🌟 Sodium Phenyl Butyrate DC Granules – A High-Performance Excipient for Reliable Formulations

 


🌟 Sodium Phenyl Butyrate DC Granules – A High-Performance Excipient for Reliable Formulations

✨ Manufactured by Swapnroop Drugs & Pharmaceuticals ✨

In the world of modern pharmaceutical manufacturing, the demand for high-efficiency, ready-to-use excipients is increasing rapidly. One such critical ingredient is Sodium Phenyl Butyrate DC Granules, a direct-compression–ready material that offers superior performance in solid dosage formulations.

At Swapnroop Drugs & Pharmaceuticals, we specialize in producing high-purity, consistent, and flow-optimized Sodium Phenyl Butyrate DC Granules that simplify tablet and capsule manufacturing while ensuring premium therapeutic efficiency. 💊🏭

🔬 What Are Sodium Phenyl Butyrate DC Granules?

Sodium Phenyl Butyrate DC (Direct Compression) Granules are a specialty pharmaceutical ingredient used mainly in formulations targeting urea-cycle disorders (UCDs). Unlike raw API, these granules offer:

✨ Excellent flowability
✨ Superior compressibility
✨ Uniform particle size
✨ Enhanced stability
✨ Easy processing

This makes them ideal for large-scale tablet production using direct compression—a cost-effective and time-saving manufacturing technique.

💊 Why Sodium Phenyl Butyrate?

Sodium Phenyl Butyrate is widely known for its role in reducing ammonia levels in patients with UCDs. It works by helping the body eliminate excess nitrogen, preventing toxic buildup.

Swapnroop Drugs & Pharmaceuticals ensures pharmaceutical-grade quality suitable for global regulatory standards. 🌍💼

⚗️ Manufacturing Excellence at Swapnroop Drugs & Pharmaceuticals

Our state-of-the-art facility uses advanced granulation and drying technologies to produce:

🔹 Uniformly sized granules
🔹 Free-flowing material for uninterrupted machine operations
🔹 Low moisture levels for enhanced stability
🔹 Consistent drug content distribution

Each batch undergoes strict quality checks, ensuring uncompromised purity and safety. ✔️🧪

📦 Applications of Sodium Phenyl Butyrate DC Granules

Sodium Phenyl Butyrate DC Granules manufactured by Swapnroop Drugs & Pharmaceuticals are ideal for:

💠 Direct-compression tablets
💠 Capsules
💠 Sachet formulations
💠 Taste-masked pediatric preparations
💠 Modified-release technologies

Their versatility makes them a preferred choice for R&D and large-scale production teams alike.

📊 Advantages of Using Swapnroop's DC Granules

✨ Reduced processing time
✨ Lower manufacturing costs
✨ Consistent batch-to-batch performance
✨ High uniformity & low segregation risk
✨ Smooth compression without sticking or capping

These advantages translate to predictable performance and faster scalability.

🧪 Quality Control & Compliance

Every batch of Sodium Phenyl Butyrate DC Granules is tested for:

✔️ Assay
✔️ Granule size distribution
✔️ Flowability index
✔️ Bulk & tapped density
✔️ Moisture content
✔️ Stability

Swapnroop Drugs & Pharmaceuticals adheres to stringent GMP guidelines and regulatory standards to meet global customer expectations. 🌍💼

📌 Conclusion

Sodium Phenyl Butyrate DC Granules play a crucial role in modern pharmaceutical formulations, offering superior manufacturability and patient-centric performance.

With the scientific strength and manufacturing expertise of Swapnroop Drugs & Pharmaceuticals, customers get access to high-purity, stable, and compression-ready granules ideal for scalable and efficient production.



Q1️⃣: What are Sodium Phenyl Butyrate DC Granules manufactured by Swapnroop Drugs & Pharmaceuticals?

