MXPA98010032A - Non-aqueous colonic purgative formulations - Google Patents

Abstract

Orally administered colonic purgative formulations and methods of their use for effecting partial or complete purgation of the colon in mammals, the formulations consisting of non-aqueous admixtures of a purgative salt selected from the group consisting of Mg3(PO4)2, MgHPO4, Mg(H2PO4)2, MgSO4, MgCl2, Na2SO4, sodium tartrate, potassium tartrate, magnesium tartrate and mixtures thereof, administered in tablet or capsule form in purgative effective concentrations. Preferred embodiments make use of at least one or more magnesium phosphate salts, more preferably dibasic magnesium phosphate;other preferred embodiments include the addition of binders, dispersants and buffers which do not adversely affect osmolality or effectiveness of the purgative formulations.

Description

NON-AQUEOUS COLONY PURGING FORMULATIONS FIELD OF THE INVENTION This invention relates to colonic purgative formulations based on inorganic salts and, more particularly, to non-aqueous purgative formulation compositions which can be administered in capsule or tablet form to prepare the colon for surgical or diagnostic procedures.

BACKGROUND OF THE INVENTION In certain medical procedures, for example, colonoscopy, radiographic examination and in the preparation for patients undergoing bowel surgery, it is often critical that the colon be emptied as completely as possible. For example, in order to obtain satisfactory radiographs, it is often essential that the intestines be sufficiently cleansed, particularly with respect to the elimination of gas from the colon. The same condition also applies when the colon is prepared preoperatively for surgery, or for diagnostic procedures such as colonoscopies, in which case it is also necessary to remove fecal waste materials. Typical colonic purgative procedures of the prior art involve emptying the colon using water enemas, where large amounts of water are introduced into the colon to induce emptying of the contents of the colon that will be expelled in the form of a suspension. However, it has been recognized that the use of enemas can be harmful to the patient. In view of the risk and disadvantages associated with high volume water enemas, an alternative has been to introduce enemas of a typically hypertonic aqueous solution of various salts to replace the high volume water enema. The advantage of these salt formulations is that they require significantly less water volume in their administration. The effect of these hypertonic enemas is based on the increase of osmotic pressure in the colon which, in turn, can have undesirable side effects, particularly if the hypertonic solution diffuses through the wall of the colon and upsets the balance of body fluid. Although this is an improvement over simple water enemas, this potential side effect limits the usefulness of these compositions.

