The method of obtaining crystalline lactulose patterns

 

(57) Abstract:

Usage: as a medicinal product for the treatment of liver encefalopatia and dietary treatment of newborns. The inventive lactulose crystal structure, the water content of 0.8%. Reagent 1: syrup of lactulose with national concentration was 65.3%. Reaction conditions: evaporation under reduced pressure of less than 0.2 bar, the temperature is below 60C to a concentration of about 85 wt.% with subsequent sowing of crystalline lactulose and continued evaporation at 65 - 75C. for 3 h.p. f-crystals.

The invention relates to methods for lactulose crystal structure that does not contain water in crystals.

Lactulose is a carbon, which can be obtained by isomerization of lactose, which is usually carried out under alkaline conditions in water solutions.

It has been proven that the connection pharmaceutically applicable due to its regular effect on the intestinal bacterial flora, in particular in the treatment of hepatic encephalopathy and dietary treatment of newborns.

Lactulose is prepared in the form of a syrup, which after purification can be administered to the patient. It would be however, it is more convenient floor is Oia, requirements for getting so dry lactulose, are stability, high purity, lack of hygroscopicity.

It was cooked a few dry forms of lactulose.

They can be classified according to the following main types:

lactulose on solid media; suitable solid carriers for this purpose are vegetable fibers, which are coated with the syrup of lactulose (for example, by spray drying), or an adsorbent, such as diatomaceous earth, absorbent kaolin, activated lignin, synthetic resin-adsorbent or activated charcoal;

amorphous lactulose, which can be obtained by rapid or slow cooling of a concentrated syrup of lactulose, by drying the syrup spray, by caramelization syrup or by drying of lactulose in the form of foam;

crystalline lactulose, which is usually obtained by crystallization of the sugar from the alcohol solution. A serious disadvantage of this type of solid lactulose is the presence of an organic solvent (usually methanol) in the crystals.

Lactulose is also possible to crystallize from aqueous solution.

According to the publication of Japanese patent N the ri 60-110aboutWith the subsequent addition of lactulose crystals when the two are thoroughly mixed to obtain a final concentration of 94-98% and keeping the mixture at 35-70aboutWith as much time as required for complete solidification of lactulose, usually for about 12-18 hours With the aim of obtaining crystalotherapy powder, solid lactulose is required to break during milling operations.

In the published European patent N 0348630 described a very long way that lactulose is crystallized at 5-40aboutC. in Addition to the duration of the procedure (up to 60 h) another disadvantage is the low yield of crystalline product (less than 70% of lactulose present in the solution, crystallizes in fact).

The invention provides a quick way of complete metamorphosis lactulose present in the aqueous solution or suspension, crystalline powder during a single stage of obtaining.

According to the present invention the method is characterized by simultaneous continuous mixing by reducing the water content by evaporation of an aqueous solution or suspension of lactulose, possibly in the presence of seeds of crystals, to obtain free flowing TEI water. Seeding crystals that can be used according to the invention preferably consist of crystalline lactulose, containing no water.

The original solution may have a low concentration of lactulose, which rises during the process of reducing the water content by evaporation and continued stirring. This reduction of the water content by evaporation preferably takes place under reduced pressure, in particular at a pressure of less than 200 mbar, particularly when lower than 100 mbar. The content of lactulose on the basis of total dry matter may preferably be not less than 80% and more in particular may be at least 95%

The possible addition of seed crystals must occur when the concentration and temperature, when no significant dissolution of the crystals, preferably at a content of dry substance in the solution 80-95% If the initial solution is already satisfy this last requirement, the seed crystals may be present from the very beginning.

The number of added seed crystals depends on the temperature of the product, and also correlated with the dry matter content in the solution of lactulose.

It is advisable, h is predpochtitelno 1-5% while reducing the water content by evaporation the temperature of the product is necessary to keep below the temperature of decomposition of lactulose, and preferably it should not exceed 70-80aboutC.

During the process, the viscosity of the material increases extremely significantly, especially at the beginning of the crystallization process. So you need a very powerful mixing equipment.

The decrease in the content by evaporation and simultaneous mixing continued until until all of the material will not be turned into a powder, and preferably to a water content below 1 wt.

Powder lactulose with the crystal structure obtained according to the invention, can be used for pharmaceutical purposes in the form of a pharmaceutical composition or in the form of a food product, either for people or for use in veterinary medicine.

P R I m m e R. Crystallization of lactulose.

50 kg of lactulose syrup with an initial concentration of lactulose in 65,3% by mass was evaporated in the drying equipment type ZA100 (R;p;ker) under reduced pressure of less than 0.2 bar (absolute) at a temperature below 60aboutWith concentrations up to about 85 wt. what took 100 minutes

In the thus obtained solution was seeded 2.4 kg of crystalline lactulose and continued concentration by evaporation for a further 40 min at 65-70about

2. The method according to p. 1, wherein the seed crystals do not contain water.

3. The method according to PP. 1 and 2, characterized in that the evaporation lead to a water content less than 1% by weight of dry matter.

 

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