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Dextrates Excipient | Uses, Suppliers, and Specifications

Dextrates is a purified mixture of saccharides (mainly dextrose and maltose, plus other polysaccharides) obtained from the enzymatic hydrolysis of starch. It is odourless with a sweet taste (about half as sweet as sucrose) and supplied as a white free-flowing porous powder. When selected for use in direct compression tabletting, dextrates exhibit superior flow, compaction, and tablet robustness.

Synonyms and Trade Names: Dextrates; CANDEX®; EMDEX®. MEGADEX® NF

Pharmacopoeial Compliance: USP-NF

Uses and Applications: Tablet Binder; Tablet and Capsule Diluent; and Sweetening Agent

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EMDEX® Dextrates - JRS Pharma

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MEGADEX® Dextrates - Paular Corporation

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Description

Dextrates is a purified mixture of different saccharide molecules obtained through the controlled enzymatic hydrolysis of Starch. The resulting product is spray crystallised to yield a free-flowing porous powder which consists of Dextrose as the principal constituent (95% w/w) as well as Maltose (3–5% w/w) and a small quantity of higher polysaccharides. In the USP-NF, Dextrates is defined as a purified mixture of saccharides resulting from the controlled enzymatic hydrolysis of starch. It may be either hydrated or anhydrous and its dextrose equivalent is not less than 93.0% and not more than 99.0%, calculated on a dried basis.

Dextrates were introduced out of the need to improve the compressibility of Dextrose, which does not acquit itself well in direct compression applications. The spray crystallisation process permits the production of an engineered material while avoiding the problems associated with spray drying low molecular weight sugar solutions. Some of the beneficial features of Dextrates include:

  • Spherical, porous particles with excellent flowability and compressibility. Dextrates does not require the addition of a glidant and produces strong and robust tablets
  • Freely and rapidly soluble in water. It is suitable for chewable, swallow, dispersible and effervescent tablets. Dextrates are well suited for products that require good mouthfeel.
  • Narrow particle size distribution

Excipient-grade Dextrates is typically available as the hydrate, being the more economical grade to produce. It is odourless with a sweet taste (about half as sweet as sucrose) and no perciptible odour.

Chemical Structure & Identifiers

 

 


Chemical Name Dextrates
CAS Registration Number [39404-33-6]
Empirical Formula Not Applicable
Molecular weight Not Applicable
EINECS Number 629-728-2
UNII Code (FDA) G263MI44RU

Regulatory Status

Dextrates is an approved excipient and is monographed in the USP-NF. It is also GRAS listed and included in the US FDA Inactive Ingredient Database. Dextrates is considered a relatively nontoxic excipient.

Physicochemical Properties

Physical form Solid, powder
Appearance White or whitish powder
Angle of repose 30
Bulk density 0.68-0.70 g/ml
Tapped density 0.72-0.75 g/ml
True density 1.540 g/ml
Hausner ratio 1.05-1.08
Flowability 9.3-9.5 g/s
Heat of combustion 16.8—18.8 J/g (4.0 – 4.5 cal/g)
Heat of solution -105 J/g
Melting point 141 0C
Moisture content 7.5—9.5 % w/w (hydrated form)
Particle size distribution Mean particle size 200 µm
Solubility Freely soluble in water; insoluble in ethanol (95%). propanol, and other common organic solvents.
Specific surface area 0.70 m²/g

Pharmacopeoeal Specifications

  USP-NF
Name Dextrates
Authorised use Excipient
Definition specified
Characters specified
Identification specified
Appearance specified
pH (20% aqueous solution) 3.8- 5.8
Loss on Drying
Anhydrous

Hydrated

≤2.0%

7.8 – 9.2%

Residue on ignition ≤0.1%
Heavy Metals ≤ 5pm
Assay 93.0-99.0%
Labelling specified

Key: n/a Specification is not listed

*All claims with respect to conformity are subject to our Terms and Conditions. No express or implied warranty is made for specific properties or fitness for any particular application or purpose.

Applications in Pharmaceutical Formulations or Technology

Dextrates was introduced to counter the challenges associated with using Dextrose which is not ideal for use in direct compression applications. It is therefore mainly marketed for use as a diluent and filler in direct compression processes. It may also be used as a tablet binder, and sweetener.

Owing to its many favourable properties (solubility, sweetness, pleasant mouthfeel and a lack of adverse effects), Detrates is mainly used as a directly compressible tablet diluent in chewable, dispersible, and effervescent tablets. Due to being highly compatible and compressible, Dextrates can be used in high levels with minimal negative effects on tablet properties. Finally, being composed of spherical particles that flow freely, Dextrates does not require the use of  glidants (e.g Silicon dioxide and Talc). However, the use of adequate lubrication (e.g with Magnesium stearate at 0.5—1.0% w/w) is advised. Wicking-type superdisintegrants (e.g Croscarmellose sodium) are most ideal and offer the most optimum results.

In wet granulation, Dextrates can be used as a binding agent simply by adding water as the granulating fluid. It is not necessary to add another binder, such as Hypromellose or Starch.

Typical Usage:

  • Tablet binder: 5-30%
  • Diluent: 5-30%

Key Attributes

  • Direct compression tabletting for chewable or swallow tablets
  • Stabilises blends for micronised APIs (ordered mixing)
  • Better oil and flavour carrying capacities due to microporous structure
  • Suitable for effervescent tablets
  • Highly compressible (Dextrates > Calcium Phosphate Dihydrate > Spray Dried Lactose >

Safety and Precautions

Dextrates is derived from starch, a biopolymer that is part of the human diet. It is approved for use in pharmaceutical products. Dextrates is used in oral pharmaceutical formulations and is generally regarded as a relatively nontoxic and nonirritant material.

 

Stability and Storage Conditions

Dextrates is a stable material. The assigned shelf life is 24-36 months. Since Dextrates is highly hygroscopic (equilibrium moisture content 7.5-9.0%), it should be stored correctly and exposure to moisture avoided to maintain their useful life and functionality. It is recommended that storage temperatures not exceed 25 oC and 60% relative humidity. When correctly stored in unopened containers.

Dextrates may be heated without any marked darkening in colour. However, if exposed to high temperatures and humidities, Dextrates may react with substances containing a primary amino group (Maillard reaction).

When handling Dextrates in a work setting, observance of the recommended precautions appropriate to the circumstances and quantity of material handled is recommended. Eye protection, gloves, and a dust mask should be used to minimise unnecessary contact with mucous membranes.

Sustainability and Environmental Impact

Dextrates has not been assessed for sustainability.

 

Manufacturers & Suppliers

JRS Pharma

  • EMDEX® Dextrates
  • CANDEX® Dextrates

Paulaur Corporation

  • MEGADEX® Dextrates

Additional Resources (Downloads)

References and Literature Used

[1] I.G. Olmo, E.S. Ghaly, Evaluation of two dextrose-based directly compressible excipients, Drug Development and Industrial Pharmacy, 24 (1998) 771-778. Pubmed | Google Scholar

[2] I.G. Olmo, E.S. Ghaly, Compressional characterization of two dextrose-based directly compressible excipients using an instrumented tablet press, Pharmaceutical development and technology, 4 (1999) 221-231.

[3] P.J.C. Sheskey, Walter G; Cable, Colin G, Handbook of Pharmaceutical Excipients – 8th Edition, Pharmaceutical Development and Technology, 18 (2017) 544-544.

[4] A.J. Shukla, J.C. Price, Effect of moisture content on compression properties of two dextrose-based directly compressible diluents, Pharmaceutical Research, 8 (1991) 336-340. Pubmed | Google Scholar

 

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