Fluvastatin Sodium SR Pellets are pharmaceutical-grade sustained-release multiparticulate pellets containing Fluvastatin Sodium 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.
Fluvastatin Sodium is identified by CAS Number 93957-55-2, molecular formula C₂₄H₂₅FNNaO₄, and molecular weight 433.45 g/mol. The USP reference specifies Fluvastatin Sodium at 98.0%–102.0% on an anhydrous basis. This is an API specification and should not be directly applied as the finished Fluvastatin Sodium SR Pellets assay specification.
Commercial pharmaceutical pellet portfolios specifically document Fluvastatin Sodium SR Pellets at 23% w/w. This makes 23% w/w a documented commercial sustained-release pellet strength. The strength should be displayed on the SDP website only when it corresponds to the current SDP product specification or COA.
Fluvastatin Sodium is a sodium salt with defined chemical characteristics and is sensitive to formulation conditions that can influence product performance. A sustained-release pellet system provides a multiparticulate platform in which active loading, pellet size, core composition, release-controlling materials, coating characteristics and manufacturing parameters can be adjusted according to the intended formulation.
Fluvastatin Sodium Sustained-Release Pellets are developed as multiple individual pellet units rather than a single-unit formulation. This multiparticulate structure provides flexibility in formulation development and allows physical and release characteristics to be evaluated at the pellet level.
The sustained-release behavior can be influenced by the composition of the pellet core and, where applicable, a functional release-controlling coating. Important formulation variables can include Fluvastatin Sodium loading, pellet size, polymer type, polymer concentration, coating weight gain, coating thickness, coating uniformity, pellet porosity and surface characteristics.
A controlled pellet system can provide consistent physical characteristics and support reproducible processing during downstream capsule-filling or other oral formulation operations.
Fluvastatin Sodium 23% SR Pellets are a commercially documented sustained-release pellet format. A current commercial pharmaceutical pellet portfolio lists Fluvastatin Sodium SR Pellets at 23% w/w.
For the SDP website:
Available Strength: 23% w/w
should be displayed when this strength is confirmed by the current SDP product specification.
Active loading is an important characteristic of Fluvastatin Sodium SR Pellets because it determines the quantity of active ingredient present in a defined quantity of pellets. It can also influence the ratio of active ingredient to excipients, pellet structure, processing characteristics and release-control requirements.
The multiparticulate structure of Fluvastatin Sodium 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 with defined physical and chemical characteristics.
Fluvastatin Sodium SR Pellets can be considered for:
The final suitability of the pellets depends on the intended formulation, manufacturing process and applicable finished-product specification.
Capsule filling is an important application of pharmaceutical multiparticulate pellets. Fluvastatin Sodium SR Pellets can be developed with suitable particle-size distribution, density and flow characteristics to support capsule-filling operations.
Consistent pellet characteristics can help maintain reproducible filling and active distribution. Important physical characteristics may include particle size, bulk density, tapped density, friability, sphericity, moisture content and pellet morphology.
For commercial formulation development, these characteristics should be controlled according to the applicable finished-product specification.
The release profile of Fluvastatin Sodium SR Pellets depends on 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.
The release-controlling system can be optimized during formulation development to provide the intended performance while maintaining appropriate pellet integrity and content uniformity.
Active loading is a key quality attribute for Fluvastatin Sodium SR Pellets. The intended Fluvastatin Sodium concentration should remain consistent throughout the manufactured pellet batch.
Content uniformity is particularly important in multiparticulate formulations because consistent active distribution helps support reproducible finished-product performance. Appropriate process controls and validated analytical testing can be used to evaluate active distribution and batch consistency.
The API specification must be clearly separated from the finished pellet specification. The USP Fluvastatin Sodium API assay is 98.0%–102.0% on an anhydrous basis, whereas a 23% Fluvastatin Sodium SR pellet requires its own finished-product assay specification based on the intended active loading.
High-quality Fluvastatin Sodium Pharmaceutical Pellets can be evaluated through chemical, physical and performance-related characteristics.
Chemical evaluation may include:
Physical evaluation may include:
Performance evaluation may include:
The final acceptance criteria should be based on the applicable finished-product specification.
Fluvastatin Sodium 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.
During formulation development, variables such as polymer selection, coating level, pellet size and active loading can be evaluated to establish a reproducible release profile.
For pharmaceutical manufacturers developing oral multiparticulate formulations, consistent pellet characteristics can support reproducible processing, capsule filling and finished-product quality.
Fluvastatin Sodium SR Pellets from Swapnroop are positioned as pharmaceutical-grade multiparticulate pellets for sustained-release formulation and bulk pharmaceutical applications.
Key product advantages include:
| 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% |
| pH (1% Solution) | 5.0 – 7.0 |
| Individual Impurity | NMT 0.5% |
| Water Content | NMT 0.5% |