Crystalline active ingredient dried with spray drying

FIELD: food industry.

SUBSTANCE: invention relates to food industry. A method provides for mixing of a crystalline active ingredient with a derivative of starch in the amount of 7 wt % to 25 wt % to total weight of the mixture prior to spray drying, the second carrier material and xanthane gum before a suspension, a dispersion or a solution of the active ingredient is formed. The crystalline active ingredient has a speed of dilution in water without any mixing at the temperature of 25°C during more than 15 minutes at concentration of the active ingredient of 14 ppm. The mixture is homogenised under pressure of at least 4000 pounds per square inch (2.758×107 Pa), and the homogenised mixture is subject to spray drying. The active ingredient obtained by spray drying has an increased speed of dilution in water in comparison to a non-encapsulated active ingredient.

EFFECT: invention allows improving a speed of dilution of an active ingredient.

12 cl, 4 tbl, 1 ex

 

The technical field to which the invention relates.

The present invention relates to the field of concentrates, namely, to a method for preparing a product containing crystalline active ingredient in water, with excellent kinetics of dissolution. The invention also relates to the product produced in accordance with this method.

The level of technology

Many potentially useful active materials insoluble in water or only slightly soluble in water. This significantly limits their suitability or require their use in combination with solvents, which almost always have a higher value than water, and which can be physiologically incompatible or harmful to the environment.

In addition, for many applications it is necessary that the active material was rapidly dissolved in the water environment. For example, powder drinks diluted with water and immediately used, and this requires that all the ingredients are quickly absorbed so that the drink had a balanced taste. Thus, there is a need to ensure sufficiently rapid dissolution of the active ingredient.

Have taken different approaches to improve the solubility of poorly soluble materials. An overview of these approaches are presented in the publication "Formulation approaches for orally administered poorly oluble drugs", Pinnamaneni S., Das, N. G., Das, S. K., Pharmazie, 2002, 57, 291-300 ("Approach to formulations for poorly soluble drugs for oral administration"). Such approaches include reduction of particle size, behavior modification crystals, the dispersion in the media, complexation and solubilization by Pavani.

In another review, improvement of solubility and dissolution rate of poorly water-soluble salicylic acid by a spray-drying technique)) Kawashima Y, Saito M, Takenaka H, J. Pharm. Pharmacol. 1975, 27, 1-5 ("Improvement of the solubility and dissolution rate of poorly soluble salicylic acid by spray drying process") discloses a spray drying a dispersion of salicylic acid in solutions Arabian gum, which leads, according to sources, the maximum to 50% to improve the solubility of the product is not only depending on the concentration of Arabian gum, but also on the number of amorphous material in the products obtained by spray drying. The dissolution rate of the product obtained by spray drying, as reported, also about 60 times higher than the rate for the source powder. This is, as mentioned, was due to a significant improvement in the wettability of the material obtained by spray drying.

However, for some crystalline active ingredients kinetics of dissolution could not significantly improve with increasing Simachev is emote.

WO-A-2008/006712 (Unilever) discloses a method of manufacturing contradictorily of nanodisperse materials having at best a weak solubility, soluble in the base material, which includes stages:

(i) providing a single phase mixture of: (a) a solvent or a mixture of miscible solvents, (b) at least one material of the carrier, soluble in the solvent (a) where the specified carrier material also has contra - solubility to load material (s) and is solid at room temperature, (C) at least one load material soluble in the solvent (a), and

(ii) drying the mixture to remove solvent and obtain, thus, the material of the carrier (b) in solid form with the load (s) dispersed therein in the form of nanoparticles. Drying is usually carried out in the form of spray drying.

However, there remains an urgent need for a simple means to improve the kinetics of dissolution.

The present invention is directed to one or more of the above-mentioned problems and/or providing one or more of the above-mentioned beneficial effects.

