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 ππ
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.
π§ͺ 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.
π CAS Number
π Sodium Phenyl Butyrate – CAS No.: 1716-12-7
π‘ 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
π 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.
𧬠Applications of
Sodium Phenyl Butyrate DC Granules
π Manufacturing of oral tablets
π Treatment of Urea Cycle Disorders (UCDs)
π Ammonia detoxification therapies
π Orphan drug formulations
π Clinical research
π Pediatric-friendly formulations (flavored/chewable
tablets possible)
π¬ Mechanism of Action (How It Works)
Sodium
Phenyl Butyrate undergoes Ξ²-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.
π Quality Specifications Ensured by Swapnroop Drugs & Pharmaceuticals
We
conduct strict QC checks on each batch, including:
π¬ Assay (Purity)
π¬ Moisture content
π¬ Particle size analysis
π¬ Flowability tests
π¬ Bulk/tapped density
π¬ Dissolution & disintegration studies
π¬ Microbial testing
π¬ Stability studies (accelerated & real-time)
Our DC
granules comply with GMP & pharmacopeial standards, ensuring safety,
efficacy, and performance.
π 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.
π Why Choose Swapnroop Drugs & Pharmaceuticals?
At Swapnroop
Drugs & Pharmaceuticals, we deliver:
π High-stability DC granules designed using advanced
granulation technologies
π Excellent flow & compression characteristics
π Customization options for strength, excipients
& particle size
π GMP-certified & globally compliant
manufacturing
π Batch-to-batch consistency
π Complete documentation: COA, MSDS, TDS, stability
data
Our
Sodium Phenyl Butyrate DC Granules are widely trusted by pharmaceutical
manufacturers for quality, stability, and performance.
π Contact Us to Order / Request Samples
Swapnroop Drugs & Pharmaceuticals
π± Phone: +91-7387999183
π§ Email: sales@sdp.org.in
π 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).
❓ 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.
❓ 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.
❓ 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.
❓ 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.
❓ Q6. What quality parameters are evaluated for Sodium Phenyl Butyrate DC
Granules?
⭐ Deep Answer:
Key QC parameters include:
π¬ Assay & purity (API strength)
π§ Moisture content (critical control)
⚖ Particle size distribution
π Flow indices (Carr’s Index, Hausner Ratio)
π¦ Bulk and tapped density
⏱ Dissolution and disintegration profiles
π¦ Microbial testing
π₯ Stability under accelerated conditions
These
tests ensure the granules meet GMP, regulatory, and pharmacopeial
requirements.
❓ 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:
πΆ Pediatric patients
π΅ Elderly individuals
π€’ 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.
❓ 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.
❓ Q9. What are the applications of Sodium Phenyl Butyrate DC Granules?
⭐ Deep Answer:
These granules are used in:
π Tablet manufacturing (standard or chewable)
π Metabolic disorder medication development
π Pediatric formulations
π Clinical trials & R&D projects
π Orphan drug product lines
π Fast-dissolving flavored tablets
Their
flexibility makes them valuable for premium-grade pharmaceutical
formulations.
❓ Q10. Why choose Swapnroop Drugs & Pharmaceuticals for Sodium Phenyl
Butyrate DC Granules?
⭐ Deep Answer:
Swapnroop offers:
π High-stability DC granules engineered with
advanced technology
π Superior taste masking & moisture
protection
π GMP & global compliance manufacturing
π Batch-to-batch consistency
π Customizable formulations (flavors, particle
size, dissolution rates)
π Complete documentation (COA, MSDS, TDS,
Stability data)
π Fast dispatch & reliable global supply
chain
Our
granules ensure excellent manufacturability, enhanced patient acceptability,
and superior therapeutic results.
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