(12) Patent Application Publication (10) Pub. No.: US 2014/ A1

Transcription

1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2014/ A1 Subramanian et al. US A1 (43) Pub. Date: (54) (71) (72) (21) (22) (86) (60) SOLID, EDIBLE, CHEWABLE LAXATIVE COMPOSITION Applicant: Gavis Pharmaceuticals, LLC, Somerset, NJ (US) Inventors: Veerappan Sellappan Subramanian, Mendham, NJ (US); Paranjothy Kanni, Mendham, NJ (US); Shyam Sundar Kumar Sarma Vangala, Pine Brook, NJ (US) Appl. No.: 14/346,668 PCT Filed: Sep. 21, 2012 PCT NO.: PCT/US2O12/0566SO S371 (c)(1), (2), (4) Date: Mar. 21, 2014 Related U.S. Application Data Provisional application No. 61/ , filed on Sep. 23, 2011, provisional application No. 61/620,688, filed on Apr. 5, Publication Classification (51) Int. Cl. A23G 3/36 ( ) A23G I/32 ( ) A2.3L I/30 ( ) A619/00 ( ) A63L/08 ( ) (52) U.S. Cl. CPC... A23G 3/364 ( ); A61 K9/0056 ( ); A61 K3I/08 ( ); A23L I/30 ( ); A23G 1/32 ( ) USPC /723 (57) ABSTRACT The invention is directed to an edible solid composition hav ing laxative properties. The composition has a Smooth mouth feel, in non-gritty and has a pleasant taste. It is prepared by melt-combining together the ingredients including a bulking agent and laxative as well as an optional agent and electrolyte. The meltis a dispersion containing a Substantially homogeneous combination of ingredients. The melt is cooled to form an amorphous solid dispersion or Solution of the ingredients. The ingredients are mutually compatible so that upon cooling they do not separately crystallize to form agritty mouth feel product.

2 SOLID, EDIBLE, CHEWABLE LAXATIVE COMPOSITION CLAIM OF PRIORITY This application claims the benefit of priority of U.S. Provisional Application No. 61/ , filed Sep. 23, 2011, entitled SOLID, EDIBLE, CHEWABLE LAXATIVE COMPOSITION, and claims the benefit of priority of U.S. Provisional Application No. 61/620,688, filed Apr. 5, 2012, entitled A SOLID, EDIBLE, CHEWABLE LAXATIVE COMPOSITION, which applications are herein incorpo rated by reference in their entirety. BACKGROUND 0002 Polyethylene glycol (PEG), particularly PEG 3350 is a known osmotic laxative. PEG 3350 is sold in US in laxative compositions which typically are to be combined with an aqueous medium. For example 17 g of PEG powder is dissolved in about 8 ounces of aqueous beverage and con Sumed to provide a laxative dosage. Examples of such prod ucts include Miralax(R) (MSD consumer care) and Gavilax(R) (Gavis Pharmaceuticals, NJ) Formulation of PEG as a beverage or in an aqueous medium is inconvenient, unsatisfying and uncomfortable to the consumer. The aqueous formulation has an undesirable mouth-feel and can create a bloated, overwhelmed feeling in the consumer's stomach. The aqueous formulation is also not a drink that can be discretely consumed so that consumers typically use restrooms in which to mix and drink the formu lation. This practice is uncomfortable, disagreeable and ill tasting. The discomfort and inconvenience leads to reduction of dose compliance of the product as directed. Thus, there is a need for more conveniently dosed polyethylene glycol While there are certain products, for example Movi colr (Norgine Ltd, Middx UB96NS, UK) that are sachets for combination with aqueous media, they contain in addition to polyethylene glycol, electrolytes Such as Sodium chloride, Sodium bicarbonate and potassium chloride. These salts do not impart good taste and Suffer from the same discomfort and inconvenience as an aqueous formulation containing only PEG Other laxatives formulated for oral consumption suffer from the same problems. All have disagreeable tastes, cause a bloated feeling in the stomach and require inconve nient mixing as aqueous formulations. Chief among these are the laxative preparations with water insoluble substances Such as psyllium, bran husk, microcrystalline cellulose and the like. These all form gritty distasteful aqueous formula tions that leave thick residue in the glass when drunk Therefore, there is a need to provide a laxative dos age form that has a good taste and would enhance patient compliance. SUMMARY OF INVENTION The present invention is directed to a laxative based edible, Solid composition. An aspect of the invention provides that the composition preferably is formed as a bar or candy. According to another aspect of the invention, the composition of Such ingredients as a laxative, a bulking agent and an optional Sweetening agent An embodiment of the invention provides that the solid composition is formed as an edible solid bar or candy by heating the ingredients to form a fluid dispersion and cooling the fluid dispersion, preferably in a mold to form a solid bar. In particular, and preferably, another aspect of the invention provides that the laxative is first melted or otherwise con verted into a flowable viscous to fluid state. The additional ingredients are then combined with the fluid bulking agent and mixed to form the hot fluid dispersion. The fluid disper sion is added to molds preferably sized to produce mouth sized pieces, and allowed to cool to ambient temperature According to yet another aspect of the invention, the dispersion constituting the chewable, edible composition is Solid at ambient temperature The edible solid composition formed in this manner has a Smooth, non-crystalline, non-gritty mouth feel. Its physical consistency is that of a Substantially homogeneous dispersion or preferably a solid solution. The laxative, bulk ing agent and Sweetening agent are physically compatible so that they will form smooth intimate mixtures and will not separate or individually crystallize out of the mixture or solu tion after formation. Additional components of the composi tion are also mutually compatible so that separation and/or crystallization do not occur Additional aspects of the invention provide that the composition may optionally include electrolytes such as Sodium chloride, Sodium bicarbonate and potassium chlo ride. Other optional aspects include Sweeteners and ing agents that can also be added to the composition as appropri ate. Specialized s that target saltiness can be also advan tageously utilized to reduce the salty taste according to fur ther aspects of the invention. Optionally soluble fibers such as wheat dextrin (for example, Nutriose(R), Roquette, France), Inulin, partially hydrolyzed guar gum can be included in the bar A further aspect of the invention is the benefit pro vided by the process employed to produce the solid compo sition. The melt process provides a better taste and mouth-feel for the Solid composition compared with processes for for mation Such as compression, mixing with adherent Sub stances, mixing with liquids that are evaporated upon stand ing and the like. DETAILED DESCRIPTION According to the foregoing aspects of the invention, the Solid, edible composition may contain Such laxatives as polyethylene glycol, castor oil, Senna, bisacodyl, Sodium pico Sulfate, magnesium citrate, magnesium hydroxide (milk of magnesia), magnesium carbonate magnesium Sulfate (Epsom salt), sodium sulfate, potassium sulfate, aloes, cascara sac rada, psyllium husk (Metamusil), guar gum, maltodextrins, inulin, docusate Sodium, methyl cellulose, monobasic Sodium phosphate, dibasic sodium phosphate, glycerin, Sor bitol, mannitol, Sodium potassium tartrate, mineral oil (liquid paraffin), lactulose, rhubarb, agaragar, figs (Syrup of Figs). L-glucose and any combination thereof. The preferred laxa tives are PEG, magnesium citrate, lactulose orbisacodyl and especially preferred laxatives include PEG's of number des ignations s 400, 3350, 4000, 6000, and Of particular preference is PEG The bulking agent forming an ingredient aspect of the composition includes carbohydrates and carbohydrate derivatives such as hydrogenated carbohydrates and com pounds mimicking carbohydrates either in taste or bulk or pharmaceutical acceptability or any combination thereof. The carbohydrates and carbohydrate derivative and mimics are selected to provide digestive and substance bulk, diluent