The invention

Accordingly, the present invention provides a method of preparation of the product obtained by spray drying, to improve the dissolution rate of the active ingredient, the de method involves the following stages:

(i) mixing crystalline active ingredient, which has a rate of dissolution in water without stirring at 25°C for more than 15 minutes at a concentration of 14 hours/million active ingredient, a derivative of starch, the second material carrier, and optional with xanthan gum to the formation of a suspension, dispersion or solution of the active ingredient,

(ii) homogenizing the mixture under a pressure of at least 4000 F./square inch (2,758 × 107PA), and

(iii) spray drying the homogenized mixture,

where obtained by spray drying an active ingredient has a high dissolution rate in water compared with the unencapsulated public active ingredient.

In addition, the invention provides particles obtained by spray drying, prepared in accordance with the above method.

Disclosure of inventions

The present invention relates to a method, in which the kinetics of dissolution of crystalline active ingredient can be significantly improved.

The present invention is based on the combination of certain components, such as compounds or ingredients, together with certain treatment conditions.

The first critical component is derived starch. Under "derivative of starch" refers to a chemically modified starch, the more predpochtitelno hydrophobic modified starch, even more preferably alkenyl-succinycholine starch.

Alkenyl-succinycholine starch preferably has a degree of substitution of from 0.001 to 0.9. The degree of substitution refers to the number of alkenyl amber functional groups on the glucose units. Thus, the degree of substitution of 0.001 means that there is 1 alkenyl-entrena functional group per 1000 glucose units. The degree of substitution, more preferably is 0.005 to 0.3, and most preferably from 0.01 to 0.1, for example between 0.015 to 0.05.

Alkenyl-succinycholine starch preferably is C3-C14 of alkenyl-succinycholine starch, more preferably C4-C12, most preferably C5-C10, such as C7-C9.

Most preferably, alkenyl-succinycholine starch is octenyl-succinycholine starch. Ideally, octenyl-succinycholine starch has a degree of substitution of up to 0.03, more preferably not more than 0.02.

It is established that the kinetics of dissolution of the active ingredient, obtained by spray drying, significantly improved when a derived starch is present in an amount of 7 wt.% up to 25 wt.%, more preferably, 7 to 20 wt.%, on the basis of the total mass of the mixture before spray drying. At less than 7% of the dissolution rate of the active ingredient, subjected to spray drying, it is difficult to improve. At the same the time when more than 25%, there is a strong feedback effect on the dissolution rate. Without going into theory, it is believed that the decrease in the dissolution rate due to the insolubility of the surplus derived starch in water.

Another critical component is the second carrier material. The second material carrier is preferably a carbohydrate. For example, the second carrier material may contain monosaccharides, disaccharides, trisaccharide, oligosaccharides, polysaccharides, or mixtures thereof.

Suitable monosaccharides include: D-apiose, L-arabinose, 2-deoxy-0-ribose, D-lyxose, 2-0-methyl-B-xylose, D-ribose, D-xylose, all of which are pentose; and hexose, such as L-fructose, L-galactose, D-galactose, D-glucose, D-mannose, L-rhamnose, L-mannose; and mixtures of two or more of them.

Mono - and disaccharides can be restored to their respective alcohols, such as xylitol, sorbitol, D-mannitol and/or ▫ maltitol. Similarly, the oxidation to aldonova, dicarboxylic acid or uronic acids, and reaction with acids, bases or amino compounds can give rise to many other compounds, such as smalltit, which may contain a second carrier material in accordance with the present invention.

Suitable oligosaccharides are molecules consisting of 3 to 10 monosaccharide units, such as multipunctata, fruit - and/or galactooligosaccharide.

Before occhialino, the second carrier material contains maltodextrin, most preferably having a value of a dextrose equivalent of from 5 to 25, preferably from 6 to 20, more preferably from 10 to 19.

In a preferred embodiment, the second carrier material is present in an amount of from 40 to 80 wt.%, more preferably from 60 to 80 wt.%, to the total weight of the mixture before spray drying.

Optional, though preferred component is xanthan gum. Xanthan gum is a polysaccharide used as a food additive and rheology modulator. It is produced by fermentation of glucose or sucrose by the Xanthomonas campestris.

Xanthan gum is preferably added as a technological means to save insoluble crystalline substances suspended in the solution before spray drying.

