Linaclotide IR Pellets
Pharmaceutical-Grade Linaclotide Immediate-Release Pellets for Oral Multiparticulate Formulations
Linaclotide IR Pellets are pharmaceutical-grade immediate-release multiparticulate pellets containing Linaclotide. Linaclotide is a synthetic 14-amino-acid cyclic peptide containing three disulfide linkages. Its confirmed molecular formula is C₅₉H₇₉N₁₅O₂₁S₆, molecular weight 1526.8 g/mol, and CAS Number 851199-59-2.
Linaclotide is a highly potent peptide ingredient, so its pellet formulation is fundamentally different from high-loading small-molecule pellets. Regulatory documentation describes the finished oral formulation as Linaclotide-coated beads, using a bead-based multiparticulate system.
A commercial pharmaceutical pellet listing specifically reports Linaclotide Pellets 0.09%, equivalent to 0.9 mg/g of pellets. This is an important numeric reference because Linaclotide is used at a very low active loading compared with many conventional pellet products.
For the SDP page, the 0.09% strength should be presented as an SDP available strength only if it matches the current SDP product specification or COA.
Key Features
- Pharmaceutical-grade Linaclotide IR Pellets
- Immediate-release multiparticulate format
- Low-dose peptide pellet formulation
- Linaclotide-coated pellet/bead technology
- Suitable for oral multiparticulate formulations
- Suitable for capsule-filling applications
- Product-specific Linaclotide loading
- Controlled content uniformity requirements
- Product-specific particle-size characteristics
- Suitable for pharmaceutical formulation development
- Suitable for bulk pharmaceutical supply
Low-Dose Pellet Technology
Linaclotide requires particular attention to content uniformity and distribution of the active ingredient because the amount of Linaclotide per dosage unit is very small.
Regulatory development documentation selected Linaclotide-coated microcrystalline-cellulose beads as the pharmaceutical form for the low-dose immediate-release formulation, with emphasis on achieving uniform content.
Therefore, important quality attributes for Linaclotide IR Pellets include:
- Active loading
- Content uniformity
- Assay
- Particle-size distribution
- Moisture/water content
- Pellet/bead morphology
- Bulk density
- Friability
- Dissolution/release characteristics
- Peptide-related impurities
Why Linaclotide IR Pellets from Swapnroop?
- Pharmaceutical-Grade Pellets: Designed for pharmaceutical formulation applications.
- Immediate-Release Format: Suitable for immediate-release multiparticulate formulations.
- Product-Specific Active Loading: Linaclotide concentration is established according to the applicable product specification.
- Multiparticulate Format: Suitable for capsule-filling and oral formulation development.
- Controlled Pellet Characteristics: Particle size and other physical parameters can be controlled according to product requirements.
- Low-Dose Formulation Focus: Suitable for formulations requiring controlled distribution of a low-dose active ingredient.
- Content Uniformity Control: Appropriate analytical control is important for consistent low-dose pellet performance.
- Formulation Flexibility: Suitable for different multiparticulate formulation-development requirements.
- Bulk Pharmaceutical Supply: Suitable for pharmaceutical manufacturing and formulation requirements.
Applications
Linaclotide IR Pellets can be used for:
- Immediate-release oral multiparticulate formulations
- Low-dose pellet formulations
- Capsule-filling applications
- Linaclotide-coated bead systems
- Pharmaceutical formulation development
- Multiparticulate oral dosage development
- Low-dose active ingredient layering
- Customized pellet formulations
- Pharmaceutical manufacturing applications
Detailed Specifications
| Parameter |
Specification |
| Appearance |
white to off-white crystalline powder |
| Identification |
IR & HPLC compliant |
| Assay (HPLC) |
98.0% – 102.0% |
| Loss on Drying |
NMT 1.0% |
| Residue on Ignition |
NMT 0.5% |
| Water Content |
NMT 1.0% |
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