3 properties as well as pharmaceutical, nutritional and consum able acceptability. Such bulking agents preferably will have physical properties that will enable melt or fluid processing and will produce firm solids at ambient temperature either as the bulking agents alone or in combination with the Sweeten ing agent and the laxative. The bulking agents include all forms of carbohydrates having the foregoing properties. The bulking agents include but are not limited to Such carbohy drates as such as corn syrup, Sorbitol. Sucrose, dextrose, invert Sugar, ludiflash, chocolate, maltitol, high fructose syrup, golden syrup, rice syrup, barley malt syrup, Sugar syrup, glycerin, maltodextrins, starch hydrolysate, honey, molasses, lecithin, condensed milk, Sweetened condensed milk and any combination thereof. Many of the bulking agents also provide Sweetness to the Solid composition which minimizes or elimi nates the inclusion of separate Sweetening agents Corn Syrup, Maltitol Syrup and/or maltodextrin are preferred. Sweetening agents that give pleasant mouth feel such as sorbitol can also be utilized. Alternatively other sugar alcohols or carbohydrates can be used such as Sugar syrup, mannitol, Sorbitol. Xylitol, lactitol, isomalt, maltitol, or hydrogenated Starch hydrolysates Sweetening agents include all manner and configu ration of natural and artificial agents that provide a mouth-feel and taste like that of Sugar. Included are Sugar, lactose, Sor bitol, Saccharine, aspartame, acesulfame potassium, Sucral ose, isomalt, mannitol, Stevia, cyclamate, dextrose, glucose, fructose, honey, high fructose syrup and any combination thereof. The natural Sweetening agents such as sorbitol, dex trose, glucose, Sucrose can also be employed in part to pro vide bulk and diluent properties to the composition Artificial sweetening agents such as sucralose, acesulfame, isomalt, mannitol, Stevia, Cyclamates, aspar tame, saccharine, Sugar and ing agents are preferred for Some purposes especially when dietary constraints are impor tant. Several types of chocolates are available such as dark chocolate, milk chocolate, semi-sweet chocolate, Sweet chocolate, hard chocolate, Soft chocolate, bitter chocolate, Cocoa mass, cocoa butter mix, hard boiled toffees, and the like. The chocolate can be added as a coat to the bar or included in the bar In certain embodiments, less or no corn syrup can be utilized to reduce the calorific value of the bar. Similarly, in certain other embodiments, less or no Sorbitol or other Sugar alcohols were utilized to reduce the calorific value of the bar. Other embodiments include bars made without bodying or Sweetening agents with only chocolate included in the bar. Another embodiment include bars using Soy lecithin and condensed milk in the bar Flavoring agents such as bubblegum, cherry, mixed berry, fruit punch, pine apple, caramel, mixed fruit, chocolate, spearmint, peppermint, menthol, licorice, orange, lemon, Watermelon, melagawine, cranberry, tutti frutti, mix of car damom and orange, Vanilla, ice cream Soda, Salt masking and any combination thereof may be included as optional ingredients Electrolytes such as sodium chloride, potassium chloride, potassium bicarbonate, magnesium chloride may also be optionally included The compositions of the invention may contain a reasonable portion of the bulking agent, typically at least about 10% by weight, preferably at least about 20% by weight and especially preferably at least about 30 to 40% by weight. The combination of the bulking agent and the natural Sweet ening agents may be formulated as a combination portion of the composition such as from about 10% to about 80% by weight. The ing agents, electrolytes and other optional ingredients may be omitted but when formulated into the composition, may constitute from about 1% up to about 20% by weight of the composition. The laxative can beformulated into the composition according to the FDA guidelines. Up to about 70% of the composition may be a PEG laxative. More potent laxatives such as magnesium citrate, docusate Sodium, Sodium pico Sulfate may be present in lesser weight percents according to the FDA monograph on laxatives If caloric intake is to be considered, the carbohy drate quantity provided by the bulking and optional Sweeten ing agents may be kept at a minimum or non-caloric semi synthetic food grade carbohydrate substitutes may be employed. Such non-caloric bulking and Sweetening agents include Xylitol, mannitol, Sorbitol., Stevia, aspar tame, neotame, cyclamate, Saccharine, and other non or mini mal caloric bulking agents and/or Sweeteners such as hydroxyethyl starch, inulin and the like According to the inventive aspects described above, the solid, edible compositions of the invention are prepared by melt forming. The bulking agent, PEG or combination there off are heated either to melt it or to convert it into a flowable fluid. The additional ingredients are added while stirring and maintaining the mixture in a melted or flowable fluid condition. After all ingredients are combined, the hot mixture is agitated untila Substantially homogeneous Suspen sion or preferably a solution of the ingredients is achieved. The Suspension or solution is then placed or poured into receptacles such as molds and allowed to cool to ambient temperature. The molds are shaped to provide appropriately sized pieces of the solid composition suitable for entry into the mouth. The weight percents of ingredients are calculated So as to provide the desired concentration and amount of laxative, Sweetening agent, ing agent and bulking agent in each piece of chewable, edible, solid composition. The ratios of ingredients can be adjusted to provide pieces of composition that are and remain Solidatambient temperature. The ratios of ingredients per piece of composition are also calculated to deliver the appropriate amount of laxative for the purpose intended. For example, use of the composition to foster natural bowel movements will employ a lesser amount of laxative than will use of the composition for colonic pur poses or for complete flushing of the colon in preparation for a full colonoscopy It has been found that the foregoing process pro vides an unexpected benefit to the solid composition of the invention in that its taste and mouth-feel are better than those characteristics of products of the same ingredients prepared by other processes such as compression forming, inclusion of adhering (adhesive) ingredients, molding and covering with edible coating, and mixing while warming but not melting. The compositions of the invention prepared by the foregoing process have little or no waxy taste, little or no gritty mouth feel and are pleasing to the consumer. In contrast, products produced by alternative methods are waxy in taste and mouth feel and are non-homogeneous in taste. Chocolate has been found to be a preferred bulking/sweetening agent with low caloric contribution and significant benefit for taste and mouth feel. The chocolate may be dark chocolate or milk chocolate and the milk ingredient may be dairy, coconut, Soybean, almond or other milk-like Substance. In another embodiment lecithin, condensed milk, Sweetened condensed

