Maltitol SR Granules are pharmaceutical excipient-based granules developed for sustained-release formulation applications. “SR” refers to the intended sustained-release performance of the finished granulated formulation, where the release of the incorporated active ingredient is controlled over an extended period through an appropriate formulation design.
Maltitol is a sugar alcohol, also known as d-glucopyranosyl-d-glucitol. It has the molecular formula C₁₂H₂₄O₁₁, molecular weight 344.31 g/mol and CAS Number 585-88-6. The current USP-NF Maltitol monograph specifies 92.0% to 100.5% d-maltitol, calculated on an anhydrous basis.
Maltitol is very soluble in water and slightly soluble in ethanol according to FCC. These characteristics make maltitol a water-soluble polyol that can be incorporated into pharmaceutical formulation systems.
For Maltitol SR Granules, the sustained-release function should come from the overall formulation design rather than from maltitol alone. The release-controlling component may involve a suitable polymeric matrix, coating system, barrier layer, or another validated formulation approach. The exact mechanism should therefore be defined according to the actual finished product.
Maltitol has been investigated in pharmaceutical formulation and granulation research. Scientific studies have evaluated maltitol in relation to granulation, binding, powder properties and tablet compression.
Research has investigated maltitol as a binder in wet-granulated formulations, demonstrating its use in pharmaceutical granulation systems. Another study evaluated maltitol and other sugar alcohols during wet granulation using a high-speed mixer.
These studies support the relevance of maltitol to pharmaceutical excipient development, while the performance of a finished Maltitol SR Granules product remains dependent on its specific formulation and processing conditions.
Sustained-release granules are designed to control the release rate of an incorporated active ingredient. This can be achieved through mechanisms such as polymeric matrices, functional coatings, diffusion barriers or combinations of formulation technologies.
Maltitol itself should not be described as the sustained-release controlling polymer. Its high water solubility means that an SR formulation generally requires an additional release-controlling strategy when prolonged release is intended.
The final release profile can depend on:
These characteristics must be established using product-specific development and dissolution testing.
Maltitol has the molecular formula C₁₂H₂₄O₁₁ and molecular weight 344.31 g/mol. Its CAS Number is 585-88-6. USP identifies Maltitol as d-glucopyranosyl-d-glucitol.
The current USP-NF monograph specifies 92.0% to 100.5% d-maltitol, calculated on an anhydrous basis.
FCC describes Maltitol as a white crystalline material that is very soluble in water and slightly soluble in ethanol.
These chemical characteristics apply to the maltitol material itself. Finished Maltitol SR Granules require additional product-specific characterization because granulation and release-controlling components can significantly alter physical and functional performance.
Granulation converts particulate material into larger, more controlled granules. In pharmaceutical manufacturing, granulation can improve material handling and provide controlled particle characteristics.
For Maltitol SR Granules, relevant physical attributes can include:
Particle characteristics can influence the surface area available for wetting and the diffusion path within a controlled-release formulation.
However, no universal D10, D50 or D90 specification should be assigned to Maltitol SR Granules without actual product-specific data.
The sustained-release behavior of a granulated formulation is determined by the interaction between the incorporated active ingredient, maltitol, release-controlling materials and the surrounding dissolution medium.
Depending on the formulation design, a controlled-release system may use:
The choice of release-control mechanism depends on the desired release profile and formulation requirements.
Because maltitol is highly water soluble, it may influence water penetration and dissolution within a formulation. Therefore, the balance between maltitol and the release-controlling component needs to be established during formulation development.
The sustained-release performance of Maltitol SR Granules should be demonstrated through appropriate dissolution testing.
Important development parameters may include:
A specific claim such as “12-hour release” or “24-hour release” should not be made unless it is supported by the actual product specification and validated dissolution data.
Similarly, a universal dissolution percentage should not be assigned to all Maltitol SR Granules because release behavior depends on the finished formulation.
Maltitol SR Granules may be considered for pharmaceutical formulation development involving:
The exact application depends on the formulation architecture, incorporated active ingredient, release-control technology and target release profile.
Granule size can influence the surface area and diffusion characteristics of a particulate formulation. Smaller granules generally provide a different surface-area-to-volume relationship compared with larger granules.
For SR formulations, particle-size distribution should therefore be controlled according to the intended formulation design.
D10, D50, D90 and sieve analysis can be used to characterize the particle population where appropriate.
The optimal particle-size range is product-specific and should be determined through formulation development rather than assumed as a universal Maltitol SR Granules specification.
Flowability is an important property for granulated excipients and finished granules. Consistent flow can support material transfer, blending, filling and other pharmaceutical processing steps.
Maltitol SR Granules can be evaluated using:
Actual flow performance depends on granule size, morphology, surface characteristics and moisture.
Numerical flow specifications should therefore only be published when supported by the actual product specification or Certificate of Analysis.
Important quality attributes for Maltitol SR Granules may include:
The current USP-NF Maltitol monograph establishes the chemical material requirements, while SR-specific characteristics must be defined for the finished granulated product.
Maltitol SR Granules should be manufactured using controlled granulation and, where applicable, controlled coating or matrix-forming processes.
Important process parameters can include granulation conditions, liquid addition, mixing, drying, particle-size classification, polymer addition, coating conditions, coating weight gain and process endpoint.
The manufacturing process should be designed to provide consistent granule characteristics and reproducible release performance.
Moisture control can also be important because moisture may influence granule structure, flowability, stability and the performance of certain release-controlling systems.
Quality control should evaluate both the chemical quality of maltitol and the physical and functional properties of the finished SR granules.
The current USP-NF Maltitol monograph specifies 92.0%–100.5% d-maltitol on an anhydrous basis.
Additional finished-product testing may include particle-size distribution, moisture, density, flowability, coating characteristics and dissolution testing.
SR dissolution specifications must be established according to the actual formulation and intended release profile. They should not be presented as universal specifications for every Maltitol SR Granules product.
| 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 0.5% |
| Individual Impurity | NMT 0.10% |
| Total Impurities | NMT 0.50% |