Sodium Phenyl Butyrate DC Granules – Advanced Direct Compression Technology for Metabolic Disorder Therapy

 

Sodium Phenyl Butyrate DC Granules – Advanced Direct Compression Technology for Metabolic Disorder Therapy

By Swapnroop Drugs & Pharmaceuticals 💊🏭

Sodium Phenyl Butyrate (CAS No. 1716-12-7) is an essential therapeutic agent used primarily for managing Urea Cycle Disorders (UCDs). Its role in detoxifying ammonia makes it a life-saving medication for patients with compromised nitrogen elimination pathways.

However, the API alone is known to have challenges related to taste, stability, hygroscopicity, and poor flow properties. To address these issues, Sodium Phenyl Butyrate DC Granules offer a superior, ready-to-compress solution ideal for efficient pharmaceutical manufacturing.

At Swapnroop Drugs & Pharmaceuticals, we specialize in producing high-performance DC granules with excellent stability, compressibility, and uniformity—designed for reliable therapeutic formulations.

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🧪 What Are Sodium Phenyl Butyrate DC Granules?

Sodium Phenyl Butyrate DC Granules are pre-formulated, flow-optimized granules containing:
✔ Sodium Phenyl Butyrate API
✔ Taste-masking excipients
✔ Stabilizers
✔ Flow enhancers
✔ Lubricants for direct tableting

These granules are designed for direct compression, eliminating the need for wet granulation—making production faster, simpler, and more cost-effective.

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🔍 CAS Number

📌 Sodium Phenyl Butyrate – CAS No.: 1716-12-7

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💡 Why DC Granules for Sodium Phenyl Butyrate?

Sodium Phenyl Butyrate is:
⚠ Highly hygroscopic
⚠ Known for unpleasant odor and taste
⚠ Difficult to compress
⚠ Sensitive to moisture
⚠ Prone to flow issues in its pure form

Therefore, DC granules bring huge formulation advantages:
✨ Improved taste-masking
✨ Reduced sticking during compression
✨ Enhanced stability & flowability
✨ Better processing performance
✨ Consistent dosage uniformity

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🌈 Key Advantages of Sodium Phenyl Butyrate DC Granules

⭐ 1. Ready-to-Compress Formulation

No wet granulation or complex processing required—granules can be directly compressed into tablets.

⭐ 2. Superior Stability

Moisture-protective excipients protect the API from degradation and caking.

⭐ 3. Taste Masking

One of the biggest problems with Sodium Phenyl Butyrate is its strong taste.
Granules significantly reduce bitterness and enhance palatability.

⭐ 4. Excellent Flow Properties

Granules ensure trouble-free filling in high-speed tablet machines.

⭐ 5. Uniform Dosage Distribution

Critical for drugs used in metabolic disorders where precision is mandatory.

⭐ 6. Improved Dissolution Control

Granules offer predictable dissolution profiles ensuring consistent therapeutic response.

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🧬 Applications of Sodium Phenyl Butyrate DC Granules

📌 Manufacturing of oral tablets
📌 Treatment of Urea Cycle Disorders (UCDs)
📌 Ammonia detoxification therapies
📌 Orphan drug formulations
📌 Clinical research
📌 Pediatric-friendly formulations (flavored/chewable tablets possible)

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🔬 Mechanism of Action (How It Works)

Sodium Phenyl Butyrate undergoes β-oxidation in the body to form phenylacetate, which combines with glutamine to form phenylacetylglutamine.
This compound is excreted through urine, removing excess nitrogen by an alternative pathway.

This action helps reduce ammonia levels, preventing neurological damage and metabolic crises.

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📊 Quality Specifications Ensured by Swapnroop Drugs & Pharmaceuticals

We conduct strict QC checks on each batch, including:
🔬 Assay (Purity)
🔬 Moisture content
🔬 Particle size analysis
🔬 Flowability tests
🔬 Bulk/tapped density
🔬 Dissolution & disintegration studies
🔬 Microbial testing
🔬 Stability studies (accelerated & real-time)

Our DC granules comply with GMP & pharmacopeial standards, ensuring safety, efficacy, and performance.

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🏭 Manufacturing Benefits for Formulators

⚙ Reduced processing steps → Lower production cost
⚙ Less dust formation → Safer handling
⚙ Consistent compressibility → Lower tablet rejection rate
⚙ High batch uniformity → Easier scale-up

DC granules streamline the entire manufacturing workflow.

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🌍 Why Choose Swapnroop Drugs & Pharmaceuticals?

At Swapnroop Drugs & Pharmaceuticals, we deliver:
🌟 High-stability DC granules designed using advanced granulation technologies
🌟 Excellent flow & compression characteristics
🌟 Customization options for strength, excipients & particle size
🌟 GMP-certified & globally compliant manufacturing
🌟 Batch-to-batch consistency
🌟 Complete documentation: COA, MSDS, TDS, stability data

Our Sodium Phenyl Butyrate DC Granules are widely trusted by pharmaceutical manufacturers for quality, stability, and performance.

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📞 Contact Us to Order / Request Samples

Swapnroop Drugs & Pharmaceuticals

📱 Phone: +91-7387999183
📧 Email: sales@sdp.org.in
🌐 Website: www.sdp.org.in

❓ Q1. What are Sodium Phenyl Butyrate DC Granules?