4 milk, evaporated milk, fat free sweetened condensed milk or the combination there off can be also used as bulking agent to obtain low calorific, non-chocolate product that is homoge neous with pleasant taste All publications, patents, and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated by reference. EXAMPLES The following experiments exemplify the invention. The process for formation is provided in each example after the tabular description of the ingredients and their amounts. The amounts are given in weight percents relative to the total weight of the composition Example 1 Corn Syrup 8 (Karo) Sorbitol 70% 1 O.O7 Strawberry O.2 Total ( ) Mix Sorbitol 70% and corn syrup together. (0029 2) Heat them in a water bath up to 70 C ) Add PEG 3350 and mix them together. Dis Solve in approximately 2 ml of water and add to the mixture ) Cool the mixture to C and add straw berry. Pour the mixture into a mold and cool it. Once the mold is set, cut the bars into appropriate size Example 2 Corn Syrup (Karo-light) 7 Sorbitol 70% 5.57 O.08 Citric acid O.15 Red #40 O.OS Strawberry O.15 Total ) Melt PEG 3350 on a water bath. When the temperature reads 70 C, add corn syrup and sorbitol 70% and mix ) Add sucralose and mix ) Add citric acid and dissolve 0036, 4) Continue heating at about 70 C for 15 minutes 0037) 5) Cool the mixture under stirring ) At or below 50 C, add color and ) Pour into a mold 0040) 8) Cut into pieces when the mold is set 0041 Example 3 Corn Syrup (Karo-light) 7 Sorbitol 70% O.OS Condensed 5 milk Pineapple O.OS Tropical fruit O.O2S Total ) Melt PEG 3350 on a water bath and heat on a hot plate. When the temperature reads 70 C, add corn syrup and sorbitol 70% and mix ) Add condensed milk, sucralose and mix ) Continue heating at about 70 C for 15 minutes ) Cool the mixture under stirring ) Between C, add color and ) Pour into a mold ) Cut into pieces when the mold is set. Observation: The product did not set. Very soft Example 4 Corn Syrup 7 Sorbitol 70% 8 O.OS Mixed Berry O.1 Total ) Mix corn syrup and sorbitol 70% and heat on water bath to 60 C 0051) 2) Add PEG 3350 and mix well ) Add sucralose and mix ) Continue heating for 30 minutes ) Cool the mixture under stirring ) Between C, add color and ) Pour into a mold ) Cut into pieces when the mold is et. Observa tion: Taste is very good.

5 0058 Example 5 Corn Syrup 8 Sorbitol 70% 8 O.OS Strawberry O.1 Total ) 1) Mix corn syrup and sorbitol 70% and heat on water bath to 70 C ) Add PEG 3350 and mix well ) Add sucralose and mix ) Continue heating for 30 minutes ) Cool the mixture under stirring ) At C, add color and ) Pour into a mold ) Cut into pieces when the mold is set. Example Corn Syrup 10 Sorbitol 70% 7 Sacralose Mint O.12 Total 35 Chocolate --5 coat ) Mix corn syrup and sorbitol 70% and heat on water bath to 70 C ) ) Add PEG 3350 and mix well. 3) Add and mix. 4) Continue heating for 30 minutes. 5) Cool the mixture under stirring. 6) At 50-55C, add. 7) Pour into a mold. 8) Cut into pieces when the mold is set. 9) Coat with melted chocolate. Example 7 Corn Syrup 10 Sorbitol 70% 4 Strawberry O.1 Red color O.OOOS Total 31 Chocolate --5 coat ) Mix corn syrup and sorbitol 70% and heat on water bath to 70 C ) Add PEG 3350 and mix well ) Add sucralose and mix ) Continue heating for 30 minutes ) Cool the mixture under stirring ) At C, add color and. I0084 7) Pour into a mold ) Cut into pieces when the mold is set. I0086) 9) Coat with melted chocolate. Example *BASF Ludiflash (R* 13 Orange Mg Stearate O.1 O.O15 Total 30 I0088 1) Mix PEG 3350, Ludiflash, and Orange ) Add Mg stearate and mix ) Compress using a tablet machine Observation: Not as good as the bar. Example Corn Syrup 5 Sorbitol 70% 3 Mint O.1 Total ] 1) Mix corn syrup and sorbitol 70% and heat on water bath to 70 C ) Add PEG 3350 and mix well ) Add sucralose and mix. ( ) Continue heating for 30 minutes ) Cool the mixture under stirring ) At C, add color and. ( ) Pour into a mold. 0099) 8) Cut into pieces when the mold is set. Observation: The bar did not set well. Sticky bar. Taste is good Example 10 Corn Syrup 10

6 ) Add sucralose and mix ) Continue heating for 30 minutes ) Cool the mixture under stirring. (0123 6) At C, add color and. Mint O.1 ( ) Pour into a mold. Total ) Cut into pieces when the mold is set ) Mix corn syrup and PEG 3350 and heat on Observation: Sticky water bath to 70 C ) Add sucralose and mix. Example ) Continue heating for 30 minutes ) Cool the mixture under stirring ) At C, add color and ) Pour into a mold. Ingredient ) Cut into pieces when the mold is set. gredients Oll Example 11 Corn Syrup 10 Sorbitol 70% Mint O.1 Total 29 Corn Syrup ) Mix corn syrup and sorbitol 70% and heat on Sorbitol 70% 4 water bath to 70 C State ) Add PEG 3350 and mix well. Chloride ) Add sucralose and mix. State O ) Continue heating for 30 minutes. Pot Chloride O ) Cool the mixture under stirring. Mint O.1 (0132) 6) At C, add color and. Total ) Pour into a mold ) 8) Cut into pieces when the mold is set ) Mix corn syrup and sorbitol and heat on water bath to 70 C. Example ) Add PEG 3350 and mix ) Add sucralose and mix. 0135) ) Dissolve sodium chloride, sodium bicarbonate and Potassium chloride in Small quantity of water and add ) Continue heating for 30 minutes ) Cool the mixture under stirring. Corn Syrup ) At Cadd. Sile ) Pour into a mold. Chloride Observation: Did not set well. Became pasty. Salts seem to Sodium O inhibit proper setting. Salty taste. bicarbonate Pot Chloride O Example 12 Mint O.1 Total ) Mix corn syrup and sorbitol and heat on water bath to 70 C ) Add PEG 3350 and mix Corn Syrup ) Add sucralose and mix. Sorbitol 70% ) Dissolve sodium chloride, sodium bicarbonate Mint O.1 and Potassium chloride in Small quantity of water and add Total ) Continue heating for 30 minutes ) Mix corn syrup and sorbitol 70% and heat on ) Cool the mixture under stirring. water bath to 70 C ) At C, add ) Add PEG 3350 and mix well. 0143) 8) Pour into a mold

