JP2007529407A - Coated conditioner for use in food and medicine - Google Patents

Abstract

An edible composition comprising a coated conditioner containing a hydrophobizing agent and inorganic particles is provided. When formulated into edible compositions (eg, powdered pharmaceuticals or foods), the coated conditioner inhibits cagging and promotes the free flowing properties of the powder. Suitable hydrophobizing agents include food grade fatty acids, food grade oils, food grade waxes and food grade gums, and suitable inorganic particles include silica, silicate, calcium carbonate, phosphorous. Selected from the group consisting of acid salts and clays. This coated conditioner is particularly suitable for use in pharmaceutical formulations such as acetaminophen.

Description

Background of the Invention In recent years, materials such as silica, sodium aluminosilicate, kaolin clay, tricalcium phosphate, and calcium silicate have been used to increase the free-flowing properties of powdered food particles and avoid agglomeration. Has been used as a "conditioner". In pharmaceuticals, fumed silica has been widely used as an excipient (conditioner or glidant) for the same reason. These conditioners absorb moisture from the atmosphere or package to prevent the food particles from sticking together to form a moisture cake or pressure cake, or to coat the surface of the food particles. It acts as a “ball bearing” to prevent agglomeration between adjacent particles. These conditioners and anticaking agents, also known as free flow agents, have been approved by the US Food and Drug Administration for use at levels below 2.0% by weight in the final food product. In addition, these conditioners can be used in other applications such as fertilizers, pesticides and polymers.

  These conditioners are used in many commercially produced food powders that tend to be pressurized cakes or water-containing cakes, but are hygroscopic, contain high concentrations of proteinaceous materials, or contain garlic powders, desiccants. It lacks effectiveness in certain foods and high numbers of pharmaceuticals that contain high contents of fats and oils such as lactose milk powder or hydrolyzed vegetable powder. In fact, for many foods and pharmaceuticals, appropriate conditioners are not available. Certain materials, such as Zeosyl® T166 from J.M. Huber Corporation (silica treated with siloxane to make the silica hydrophobic) can greatly inhibit solidification in food and pharmaceuticals. However, silane-treated silica is only recognized in food applications as an antifoaming agent for beets and cane sugar. They are not approved for use as food conditioners.

  Thus, for many pharmaceuticals and foods, there are no approved commercially available conditioners that provide excellent anti-caking performance. For example, the common analgesic acetaminophen (N-acetyl-para-aminophenol) has a closely packed crystalline form in which the powder often forms a pressurized cake and a hydrous cake during storage. Because it has, the flow performance is bad. Commercially available fumed silica, such as Cab-O-Sil® M5 (Cabot Corporation, Bellrica, Mass.) Provides some superior fluidity, but these completely solve the problem. Absent.

  Judging from the above, certain medicinal products that provide excellent anti-caking properties to ensure superior fluidity and at the same time have no health or safety issues that prohibit their use by food safety supervisors There continues to be a need for chemical conditioners suitable for use in food.

SUMMARY OF THE INVENTION The present invention includes an edible composition comprising a coated conditioner, wherein the conditioner contains a hydrophobization agent and inorganic particles.

The invention also encompasses a pharmaceutical formulation comprising a pharmaceutically active ingredient and a coated conditioner, said conditioner containing inorganic particles and a hydrophobizing agent.
The present invention relates to acetamino comprising a coated conditioner and acetaminophen comprising (i) inorganic particles and (ii) 1% to about 20% hydrophobizing agent, based on the total weight of the conditioner. Also includes phen pharmaceutical formulations.

DETAILED DESCRIPTION OF THE INVENTION All parts, percentages and proportions used herein are expressed by weight unless otherwise stated. All documents cited herein are included for reference.

  The term “mixture” shall mean any combination of two or more substances in a form including but not limited to a homogeneous mixture, suspension, solution, sol, gel, dispersion or emulsion. .

The term “coated” means that a particular coating component covers at least a portion of the outer surface of the particle or support.
The term “inorganic particles” is intended to mean both natural inorganic minerals and synthetically produced inorganic compounds.

  The term “food” refers to any product to be consumed and to foods such as, but not limited to, spices, seasonings, food colorants, anti-caking agents and free flow agents. Means the additive.