⭐ Deep Answer:
Sodium Phenyl Butyrate DC Granules are pre-formulated, ready-to-compress granules designed for direct tablet manufacturing. They contain:
✔ Sodium Phenyl Butyrate API
✔ Stabilizers
✔ Taste-masking agents
✔ Flow enhancers
✔ Lubricants and binders

The purpose of DC (Direct Compression) granules is to improve manufacturability, enhance stability, optimize flowability, and ensure uniform dose delivery—especially important for a hygroscopic and strong-tasting API like Sodium Phenyl Butyrate (CAS No: 1716-12-7).

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❓ Q2. Why is Sodium Phenyl Butyrate difficult to formulate in pure API form?

⭐ Deep Answer:
The API has several formulation challenges:
⚠ Highly hygroscopic nature → absorbs moisture easily
⚠ Unpleasant taste & odor → requires strong taste masking
⚠ Poor flow properties → difficult to handle in tablet machines
⚠ Tendency to cake or solidify in humid conditions
⚠ Compression problems → high sticking, picking & friability issues

These difficulties make it unsuitable for direct use in tablet manufacturing.
DC granules solve all these limitations with advanced excipient engineering.

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❓ Q3. How do DC Granules improve the stability of Sodium Phenyl Butyrate?

⭐ Deep Answer:
DC granules stabilize the API through multiple mechanisms:
✔ Moisture-protective excipients prevent degradation & caking
✔ Granulation coating reduces direct exposure to humidity
✔ Antioxidants & stabilizers preserve chemical integrity
✔ Controlled particle size minimizes moisture uptake
✔ High-quality packaging systems extend shelf-life

This ensures the granules remain flowable, potent, and stable throughout storage and processing.

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❓ Q4. What is the therapeutic importance of Sodium Phenyl Butyrate?

⭐ Deep Answer:
Sodium Phenyl Butyrate is a critical drug for Urea Cycle Disorders (UCDs).
It works by converting into phenylacetate, which binds with glutamine to form:
➡ Phenylacetylglutamine
This compound is safely excreted via urine, eliminating excess nitrogen and reducing ammonia levels in the blood.

High ammonia can cause:
⚠ Severe neurological damage
⚠ Metabolic crisis
⚠ Coma

Thus, Sodium Phenyl Butyrate is considered a life-saving therapy for hereditary metabolic disorders.

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❓ Q5. What advantages do Sodium Phenyl Butyrate DC Granules offer to manufacturers?

⭐ Deep Answer:
DC granules provide major manufacturing advantages:
✨ Ready-to-compress form → Faster production
✨ Reduced dust generation → Safer handling
✨ Excellent flowability → Suitable for high-speed tablet machines
✨ Uniform API distribution → Consistent dose accuracy
✨ Flexible for creating chewable or flavored tablets
✨ Less equipment workload → Lower operational cost

This leads to smooth manufacturing, fewer rejections, and superior tablet quality.

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❓ Q6. What quality parameters are evaluated for Sodium Phenyl Butyrate DC Granules?

⭐ Deep Answer:
Key QC parameters include:
🔬 Assay & purity (API strength)
💧 Moisture content (critical control)
⚖ Particle size distribution
📉 Flow indices (Carr’s Index, Hausner Ratio)
📦 Bulk and tapped density
⏱ Dissolution and disintegration profiles
🦠 Microbial testing
🔥 Stability under accelerated conditions

These tests ensure the granules meet GMP, regulatory, and pharmacopeial requirements.

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❓ Q7. Why is taste masking crucial for Sodium Phenyl Butyrate formulations?

⭐ Deep Answer:
The API has a strong, unpleasant, salty-bitter taste, making oral administration especially difficult for:
👶 Pediatric patients
👵 Elderly individuals
🤢 Sensitive patients

DC granules use:
✔ Flavoring agents
✔ Coating excipients
✔ Polymer-based taste barriers

These approaches significantly reduce bitterness and improve patient compliance, especially in long-term therapy.

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❓ Q8. How do DC Granules improve tablet machine performance?

⭐ Deep Answer:
Because DC granules have uniform particle size, ideal flow properties, and built-in lubrication, they help in:
▶ Prevention of die blockage
▶ Smooth die feeding
▶ Reduced sticking/picking on punches
▶ Consistent compression force distribution
▶ Fewer weight variations
▶ Higher output on rotary machines

This ensures high-speed production with minimal downtime.

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❓ Q9. What are the applications of Sodium Phenyl Butyrate DC Granules?

⭐ Deep Answer:
These granules are used in:
📌 Tablet manufacturing (standard or chewable)
📌 Metabolic disorder medication development
📌 Pediatric formulations
📌 Clinical trials & R&D projects
📌 Orphan drug product lines
📌 Fast-dissolving flavored tablets

Their flexibility makes them valuable for premium-grade pharmaceutical formulations.

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❓ Q10. Why choose Swapnroop Drugs & Pharmaceuticals for Sodium Phenyl Butyrate DC Granules?

⭐ Deep Answer:
Swapnroop offers:
🌟 High-stability DC granules engineered with advanced technology
🌟 Superior taste masking & moisture protection
🌟 GMP & global compliance manufacturing
🌟 Batch-to-batch consistency
🌟 Customizable formulations (flavors, particle size, dissolution rates)
🌟 Complete documentation (COA, MSDS, TDS, Stability data)
🌟 Fast dispatch & reliable global supply chain

Our granules ensure excellent manufacturability, enhanced patient acceptability, and superior therapeutic results.