🌟 In-Depth Answer with Emojis

Sodium Phenyl Butyrate DC Granules manufactured by Swapnroop Drugs & Pharmaceuticals are a specialized, ready-to-use, direct-compression grade pharmaceutical material designed for easy and efficient production of solid dosage forms like tablets and capsules. 💊⚙️

These granules are created by processing Sodium Phenyl Butyrate, a medication widely used to manage Urea Cycle Disorders (UCDs), into a granular, free-flowing, stable powder ideal for high-speed manufacturing. 🧬🧠

🔍 1. Pharmaceutical-Grade, High-Purity Material

The Sodium Phenyl Butyrate used in these granules is of premium pharmaceutical grade, ensuring:
✔️ Low impurities
✔️ High assay value
✔️ Consistent chemical profile
✔️ Global regulatory compliance

Swapnroop Drugs & Pharmaceuticals follows strict GMP guidelines to guarantee absolute purity and safety. 🧪🔬

🌾 2. Direct-Compression (DC) Technology

These granules are engineered specifically for DC applications, meaning they can be directly compressed into tablets without wet granulation.

✨ Benefits include:

  • Faster production ⏱️

  • Reduced processing steps

  • Lower operational costs 💰

  • Consistent batch performance

This makes them highly attractive for large-scale manufacturers. 🏭📦

⚙️ 3. Optimized Flowability & Compressibility

Sodium Phenyl Butyrate DC Granules by Swapnroop are processed to have:
🌬️ Excellent flow properties – enabling smooth feeding in tablet presses
🔘 High compressibility – giving strong, stable tablets
🌾 Uniform particle size – ensuring dose uniformity and minimizing segregation

These enhancements make the granules extremely machine-friendly. 🤖⚙️

🛡️ 4. Greater Stability & Shelf Life

Granulation improves:
🧊 Moisture stability
🛡️ Physical stability
💎 Chemical stability

Thus, the granules maintain performance over long-term storage, ensuring product reliability for global distributors. 📦🌍

🧒 5. Patient-Friendly Features

Sodium Phenyl Butyrate is known for its strong, unpleasant odor and taste.
The DC granules by Swapnroop Drugs & Pharmaceuticals help in:

  • Masking bitterness 😖➡️😊

  • Making pediatric dosage forms easier

  • Creating more acceptable tablet sizes

This improves patient adherence dramatically. 👶💙

🌍 6. Ideal for Multiple Formulations

These DC granules are suitable for:
💊 Tablets
🌱 Capsules
🧃 Sachets
🍼 Pediatric oral blends

Their flexibility makes them a preferred ingredient in R&D and commercial-scale manufacturing. 🧪🏭

🏢 Conclusion

Sodium Phenyl Butyrate DC Granules manufactured by Swapnroop Drugs & Pharmaceuticals are a high-performance, stable, direct-compression–ready material crafted for efficient, scalable, and patient-centric pharmaceutical production.

They combine advanced granulation technology, superior flowability, and high-purity API to meet global industry standards. 🌟🌍




Q2️⃣ What is Sodium Phenyl Butyrate DC Granules used for?

⭐ Deep Answer with Emojis

Sodium Phenyl Butyrate DC Granules manufactured by Swapnroop Drugs & Pharmaceuticals are primarily used for the treatment of Urea Cycle Disorders (UCDs) — rare genetic conditions that impair the body's ability to eliminate ammonia. 🧬💥

🧪 Main Uses:

🔹 Ammonia Detoxification:
Sodium Phenyl Butyrate works as an ammonia scavenger, converting toxic ammonia into excretable compounds. 🚫🧪→💧

🔹 Solid Oral Dosage Forms:
The DC granules are specifically used for manufacturing:

  • Tablets 💊

  • Capsules 🌱

  • Sachets 🧃

  • Pediatric formulations 👶

🔹 Ready-to-Use for Pharma Companies:
These granules reduce process time, enabling faster production cycles and ensuring dose uniformity in the final product. ⚙️⏱️

Q3️⃣ What are the physicochemical properties of Sodium Phenyl Butyrate DC Granules?