  The present invention relates to a coated conditioner that inhibits solidification and promotes the free-flowing properties of powders when formulated into powdered pharmaceuticals or foods. These coated conditioners are mixtures of hydrophobizing agents (eg stearic acid compounds or oils) with known inorganic particles such as kaolin clay, silica, silicates, phosphates and calcium carbonate. Not only are these coated conditioners functionally effective, but this conditioner is simply a mixture of two components (hydrophobizing agent and inorganic particles) that are already approved additives. Is safe for use in medicine and food.

  Details of the components of the coated conditioner as well as the method of making the coated conditioner are described. A powdered pharmaceutical or food product using a coated conditioner is then described and an example of such a product is provided.

  The coated conditioner produced according to the present invention is composed of at least two components: inorganic particles and a hydrophobizing compound. The inorganic particles can be any compound commonly used as a conditioner in food and pharmaceutical powders, such as silica (e.g. precipitated silica or fumed silica and silica gel), precipitated or powdered calcium carbonate, kaolin clay, silicates (e.g. Calcium silicate, magnesium silicate, aluminum calcium silicate, tricalcium silicate, sodium calcium aluminosilicate, sodium magnesium aluminosilicate, and sodium aluminosilicate) and phosphates (eg, tricalcium phosphate, dicalcium phosphate, monocalcium phosphate , Magnesium phosphate). Preferably, the inorganic particles function as a support. That is, the inorganic particles are coated with a hydrophobizing agent.

  Preferred silica is amorphous precipitated silica prepared from the liquid phase by acidifying the alkali metal silicate with a strong acid such as sulfuric acid in the presence of heat. Useful methods for carrying out the precipitation (acidification) reaction itself to produce homogeneous amorphous silica particles are known and understood. The resulting silica precipitate is filtered, washed and dried as is practiced. Examples of many patent publications describing such precipitated silicas include Wason et al. U.S. Pat.Nos. 4,122,161, 5,279,815 and 5,676,932 and McGill et al. U.S. Pat.Nos. 5,869,028 and 5,981,421. is there.

  After being produced by the liquid phase method, the precipitated silica can be pulverized to obtain a desired particle size range of about 4 μm to 25 μm, such as about 4 μm to about 15 μm. The silica preferably has an oil absorption of about 50 ml / 100 g to about 475 ml / 100 g. Suitable silicas are manufactured by J.M. Huber Corporation, Edison, NJ and are sold under various brand names under the trade names Zeofree (R), Zeosyl (R) and Zeothix (R).

  Synthetic amorphous alkaline earth metal silicates such as amorphous calcium silicate can also be used as inorganic particles. These silicates are usually produced by reaction of reactive silica with an alkaline earth metal reactant, preferably an oxide or hydroxide of an alkaline earth metal, and an aluminum source such as sodium aluminate or alumina. To do. Since the final properties of the silicate depend on the reactivity of the silica, the silica source is preferably a clay that is treated with a mineral acid (eg sulfuric acid) to produce alum (aluminum sulfate) and insoluble reactive silica. . A suitable example of this is reactive acid leached reactive clay leached with sulfuric acid. Suitable synthetic amorphous alkaline earth metal silicates are manufactured by JMHuber Corporation and sold under various trade names under the trade name Hubersorb®. No. 4,557,916. Other suitable silicates such as sodium aluminosilicate commercially available under the trade name Zeolex® and sodium magnesium aluminosilicate commercially available under the trade name Hydrox® are commercially available from JMHuber Corporation Has been.

  Also suitable for use as inorganic particles are powdered calcium carbonate or precipitated calcium carbonate. Powdered calcium carbonate is first mined and then ground to the appropriate particle size. In some cases, powdered calcium carbonate can be classified into a narrower particle size fraction. Precipitated calcium carbonate is usually obtained by exposing a calcium hydroxide slurry (ie lime milk) to a carbonation reaction. This can be done by injecting carbon dioxide gas into a reaction vessel containing a calcium hydroxide aqueous slurry. Methods and techniques for producing these precipitated calcium carbonates are described in detail in US Pat. No. 4,888,160. Suitable precipitated calcium carbonate is manufactured by J.M. Huber Corporation and sold under various trade names under the trade name HuberCal®.

  Clays such as kaolin clay are suitable for use as inorganic particles. These clays are manufactured by first mining the coarse clay and then subjecting the mined clay to several beneficiation stages until it is suitable for use in consumer goods. This beneficiation step can be done, for example, by removing gravel particles and classifying clay particles to obtain a more desirable particle size distribution; removing various impurities found in coarse clays and giving the clay the desired final color And stages. Suitable kaolin clays are manufactured by J.M. Huber Corporation and sold under various trade names under the trade name Polygloss®.