It was found that the optimum level of application to maintain adequate suspension occurs when the xanthan gum is present in an amount of 0.3 wt.% to 0.6 wt.%, to the total weight of the mixture before spray drying. If the number is less than 0.3%, the important issue is that insoluble solids remain suspended. At the same time, if the number exceeds 0.6%, the viscosity of the slurry is too high is Oh, that may adversely affect the homogenization stage.

The encapsulated active ingredient is a compound, which preferably has a rate of dissolution in the absence of mixing in water at 25°C for more than 15 minutes at a concentration of 14 hours/million (ppm). For the purposes of the present invention, the dissolution rate" is measured in accordance with the method described in examples described below.

The active ingredient is crystalline. "Crystalline" means that the active ingredient forms a structure exhibiting long-range order in three dimensions. The crystallinity can be measured using known techniques such as crystallography, powder x-ray diffraction (PXRD), NMR in the solid state, or thermal techniques such as differential scanning calorimetry (DSC).

The active ingredient may also be organic active agent is poorly soluble in water." This ingredient is usually a compound which has a solubility in water of less than 5 wt.%. preferably less than 1 wt.%, more preferably less than 0.1 wt.%, even more preferably less than 0.01 wt.% in water at 20°C.

Suitable active ingredients include those that are used in food, pharmaceutical and cosmetic products. A non-limiting list of examples includes the t: flavor and fragrance materials of natural and synthetic origin, compounds and mixtures, such as heliotropin, bromeliads, (5RS,6RS)-2,6,10,10-tetramethyl-1-oxaspiro-[4,5] Dec-6-yl acetate, acetarsol, methylsalicylate aldehyde, para-ethyl phenol, phenol, phenylethyl salicylate, menthol, cyclohexanecarboxylic, veratraldehyde, Xylenol, dodekanisa acid, thymol, heliotropiaceae, methylenethf, methylnaphthalene, myristic acid, palmitic acid, dimethylphenol, dimethylacrylic acid, coumarin, methylcyclopentanone, 7-methylcoumarin, phenylacetate, acetylpyrazine, phenylacetic acid, isoeugenol, raspberry ketone, naringin, propergate, tetramethylpyrazine, acetylaminophenol, 3-hydroxy-2-ethyl-4-pirano, malic acid, resorcinol, benzoic acid, cinnamic acid, Sumatran benzoin, Siam benzoin, citric acid, tartaric acid, camphor, quinine hydrochloride, ascorbic acid, borneol, glutamic acid, 5-methylphenoxy and malt extract; fat-soluble vitamins, such as vitamin a and its derivatives, vitamin D2vitamin D3natural or synthetic α-, β-, γ - or δ-tocopherol, preferably natural or synthetic α-tocopherol, and tocotrienol and Tocopheryl1With20-carboxylates; insoluble in water or slightly soluble in water, organic matter, shielding UV radiation, such as a connection is possible from the group of triazines, anilides, benzophenone, triazole, cynamide and from sulphonated of benzimidazole; polyunsaturated fatty acids, such as arachidonic acid, eicosapentaenoic acid or docosahexaenoic acid, food coloring agents, such as curcumin, Carmine or chlorophyll; carotenoids, such as β-carotene and lycopene; and xanthophylls, such as lutein, astaxanthin, zeaxanthin, capsanthin, capsorubin, cryptoxanthin, citranaxanthin, canthaxanthin, bixin, β-APO-4-carotenal, β-APO-8-carotenal and β-APO-8-carotene acid ethyl ester. The technical scope is not critical.

The active ingredient is preferably present in an amount of from 15 to 25 wt.%, to the total weight of the spray dried particles.

Suitable method for the production of spray dried particles in accordance with the present invention includes a first stage for receiving the dispersion, suspension or solution of the starch and the second material carrier. It can be done by simply mixing with water, preferably hot water at a temperature of from 60°to 80°C. Separately prepare a dispersion or solution of the active ingredient in a suitable solvent, such as propylene glycol. Then mix the two solutions.

