant manufacturing
  • 📦 Customizable DC formulations
  • 🧪 Advanced solubility & dissolution enhancement technologies
  • 🛡️ Zero-defect quality standards
  • ⚙️ Strong R&D for lipid-lowering drug formulations

 

Q1. What are Fenofibrate DC Granules?

Fenofibrate DC (Direct Compression) Granules are ready-to-compress, pre-processed granules of Fenofibrate designed to provide:

  • Improved compressibility
  • Enhanced flow properties
  • Superior uniformity during tableting
  • Simplified manufacturing, avoiding complex wet granulation steps

Fenofibrate is a lipid-modifying agent, primarily used to reduce triglycerides, VLDL, and LDL levels, while increasing HDL cholesterol. Because Fenofibrate is highly lipophilic and poorly water-soluble, DC granules are engineered to improve bioavailability, content uniformity, and tablet performance.

Q2. How are Fenofibrate DC Granules different from standard Fenofibrate API?

Standard Fenofibrate API has:

  • Poor flow due to fine particle size
  • Extremely low aqueous solubility
  • Low compressibility
  • High risk of segregation in blends
  • Challenges in producing uniform tablets

Fenofibrate DC Granules overcome these problems using:

  • Granulation with excipients
  • Particle size control
  • Binder and disintegrant optimization
  • Flow-enhancing agents like MCC or colloidal silica
  • Compressibility enhancers to support direct compression

Thus, DC granules reduce processing time and improve tablet consistency.

Q3. What are the physicochemical characteristics of Fenofibrate DC Granules?

Typical properties include:

  • Appearance: Off-white to pale yellow free-flowing granules
  • Bulk Density: Moderate, designed for ideal die fill during tableting
  • Particle Size Distribution: Optimized to prevent segregation (typically 150–600 µm)
  • Flowability: Excellent (Angle of repose < 30°)
  • Solubility: Practically insoluble in water; soluble in alcohols and organic solvents
  • Melting Point: 79–82°C (Fenofibrate API)
  • Stability: Sensitive to light; stable under normal dry storage

The engineered granules greatly enhance handling stability and manufacturing efficiency.

Q4. How are Fenofibrate DC Granules manufactured?

The manufacturing process usually includes:

  1. Pre-blending of Fenofibrate micronized API with carriers like lactose/MCC
  2. Wet or dry granulation depending on the manufacturer
  3. Drying (if wet granulation is used) to controlled moisture levels
  4. Sieving to achieve uniform granule size
  5. Blending with lubricants (magnesium stearate) and glidants (talc)
  6. Quality checks for flow, compressibility, and PSD

The granules are designed specifically for direct compression without additional processing.

Q5. What are the applications of Fenofibrate DC Granules?

They are primarily used to manufacture:

  • Fenofibrate tablets
  • Fenofibrate chewable tablets
  • Fenofibrate fixed-dose combinations
  • Customized sustained-release systems (if modified further)

Pharma companies prefer DC granules because they reduce processing time and variability.

Q6. What dosage forms can be made using Fenofibrate DC Granules?

Common dosage options include:

  • Immediate-release tablets
  • Hard-gelatin capsules (filled with granules)
  • Effervescent granules (post-modification)
  • Chewable tablets
  • Orally disintegrating tablets (with added superdisintegrants)

DC granules allow flexible formulation while ensuring uniform dose delivery.

Q7. What are the major formulation challenges with Fenofibrate, and how do DC granules solve them?

Challenges with raw API:

  • Poor wettability
  • Very low water solubility
  • Poor flowability
  • Segregation of powder blend
  • Content uniformity issues
  • Low hardness and capping during compression

DC granules solve these by providing:

  • Better compressibility
  • Even distribution of API in granule matrix
  • Reduced segregation inside hopper
  • Improved flow and die filling
  • Consistent dissolution profile

This leads to regulatory-friendly, high-performance tablets.

Q8. How are Fenofibrate DC Granules tested during quality control?

QC tests include:

  • Assay & related substances (HPLC)
  • Granule size distribution (sieving)
  • Bulk & tapped density
  • Flowability tests
  • LOD (loss on drying)
  • Angle of repose
  • Compression behavior
  • Dissolution testing (finished tablets)
  • Stability studies under ICH conditions

These tests ensure uniformity and suitability for direct compression.

Q9. How should Fenofibrate DC Granules be stored and packed?

Storage Conditions:

  • Store below 25°C
  • Protect from light and moisture
  • Keep in airtight HDPE bags inside fiber/HDPE drums
  • Maintain humidity levels below 50% RH

Packaging Options:

  • 5 kg / 10 kg / 25 kg lined HDPE drums
  • Double polyethylene bags for protection

Granules must remain dry to avoid clumping or degradation.

Q10. What are the advantages of using Fenofibrate DC Granules for pharmaceutical manufacturers?

✔ No wet granulation, saving time, cost, and equipment
✔ Improved flowability leading to consistent die filling
✔ Superior content uniformity
✔ Quick production scale-up
✔ Regulatory-friendly reproducibility
✔ High tablet compressibility and hardness
✔ Better dissolution performance
✔ Reduced batch failure and rework

Overall, DC granules streamline the entire tablet manufacturing process and improve product quality.

 

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