Sodium Phenylbutyrate DC Granules are pharmaceutical-grade granulated materials developed for direct-compression and oral solid dosage formulation applications. Direct compression requires controlled physical characteristics such as particle-size distribution, flowability, bulk density, tapped density, compressibility, compactability and blend uniformity. Granulation and particle engineering can help establish suitable material properties for consistent handling and tablet manufacturing.
Sodium Phenylbutyrate is the sodium salt of 4-phenylbutyric acid. It has the molecular formula C10H11NaO2, molecular weight approximately 186.18–186.19 g/mol and CAS Number 1716-12-7. It is described as a white to yellowish-white powder and is freely soluble in water. These chemical and physical characteristics are important considerations when developing a granulated material for pharmaceutical formulation.
Sodium Phenylbutyrate DC Granules are engineered granules containing sodium phenylbutyrate and suitable formulation components, designed for direct-compression processing.
The term DC refers to Direct Compression. In this approach, appropriately characterized granules are blended with suitable excipients and compressed into the intended solid dosage form. The physical characteristics of the granules can influence powder movement, blending, die filling and compression.
Sodium phenylbutyrate has also been developed in granulated oral formulations, including coated granule systems. Published formulation research has evaluated granule characteristics, dissolution and taste-masking approaches. These examples demonstrate that granule structure and formulation design can significantly affect the performance and acceptability of sodium phenylbutyrate formulations.
Sodium Phenylbutyrate has the molecular formula C10H11NaO2 and molecular weight approximately 186.18 g/mol. Its CAS Number is 1716-12-7.
The material is highly water soluble, and its formulation characteristics can therefore be influenced by particle size, granule structure, excipient selection and processing conditions.
A historical USP-NF pharmaceutical-substance entry identifies Sodium Phenylbutyrate as C10H11NaO2 with molecular weight 186.18 and includes testing related to identification, assay, impurities, water and pH. Current finished-product specifications should be based on the actual raw-material specification and approved finished-granule specification rather than transferring historical monograph values directly.
Direct compression is a formulation process in which appropriately characterized particulate materials are blended and compressed into tablets.
Sodium Phenylbutyrate DC Granules can be considered for:
The final performance depends on the active-component loading, granule structure, excipient selection, compression conditions and finished formulation.
Particle-size distribution is an important quality attribute for Sodium Phenylbutyrate DC Granules. Particle size can influence flowability, packing, segregation, blending and die filling.
Relevant measurements may include:
The appropriate limits should be established according to the actual finished-product specification. Generic D10, D50 or D90 values should not be presented as commercial specifications without product-specific data.
Controlled particle-size distribution can support predictable material handling and may contribute to improved blend uniformity.
Flowability is important for direct-compression materials because consistent material movement can support reliable transfer, hopper feeding and die filling.
Sodium Phenylbutyrate DC Granules may be evaluated for:
The actual acceptance limits should be established using the approved product specification and suitable analytical methods.
For direct-compression formulations, flowability should be considered together with compressibility, compactability and blend uniformity.
Compressibility describes the reduction in volume of a particulate system under applied pressure, while compactability describes its ability to form a mechanically suitable compact.
These characteristics are important when developing Sodium Phenylbutyrate DC Granules because the material must provide predictable behavior during tablet compression.
Development may evaluate:
The appropriate compression properties depend on the complete formulation and should be established through formulation-development studies.
Granule morphology can affect flow, packing, compression and handling. Consistent granule structure can help reduce excessive fines generation and support more predictable processing.
Potential physical characteristics include:
The desired granule morphology depends on the manufacturing process and formulation requirements.
Content uniformity is an important quality attribute for pharmaceutical formulations. Consistent distribution of sodium phenylbutyrate throughout the granulated material and final blend supports reproducible dosage-unit composition.
Development and quality-control assessments may include:
The applicable acceptance criteria should be established through validated analytical procedures and the approved finished-product specification.
Sodium phenylbutyrate has a characteristic salty and bitter taste. Published formulation research has investigated coated and taste-masked granule systems designed to reduce exposure of the active material to taste receptors before swallowing.
This demonstrates the importance of granule architecture in sodium phenylbutyrate formulation development. However, a commercial Sodium Phenylbutyrate DC Granules product should not be described as taste-masked, coated or modified-release unless the actual finished product incorporates and validates the corresponding formulation technology.
Sodium phenylbutyrate is highly water soluble, so dissolution can be strongly influenced by granule structure, particle size, excipient composition and any coating or barrier system.
For an uncoated direct-compression system, dissolution may be influenced by:
If a coating or taste-masking system is used, coating properties can additionally influence the timing and rate of release.
Specific dissolution percentages or time points should not be claimed unless supported by product-specific validated data.
Sodium Phenylbutyrate DC Granules can be developed with appropriate excipients to achieve suitable flow, compression and dosage-form characteristics.
Formulation development may evaluate:
The high water solubility of sodium phenylbutyrate makes formulation composition particularly relevant to dissolution and release behavior.
During formulation development, Sodium Phenylbutyrate DC Granules may be evaluated under different compression conditions.
Resulting tablets can be assessed for:
Compression conditions should be optimized according to the complete formulation and intended tablet characteristics.
Quality control for Sodium Phenylbutyrate DC Granules can include chemical, physical and performance-related attributes.
Potential quality attributes include:
Not every parameter is necessarily applicable to every commercial product. The final specification should reflect the actual manufacturing process and approved product requirements.
Manufacturing Sodium Phenylbutyrate DC Granules requires consistent control of raw-material quality and granule characteristics.
Important process considerations may include:
Batch-to-batch consistency is important because changes in particle size, density, moisture or granule morphology can affect downstream compression.
Sodium Phenylbutyrate DC Granules may be considered for:
The final dosage form and manufacturing process should be established according to the intended product requirements and validated process.
Quality control should address both chemical identity and physical processing characteristics.
Chemical testing can include identification, assay and relevant impurity evaluation. Physical testing can include particle-size distribution, density, flowability, moisture and granule integrity.
Depending on the approved specification, testing may include:
Numerical acceptance criteria for finished Sodium Phenylbutyrate DC Granules should be taken from the actual approved product specification and validated analytical methods.
Stability evaluation is important for sodium phenylbutyrate-containing formulations. The finished granules should be evaluated under appropriate stability conditions using validated analytical methods.
Relevant stability attributes may include:
Specific storage conditions and shelf-life claims should only be published when supported by the actual stability program and approved product documentation.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white granules |