Additionally, many enema compositions in aqueous solutions include a contact laxative agent that causes peristalsis in the colon with sufficient concentration of laxation without the need for excessive amounts of water. Such compositions often include salt mixtures and may also contain chemical agents such as propylene glycol and nonionic wetting agents such as polyether alcohols. Problems with these formulations, apart from frequently problematic enema administration methods, are incomplete evacuation of the intestines, repeated administrations and the inclusion of certain chemicals that may have an irritant effect on the colonic walls. In addition, because it is often necessary to use repeated wash enemas to effectively cleanse the colon, the potential for such chemical irritation is greatly increased. More recently, a number of liquid pharmaceutical compositions administered orally have been developed for use as gastrointestinal washes for diagnostic purposes or for use as cathartic laxatives. Such preparations consist of aqueous solutions of polyethylene glycol and electrolytes such as sodium sulfate, sodium bicarbonate, sodium chloride and potassium chloride. These orally administered compositions are particularly useful in rapidly flushing the colon for diagnostic purposes. For example, when a powerful gastrointestinal wash is required, such preparations are generally administered in an amount of about four liters, the composition will typically be formulated in accordance with the following: 59 g of polyethylene glycol, 5.68 g of sodium sulfate, 1.69 g of sodium bicarbonate, 1.46 g of sodium chloride, 0.745 g of potassium chloride and water to make a liter. Laxation and relatively complete evacuation is often significantly improved by enema formulations, and in general without the problems frequently encountered with enema administrations. The advantages of using these preparations over other preparations administered orally are a drastic reduction in the washing time (from 2-3 days to 4-5 hours) and the minimization of water and electrolyte losses. The advantages provided by these types of solutions are derived from two essential characteristics of the preparation, that is, isoosmoticity with physiological liquids, and the balance of the ionic species in solution, to compensate for the transport mechanism that regulates gastrointestinal absorption. These characteristics result in substantial isotonicity between the preparation and the intracellular and extracellular fluids in the tissues of the walls of the digestive tubes. Commercially available products that modalize these formulations typically use a polyethylene glycol formula that serves as a non-absorbable osmotic agent with a mixture of electrolytes to be filled in, so that patients do not become dehydrated. Patients are required to ingest a significant amount of volume per purge which can include a one-eighth-ounce container every ten minutes for a total gallon of fluid. Due to the fact that the volume is too high, the use of this type of formulation is often associated with distension and nausea on a significant scale. Another serious drawback of these known preparations is their unpleasant, bitter and salty taste, which in most sensitive patients can lead to vomiting, thus preventing their ingestion. However, as the isotonicity requirement of the solution is necessary to obtain the advantages mentioned in the foregoing, the introduction of water-soluble adjuvants should be avoided, for example, to alter the taste. Although most common natural sweeteners such as glucose, fructose, sucrose and sorbitol could change the osmolarity of these solutions, the inclusion of such adjuvants in general is expressly prohibited. In addition, one should still avoid altering the unpleasant taste of these preparations with artificial sweeteners and flavors in these commercial preparations as they could also alter critical isotonicity. Furthermore, in the preparations mentioned in the prior art of the known art, it is also recognized that the addition of appreciable amounts of substances that can be fermented by the intestinal flora must be avoided. This is because the gas that would form could be extremely dangerous in the case of colonoscopy with electrocautery. In an attempt to avoid the problems associated with the high volume types of the preparations, other researchers have used ingestible preparations consisting of aqueous solutions of phosphate salts. The aqueous phosphate salt solution produces a huge osmotic effect on the intra-luminal contents of the intestine and therefore, bowel evacuation occurs with a huge increase in the influx of water and electrolytes in the colon. This has been developed for the express purpose of decreasing the volume required in colonic purges. One such preparation basically comprises 480 grams per liter of monobasic sodium phosphate and 180 grams per liter of dibasic sodium phosphate in buffered, stabilized aqueous solution and sold under the trade name Fleets Phospho-Soda ™. Typically, patients are required to take two-thirds ounce doses of this preparation, separated by a three-hour interval for a total of six ounces, which is a significant reduction compared to the large volumes required by other high-volume preparations. The greatest deficiency of such administration of concentrated aqueous phosphate solution is that the aqueous solution is extremely unpleasant, so much so that the recommended dosage form is administered frosty to minimize the pleasant taste. Frequently, patients complain of severe nausea and vomiting, secondary to the extremely salty taste of the preparation. Frequently, patients can not yet tolerate the ingestion of this preparation in the • Initial dose and often the second dose becomes even more problematic due to the extremely salty, unacceptable taste, even when the taste is partially masked by the use of flavoring agents. In this way, while the concentrated purge solutions represent a slight improvement over other methods for inducing purgation, the deficiencies of these solutions are readily apparent. From the foregoing, it can be seen that this is desirable to have an orally administered colonic formulation that can be easily and conveniently administered and that the pleasant problems and flavors of the known formulations.

- It can also be seen that this is desirable to have a purging formulation that can be administered without large volumes of water needed in conventional formulations and that avoids other potentially irritating or chemical chemicals that could cause osmolality. It is an object of the present invention to provide easily and conveniently administered dose formulations of effective colonic purgatives.

It is yet another object of the present invention to provide a purgative colonic formulation that provides purging activity at lower salt doses than the sodium phosphate tablets of the prior art. It is yet another object of the present invention to provide a method for administering a colonic purgative with a minimum amount of discomfort for the patient. Still another object of the present invention is to provide a formulation for colonic purgatives that avoids the addition of other components that can be broken down by the intestinal flora. These and other objects and advantages of the invention will become apparent after reading the following description.

BRIEF DESCRIPTION OF THE INVENTION The present invention relates to purgative colonic formulations containing active amounts of purgative of a salt selected from the group consisting of Mg 3 (P04) 2 MgHP04, Mg (H2P04) 2, MgSO4, MgCl2, Na2SO4, potassium tartrate, sodium tartrate and magnesium tartrate and mixtures thereof, in a stable, non-aqueous tablet dosage form. In a preferred embodiment, the dose formulation comprises dibasic magnesium phosphate (MgHP04). In preferred embodiments, the formulation comprises an effective amount of a purging salt, preferably, dibasic magnesium phosphate comprising about 0.05 to about 2.0 grams per kilogram of body weight which can be conveniently administered to the patient in a tablet or capsule form. Preferably, the dose for the patient of the purging salt falls within the range of from about 0.1 to about 1.2 grams per kilogram of body weight, the magnesium phosphate salts, more preferably from about 0.2 to 0.7 grams per kilogram of body weight . In preferred embodiments, according to the present invention, the salt is magnesium acid phosphate (dibasic magnesium phosphate) or a mixture of magnesium acid phosphate and magnesium diacid phosphate (monobasic magnesium phosphate). In other preferred embodiments, the formulation may be a mixture of dibasic magnesium phosphate and monobasic magnesium phosphate wherein the total amount of the two salts falls within the above ranges. The formulations, according to the present invention, may further include tablet binders, dispersing and / or buffering agents. In addition, in other embodiments, the formulation may include tribasic magnesium phosphate in addition to magnesium phosphate either monobasic or dibasic, or both, within the above ranges.