7 6 Sticky. Little rubbery. Little rubbery. Taste is good. Example 15 Example ) (0163 Corn Syrup 10 Corn Syrup 15 Chocolate- 8 Chocolate- 8 semisweet Dark Ghirardelli Mint O.1 chocolate o Total 35 Sodium O.351 Chloride *Nestle TM semi-sweet chocolate ( ). : semisweet chocolate, Sodium O.179 sugar, chocolate, cocoa butter, milk fat, soy lecithin, natural s bicarbonate Pot Chloride O ) Mix corn syrup and sorbitol and heat on water Mint O.1 bath to 70 C Total ) Add PEG 3350 and mix ) Add chocolate and mix Shirardelli unsweetened chocolate ( ); ; Unsweetened choco ) Add sucralose and mix. 5) Continue heating for 30 minutes ) Mix corn syrup and sorbitol and heat on water bath to 70 C ) Cool the mixture under stirring. ( ) Add PEG 3350 and mix ) At C, add ) Add chocolate and mix ) Pour into a mold ) Add sucralose and mix. Observation: Sets well. Good taste & texture. (0168 5) Cool to 50 C or less and add the salts ) Continue heating for 30 minutes. Example ) Cool the mixture under stirring. O153 (0171 8) At Cadd. (0172 9) Pour into a mold. (0173 Good taste and texture. Example 18 Corn Syrup Chocolate (0174 semisweet Sodium O.351 Chloride Sodium O.179 PEG S bicarbonate Dark 6.18 Pot Chloride O.047 Chocolate* Mint O.1 o Sodium O.351 Total 40 Chloride Sodium O.179 *Nestle TM semi-sweet chocolate ( ). : semisweet chocolate, bicarbonate sugar, chocolate, cocoa butter, milk fat, soy lecithin, natural s Pot Chloride O.047 Mint O ) 1) Mix corn syrup and sorbitol and heat on water bath to 70 C. Total 2O O155 2) Add PEG 3350 and mix. *ADM cocoa: DC-1015 valuebs Choc. : Sugar, chocolate liquor, cocoa butter, chocolate liquor processed with alkali, soy lecithin, vanilla, salt and artificial, May ) Add chocolate and mix. contain milk ) Add sucralose and mix. (0175 1) Melt PEG to 65 C on a water bath ) Cool to C or less and add the water 0176) 2) Add chocolate and mix. Solution of salts ) Add sucralose and mix ) Continue heating for 30 minutes. 7) Cool the mixture under stirring (0179 4) Cool to below 60 C and add salts and mix. 5) Cool the mixture under stirring. (0161 8) At C, add ) At Cadd. (0162 9) Pour into a nmold ) Pour into a mold.

8 Example Sodium O.179 bicarbonate Pot Chloride O.047 PEG S Mint O.1 Milk 6.18 Chocolate* Total 31 Sodium O.351 Chloride Sodium O.179 experiment 20. bicarbonate Pot Chloride O.047 Mint O.1 Example 22 Total 2O (0192 *ADMMC-050 Marquis MC. : Sugar, milk, cocoa butter, chocolate liquor, soy lecithin, and vanilla, The processing procedure used is the same as described for The processing procedure used is the same as described for experiment 18. PEG S Dark Chocolate Example 2O (ADM DC 0183) 1015) Sodium O.351 Chloride Sodium bicarbonate O.179 PEG S Pot Chloride O.047 Corn Syrup 11.7 Mint O.1 Dark 6.18 Chocolate Total 22 (ADM DC 1015) The processing procedure used is conducted as describe for Sodium O.351 experiment 20. Chloride Sodium O.179 bicarbonate Example 23 Pot Chloride O.047 Mint O ) Total 31 ( ) Melt PEG to 65 C on a water bath. Add corn syrup and mix. Corn Syrup ) Add chocolate and mix. R. gal t ) Add sucralose and mix. 18WO ) Cool to below 60 C and add salts and mix. Total ) Cool the mixture under stirring. (0189 6) At Cadd. (0194 1) Melt PEG to 70 C on a water bath. Add corn ( ) Pour into a mold. syrup and mix ) Add sucralose and mix. Example 21 (0196) 3) At about 65 Cadd. (0191) (0197) 4) Pour into a mold. Example 24 PEG S (0198 Corn Syrup 11.7 Milk 6.18 Chocolate (MC-050) Sodium O.351 Corn Syrup 12 Chloride

9 Strawberry O.1 Pot Chloride O.047 Mint O.1 Red #40 O.OS Total 22 Total The processing procedure used is similar to that of experi- The processing procedure used is similar to that of experi ment 20. ment 23. Example 28 Example 25 ( PEG S Dark 9.0 Dark 12 Chocolate 8. (ADM DC chocolate 1015) (ADM DC 1015) Sodium O.351 Mint f O.1 Chloride 18WO Sodium O.179 bicarbonate Total Pot Chloride O.047 Strawberry O.1 The processing procedure used is similar to that of experi ment 23. Total 22 Example ment The processing procedure used is similar to that of experi Example 29 Dark 12 chocolate (ADM DC 1015) PEG S Corn Syrup 15 Strawberry O.1 Sodium O.351 Chloride Total Sodium O.179 bicarbonate Pot Chloride O.047 The processing procedure used is similar to that of experi- Sybery O.1 8WO ment 23. Total 28 Example The processing procedure used is similar to that of experi ment 20. Example 3O PEG S 0204 Dark 9.0 Chocolate (ADM DC- 1015) PEG S Sodium O.351 Corn Syrup 15 Chloride Sodium O.179 Sodium O.351 bicarbonate Chloride

10 Sodium O.179 bicarbonate Pot Chloride O.047 Strawberry O.1 Mint O.1 Red #40 O.OS Total 29 Total 28 The processing procedure used is similar that of experiment 2O. ment The processing procedure used is similar as that of experi Example 31 Example Bisacodyl O.OOS Dark 12 Chocolate ADMDC- 101S Docusate O.1 Mint O.1 Sodium Total 29 The processing procedure used is similar as that of experi- ment 20. Dark 12 Chocolate 101S ADMDC Example 32 Mint O Total 29 The processing procedure used is similar as that of experi Sod Pico O.OOS ment 20. Sulfate Dark 12 Chocolate Example 35 ADMDC 101S Mint O Total 29 The processing procedure used is similar as that of experi ment 20. Example 33 White 12 Chocolate 0207 Mint O.1 Total 29 Dark 12 Chocolate 101S The processing procedure used is similar as that of experi ment 20. ADMDC

