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Reproduced courtesy of PharManufacturing
THE POLYOL WORLD LEADER
Roquette offers the broadest polyol excipient range providing excellent chemical stability with good taste, sugar-free sweetness and oral health benefits for numerous pharmaceutical applications.
All are produced exclusively from starches, obtained by the hydrolysis of corn, wheat, potatoes or peas.
Our range includes:
- PEARLITOL® crystalline mannitol and granulated mannitol,
- NEOSORB® sorbitol,
- MALTISORB® maltitol,
- XYLISORB® xylitol and
- LYCASIN® maltitol syrups
PEARLITOL® mannitol - An outstanding diluent-binder for solid dosage forms, and an active ingredient in parenteral diuretics.
Roquette recently announced an investment to increase its Mannitol production with new capacity in its USA facilities. This will support the existing production in Lestrem, France and consolidate Roquette’s established leading position in an increasingly important excipient. Roquette will be the only producer offering risk mitigation through multiple production sites.
Mannitol takes its name from manna, a sweet exudate from the manna ash tree (Fraxinus Ornus) of which it is the major ingredient. It also occurs in olives, figs and certain species of edible fungi, as well as Laminaria seaweed.
Historically it was obtained by extraction from seaweed. Mannitol is one of the “sugar alcohols” or “polyols” and has been widely used in diverse applications for many years.
Roquette pioneered the industrial production of Mannitol in the 1970’s, and this process has assured a constant high purity grade unaffected by seasonal variations. Beginning from starch extracted from cereals, Roquette produces a glucose mannose solution which is transformed to mannitol by catalytic hydrogenation. Because of Roquette world leading technology, a product of constant purity is obtained. PEARLITOL® mannitol grades have been fully characterised both chemically and physically.
Mannitol is a polyol with a molecular weight of 182.17, and empirical formula C6H14O6. It is a slightly sweet, and a white crystalline powder or granule, giving a cooling sensation in the mouth. Mannitol is partially absorbed when administered orally, although the majority is fermented by colonic micro flora. Mannitol which is absorbed is not metabolised and is excreted through the kidney in urine. There is no specified maximum daily intake, (JECFA 1987 and subsequent regulatory decisions) which means that mannitol is “safe” based on a complete bio toxicological characterisation. It is not fermented by human buccal micro flora, thus it is neither acidogenic nor cariogenic, and these properties grant it a useful role in preventing tooth decay.
It is remarkably stable, and does not react with diluted acids, buffer solutions or amino groups. No Maillard type reactions have been observed, nor does mannitol undergo discolouration reactions below 220oC. Mannitol has many virtues and numerous uses in the food industry, but it has been in the pharmaceutical and health industry that this product has excelled: The availability of a consistent and reliable quality grade has made Mannitol a particularly suitable excipient for the pharma and health industries.
Mannitol has a large share of the most desirable qualities that formulators seek in mineral, sugar or even polymeric excipients: notably a characteristic low chemical reactivity, an extraordinarily low level hygroscopicity making it one of the lowest residual moisture content products and all this coupled with a pleasant taste and mouth feel.
Such remarkable intrinsic properties have been built on over the years by Roquette’s technical teams creating the largest Mannitol range for the pharmaceutical and health industries. This range includes filler-diluents with different particle sizes, innovative and patent protected forms produced by spray-drying and by melt extrusion for use as filler-binders for direct compression.
PEARLITOL® mannitol granular grades offer all the characteristics necessary for direct compression excipients without the disadvantages of the alternative excipients used historically:
- Excellent free flow
- Good compactibility with low friability
- No sensitivity to tabletting speed
- No lubricant sensitivity
- Good dilution potential
PEARLITOL® mannitol granular grades give good hardness results under industrial compression conditions. All Roquette grades of PEARLITOL® mannitol comply with the existing EP, USP and JP monographs. The products are free from GMO contamination.
Applications for PEARLITOL® mannitol in which Roquette’s technical team are fully experienced include conventional chewable tablets, sachets, fast dissolving and orodispersible tablets.
PEARLITOL® PF, an endotoxin controlled grade for parenteral use as an active diuretic ingredient is the only fully GMP certified to the ICH Q7A rules.
Commercially all these products are available in quantities from kilogrammes to thousands of tonnes and can be delivered in a range of packing from 25 Kg bags through 1 tonne semi bulk containers up to bulk powder tankers.
These chemical and technical virtues of Mannitol, coupled with the controlled properties of the PEARLITOL® range have brought this product from a relatively elite and exotic status firmly into the frame for pharmaceutical and nutraceutical formulations: Today Mannitol is becoming a centre piece excipient in the formulators “toolbox”.
Sample quantities can be obtained directly from Roquette via the contact cards or through the web site and email addresses below.
Contact us: You can now gain immediate access to Roquette’s extensive range of excipients and actives, as well as services through our dedicated pharma website: www.roquettepharma.com
You can also contact us directly at the following e-mail address: pharma.business.unit@roquette.com
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