The resulting mixture was homogenized in accordance with defined and process parameters for the manufacture of a product with excellent kinetics of dissolution.

It is important that the spray dried particles prepared using a method in which stage homogenization is carried out at a minimum pressure of 4000 F./square inch, more preferably 5000 F./square inch or more, most preferably 5500 F./square inch or more before stage spray drying.

Stage homogenization is preferably carried out in two or more full cycle in a standard homogenizer. For this purpose, suitable two-stage homogenizer.

After homogenization, the mixture is subjected to stage spray drying. Spray drying is preferably carried out only with the use to allow atomization. The spray pressure is preferably from about 1500 to 2500 F./square inch. the inlet temperature is preferably from 180°C to 200°C. the outlet Temperature is preferably from 70°C to 100°C.

Dried spray particles can then be collected using any standard method. Optional and preferably, they pass through a sieve, such as 20 mesh to obtain a more uniform particle size.

Dried spray particles provide a significantly improved rate of dissolution of an ingredient in a 0.05% aqueous solution of citric acid compared to the dissolution rate of non-encapsulated asset of the second ingredient. In addition, a large part of the spray dried particles have improved the dissolution rate of the active ingredient in water compared with the dissolution rate unencapsulated public of the active ingredient.

For example, the dissolution rate of spray dried particles in a 0.05% aqueous solution of citric acid at 25°C. is preferably less than 15 minutes when the concentration of the active ingredient 14 PM/million, more preferably less than 10 minutes, even more preferably less than 4 minutes, most preferably less than 2 minutes.

Examples

The invention is hereinafter described with reference to the following examples. You must understand that the examples of the invention are illustrative and that the invention is not limited to them.

Samples in accordance with the invention are represented by the numbers, and comparative examples letters.

In the examples and in General for the purposes of the present invention, the calculations of the kinetics of dissolution dried by spraying the active ingredient performed as follows.

The determination was carried out using the fiber-optic spectrometer, including D2Lite calibrated deuterium-tungsten light source, TR 600-10 transmission probes (tip path length 10 mm) and S2000 spectrometer (World Precision Instruments/ Ocean Optics). Data were recorded using the software Oean Optics OOIBase32. Search volume was set at one measurement per second.

Spectrum is completely dissolved active ingredient source was determined in a suitable solvent (water or an aqueous solution of citric acid) to find a suitable wavelength for measurement. The number of spray dried powder used in each experiment, gave the equivalent of a nominal concentration of 14 hours/million of active ingredient. Values λ at 324 nm was chosen as the wavelength of the signal. The second wavelength (400 nm), where no absorption of the active ingredient was determined for the correction changes the baseline of the signal, caused by particles, turbidity, etc.,

Dried spray powders were weighed on weighing paper and quickly transferred into a vessel for dissolution (Distek 2100, 1 l bottle with a maintained temperature of 25°C using a water bath containing deionized water as a solvent for one series of experiments, a solution of 500 hours/million citric acid in deionized water for the second series of experiments. The contents were stirred using a paddle stirrer at 200 rpm./minutes of the Experiments conducted up until not stopped a significant increase in the absorption at the absorption curve depending on time. The results were normalized by dividing the absorption at each data point on the Maxi is the material absorption. The kinetics of absorption was calculated by determining the time at which the normalized absorption reached 0,95. These values are equivalent to the dissolution of 95% of the active ingredient.

The same method was used to calculate the dissolution rate of the same active ingredient.

Example 1

Preparation of spray dried particles

The compositions shown in table 1, was prepared as follows. Xanthan gum, maltodextrin and starch were added to the water, preheated to 70°C and stirred until complete dissolution. Separately, the active ingredient was added to a solution of propylene glycol and stirred for 30 minutes. Two mixtures were then combined and continued stirring for another 30 minutes.

Then the mixture was transferred to a homogenizer, high pressure homogenization was performed in two cycles under pressure specified in the following table. Gomogenizatory product was then subjected to spray drying under standard conditions, the inlet temperature of 171°C and outlet temperature of 82°C. the Obtained spray dried particles were collected in the form of a yellow powder. All quantities stated in mass percent.

