Dextrose-Coated Pellets are pharmaceutical-grade multiparticulate pellets based on Dextrose Monohydrate and designed for use in pharmaceutical formulations requiring uniform, free-flowing pellet cores or coated multiparticulate systems. Dextrose Monohydrate is also known as D-Glucose Monohydrate or Glucose Monohydrate and is widely used as a pharmaceutical excipient because of its water solubility, compatibility and established use in oral dosage formulations.
Dextrose-Coated Pellets can be used as pellet cores or as intermediate coated multiparticulates for further functional coating, drug layering, barrier coating or modified-release applications. Depending on the formulation, the dextrose pellet may receive a barrier layer, seal coat or functional polymer coating. Published formulation work has described Dextrose Monohydrate Granules/Pellets containing approximately 95% uncoated dextrose monohydrate pellets, followed by polymeric barrier and functional coating systems.
Dextrose Monohydrate has the molecular formula C₆H₁₂O₆·H₂O and a molecular weight of 198.17 g/mol. Its CAS Number is 5996-10-1. Pharmaceutical-grade Dextrose Monohydrate is available as a white crystalline material and is freely soluble in water. USP-grade references specify a water content of approximately 7.5–9.5%, residue on ignition of not more than 0.1%, and specific rotation of +52.6° to +53.2° on a dried basis.
Dextrose-Coated Pellets can be considered for multiparticulate pharmaceutical development, pellet-based capsule formulations, drug-layering applications and further functional coating processes. Dextrose pellets may serve as a soluble pellet core where rapid aqueous dissolution of the core is desirable.
The pellet core can be further processed using pharmaceutical coating technologies such as fluid-bed coating or coating-pan processes. Depending on the target dosage form, polymers may be applied as barrier, seal, enteric or other functional layers.
A Dextrose-Coated Pellet system can contain a Dextrose Monohydrate core followed by one or more coating layers. A barrier or seal coating can help separate the soluble core from an active pharmaceutical ingredient or subsequent functional coating. Additional polymer layers can then be selected according to the desired release characteristics.
Published formulation literature describes Dextrose Monohydrate Granules/Pellets coated with HPMC or equivalent polymers as barrier and seal coats, followed by a pH-sensitive polymer coating. One described formulation contains 95% uncoated Dextrose Monohydrate Granules/Pellets, 1% HPMC or equivalent polymer coating and 4% pH-sensitive polymer coating.
Quality evaluation of Dextrose-Coated Pellets should consider the specifications of the underlying Dextrose Monohydrate grade as well as the characteristics of the finished coated pellet. Important parameters may include identification, moisture or water content, specific rotation, residue on ignition, heavy metals, particle-size distribution, pellet morphology, coating uniformity, flow properties and dissolution behavior where applicable.
For USP-grade Dextrose Monohydrate, published specifications include 7.5–9.5% water, residue on ignition not more than 0.1%, heavy metals not more than 5 ppm and specific rotation of +52.6° to +53.2° on a dried basis.
Pharmaceutical-grade Dextrose-Coated Pellets can provide a consistent and processable pellet platform for oral multiparticulate dosage-form development. Their spherical or granular structure can support uniform coating and subsequent processing. The exact pellet size, coating weight gain, moisture specification, coating composition and release characteristics should be established according to the intended formulation and validated manufacturing process.
Dextrose Monohydrate is already recognized as a pharmaceutical excipient and is commercially available in USP and other compendial grades. Pharmaceutical excipient suppliers list Dextrose Monohydrate in USP and multi-compendial grades for dosage-form applications.
Dextrose-Coated Pellets can be developed and supplied according to formulation requirements, including pellet size, coating system, drug-loading requirements and intended dosage form. The product can be evaluated for particle-size distribution, moisture, assay where applicable, coating uniformity, flow properties and other quality attributes relevant to the final pharmaceutical application.
For pharmaceutical formulation development, the appropriate Dextrose Monohydrate grade and coating system should be selected according to the applicable pharmacopoeial requirements and the intended manufacturing process.
Dextrose-Coated Pellets are therefore a useful multiparticulate platform for pharmaceutical applications where a water-soluble, carbohydrate-based pellet core is required.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 99.5–100.5% |
| Loss on Drying | 7.5–9.5% |
| Heavy Metals | NMT 10 ppm |
| Water Content | 7.5–9.5% |
| Specific Rotation | +52.6° to +53.2° |