11 Formulation Summary (Per Bar in Grams) Item RB1 RB11 SOO2 RB RB RB11SOOS RB11 SOO Corn Syrup O.O 3 Sorbitol 70% O.O7 O.O8 O.OS O.OS O.OS O.04 5 Chocolate S.O coat 6 Mint O.12 7 Strawberry Flavor O.2 O.15 8 Pine app. Fla O.OS 9 Mixed berry 10 Trop. fla O.O3 11 Orange fla O.1 12 Citric acid O Ludiflash 14 Mag. Stear 15 Red # mg 16 Condensed milk S.O Total Wt O Comments Exploratory Waxy Very soft Very soft Good Good Waxy taste Taste ok More Sweet RB11SOO O.O 4.0 O.04 S.O coat O.O Good Chocolate coat Formulation Summary (Per Tablet Equivalent) Tablet Dosage Form Item # Ludiflash 5 Mag. Stear RB RB RB S.OO 13.OOO O.O150 Total Wt RB RB RB Comments Item # O.OS 3 Orange O.13 O.13 O Tablets Tablets Tablets compressed by compressed by compressed manual manual with Mini Hard operation press Not Hard as good as bar Formulation Summary with PEG--Electrolytes (Per Bar in Grams) 0212 Item Ingredient. RB RB115O12 RB11 SOO13 RB RB115O15 RB RB RB RB Corn Syrup S.O 1O.O 1O.O 7.0 1O.O 3 Sorbitol 70% O.04 O.04 O.04 O.04 O.04 5 Chocolate 6 Sodium Chloride O.35 7 Sod. Bi carb O.17 8 Pot. Chloride O.04 9 Mint O.1 O.1 O.1 O.1 O S.O 1O.O O.04 O O3S O.17 O.04 O.1 O S.O O Semi Sweet O.35 O.17 O S.O O Dark Chiredelli O.35 O.17 O.04 O.1 Total Wt Comments Poor Good Do not Sticky Sticky Set Set Set Rubbery Taste Taste Salt ok ok affects Setting Less Good sticky Set Taste Good ok taste 40.7 Good Set Taste good 40.7 Good Set Taste good

12 Formulation Summary with Electrolytes (Per Bar in Grams) 0213 Item 1 PEG Corn Syrup 3 4 Chocolate 5 Sodium Chloride 6 Sod. Bicarb 7 Pot. Chloride 8 Mint Total Wt Comments RB RB S 13.12S O O 6.18O Dark Milk O.351 O.351 O.179 O.179 O.047 O.O47 O.100 O.100 2O.O 2O.O W. Good Set Good Set Release from mold easily A little sticky Release from mold is bad RB11 SOO22 RB RB11SO2S 13.12S 13.12S 13.12S O 6.18O Dark Milk Dark O.351 O.351 O.351 O.179 O.179 O.179 O.O47 O.O47 O.047 O.100 O.100 O Harder chocolate Sticky Taste good Release form Taste Easy release mold easily ok from mold Taste good A lead for future experiments 0214 Formulation Summary (Per Bar in Grams) Bar Formulation Summary with PEG+Electrolytes (Per Bar in Grams) 0215 RB Item 11SO26 1.OOO 2 Corn Syrup Chocolate 5 Mint O Strawberry 7 Red #40 Total Wt Comments Difficulty in releasing from mold RB RB O.041 O mg O Difficulty Good in releasing from mold taste; release from mold easily RB RB RB RB RB1 Item SO32 11SO33 1 PEG S 13.12S 13.12S 13.12S 1 2 Corn Syrup 1S.OOO 1S.OOO 3 4 Chocolate 9.OOO 9.OOO O. 5 Sodium O.351 O.351 O.351 O Chloride 6 Sod. Bicarb O.179 O.179 O.179 O Pot. Chloride O.049 O.049 O.049 O.049 O. 8 Mint O.100 O Strawberry O.100 O.100 Flavor 10 Red # mg Total Wt Comments Good Good Difficult Difficult to Good taste; taste; to release from taste; Good Good release mold release release from {{8Se. from from mold from mold mold mold easily Formulation Summary (Per Bar in Grams) 0216 Item RB11 SO34 RB RB11 SO36 RB11 SO37 RB Bisacodyl O.OOS 3 Sod Pico Sulfate O.OOS 4 Docusate Sodium O.1 5 Dark Chocolate White Chocolate Mint O.100 O.100 O.100 O.1 O.1 Total Wt

13 Formulation Summary (Per Bar in Grams) Item RB RB1150S6 Hard in taste Item RB-11SO39 RB RB-11SO41 texture and 1 PEG OOO 4.OOO 2 Pectin O.32O O.32O O.32O 3 4 Corn Syrup Sugar 4.OOO OOO 3.28O 4.OOO 3.28O Chocolate Bars 5 Citric acid O.128 O.128 O ) Item RB RB RB RB RB OOO 17.OOO 17.OOO 17.OOO 17.OOO 2 O Dark Chocolate - ADM 13.OOO 13.OOO 13.OOO (ADM) 4. White Chocolate 13.OOO 13.OOO (ADM) (Nestle) (ADM) 5 Purified Water O416 6 Mint 7 Strawberry O.100 O.100 O.100 O.100 O Red #40 O.OOOS O.OOOS Total Wt Comments Good Good Silicon Appearance Appearance Taste Taste pop mold is good is good Appearance Appearance Good taste Good taste Good taste not good not good Appearance Texture is not good good Procedure 068: MeltPEG in a container on a water bath at 80 C. Add and dissolve. Mixwell. Add Chocolate and mix well to disperse uniformly, Start cooling, add. Mix well. Pour into molds. Cool to set. 069: MeltPEG in a container on a water bath at 80 C. Add and dissolve. Mixwell. Add Chocolate and mix well to disperse uniformly. Add color and mix well. Start cooling, add, Mix well. Pour into molds. Cool to set. O72: Same as 068 O73; ame as : Melt PEG in a container on a water bath at 80 C. Dissolve in a small quantity of water and add to the bulk. Mix well. Add Chocolate and mix well to disperse uniformly, Start cooling, add. Mix well. Pour into molds. Cool to set. Chocolate Bars Item RB-11SO39 RB RB-11SO Strawberry fla O.O10 O.O10 O.O2O 7 Purified water 2.28O 2.28O 2.88O Comments Good Good taste Good taste Item RB RB taste A little A little Soft harder harder 1.OOO 17.OOO in in 2 texture texture 3 Sod. Chloride O.351 O Pot. Chloride O.049 O.049 Chocolate Bars 5 Sod. bicarbonate O.179 O Dark 16.15S 0218 Chocolate - ADM 7 White S Item RB11 SOS3 RB1150S6 Chocolate 1 2 PEG 3350 Bisacodyl 17.OOO 17.OOO 8 (Nestle) Mint O.100 O Sodium Pico Total Wt 3O.OOO 3O.OOO Sulfate Comments Good Taste Good Taste 4 Docusate Sod Appearance Appearance 5 not is 6 Chocolate ,000 good okay (white) (white) Texture Texture is 7 Mint 8 Strawberry O.100 O.100 is spotty hard 9 Red #40 OOOO4 O.OOS Procedure o 070 & 071: Melt PEG in a container on awater bath at 80 C. till it forms a clear solution. Total Wt OO ENER Comments Good Not the temperature at 80 C. Add the, mix well pour into molds and cool to set, taste good