Table 1
Obra set of technical documents PG (1)Xanthan gum (2)Maltodextrin 18DE (3)Active ingredient (4)Derived starch (5)WaterThe pressure homogenization (F./square inch)
1thcycle2thcycle
14,480,471,4615,7of 7.9615858005800
24,480,471,4615,7of 7.9615858005800
34,480,475,7111to 8.4115858005800
44,48 0,475,7111to 8.4115858005800
54,480,457,4215,72215858005800
64,480,453,12202215858005800
74,480,467,61207,5115858005800
84,480,453,12202215840004000
94,4 0,445,12203015840004000

(1) Propylene glycol

(2) from Firmenich, No. 946867

(3) Glucidex 19D, from Roquette Freres

(4) Poorly soluble crystalline modifying the taste of the active ingredient, from Firmenich, No. 983950

(5) Capsul, from National Starch

The samples were then dissolved in water or an aqueous solution of citric acid, as described above, to obtain a solution containing 14 PM/million of active ingredient.

Table 2
SampleGrams, was added per liter of solution (for 14 hours/million of the active ingredient
10,089
20,089
3to 0.127
4to 0.127
50,089
60,07
70,07
8 0,07
90,07

The dissolution rate of different samples was evaluated in accordance with the methodology described above. The results for 95% dissolution in the following tables.

Table 3
SampleIn water (sec)
experience 1experience 2experience 3experience 4average
1925853--889
2749665--707
3573599--586
4479556-- 518
511621300--1231
6721818802622741
77621310--1036
813341184114812151220
920712188--2130

Table 4
Sample0.05% aqueous citric acid solution (s)
experience 1experience 2experience 3experience 4average
1230---230
2228---228
378---78
4113---113
5154---154
6113165130-136
7111---111
8193 228311219
9220323--272

The active ingredient separately had a dissolution rate 1106 seconds in water at 25°C and 437 seconds in 0.05% aqueous solution of citric acid. Thus, the dried dispersion system containing the active ingredient showed a significant improvement in dissolution kinetics in all cases where dried by spraying the active ingredient was dissolved in dilute aqueous citric acid solution, and in most cases where it is dried by spraying the active ingredient was dissolved in the water.

1. Method of preparation of spray dried product to improve the dissolution rate of the active ingredient, comprising the steps:
(i) mixing crystalline active ingredient, which has a rate of dissolution in water without stirring at 25°C for more than 15 minutes at a concentration of active ingredient 14 PM/million, with a derivative of starch in an amount of 7 wt.% up to 25 wt.% to the total weight of the mixture before spray drying, the second material carrier and xanthan gum until the formation of a suspension, dispersion or solution actively what about the ingredient,
(ii) homogenizing the mixture under a pressure of at least 4000 F./square inch (2,758×107PA),and
(iii) spray drying the homogenized mixture,
where obtained by spray drying an active ingredient has a high dissolution rate in water compared with the unencapsulated public active ingredient.

2. The method according to p. 1, in which the derived starch is present in an amount of 7 wt.% up to 25 wt.% to the total weight of the spray dried particles.

3. The method according to p. 1, in which the amount of xanthan gum is from 0.3 to 0.6 wt.% to the total weight of the mixture before spray drying.

4. The method according to p. 1, in which the active ingredient is present in an amount of 3 wt.% up to 25 wt.% to the total weight of the mixture before spray drying.

5. The method according to p. 1, in which stage homogenization is performed for two or more cycles in the homogenizer.

6. The method according to p. 1, in which the derived starch includes alkenyl-succinycholine starch, preferably octenyl-succinycholine starch, more preferably octenyl-succinycholine starch has a degree of substitution of up to 0.03, more preferably not more than 0.02.

7. The method according to p. 6, in which alkenyl-succinycholine starch is octenyl-succinycholine starch.

8. The method according to p. 7, in which octenyl-succinycholine starch has a degree of substitution of not more than 0.03 in.