  Hydrophobizing agents include food grade fatty acids, particularly stearic acid compounds, food grade oils, and food grade waxes and gums. Suitable fatty acids include capric acid, caprylic acid, lauric acid, myristic acid, oleic acid, palmitic acid and stearic acid, and Title 21C.FR (Federal Code of the United States Code) approved for direct addition to food, feed or pharmaceuticals. ). The fatty acid compounds listed in Suitable stearic compounds include stearic acid, stearic acid salts and stearic acid esters. Suitable salts of stearic acid include magnesium stearate, calcium stearate, potassium stearate and zinc stearate. A suitable magnesium stearate is a vegetable food grade magnesium stearate commercially available under the trade name Synpro® from Ferro Chemicals, Cleveland, Ohio. Suitable esters of stearic acid include alcohol stearates such as glyceryl monostearate and triglyceryl stearate. Suitable esters of stearic acid include alcohol stearates such as glyceryl monostearate and glyceryl tristearate, and other esters such as glyceryl palmitostearate and sorbitan monostearate. Glyceryl monostearate and glyceryl tristearate are commercially available from Patco Corporation, Wilmington, Delaware under the trade names Pationic® 901 and Pationic® 919, respectively.

  Food grade oils are those listed in 21C.F.R. as approved for direct addition to food, feed or pharmaceuticals. Suitable food grade oils include white mineral oil, rapeseed oil, soybean oil, castor oil, coconut butter, and oils defined as “essential oils” in chapter F.D.A.21C.F.R, 182.20. Suitable food grade waxes and gums are also defined in 21C.F.R. Suitable food grade waxes include candelilla wax, carnauba wax and paraffin wax. Suitable food grade gums include karaya gum, tragacanth gum, carrageenan gum, xanthan gum, and guar gum.

  A preferred process for mixing the above components to form a coated conditioner (the hydrophobizing agent is a stearic acid compound) can be summarized as follows. In the first stage of the process, it is added to a mixing bowl and heated to a temperature preferably between 10 ° F. and 30 ° F. above the melting point of the stearic acid compound. Turn on the rotating blade of the mixer and add the stearic acid compound to the bowl. Continue stirring for about 30 minutes. After mixing is complete, the material in the mixing bowl (coated conditioner) is allowed to cool before being added to the powdered food or pharmaceutical product. When the hydrophobizing agent is an oil, the oil is a liquid at ambient temperature and therefore follows the same process as described, except that no heating is required.

  The invention will be described in greater detail with reference to the following specific, non-limiting examples.

  In Examples 1-8, coated conditioners that were a mixture of stearic acid compounds and inorganic particles were prepared according to the present invention. The inorganic particles have a median particle size and oil absorption value given in Table A below (a method for measuring the particle size and oil absorption value is described below).

  In this process, first (as described in Table I below), a predetermined amount of inorganic particles such as silica, calcium carbonate or kaolin clay is added to a mixing bowl and the mixing bowl is added to a Kitchen Aid Heavy Duty mixer, model K5SS. Attached. In order to control the temperature of the contents of the mixing bowl, a thermal jacket was wrapped around it and the mixing bowl was heated to raise the temperature of the contents of the mixing bowl. The temperature of the contents was measured with a thermocouple placed in contact with the contents of the mixing bowl, and the temperature was electrically adjusted with a solid phase temperature controller connected to both the thermocouple and the thermal jacket.

  The temperature controller was set to 177 ° C and the mixer was turned on at low speed. When the temperature of the inorganic particles in the mixing bowl reaches 177 ° C, add powdered magnesium stearate (plant-based, magnesium for food grade, Ferro Chemicals, Cleveland, Ohio, trade name Synpro (registered trademark)) below Were added to the inorganic particles in the mixing bowl at the weight ratio shown in Table 1 and allowed to stir for 10 minutes. The weight percent of magnesium stearate added is based on the total weight of the coated conditioner (ie, the weight of the inorganic support + the weight of magnesium stearate). After mixing, the resulting coated conditioner powder was allowed to cool to ambient temperature. During mixing, the magnesium stearate melted onto the particulate inorganic substrate, so the coated conditioner was a mixture of magnesium stearate and a particulate mineral support.