14 13 Aug 21, ) Chocolate Bar PEG Electrolytes PEG 3350 alone Item RB RBMP RB RB RB OOO 17.OOO 17.OOO 13.12S 13.12S 2 O.042 O.040 O.042 O.042 O P. Water O.832 O.830 O.832 O.832 O Sod. Benzoate O.O3O 5 Sodium Chloride O.351 O Pot. Chloride O.049 O Sod. bicarb O.179 O Dark Chocolate (ADM) OOO 9 White Chocolate 12.OOO 11.OOO (Nestle) (Nestle) 10 Mint O.100 O.100 O Strawberry Flavour O.100 O.100 Total Wt O.OOO Comments Brown Brown White Brown White Taste texture appearance good RB A Chocolate coated 13.12S O.042 O.832 O.351 O.049 O (Nestle) O gm. dark chocolate coat White core inside brown coat outside Procedure 081: Melt PEG in a container on a water bath at 80 C. till it forms a clear solution. Dissolve in a small quantity of water and add to the bulk. Add the chocolate, mix well to distribute uniformly maintaining the temperature at 80 C. Discontonue heating, add the and mix well. Pour into molds and cool to set, 082: Same as : Melt PEG in a container on a water bath at 80 C. till it forms a clear solution. Dissolve Sodium benzoate and in a small quantity of water and add to the bulk. Add the chocolate, mix well to distribute uniformly maintaining the temperature at 80 C. Discontonue heating, add the and mix well. Pour into molds and cool to set. 080: Melt PEG in a container on a water bath at 80 C. till it forms a clear solution. Add and dissolve. Grindall the 3 salts with a mortar and pestle and add to the bulk and mix well to disperse uniformly, Add the chocolate and disperse uniformly maintaining the temperature at 80 C. Add the, mix well. Pour into molds and cool to set. 083A: The core chocolates from the experiment 083 are coated with 5gms of dark chocolate to form a uniform coat, 0222 Non-Chocolate Bars (Grams Per Bar) Item RB RB RB RB RB115-09S PEG 3350 Sod. Chloride Pot. Chloride Sod. bicarb Maltitol Syrup Pectin Citric acid Orange shade color Red #40 Mint Flavor Orange Strawberry Flavor Purified water 17.OOO O.042 S.OOO O.100 O.OO2 O OOO 13.12S O.351 O.049 O.179 O OOO 17.OOO O.042 O.167 O Total Comments PEG gets separated Waxy taste PEG gets separated Waxy taste Taste, Texture and appearance

15 14 Item RB RB RB RB RB115-09S are not good at all Procedure: RB : Melt PEG 3350 in a SS container kept on a water bath at 80 C. till it forms a clear liquid. Dissolve in it, MixMaltitol syrup, orange color, orange, Dissolve citric acidinwater and add to the maltitol syrup solution containing the and color. Add this mixture to the melted PEG solution and mix well to form homogeneous mixture. Pour into Silicon molds. Cool to set. RB : Melt PEG 3350 in a SS container kept on a water bath at 80 C. till it forms a clear liquid. Dissolve in it, Dissolve, color and citric acid in water and add to the melted PEG Mix well.. It forms a clear solution. Pour into the molds. Cool to set. RB : Melt PEG 3350 in a SS container kept on a water bath at 80 C. till it forms a clear liquid. Dissolve in it. Dissolve all the 3 salts, citric acid in water. It forms a hazy solution. Add this solution to the melted PEG solution. Pour into molds. Cool to set. RB ; Melt PEG 3350 in a SS container kept on a water bath at 80 C. till it forms a clear liquid. Dissolve in it. Add the mint, add the water, mix well. Pour into the molds, Cool to set, RB : Melt PEG 3350 in a SS container kept on a water bath at 80 C. till it forms a clear liquid. Dissolve in it. Suspend the Pectin in it. Dissolve the color, in water and add the bulk. Pour in to the molds. Cool to set Non-Chocolate Bars (Grams Per Bar) Item RB RB RB RB RB OOO 17.OOO 17.OOO 17.OOO 17.OOO 2 O Glycerin OOO 4 Sugar Isomalt Red #40 O.OO2 O.OO2 O.OO1 7 Vanilla Flavor O.OSO 8 Strawberry Flavor O.100 O.1OO O Purified water Total Wt Comments Taste not Taste not Taste not Bad taste Waxy taste good good good Procedure: RB : Melt PEG 3350 in a container on a water bath at 80 C. till it forms a clear solution. Add glycerin and mix well Cool to 60 C, and pour into molds, Cool to set, RB : Melt PEG 3350 in a container on a water bath at 80 C. till it forms a clear solution. Add glycerin and mix well. Suspend sugar and mix well. Pour into molds. Cool to set. RB : MeltPEG 3350 in a container on a water bath at 80 C. till it forms a clear solution. Dissolve the color and in glycerin and add to the bulk, Suspend the sugar and mix well. Pour into the molds and cool to set, RB : MeltPEG 3350 in a container on a water bath at 80 C. till it forms a clear solution. Dissolve the color and in glycerin and add to the bulk. Suspend Isomalt and mix well. Pour into molds and cool to set. RB : Melt PEG 3350 in a container on a water bath at 80 C. till it forms a clear solution. Add sucralose and dissolve. Dissolve the color and in glycerin and add to the bulk. Cool to 70. Pour in to molds, Cool to set Non-Chocolate Bars (Grams Per Bar) PEG 3350 alone PEG Electrolytes 17 gms O.179 Item RB RB RB OOO 17.OOO 13.12S 2 O.O21 O.042 O Soy Lecithin O OOO 1.OOO 4 Sweetened 1S.OOO 1S.OOO 13.OOO Condensed milk 5 Sod. Chloride O Pot. Chloride O Sod.bi. carb O Redhi 40 O.OO2 O.OO2 9 Vanilla Flavor O Strawberry Flavor O.100 O.100 Total Wt