9. The method according to p. 1, in which the second carrier material contains maltodextrin with an average dextrose equivalent of from 5 to 25.

10. The method according to p. 1, in which stage homogenization (ii) carry out two full cycle.

11. The method according to p. 1, in which the second carrier material is present in an amount of from 60 to 80 wt.% to the total weight of the mixture before spray drying.

12. Dried spray particle, prepared in accordance with the method according to any of paragraphs.1-11.



 

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EFFECT: improved quality of ready product owing to preventing reducing substances from decomposition and color reduction, and intensified process.

3 ex

FIELD: production of foods, in particular, introduction of condiment and transportation of products such as snacks.

SUBSTANCE: apparatus has pipe mounted for rotation on supports. Pipe has inlet and outlet openings and device for feeding of condiment to each group of products. Transportation means positioned within pipe is made in the form of screw with spiral blade defining partitions for dividing pipe interior into sections. Screw is made in such a manner that each group of products fed to inlet opening is delivered into individual section and transported, without mixing with products of adjacent section, up to outlet opening. Product preparing system has weighing device and condiment adding apparatus.

EFFECT: uniform adding of condiment to each product in predetermined optimal proportion owing to individual transportation of condiment to each group of products to which condiment is to be added.

32 cl, 38 dwg

FIELD: fat-and-oil industry.

SUBSTANCE: method involves joining one or more phases of basic components in reservoir for preliminary mixing in order to produce coarse-dispersion emulsion and treating coarse-dispersion emulsion for one passage through flow mixing/emulsifying apparatus comprising at least one set of stator and rotor, which are adapted to be brought into coaxial engagement of teeth crowns having combination of concentric blades and concentric slots with substantially inclined side walls extending from each of said blades to each of said slots. When brought into engagement, stator and rotor are arranged in such a manner that concentric stator blades are aligned with related concentric rotor slots, concentric rotor blades are aligned with related concentric stator slots, and related substantially inclined walls of stator and rotor are aligned with respect to one another. When brought into engagement, each of concentric blades and each of concentric slots define, in conjunction with aligned inclined walls, gap which is sized similarly to that of axial slot. Said gap may be adjusted.

EFFECT: improved quality of products obtained.

56 cl, 8 dwg, 4 ex

FIELD: food-processing industry, in particular, production of additives used in preparing of food products.

SUBSTANCE: method involves washing roots; skinning; providing coarse grinding and thermal processing by means of two-staged microwave heating; performing fine grinding of processed beet mass. Coarse ground beet is water diluted until hydraulic modulus reaches 0.5-1.5 and is acidified to pH value of 4.0-4.5. First thermal processing stage is carried out at microwave heating power of 750 W during 15-20 min, and second heating stage is carried out at vacuum extent of 0.2 kgf/cm2 and power of 450 W during 3-5 min.

EFFECT: improved quality of ready product and simplified process for producing of pulp from sugar beet.

1 tbl, 4 ex

FIELD: cannery industry.

SUBSTANCE: claimed method includes paprica cutting with simultaneous seed removing, blanching thereof in aqueous solution of table salt, sugar and ascorbic acid. Then product is dried by subsequent convective and microwave drying, pre-packed, and pouring with vegetable oil, sealed and sterilized.

EFFECT: new foodstuff with unique combination of organoleptic characteristics of dried prune and paprika.

FIELD: cannery industry.

SUBSTANCE: claimed method includes turnip cutting, blanching thereof in aqueous solution of table salt, sugar and ascorbic acid. Then product is dried by subsequent convective and microwave drying, pre-packed, pouring with vegetable oil, sealed and sterilized.

EFFECT: new foodstuff with unique combination of organoleptic characteristics of dried prune and vegetable salad.

FIELD: cannery industry.

SUBSTANCE: claimed method includes watermelon cutting, blanching thereof in aqueous solution of table salt, sugar and ascorbic acid. Then product is dried by subsequent convective and microwave drying, pre-packed, pouring with vegetable oil, sealed and sterilized.

EFFECT: new foodstuff with unique combination of organoleptic characteristics of dried prune and vegetable salad.

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