Fenofibrate SR Pellets are pharmaceutical-grade sustained-release multiparticulate pellets containing Fenofibrate as the active pharmaceutical ingredient. They are designed for oral formulation applications where a controlled and prolonged release profile is required from individual pellet units.
Fenofibrate is identified by CAS Number 49562-28-9, molecular formula C₂₀H₂₁ClO₄, and molecular weight 360.83 g/mol. The current USP-NF reference defines Fenofibrate at 98.0%–102.0% on a dried basis. This range applies to the Fenofibrate API and should not be directly used as the finished Fenofibrate SR Pellets assay specification.
Commercial pharmaceutical pellet portfolios document Fenofibrate SR Pellets at 75% w/w, while other commercial references report strengths such as 66.3%, 75% and 85%. Therefore, 75% w/w is a documented commercial SR pellet strength, but the strength published on the SDP website should be used only when it matches the current SDP product specification or COA.
Fenofibrate has limited aqueous solubility, making formulation design, active distribution, pellet composition and release-control technology important considerations during pharmaceutical development. A sustained-release pellet system can provide a multiparticulate platform in which release characteristics are influenced by the pellet matrix, functional coating, active loading, particle size and manufacturing process.
Fenofibrate Sustained-Release Pellets are developed as multiple individual pellet units rather than a single-unit formulation. This multiparticulate structure provides flexibility in controlling the physical and performance characteristics of the finished formulation.
The sustained-release behavior can be influenced by the composition of the pellet core and, where applicable, a functional release-controlling layer. Important formulation variables may include Fenofibrate loading, pellet size, polymer selection, polymer concentration, coating weight gain, coating thickness, coating uniformity, pellet porosity and surface characteristics.
Because these parameters vary between formulations, the final release profile should be established through the applicable finished-product development and validation process.
Fenofibrate 75% SR Pellets are a commercially documented high-loading sustained-release pellet format. Commercial pharmaceutical pellet portfolios specifically list Fenofibrate SR Pellets at 75%, with other commercial references also reporting 75% and additional strengths.
For the SDP website:
Available Strength: 75% w/w
should be displayed only when the current SDP product specification confirms this strength.
The active loading is an important characteristic of Fenofibrate SR Pellets because it determines the quantity of Fenofibrate contained within a defined quantity of pellets. Higher active loading can also influence pellet composition, manufacturing parameters, physical properties and release-control requirements.
The multiparticulate structure of Fenofibrate SR Pellets provides flexibility for oral formulation development. Each pellet functions as an individual unit, while the complete formulation contains a controlled population of pellets.
Fenofibrate SR Pellets can be considered for:
The final suitability depends on the intended formulation, manufacturing process and finished-product requirements.
One important application of pharmaceutical pellets is capsule filling. Fenofibrate SR Pellets can be developed with appropriate particle-size distribution, density and flow characteristics to support capsule-filling operations.
Consistent pellet size and physical properties are important because differences in pellet characteristics can influence filling behavior, active distribution and finished-product uniformity.
Important physical parameters may include:
These characteristics should be controlled according to the applicable finished-product specification.
The release profile of Fenofibrate SR Pellets depends on the formulation and manufacturing design. Important variables can include:
A sustained-release pellet system is therefore not defined by a single universal dissolution profile. The appropriate dissolution method and acceptance criteria should be established for the specific finished product.
Active loading is a key quality attribute for Fenofibrate SR Pellets. The intended Fenofibrate concentration should remain consistent throughout the manufactured batch.
Content uniformity is particularly important for multiparticulate formulations because the active ingredient needs to be distributed consistently within the pellet population. Appropriate process controls and analytical testing can be used to evaluate active distribution and batch consistency.
The API specification should not be confused with the finished pellet specification. For example, the USP Fenofibrate API assay is 98.0%–102.0% on a dried basis, whereas a 75% Fenofibrate pellet requires a separate finished-product assay specification based on its intended loading.
Fenofibrate SR Pellets provide a flexible multiparticulate platform for sustained-release formulation development. Formulation developers can evaluate active loading, pellet size, core composition and release-controlling characteristics to achieve the intended product performance.
The pellet format can also support process optimization and scale-up by providing defined physical characteristics for downstream manufacturing operations.
For pharmaceutical manufacturers developing oral multiparticulate formulations, consistent pellet characteristics can help support reproducible processing and finished-product quality.
Fenofibrate SR Pellets from Swapnroop are positioned as pharmaceutical-grade multiparticulate pellets for sustained-release formulation and bulk pharmaceutical applications.
Key product advantages include:
As a Fenofibrate SR Pellets Manufacturer and Supplier in India, Swapnroop can position Fenofibrate sustained-release pellets for pharmaceutical formulation development, multiparticulate applications, capsule filling and bulk pharmaceutical requirements, subject to the applicable product specification.
The product can be optimized around relevant formulation parameters including active loading, pellet size, physical characteristics and sustained-release performance.
Customers searching for Fenofibrate SR Pellets Manufacturer in India, Fenofibrate SR Pellets Supplier in India, Fenofibrate 75% SR Pellets, Fenofibrate Pharmaceutical Pellets, Fenofibrate Sustained-Release Pellets, Fenofibrate Multiparticulate Pellets, and Fenofibrate Pellets for Capsule Filling can be naturally addressed through the product page's topical content.
Fenofibrate SR Pellets can be supplied in suitable pharmaceutical packaging according to the required:
Available Strength: 75% w/w, where confirmed by the applicable SDP specification.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 0.5% |
| Residue on Ignition | NMT 0.1% |
| Individual Impurity | NMT 0.10% |
| Total Impurities | NMT 0.50% |
| Water Content | NMT 0.5% |