  The particle size and oil absorption value of the inorganic particles used in the following examples were as follows.

  Zeofree® 80 and Zeothix® 265 amorphous precipitated silica are commercially available from J.M. Huber Corporation. Polygloss® 90, kaolin clay, and HuberCal ™ 250, powdered calcium carbonate are all commercially available from J.M. Huber Corporation. Hubersorb® 600 is calcium silicate manufactured by J.M. Huber Corporation.

  The oil absorption was measured using linseed oil by the rubout method. In this test, the oil was mixed with silica and rubbed on a smooth surface with a spatula until a firm putty-like paste was formed. By measuring the amount of oil required to obtain a paste mixture that bends when deployed, the silica oil absorption value—represents the volume of oil required per unit weight of silica to fully saturate the silica adsorption capacity. The value can be calculated. The oil absorption value is calculated using equation (I):

Carried out by.
The particle size was measured using a model LA-910 laser light scattering device manufactured by Horiba Instruments, Boothwyn, Pennsylvania. The laser beam projects through a transparent cell that contains a stream of moving particles suspended in a liquid. Rays that strike a particle are scattered by angle, which is inversely proportional to its size. The photodetector array measures the amount of light at several predetermined angles. The electrical signal proportional to the measured light flux value is then processed by a microcomputer system to form a multichannel histogram of particle size distribution.

  The composition of the coated conditioners of Examples 1-8 is as follows.

  Additional coated conditioner samples (Examples 9-25) were prepared by a method similar to that of Examples 1-8 above, except that a Thysson Henschel FM100 mixer was used. As shown in Table II below, the particulate inorganic support was placed in a mixing bowl connected to a mixer and preheated to 77 ° C. during which time the mixing blade was rotated at 860 rpm. When 77 ° C is reached, a predetermined amount of stearate is added as shown in Table II below. The inorganic particles and stearate were allowed to stand and stirred at 77 ° C. for 10 minutes. The exception is that when using magnesium stearate, the temperature is set to 170 ° C. After mixing, the resulting coated conditioner powder is allowed to cool to ambient temperature.

  The compositions of the coated conditioners of Examples 9-25 are as follows:

  Hubersorb 600 calcium silicate is commercially available from J.M. Huber Corporation. The weight percent of stearate added is based on the total weight of the coated conditioner (mineral support weight + stearate weight).

  In Examples 26-29, coated conditioners that were a mixture of mineral oil and precipitated silica were produced according to the present invention. First, 100 grams of precipitated silica (as shown in Table III below) was added to the mixing bowl and the mixing bowl was connected to a lab scale Hobart mixer. The mixer was turned on at low speed and 4.0% or 10% mineral oil was added at ambient temperature and mixed with silica for 10 minutes (shown in Table III below).

  The possibility of the powder forming a water-containing cake was evaluated using a moisture caking test. Baseline correlation between moisture and cagging for unconditioned drug or food powder before conducting actual testing of conditioned powder on the wet cake itself (i.e., drug or food powder containing conditioner) Was measured. To establish this correlation, titrate acetaminophen powder with a minimum amount of water to produce about 0% cagging, and titrate acetaminophen powder with a maximum amount of water to 70-80% cagging. Manufacturing. These points are then plotted against a straight line and the amount of water needed to produce about 50% cagging is the amount used for the remaining conditioned acetaminophen powder sample to be tested. .

  The moisture absorption test was conducted as follows. A sufficient amount of screened, unadjusted sample was placed on an 8 ounce Spex® mill jar to fill the jar approximately half way. 1 ml or 1 g of water was titrated or weighed into a sample in a jar and then the jar and its contents were placed on a Spex Mill (model 8000-115, Sepx Corporation, Edison, New Jersey) for 30 seconds. A small aluminum pan was then made for use by pushing the Spex Jar lid to the bottom of the pan to form the contour of the pan in the shape of a lid. A 20 g wet sample was then weighed onto the pan. From this sample 20g, a jar filled with a shot was placed on each sample and a level cake was formed by lowering the sides. The sample was then placed in an oven at least 50 ° C. to release the added water and solidify the cake. The sample weight should be checked to ensure that all added water is gone. It takes a long time or high temperature to remove all the water. Since the test is performed three times, prepare three jars for each sample component.