DETAILED DESCRIPTION OF THE INVENTION The term "patient" is used throughout the specification to describe an animal, preferably a human, to whom treatment with the compositions in accordance with the present invention is provided. For the treatment of these conditions that are specific to a specific animal such as a human patient, the term patient refers to that specific animal. In most cases, in the description of the present invention, the term "patient" will refer to human patients. The term "salt" or "purging salt" is used throughout the present application to describe one or more of the anhydrous compounds that find use in the purging products according to the present invention. The salts, according to the present invention, can be found in their anhydrous form or as a hydrated crystalline form (ie, in complex form or crystallized with one or more water molecules). Purging salts for use in the present invention include, for example, Mg3 (P04) 2, MgHP04, Mg (H2P04) 2, MgSO4, MgCl2, Na2SO4, potassium tartrate, sodium tartrate and magnesium tartrate or mixtures thereof. . Preferred salts include the magnesium phosphate salts, with a particularly preferred salt being magnesium acid monophosphate (dibasic magnesium phosphate) or a mixture of magnesium acid monophosphate salts and magnesium acid diphosphate. Magnesium phosphate salts are preferred for use in the present invention due to the dual effect that is produced by both phosphate anions and the magnesium cation. As a result of this dual action, the magnesium phosphate salts can be used in the present invention in amounts that are considered "low dose", that is, in an amount that is unexpectedly low based on or compared to other salts, such as sodium phosphate salts that find use in anhydrous purging formulations.