🧪 Detailed Answer with Emojis

Sodium Phenyl Butyrate DC Granules by Swapnroop Drugs & Pharmaceuticals are engineered to exhibit optimized physicochemical properties suitable for modern solid dosage designs. 🌟

🔬 Key Properties:

✔️ Appearance:
Free-flowing white to off-white granules 🌾⚪

✔️ Solubility:
Highly soluble in water 💧 — enables rapid dissolution in the gastrointestinal tract

✔️ Odor & Taste:
A characteristic odor, often masked through granulation for patient acceptability 😊🙌

✔️ Particle Size Distribution:
Uniform particle size for improved blending, flow, and compression ⚙️📏

✔️ Flow Properties:
Enhanced due to granulation → ideal for high-speed equipment 🤖👍

✔️ Moisture Content:
Controlled low moisture to improve stability and prevent degradation 🛡️💨

✔️ Stability:
Excellent chemical stability when stored under recommended conditions 🧊🏆

Q4️⃣ How are Sodium Phenyl Butyrate DC Granules manufactured by Swapnroop Drugs & Pharmaceuticals?

🏭 Deep Technical Answer with Emojis

The DC granules are produced using a controlled granulation process combined with advanced drying, blending, and sizing technologies. ⚙️🧪

🛠️ Manufacturing Steps:

1️⃣ API Selection & Pre-Processing
High-purity Sodium Phenyl Butyrate is sourced and verified through stringent QA checks. 💎🔬

2️⃣ Wet or Melt Granulation
The drug is granulated using either:

  • Binder solutions 🧴💧 or

  • Melt-solidification techniques (depending on formulation needs).

3️⃣ Drying Stage
Granules are dried to an optimal moisture level to ensure stability and free-flowing characteristics. 🌬️🧊

4️⃣ Milling & Sizing
Granules are passed through calibrated mills to achieve uniform particle size. 📏⚙️

5️⃣ Blending with Excipients
Functional excipients are added to enhance:

  • Flowability 🌾

  • Compressibility 🧱

  • Stability 🛡️

6️⃣ Quality Control
Every batch is tested for assay, uniformity, impurities, and flow metrics. 📊🧪

7️⃣ Packing & Sealing
Final product is sealed in moisture-resistant packaging. 📦🔒

Q5️⃣ What are the different dosage forms of Sodium Phenyl Butyrate DC Granules?

💊 Detailed Answer with Emojis

Because these granules are direct compression–ready, they are highly versatile for multiple pharmaceutical formats. 🌟

✔️ Available Dosage Forms:

💊 1. Tablets

  • Most common form

  • Can be film-coated to mask taste

  • Highly stable and easy to dose

🌱 2. Hard Gelatin Capsules

  • Ideal for precise dosing

  • Good for patients sensitive to taste

🧃 3. Sachets

  • Pediatric friendly

  • Easy to mix with food or liquid

🍼 4. Oral Powders/Granules

  • Ideal for infants or elderly patients

  • Flexible dosing

🌡️ 5. Custom R&D Blends

  • For formulation trials

  • Used in product development labs


Q6️⃣ How are dosage forms containing Sodium Phenyl Butyrate DC Granules (from Swapnroop Drugs & Pharmaceuticals) prepared?

🏭 Deep Answer with Emojis

Dosage forms made using Sodium Phenyl Butyrate DC Granules are prepared using streamlined, industry-standard solid oral manufacturing processes. ⚙️💊

🔧 Steps in Preparing Dosage Forms:

1️⃣ Weighing & Dispensing
Accurate weight measurement of the granules and excipients ensures dose precision. ⚖️📦

2️⃣ Blending
Granules are mixed with lubricants (like magnesium stearate) for improved compression. 🔄🌾

3️⃣ Compression or Encapsulation

  • Tablets: Created using direct compression machines 💊🤖

  • Capsules: Filled using automatic capsule fillers 🌱⚙️

4️⃣ Optional Coating (for tablets)
Film-coating masks taste and improves stability. 🎨🛡️

5️⃣ Sachet Filling
For pediatric or flexible doses, granules are packed into small sachets. 🧃📩

6️⃣ In-Process Quality Checks
Continuous monitoring ensures hardness, weight uniformity, and content uniformity. 🎯🧪

7️⃣ Final Packing
Blister packs, bottles, or laminated sachets are used. 📦

Q7️⃣ What is the appropriate dosage form of Sodium Phenyl Butyrate DC Granules produced by Swapnroop Drugs & Pharmaceuticals?