  The sample is then removed from the oven and allowed to cool to room temperature for 10 minutes. If the sample is not allowed to cool to room temperature, artificially low water content cagging will result. (Once cooled, the sample began to absorb moisture, which made the cake softer and artificially made a low moisture cake). The sample did not cool for more than 15 minutes.

  Next, reverse the # 12 Tyler screen and collect it on each aluminum pan, hold that aluminum pan against the # 12 screen, and at the same time carefully reverse the sample to the screen and move the aluminum pan as the cake moves. # 12 Leave it on the screen. The screen was then transferred to a Thomas annular sieve shaker (Thomas Scientific Apparatus) without breaking, and the caked sample was shaken on the Thomas Shaker for 1 minute. Weigh the amount of sample remaining on the screen and calculate the percent cake with equation (II):

{Wherein x = sample g used in an aluminum pan;
y = H ₂ O ml added to sample in jar;
Calculate according to z = sample g added to jar}.

  After measuring the percent cagging 3 times per 1 ml of added water, the above process was repeated until 80% cagging was reached, such as 2 ml of water then 3 ml. Products that are very sensitive to moisture may require less than 1 ml of water increments. The water addition level must be adjusted until at least 4 data points are on the cagging curve between 10 and 80%. The results of the% cake test for garlic powder and acetaminophen are shown below.

  A modified 250-mL graduated cylinder is used to measure the loose bulk density. The cylinder is modified by cutting the cylinder with a 100-mL mark so that the top of the cylinder has a level of 100 ml. Record the empty cylinder weight as "Tare Weight". Pour sample powder into this deformed cylinder until it overflows. The level of powder in the cylinder is immediately leveled by scooping across the top with a spatula; this leveling step is carried out as quickly as possible so that the powder does not sink, thereby artificially high sparse bulk density values Is obtained. Scrape off excess powder over the side or bottom of the graduated cylinder, weigh the cylinder and record the weight as the “total weight”. The volume change noticed after leveling the powder and removing excess powder should be ignored. This is because this volume change tends to clog the powder down. The sparse bulk density is equation II:

Calculate from
Another useful measure of powder flow is avalanche time, which is measured as an “Aeroflow parameter”. The shorter the time between disintegration, the higher the free flowability of the powder. In this test, an initial amount of unadjusted sample was used to determine the weight required to fill a 100 ml graduated cylinder as seen in the sparse bulk density test. This weight was then used for all experiments in the Aeroflow® test. Aeroflow® powder flowability analyzer model 0-8030 (TSI Incorporated of St. Paul, Minnesota) was used in these tests. In the first stage of these tests, a masking tape ring was applied to the inner surface of the Aeroflow test drum. In effect, the masking tape functions as a packing (gasket) so that powder does not leak during operation. The powder sample was then filled into a drum and the drum was placed in an Aeroflow test apparatus. Using the computer interface, the Aeroflow test was selected and the hardware placement on the device was checked to see if the drum speed was 60 rpm. The “apply” feature was then selected and the drum was spun for 5 minutes. After 5 minutes, the device was manually stopped by the operator by pressing the “Close” button. The average disintegration time was then measured by setting the drum rotation speed at 60 rpm and setting the test duration to 300 seconds. For each sample, the test was repeated once more and the results averaged in seconds.

  Flowdex parameters were also measured. Flowdex is a measure of fluidity that simulates the fluidity of a powder in a silo. Place 25g of sample into funnel and place it on Flowdex upright wall, open cylinder. At the bottom of the cylinder is a plate with an opening of known diameter. Since a variety of different plates with different diameter openings (orifices) are available, the plates can be exchanged until the minimum opening required for the sample to flow through is determined. The smaller the opening required for a given material to flow, the easier the material can flow into the bag house or silo.

  Manufacturer with Flowdex device (model 21-100-004, Hanson Research, Chatsworth, Calif.) With minimum orifice (and movable movable stopper installed below the orifice) supplied by the manufacturer who installed it Manufactured according to the instructions of A 25.00 g sample was weighed and poured into the upper funnel and the timer was started. After 30 seconds, the stopper was removed from the funnel and the sample was allowed to flow through the orifice (if possible). The device is examined to determine if the sample flows through the orifice so that the bottom of the device is visible, and if the bottom of the device is visible, the orifice diameter is recorded and this is recorded as the Flowdex value. If the bottom is not visible, replace the orifice with the next larger size and repeat the above procedure. Once the orifice is found to flow, the test is repeated with the same orifice to verify the orifice diameter value.