The term "purging effective amount" or "effective purging dose" is used throughout the specification to describe the amount or concentration of purging salts used in the present invention that is effective to produce a purging effect, i.e. the removal or disposal of the intestines of its contents. In the case of the magnesium phosphate salts, it has unexpectedly been found that these salts are advantageously employed in amounts that are significantly lower than the sodium phosphate salts. The term "active purgative" is used to describe salts according to the present invention that exhibit biological or pharmacological activity in the form of purgative activity. In the case of cathartic compounds / compositions which may be used in combination with the present compounds or related prior art compounds such as mono-, di- and tribasic sodium phosphate salts, the term "effective amount" is that amount which is considered effective to produce a proposed result, if the proposed result or effect is a cathartic effect or a purgative effect. The term "anhydrous" is used throughout the specification to describe the manner in which purging salts are administered in accordance with the present invention. Anhydrous formulations are those that have essentially excluded water from the formulations, except in cases where the salt is hydrated or otherwise complexed with small amounts of water. The physiology of intestinal secretion and absorption is generally well known as it is reflected in the literature reported. While not limited by any form or theory, the invention of the applicant is believed to function by creating an increase in the intraluminal fluid of the small intestine to a significant degree and / or creating favorable osmotic conditions in the intestine that allows a net secretion of sodium and water in the lumen. In addition, in certain embodiments using magnesium phosphate anions, the osmotic effect of the phosphate anions in combination with the effect of improving the motility of the magnesium cations creates a purifying synergistic effect that makes the magnesium phosphate salts particularly preferred for use in the present invention. This allows huge flows of water to be present within the gastrointestinal lumen exhibiting increased motility, thus producing an unexpectedly effective purging effect. In the production of the formulations, according to the present invention, in a preferred embodiment, the present invention consists of a dry mixture of dibasic magnesium phosphate or a mixture of monobasic and dibasic magnesium phosphate in an anhydrous state. The formulations, according to the present invention, can be prepared by placing one or more of the purging salts, according to the present invention, in pharmaceutical form, in a ribbon blender or other similar mung apparatus to effect the complete mixing of the components. Additional constituents such as tablet binders, dispersants and / or buffering agents in the range of about 0.025% to 25% by weight, more preferably from about 1% to 5% by weight, may also be included in the mixture. The formulations can be formulated in the form of a tablet or capsule for oral administration to the patient. In preferred embodiments, in accordance with the present invention, the phosphate salts are preferably used, magnesium phosphate salts and more preferably magnesium acid monophosphate or mixtures of magnesium acid monophosphate and magnesium acid diphosphate. In other preferred embodiments, the amount of magnesium acid diphosphate can be substantially reduced or eliminated in its entirety. In these formulations, the dibasic phosphate or the tribasic phosphate salts such as magnesium dibasic phosphate and tribasic magnesium phosphate can be used alone or in combination as the main or exclusive form of phosphate in the formulation, while a full purgative effect is maintained. Other phosphate salts, according to the present invention, can be used, but these salts are less preferred. Until ingestion, the phosphate salts cause an enormous amount of water to infuse into the intestine. This influx of water causes an increase in intraluminal pressure, which in turn exerts a mechanical stimulus causing an increase in intestinal motility. The purging effect of the phosphate salts seems to be proportionally related to the increase in the anionic state of the phosphate salt and can be differentiated in its action form from other salt formulations which are capable of producing a limited cathartic effect. One such salt, magnesium sulfate, for example, exerts its effect by means of the magnesium cation which causes hyper-tractility of the intestine. Although not limited by some form of the theory, it is believed that the magnesium phosphate salts, according to the present invention, exert their unexpected enhanced activity by virtue of the combined activity of the phosphate anion and magnesium cation, creating a dual effect. The mixture of the present invention is formed in an easily administered dosage form, such as tablets or within capsules or methods well known in the art. As used herein, the term "mixture" refers to a formulation that includes at least one purgative salt, preferably a phosphate or magnesium salt, more preferably at least one magnesium phosphate salt and even higher preferably magnesium acid phosphate (alone or in combination with another laxative salt, preferably a magnesium phosphate salt) and at least one other component including other phosphate salts or other additives as described herein. When the tablets containing the purging formulation are formed, it will be appreciated that the salts can be compressed into a uniform mixture and can optionally include inert diluents such as a tablet binder. Preferably, the tablet binder is a pharmaceutically acceptable binder and is one that does not produce appreciable osmotic effects. Examples of useful binders include nonionic detergents from the Pluronic ™ series, such as Pluronic F-68 (a trademark of BASF-Wyandotte Chemicals, defined as a condensate of ethylene oxide with a condensate of propylene oxide and propylene glycol), related nonionic surfactants and mechanical adhesives such as polyvinyl alcohol and sodium carboxymethylcellulose, among many others. Microcrystalline cellulose (MCC) can also be used to improve the compactability of purging salts in the form of a tablet or capsule. An ordinary expert could easily modify the combined adhesives with the purging salts, according to the present invention, to optimize the formulations for oral administration. In another preferred embodiment of the present invention, the tablet or capsules may also include inert dispersing agents that would facilitate dissolution of the contents of the tablet or capsule in the patient's stomach. Preferably, the dispersing agent is a pharmaceutically acceptable dispersant and is one that also does not produce appreciable osmotic effects. Examples of acceptable dispersants include microcrystalline cellulose (which is also useful as a compacting agent) and anhydrous lactose. A preferred dispersing agent is AC-DI-SOL, a cross-linked starch. In another preferred embodiment of the present invention, the preferred composition may also include a quenching agent to minimize any disproportionation of acid that may accompany the ingestion of the purging formulation of the Applicant's invention. Suitable buffering agents include magnesium hydroxide, aluminum hydroxide, calcium carbonate and magnesium carbonate. An important feature of the purgative colonic formulations of the present invention is that they effectively function as purgatives when administered in low volume doses., as compared to known formulations. Thus, from 2 to 12 tablets, and preferably from 4 to 10 tablets per dose, depending on the size of the tablet and weight, with only the fluids needed to aid in the ingestion of the tablets, will provide complete purgation. The dose can be administered in a single application but can be administered preferably in two separate applications for approximately 2 to 4 hours. The use of the formulations of this invention in tablet form effectively eliminates the colonic contents without requiring the injection of large amounts of water. The conventional purgative products historically and currently available in the market have had to employ much larger volumes of liquid to obtain the desired result. A further aspect of the present invention relates to the inclusion of purgative salts described herein in combination with other purgative and / or laxative compounds and / or compositions of the prior art. Thus, any or more of the purging salts, according to the present invention, can be combined in an effective amount with and / or co-administered with an effective amount of any one or more of the many different purging salts and / or laxative compounds. which include, for example, sodium phosphate salts (mono-, di- and tribasic salts) of U.S. Patent No. 5,616,346 to Craig Aronchick, related preparations of aqueous sodium phosphate salts, eg, polyethylene glycol, electrolytes such as sodium sulfate, sodium bicarbonate, sodium chloride and potassium chloride, among others, which include Mg (0H) 2, citrate salts such as magnesium citrate, sorbitol, and magnesium carbonate hydroxide, among many others. In yet another aspect of the present invention, sodium phosphate salts (mono-, di- and tribasic) can be combined with any one or more of the compounds of the present invention or of the prior art can be combined in effective amounts to produce potentially synergistic purgative activity. Thus, in this aspect of the present invention, sodium phosphate salts (mono-, di- and tribasic salts) as described by Aronchick, U.S. Patent No. 5,616,346, are combined with any or more of Mg3 (P04) 2, MgHP04, Mg (H2P04) 2, MgSO4, MgCl2, Na2SO4, sodium tartrate, potassium tartrate, magnesium tartrate or mixtures thereof of the present invention or alternatively, the phosphate salts of the prior art of Aronchick can be combined with any or more of the purging or laxative compounds of the prior art or compositions including, for example, phosphate salts aqueous sodium, polyethylene glycol or aqueous polyethylene glycol, electrolyte solutions such as sodium sulfate, sodium bicarbonate, sodium chloride and potassium chloride, among others, including Mg (OH) 2, citrate salts such as magnesium citrate , lactate salts such as magnesium lactate, sorbitol, magnesium carbonate hydroxide, diphenylmethane such as phenolphthalein and bisacodyl, methylcellulose, sodium carboxymethylcellulose, psyllium preparations (plantago) , tragacanth and related natural gums, bran and other fibers, sodium and potassium tartrate, castor oil, anthraquinones such as sena, cascara sagrada, aloe and dantrone, dioctyl sodium sulfosuccinate, dioctyl calcium sulfosuccinate and mineral oil, among others, in effective amounts, to produce a laxative and / or laxative composition that manifests synergistic activity as compared to prior art compositions and / or compounds that are used alone. In this aspect of the present invention, a combination of the compounds described in the foregoing is administered to a patient in an effective amount to produce a purgative or cathartic / laxative effect. These compounds / compositions can be administered in solid or liquid (aqueous) form and are taken orally to produce the proposed effect. An ordinary expert can easily determine the amount and types of the compounds / compositions to be used in treating a particular patient. Combinations of the compounds / compositions as described above can be administered at the same time, or within the activity period of a first compound / composition to improve the effect of the first compound or compounds or composition or compositions used. In this regard, combinations of the compounds or compositions as described herein can be co-administered to produce an improved purgative effect. The above description is illustrative of the preferred embodiments shown. It is not intended to limit the present invention to the specific formulations shown and described, but instead it will be appreciated that the adaptations and modifications will become apparent from the present disclosure and are intended to be within the scope of the claims.

