Rice Starch-Coated Pellets are pharmaceutical-grade multiparticulate pellets developed using rice starch as a key component of the pellet system with a defined coating layer applied to the pellet surface. Rice starch is obtained from Oryza sativa L. and is recognized as a pharmaceutical excipient. Starch is used in pharmaceutical formulation systems as a binder, diluent and disintegrant.
The coated-pellet format provides a particulate system with a defined surface and can be developed for applications requiring improved pellet handling, surface protection, controlled wetting or formulation-specific release characteristics. The final properties of Rice Starch-Coated Pellets depend on the pellet core, coating composition, coating level and manufacturing process.
Rice Starch-Coated Pellets can be considered for multiparticulate oral formulations, capsule filling, pellet coating applications and pharmaceutical formulation development. Particle size, moisture, density, friability, coating weight gain and coating uniformity are important quality attributes for the finished product.
Rice starch has CAS Number 9005-25-8 and the polymeric molecular formula (C₆H₁₀O₅)n. Because starch is a polymeric material, it does not have one fixed molecular weight. Pharmacopoeial rice starch is described as practically insoluble in cold water and ethanol.
Rice Starch-Coated Pellets can be manufactured with controlled physical characteristics according to the intended pharmaceutical application. The coating can be selected and applied according to the desired surface and performance requirements.
Depending on the formulation, the coating system may be designed to provide:
The coating polymer, coating weight gain, coating thickness and release profile should be specified according to the individual finished-product specification rather than assumed as universal values.
Rice Starch-Coated Pellets can be used for:
Finished Rice Starch-Coated Pellets can be evaluated for:
These characteristics are finished-product specifications and should be established from the actual formulation and manufacturing process.
The quality evaluation of Rice Starch-Coated Pellets may include identification, moisture/LOD, ash, particle size, density, friability, sphericity, coating uniformity and microbiological quality.
It is important to distinguish between rice starch raw-material specifications and finished coated-pellet specifications. Pharmacopoeial rice-starch values should not automatically be used as acceptance limits for the finished coated pellets.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 15.0% |
| Residue on Ignition | NMT 0.5% |
| pH (1% Solution) | 5.0–8.0 |
| Water Content | NMT 5.0% |