  Formulated coated conditioners prepared according to Examples 1-24 in acetaminophen powder compositions at three concentration levels, 0.1 wt%, 0.5 wt%, and 1.0 wt% to demonstrate efficacy in consumer goods did. As a control, the most widely used conditioner for acetaminophen, Cab-O-Sil® M5 fumed silica, was added to another acetaminophen composition. As mentioned above, acetaminophen takes a squeezed crystalline form that often forms a powdered and wet cake during storage.

  Percent cake, sparse bulk density, Aeroflow parameters and Flowdex parameters were measured for acetaminophen and the results are shown in Tables IV-VII below.

  Hydrous cagging is not a major problem with unconditioned acetaminophen powder. However, it is important that the conditioner added to acetaminophen to improve flow does not adversely affect hydrous caking. It can be seen from the above data that the industrial standard (Cab-O-Sil M5) used to actually improve the fluidity of acetaminophen has an adverse effect on hydrous caking, but most of the conditioners of this example. Works better than Cab-O-Sil M5 and some improve hydrous cagging. Tables V and VI below show the flow characteristics of these same conditioners.

  As can be seen from the data in Table V, acetaminophen powder containing coated conditioners prepared according to Examples 1, 2, 3, 4, 9, 10, 11, 12, 13 and 14 is a control fumed silica. It had excellent Aeroflow parameters (ie short disintegration time) compared to acetaminophen powder with conditioner.

  As can be seen from Table VI, all acetaminophen powders prepared according to the present invention and including a coated conditioner using silica as inorganic particles are all flowdex tested (i.e., narrow orifices compared to untreated acetaminophen powder). Show excellent performance. Many of the acetaminophen powders containing coated conditioners made according to the present invention also showed superior performance in the Flowdex test compared to acetaminophen powder containing the Cab-O-Sil product.

  The sparse bulk density measurement generally indicates whether the material was properly adjusted. A correctly tuned material (ie with maximum flow and minimum cagging) usually has a high bulk density. High sparse bulk density means that the product container package does not have to be large when using the conditioner. As can be seen from Table VII, some of the acetaminophen powders with coated conditioners made according to the present invention have high sparse bulk density at all concentration levels compared to the Cab-O-Sil product. showed that.

  To demonstrate their effectiveness in food, coated conditioners prepared according to Examples 1-24 were formulated into garlic powder compositions at three concentration levels: 0.5 wt%, 1.0 wt%, and 2.0 wt%. . As a control, J.M.Huber's Zeofree 80, widely used for food, was also added to the garlic powder composition.

  As can be seen from the data in Table VIII above, all of these conditioners made in accordance with the present invention reduce the hydrated caking of garlic powder. At the optimal treatment level of 2%, the compositions of Examples 2, 3 and 29 performed better than the control conditioner.

  As can be seen from the data in Table IX, the garlic powder containing the coated conditioner prepared according to Examples 1-3, 9, 12, 27 and 29 is compared to the garlic powder containing the control coated conditioner, Zeofree80. And had excellent Aeroflow parameters (ie short disintegration time). Short disintegration times are not obtained with coated conditioners prepared according to other examples, and this result is not shown.

  As can be seen from Table X, the garlic powder containing the coated conditioner prepared according to Examples 2-3, 9, 12, 27 and 29 was compared with the garlic powder containing the control conditioner, Zeofree 80, in the Flowdex test. Excellent performance.

  The sparse bulk density of the garlic powders treated with conditioners 2, 9 and 27 at 0.5% loading level increased (improved). At high loading levels, all conditioners reduced the sparse bulk density of the garlic powder.

  Those skilled in the art will appreciate that modifications can be made to the above embodiments without departing from the broad concept of the invention. Accordingly, it is to be understood that the invention is not limited to the specific embodiments disclosed, but encompasses variations within the spirit and scope of the invention as defined in the appended claims.

