Maltitol Granules are pharmaceutical-grade granulated materials based on maltitol, a sugar alcohol used in pharmaceutical formulation and excipient development. Maltitol is also known as d-glucopyranosyl-d-glucitol and has the molecular formula C₁₂H₂₄O₁₁ with a molecular weight of 344.31 g/mol. Its CAS Number is 585-88-6. The current USP-NF Maltitol monograph specifies 92.0% to 100.5% d-maltitol, calculated on an anhydrous basis.
Maltitol Granules provide maltitol in a controlled granulated form rather than as a conventional fine powder. Granulation can modify the physical characteristics of the material, including particle-size distribution, bulk density, flowability, handling characteristics and compression behavior. These properties are important during pharmaceutical manufacturing and formulation development.
Maltitol is a polyol with high water solubility. FCC describes Maltitol as a white crystalline powder that is very soluble in water and slightly soluble in ethanol.
Maltitol is used in pharmaceutical research as a sugar alcohol excipient and has been investigated for applications involving tablet formulation and compression. Research has evaluated maltitol's physicochemical and pharmacotechnical properties, including its tabletability and compression behavior.
Maltitol Granules can be developed to provide a controlled particulate material suitable for pharmaceutical formulation processing. The granulated form can offer different handling and processing characteristics compared with ungranulated maltitol.
The performance of finished Maltitol Granules depends on the grade of maltitol, granulation technology, moisture conditions, particle-size distribution and other manufacturing parameters. Therefore, finished-product specifications should always correspond to the actual product specification and Certificate of Analysis.
Maltitol has the chemical formula C₁₂H₂₄O₁₁ and molecular weight 344.31 g/mol. The CAS Number is 585-88-6. USP identifies maltitol as d-glucopyranosyl-d-glucitol.
The current USP-NF definition specifies a d-maltitol content of NLT 92.0% and NMT 100.5%, calculated on an anhydrous basis. The material may also contain other sugars, polyhydric alcohols and hexitol anhydrides within the monograph framework.
Maltitol's high water solubility is an important characteristic for formulation development. FCC reports that Maltitol is very soluble in water and slightly soluble in ethanol.
Granulation is a particle-engineering process used to convert fine powders or particulate materials into larger, more controlled granules. For pharmaceutical manufacturing, granulation can influence flow, packing, density, compression and downstream processing.
Maltitol has been investigated as a material in pharmaceutical granulation systems. Research on wet granulation has specifically evaluated maltitol among sugar alcohols used as binders and examined the granulation mechanism and resulting material characteristics.
Maltitol can therefore be considered in formulation development where a sugar-alcohol-based material is required in a granulated format.
Important characteristics of Maltitol Granules may include:
These characteristics are product-specific and should not be represented as universal values without supporting product data.
Maltitol has been studied as a pharmaceutical excipient for tablet formulation. Research comparing different physical states of maltitol demonstrated differences in tabletability and compression behavior, highlighting the importance of the physical form of the excipient during tablet development.
Maltitol Granules can be evaluated for applications where controlled particulate characteristics are required during tablet manufacturing. Granule size, moisture, density and flow can affect blending, feeding and compression.
The suitability of a particular Maltitol Granules grade for direct compression, wet granulation or another manufacturing process should be established from the actual product characteristics rather than assumed from the product name.
Published pharmaceutical research has investigated maltitol as a binder in wet-granulated tablet systems. In one study, maltitol was evaluated alongside other binders for producing granules and compressed tablets, demonstrating that maltitol can contribute to granule and tablet formation under suitable formulation conditions.
The amount of maltitol required and its functional contribution depend on the formulation, manufacturing process and other excipients present. Therefore, binder concentration and granulation performance should be determined during formulation development.
Particle size is an important quality attribute for pharmaceutical granules. D10, D50 and D90 values can be used to describe the particle-size distribution when these measurements are part of the approved product specification.
Bulk density and tapped density can also provide useful information about powder and granule packing. Flowability may be evaluated using suitable validated methods depending on the intended application.
For Maltitol Granules, these characteristics can influence material transfer, blending, hopper discharge, capsule filling and tablet compression.
However, numerical particle-size and density specifications should only be published when supported by the actual Maltitol Granules grade and Certificate of Analysis.
Maltitol is highly water soluble. FCC describes Maltitol as very soluble in water and slightly soluble in ethanol.
This characteristic can be relevant when Maltitol Granules are incorporated into formulation systems where aqueous solubility is required. The dissolution behavior of a finished granulated product can nevertheless differ from that of the starting material because granule size, porosity, binders and other formulation components can influence wetting and dissolution.
Therefore, finished-product dissolution or disintegration claims should be based on product-specific testing.
Maltitol Granules may be considered for pharmaceutical formulation development involving:
The exact role of Maltitol Granules depends on the grade, formulation composition, concentration and manufacturing process.
Quality control should address both the chemical identity of maltitol and the physical characteristics of the finished granules.
Typical quality attributes may include:
The current USP-NF Maltitol monograph establishes the chemical definition and assay range for Maltitol. Finished Maltitol Granules may require additional physical specifications based on the manufacturing process and intended application.
Maltitol Granules can be produced through controlled granulation and particle-size classification processes. Depending on the product design, process parameters may include granulation method, liquid addition where applicable, mixing, granule formation, drying, milling and screening.
Control of moisture and particle-size distribution is particularly important because these characteristics can influence flow, density and compression performance.
The finished product should be evaluated against validated quality specifications before use in pharmaceutical formulation.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |