Sugar – starch – and carbohydrates – Processes – Carbohydrate manufacture and refining
Patent
1992-01-15
2000-03-21
Bell, Mark L.
Sugar, starch, and carbohydrates
Processes
Carbohydrate manufacture and refining
106213, 106214, B29C 104
Patent
active
060398132
DESCRIPTION:
BRIEF SUMMARY
This invention relates to a granulated product which is suitable for use in the manufacture of tablets by direct compression means and which contains fructose and a minor amount of a physiologically acceptable polyol, and to a process for the production thereof.
Direct compression techniques have become increasingly popular in tablet manufacturing in the pharmaceutical and food industries. A good material for use in direct compression techniques should be free-flowing, it should not get cloddy or lumpy and it should form firm and hard tablets with a reasonable compression force.
Many ingredients used in tablets are, as such, not suited for direct compression due to their insufficient flowability and/or compressibility. Therefore, binding and diluting agents suited for direct compression have been developed, which may also function as, e.g., flavour improving agents.
Sweet carbohydrates such as sugars and sugar alcohols are suitable for use as raw materials of tablets as binding and diluting agents for other active ingredients (e.g. pharmaceuticals) or as the major component of tablets (e.g. confectionery or energy tablets) because of their pleasant taste. However, most crystalline sugars and sugar alcohols as such are poorly suited for direct compression techniques, since as crystals they do not form tablets, and powders prepared therefrom are very poorly flowable. Therefore, various granulated products of sugars and sugar alcohols have been developed for use in direct compression. In the pharmaceutical and food industries, these products can be regarded as semifinished products which are utilized as raw materials in effective tableting techniques.
Examples for commercial binding and diluting agents include EMDEX, which is an agglomerated dextrose; DIPAC, which is an agglomerated sucrose containing dextrins; and STARCH 1500, which is pre-gelatinized directily compressible starch and mannitol. U.S. Pat. No. 4,352,821 discloses a product consisting of fructose and a salt. U.S. Pat. No. 4,159,345 discloses an excipient prepared from microcrystalline cellulose.
Fructose has several advantages as a raw material of tablets. The taste is sweet, it is suitable for diabetics and the water solubility thereof is good. Agglomeration of fructose to a directly compressible product, however, presents problems.
Fructose granules agglomerated from a water solution are hard and the compressibility is unsatisfactory. A granular fructose product has been prepared also from a fructose-alcohol mixture; for example, see U.S. Pat. No. 3,684,573. The use of alcoholic solutions, however, calls for special precautions in industrial applications. It is therefore a great advantage if a compressible product can be prepared using only water as solvent. According to European Patent Application published with No. 0036738, such a product can be prepared by adding a comparatively large amount of dextrins to a fructose solution and spray-drying the mixture. This method does not provide a product that is predominantly fructose, but rather a sugar mixture including fructose as one of several carbohydrates. Furthermore, U.S. Pat. No. 4,698,101 discloses a fructose-based binding and diluting agent, namely a fructose agglomerate, suited for use in direct compression tableting techniques. This agglomerate contains in combination with fructose about 2% to about 20% by weight of a disaccharide, preferably maltose, wherefore it is unsuitable for diabetics.
The object of the present invention is to provide an essentially fructose-based granular product having flowability and compressibility characteristics which make it suitable for the manufacture of tablets by direct compression techniques, and which is suitable also for diabetics.
This object is achieved according to the present invention with a granulated product which consists of free-flowing granules comprising about 92% to about 98% by weight of fructose, about 1% to about 7% by weight of a physiologically acceptable polyol selected from sorbitol, maltitol, lactitol, xylitol, mannitol, isomalt
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Kruger Christof
Makela Matti
Pepper Tammy
Bell Mark L.
Hailey Patricia L.
Xyrofin Oy
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