💊 Deep Answer with Emojis

The “appropriate dosage form” depends on the patient’s needs, age group, and therapeutic goals.

✔️ Most Suitable Dosage Forms:

🔹 Film-coated Tablets

  • Best for adults

  • Offers superior stability & taste masking 🎨💊

🔹 Hard Gelatin Capsules

  • Useful for patients who cannot tolerate powdered forms 🌱

🔹 Sachets / Granule Packs

  • Most suitable for children and elderly patients

  • Can be mixed with food or beverages 👶🍼

🔹 Oral Granule Dispersion

  • Ideal for patients with swallowing difficulties

The versatility of DC granules manufactured by Swapnroop Drugs & Pharmaceuticals ensures easy adaptation across all these forms. 🌟

Q8️⃣ When should Sodium Phenyl Butyrate DC Granules or its dosage forms be taken?

🕒 Detailed Answer with Emojis (General Information Only)

⚠️ Note: Always follow a doctor’s dosage instructions.

⏱️ General Timing Guidelines:

🕗 With Meals
Sodium Phenyl Butyrate is typically taken with meals to improve tolerability and avoid gastrointestinal discomfort. 🍽️💊

🧒 Pediatric Use
Children may take sachet granules mixed with:

  • Water 💧

  • Juice 🍎

  • Soft foods (yogurt, applesauce, etc.) 🍨

🔁 Multiple Daily Doses
Because the drug acts as an ammonia scavenger, it is taken multiple times per day, depending on the physician's plan.

🚫 Do NOT Miss Doses
Maintaining blood ammonia levels is crucial, especially in UCD patients.

Q9️⃣ What are the effects and side effects of Sodium Phenyl Butyrate DC Granules manufactured by Swapnroop Drugs & Pharmaceuticals?

🌟 Deep Medical-Scientific Answer with Emojis

✔️ Therapeutic Effects:

🔹 Ammonia Detoxification
Converts ammonia into excretable compounds → reduces neurological risk 🧠🛡️

🔹 Improved Metabolic Balance
Helps maintain safe plasma ammonia levels 🔬⚖️

🔹 Prevents Hyperammonemia Episodes
Reduces emergency hospitalizations 🏥✨

⚠️ Possible Side Effects:

(Common, mild, and manageable)

😣 Gastrointestinal:

  • Nausea

  • Bloating

  • Loss of appetite

  • Abdominal pain

😩 Neurological (rare):

  • Headache

  • Fatigue

🩺 Others:

  • Menstrual irregularities

  • Body odor (phenylacetate metabolite)

🔥 Severe but rare:

  • Edema

  • Severe vomiting

  • Hyperventilation

Patients must report severe symptoms immediately.

🔟 How is Sodium Phenyl Butyrate DC Granules tested in quality control?

🧪 Deep Technical QC Answer with Emojis

Swapnroop Drugs & Pharmaceuticals follows strict GMP-compliant quality control protocols to ensure every batch meets global standards. 🌍💼

🧪 QC Tests Include:

📊 1. Assay (API Strength)
Measures the exact content of Sodium Phenyl Butyrate in the granules.

🔬 2. Impurity Profiling (HPLC)
Checks for organic impurities & degradation products.

📏 3. Particle Size Distribution
Ensures uniform blending & compressibility.

🌾 4. Flowability Tests
Angle of repose, Carr’s index, Hausner ratio.

💧 5. Moisture Content (LOD/KF)
Ensures stability and prevents degradation.

💊 6. Dissolution / Disintegration
Tests how quickly the granules release the drug.

🧱 7. Compressibility Index
Ensures suitability for direct compression.

🛡️ 8. Microbial Limit Testing
Verifies that the product meets pharmacopeial microbiological standards.

📦 9. Stability Studies
Accelerated & real-time stability evaluated in ICH chambers (25°C / 60% RH, 40°C / 75% RH).

✔️ 10. Uniformity Tests
Evaluates consistency of each dosage unit.


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