Claims (29)

An edible composition comprising a coated conditioner, wherein the conditioner comprises a hydrophobizing agent and inorganic particles. The edible composition of claim 1, wherein the hydrophobizing agent is selected from the group consisting of food grade fatty acids, food grade oils, food grade waxes, and food grade gums. The edible composition according to claim 1, wherein the hydrophobizing agent is a stearic acid compound. The edible composition according to claim 1, wherein the hydrophobizing agent is magnesium stearate. The edible composition according to claim 1, wherein the hydrophobizing agent is selected from the group consisting of stearates and stearates. The edible composition according to claim 1, wherein the inorganic particles are selected from the group consisting of silica, silicate, calcium carbonate, phosphate and clay. The edible composition of claim 1, wherein the conditioner comprises about 1 wt% to about 10 wt% hydrophobizing agent, based on the total weight of the conditioner. The edible composition according to claim 1, wherein the hydrophobizing agent is selected from the group consisting of glyceryl-monostearate and glyceryl tristearate. The edible composition according to claim 1, wherein the composition is a powdered food. The edible composition according to claim 1, wherein the edible composition is a pharmaceutical preparation and further contains a pharmaceutically active ingredient. The pharmaceutical formulation of Claim 10 whose said formulation is a powder form. The pharmaceutical formulation according to claim 10, wherein the formulation is in the form of a tablet. The pharmaceutical formulation according to claim 10, wherein the pharmaceutically active ingredient is acetaminophen. The pharmaceutical formulation according to claim 10, wherein the pharmaceutically active ingredient is nutrition and health-promoter, antipyretic-analgesic-anti-inflammatory agent, antipsychotic, anxiolytic, antidepressant, hypnotic sedative, Antispasmodic agent, central nervous system agent, cerebral metabolism improving agent, antiepileptic agent, sympathomimetic agent, gastrointestinal function regulator, antacid, antiulcer agent, antitussive-expectorant, antiemetic agent, respiratory accelerator, bronchodilator Agents, antiallergic agents, dental sublingual tablets, antihistamines, cardiotonic agents, antiarrhythmic agents, diuretics, antihypertensive agents, vasoconstrictors, coronary dilators, peripheral vasodilators, antilipoprotein hyperlipidemic agents, antibacterial agents , Antibiotics, chemotherapy drugs, antidiabetic drugs, osteoporosis drugs, skeletal muscle relaxants, antipruritic drugs, hormones, alkaloid drugs, sulfa drugs, gout drugs, anticoagulants, antimalarial tumor drugs, and Alzheimer's disease treatment Selected from the group consisting of drugs, Medicine formulations. The edible composition according to claim 3, wherein the inorganic particles are coated with the stearic acid compound. The edible composition according to claim 1, wherein the hydrophobizing agent is selected from an alkaline earth metal salt of stearic acid. The edible composition according to claim 1, wherein the hydrophobizing agent is a food grade mineral oil. The edible composition of claim 1, wherein the conditioner comprises about 1 wt% to about 20 wt% of food grade mineral oil, based on the total weight of the conditioner. 2. The pharmaceutical formulation of claim 1, wherein the hydrophobizing agent is present at a concentration of about 1% to about 20% by weight, based on the total weight of the conditioner. A pharmaceutical formulation comprising a pharmaceutically active ingredient and a coated conditioner, wherein the conditioner comprises inorganic particles and a hydrophobizing agent. 21. A pharmaceutical formulation according to claim 20, wherein the pharmaceutically active ingredient is acetaminophen. 21. The pharmaceutical formulation according to claim 20, wherein the pharmaceutical formulation is in the form of a tablet. 21. The pharmaceutical formulation of claim 20, wherein the hydrophobizing agent is present at a concentration of about 1% to about 20% by weight, based on the total weight of the conditioner. 21. The pharmaceutical formulation of claim 20, wherein the hydrophobizing agent is selected from the group consisting of food grade fatty acids, food grade oils, food grade waxes, and food grade gums. The pharmaceutical preparation according to claim 20, wherein the hydrophobizing agent is a stearic acid compound, and the inorganic particles are coated with the stearic acid compound. 21. A pharmaceutical formulation according to claim 20, wherein the hydrophobizing agent is magnesium stearate. 21. The pharmaceutical formulation of claim 20, wherein the hydrophobizing agent is a food grade mineral oil. (a) acetaminophen; and
(b) (i) inorganic particles; and
(ii) Acetaminophen pharmaceutical formulation comprising a coated conditioner comprising 1% to about 20% by weight of a hydrophobizing agent, based on the total weight of the conditioner. 30. The acetaminophen pharmaceutical formulation of claim 28, wherein the formulation is in the form of a tablet.