16 PEG 3350 alone PEG Electrolytes 17 gins O.179 Item RB RB RB Comments Taste, Texture Taste, Texture and Appearance and Appearance are good are good Taste, Texture and Appearance are good Procedure: RB : MeltPEG in a container on a water bath at 80 C. till it forms a clear solution. Dissolve in it. Add Lecithin and dissolve. Add Sweetened Condensed Milk and mix well maintaining the temperature at 80 C, for 20 minutes, Cool to 70 C., add the and mix well. Pour into molds and cool to set, RB : Same as 101 RB : MeltPEG in a container on a water bath at 80 C. till it forms a clear solution. Dissolve in it. Add Lecithin and dissolve. Add Sweetened Condensed Milk and mix well maintaining the temperature at 80 C, for 20 minutes, Add and mix well the salt blend previously powdered and mixed. Cool to 70 C., add the and mix well. Pour into molds and cool to set, SUMMARY for Non-Chocolate bars for experiments : Maltitol syrup, Pectin and Glycerin were tried in the formulation and were unsuccessful. Subsequently, Sweet ened Condensed Milk/Soy lecithin were tried and found to produce good soft tasty bars Dark Chocolate Bar with Fiber Item RB Per bar (gms) 1.OOO 2 Soluble fiber - (Wheat 6.OOO Dextrin); (Nutriose (R) 3 O Purified water 2.SOO 5 Sod. Benzoate O.O3O 6 7 Dark Chocolate (ADM) Strawberry Flavor 12.OOO O.100 Total wt Comments Good taste, Good texture Procedure: Melt PEG in a container on a water bath at 80 C. till it forms a clear solution. Dissolve in it. Dissolve Sod. Benzoate in a small quantity of water and add to the bulk. Add Chocolate chips and disperse well by mixing and continuous heating at 80 C. Add the Nutriose (R) and disperse well by mixing. Add the. Pour in to molds and cool to set 0226 Item Non-Chocolate bar with Fiber RB Per bar (gms) 1.OOO 2 Soluble fiber - Wheat 6.OOO Dextrin (Nutriose (R) 3 O Soy - Lecithin (WhC) 1.OOO 5 Sweetened Condensed Milk 1S.OOO 6 Vanilla Flavor O Caramel Flavor O.OSO Total Wt Comments Good taste, Soft bar in texture Procedure: Melt PEG in a container on a water bath at 80 C. till it forms a clear solution. Dissolve in it followed by Lecithin. Mix well. Add Sweetened Condensed Milk and mix well. Stop heating. Add the s and mix well. Pour into molds and cool to set. Aspects and Embodiments of the Invention 0227 Embodiment 1: An edible, solid composition, com prising: a laxative and a bulking agent wherein the composi tion is formed by heating the laxative and bulking agent together to form a fluid dispersion and cooling the fluid dis persion to form the edible solid composition, and wherein the edible Solid composition has laxative properties Embodiment 2: The edible, solid composition according to embodiment 1 or embodiment 22 wherein the bulking agent is selected from the group consisting of corn syrup, Sorbitol. Sucrose, dextrose, invert Sugar, ludiflash, chocolate, maltitol, high fructose syrup, rice syrup, barley malt syrup, glycerin, maltodextrins, starch hydrolysate, honey, molasses, soy lecithin, condensed milk, fat free Sweet ened condensed milk, evaporated milk, Sweetened condensed milk and any combination thereof Embodiment 3: The edible, solid composition according to embodiments 1 or 2 or embodiment 22 further comprising a Sweetening agent Embodiment 4: The edible, solid composition according to embodiment 3 or embodiment 22 wherein the Sweetening agent is selected from the group consisting of Sugar, Sorbitol, Saccharine, aspartame, acesulfame potassium,, isomalt, mannitol, Stevia, cyclamate, dextrose, glu cose, fructose, honey, high fructose syrup and any combina tion thereof Embodiment 5: The edible, solid composition according to any one of embodiments 1-4 or embodiment 22 wherein the laxative is selected from the group consisting of polyethylene glycol, castor oil, Senna, bisacodyl, Sodium pico Sulfate, magnesium citrate, magnesium hydroxide (milk of magnesia), magnesium carbonate magnesium Sulfate (Epsom salt), Sodium sulfate, potassium sulfate, Sodium chloride, potassium chloride, Sodium bicarbonate, aloes, cascara sac rada, psyllium husk (Metamusil), guar gum, maltodextrins, inulin, docusate Sodium, methyl cellulose, monobasic Sodium phosphate, dibasic sodium phosphate, glycerin, Sor bitol, mannitol, Sodium potassium tartrate, mineral oil (liquid paraffin), lactulose, rhubarb, agaragar, figs (Syrup of Figs). L-glucose and any combination thereof Embodiment 6: The edible, solid composition according to embodiment 5 or embodiment 22 wherein the laxative is polyethylene glycol, magnesium citrate, inulin, castor oil or lactulose Embodiment 7: The edible, solid composition according to any one of embodiments 1-6 or embodiment 22 wherein the laxative comprises at least 40 wt.% relative to the total weight of the composition Embodiment 8: The edible, solid composition according to any of embodiments 1, 2, 3, 4 or 7 or embodi ment 22 wherein the laxative is polyethylene glycol and the

17 polyethylene glycol is melted or its physical form is converted to a flowable viscosity by application of heat Embodiment 9: The edible, solid composition according to any one of embodiments 1-8 or embodiment 22 wherein the bulking agent is mixed with the melted or flow ably viscous polyethylene glycol to form a flowable disper sion of ingredients and the flowable dispersion is placed into one or more molds and cooled to form the Solid composition Embodiment 10: The edible, solid composition according to any one of embodiments 1-9 or embodiment 22 in the form of a bar, a lozenge, a chewable candy, or a chew able solid confection Embodiment 11: The edible, solid composition according to any one of embodiments 1-10 or embodiment 22 wherein the form is Substantially homogeneous Embodiment 12: The edible, solid composition according to any one of embodiments 1-11 or embodiment 22 which remains Solid at ambient temperature Embodiment 13: The edible, solid composition according to any one of embodiments 1-12 or embodiment 22 wherein the bulking agent is selected from the group consist ing of Soy lecithin, condensed milk, fat free Sweetened con densed milk, evaporated milk, Sweetened condensed milk and any combination thereof; and the laxative is selected from the group consisting of polyethylene glycol, magnesium citrate, lactulose and any combination thereof, and the composition is in the solid form of a bar or chewable candy Embodiment 14: The edible, solid composition according to embodiment 13 or embodiment 22 wherein the bulking agent is a combination of Soy lecithin and a second bulking agent selected from the group consisting of con densed milk, fat free Sweetened condensed milk, evaporated milk Sweetened condensed milk and any combination thereof the laxative is polyethylene glycol; and the compo sition is in the solid form of a bar or chewable candy Embodiment 15: The edible, solid composition according to any one of embodiments 1-14 or embodiment 22 further comprising an electrolyte Embodiment 16: The edible, solid composition according to any one of embodiments 1-15 or embodiment 22 further comprising a ing agent Embodiment 17: The edible, solid composition according to embodiment 15 or embodiment 22 wherein the electrolyte is selected from the group consisting of sodium chloride, potassium chloride, potassium bicarbonate, magne sium chloride and any combination thereof Embodiment 18: The edible, solid composition according to embodiment 16 or embodiment 22 wherein the ing agent is selected from the group consisting of bubble gum, cherry, mixed berry, fruit punch, pine apple, caramel, mixed fruit, chocolate, spearmint, peppermint, men thollicorice, orange, lemon, Watermelon, melagawine, cran berry, tutti frutti, mix of cardamom and orange, Vanilla, ice cream soda, Salt masking and any combination thereof Embodiment 19: The edible, solid composition according to any of the foregoing embodiments or embodi ment 22 wherein the laxative is polyethylene glycol is poly ethylene glycol Embodiment 20: The edible composition according to any of the foregoing embodiments or embodiment 22 wherein the bulking agents are less than 20% of the weight of the bar Embodiment 21: The edible, solid composition according to any of the foregoing embodiments or embodi ment 22 wherein the bulking agents are less than 10% of the weight of the bar Embodiment 22: An edible solid composition com prising a Substantially homogeneous, Solid, amorphous dis persion of a laxative, a bulking agent and a Sweeting agent, the dispersion having a smooth, non-crystalline, non-gritty mouth feel and a Sweet taste Embodiment 23: The edible solid composition according to embodiment 22 wherein the laxative is polyeth ylene glycol magnesium citrate, inulin, castor oil or lactulose Embodiment 24: The edible solid composition according to embodiment 22 wherein the laxative is polyeth ylene glycol 0251 Embodiment 25: The edible solid composition according to embodiment 22 containing chocolate While preferred embodiments of the present inven tion have been shown and described herein, it will be apparent to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions will now occur to those skilled in the art without departing from the invention. It should be understood that various alternatives to the embodiments of the invention described herein may be employed in practicing the inven tion. It is intended that the following claims define the scope of the invention and that methods and structures within the Scope of these claims and their equivalents be covered thereby. 1. An edible, Solid composition, comprising: a laxative and a bulking agent wherein the composition is formed by heating the laxative and bulking agent together to form a fluid disper sion and cooling the fluid dispersion to form the edible solid composition, and wherein the edible solid composition has laxative properties. 2. The edible, Solid composition according to claim 1 wherein the bulking agent is selected from the group consist ing of corn Syrup, Sorbitol. Sucrose, dextrose, invert Sugar, ludiflash, chocolate, maltitol, high fructose syrup, rice syrup, barley malt syrup, glycerin, maltodextrins, starch hydroly sate, honey, molasses, Soy lecithin, condensed milk, fat free Sweetened condensed milk, evaporated milk, Sweetened con densed milk and any combination thereof. 3. The edible, solid composition according to claim 1 fur ther comprising a Sweetening agent. 4. The edible, Solid composition according to claim 3 wherein the Sweetening agent is selected from the group consisting of Sugar, Sorbitol, Saccharine, aspartame, acesulfame potassium,, isomalt, mannitol, Stevia, cyclamate, dextrose, glucose, fructose, honey, high fructose syrup and any combination thereof. 5. The edible, solid composition according to claim 1 wherein the laxative is selected from the group consisting of polyethylene glycol, castor oil, Senna, bisacodyl, Sodium pico Sulfate, magnesium citrate, magnesium hydroxide (milk of magnesia), magnesium carbonate magnesium Sulfate (Epsom salt), Sodium sulfate, potassium sulfate, Sodium chloride, potassium chloride, Sodium bicarbonate, aloes, cascara sac rada, psyllium husk (Metamusil), guar gum, maltodextrins, inulin, docusate Sodium, methyl cellulose, monobasic Sodium phosphate, dibasic sodium phosphate, glycerin, Sor bitol, mannitol, Sodium potassium tartrate, mineral oil (liquid paraffin), lactulose, rhubarb, agaragar, figs (Syrup of Figs), L-glucose and any combination thereof.

18 6. The edible, solid composition according to claim 5 wherein the laxative is polyethylene glycol, magnesium cit rate, inulin, castor oil or lactulose. 7. The edible, solid composition according to claim 1 wherein the laxative comprises at least 40 wt % relative to the total weight of the composition. 8. The edible, solid composition according to claim 1 wherein the laxative is polyethylene glycol and the polyeth ylene glycol is melted or its physical form is converted to a flowable viscosity by application of heat. 9. The edible, solid composition according to claim 8 wherein the bulking agent is mixed with the melted or flow ably viscous polyethylene glycol to form a flowable disper sion of ingredients and the flowable dispersion is placed into one or more molds and cooled to form the Solid composition. 10. The edible, solid composition according to claim 1 in the form of a bar, a lozenge, a chewable candy, or a chewable Solid confection. 11. The edible, solid composition according to claim 10 wherein the form is Substantially homogeneous. 12. The edible, solid composition according to claim 11 which remains Solid at ambient temperature. 13. The edible, solid composition according to claim 10 wherein the bulking agent is selected from the group consist ing of Soy lecithin, condensed milk, fat free Sweetened con densed milk, evaporated milk, Sweetened condensed milk and any combination thereof; and the laxative is selected from the group consisting of polyethylene glycol, magnesium citrate, lactulose and any combination thereof, and the composition is in the solid form of a bar or chewable candy. 14. The edible, solid composition according to claim 13 wherein the bulking agent is a combination of soy lecithin and a second bulking agent selected from the group consisting of condensed milk, fat free Sweetened condensed milk, evapo rated milk, Sweetened condensed milk and any combination thereof the laxative is polyethylene glycol; and the compo sition is in the solid form of a bar or chewable candy. 15. The edible, solid composition according to claim 1 further comprising an electrolyte. 16. The edible, solid composition according to claim 1 further comprising a ing agent. 17. The edible, solid composition according to claim 15 wherein the electrolyte is selected from the group consisting of sodium chloride, potassium chloride, potassium bicarbon ate, magnesium chloride and any combination thereof. 18. The edible, solid composition according to claim 16 wherein the ing agent is selected from the group con sisting of bubblegum, cherry, mixed berry, fruit punch, pine apple, caramel, mixed fruit, chocolate, spearmint, pepper mint, menthol, licorice, orange, lemon, Watermelon, mela gawine, cranberry, tutti frutti, mix of cardamom and orange, Vanilla, ice cream Soda, salt masking and any combi nation thereof. 19. The edible, solid composition according to claim 1, wherein the laxative is polyethylene glycol is polyethylene glycol The edible composition according to claim 1, wherein the bulking agents are less than 20% of the weight of the bar. 21. The edible, Solid composition according to claim 1, wherein the bulking agents are less than 10% of the weight of the bar. 22. An edible solid composition comprising a Substantially homogeneous, Solid, amorphous dispersion of a laxative, a bulking agent and a Sweeting agent, the dispersion having a Smooth, non-crystalline, non-gritty mouth feel and a Sweet taste. 23. The edible solid composition according to claim 22 wherein the laxative is polyethylene glycol, magnesium cit rate, inulin, castor oil or lactulose. 24. The edible solid composition according to claim 22 wherein the laxative is polyethylene glycol. 25. The edible solid composition according to claim 22 containing chocolate. k k k k k