Claims (27)

RE IVINDICATIONS

1. A non-aqueous, orally administrable composition capable of inducing colon purge of a patient, characterized in that it comprises an effective purging amount of a non-aqueous mixture of a compound selected from the group consisting of magnesium and sodium phosphates, sulfates and tartrates, and mixtures thereof. same.

2. An orally administrable non-aqueous composition capable of inducing colon purge of a patient, characterized in that it comprises an effective purgative amount of a non-aqueous mixture of a salt selected from the group consisting of Mg 3 (P04) 2, MgHP04, Mg (H2P04) 2 , MgSO4, MgCl2, Na2SO4, sodium tartrate, potassium tartrate, magnesium tartrate and mixtures thereof.

3. The composition, according to claim 1 or claim 2, characterized in that the salt is a phosphate salt.

4. The composition, according to claim 1 or claim 2, characterized in that the phosphate salt is selected from the group consisting of monobasic magnesium phosphate, dibasic magnesium phosphate and tribasic magnesium phosphate.

5. The composition according to claim 3, characterized in that the phosphate salt is dibasic magnesium phosphate or a mixture of dibasic magnesium phosphate and monobasic magnesium phosphate.

6. The composition, according to claim 1 or claim 2, characterized in that the salt is included in an amount ranging from about 0.05 grams per kilogram of body weight to about 2.0 grams per kilogram of the patient's body weight.

7. The composition, according to claim 4, characterized in that the magnesium phosphate salt is included in an amount ranging from about 0.1 to about 1.2 grams per kilogram of the patient's body weight.

8. The composition, according to claim 4, characterized in that the magnesium phosphate salt is dibasic magnesium phosphate included in an amount ranging from about 0.2 to about 0.7 grams per kilogram of the patient's body weight.

9. The composition according to claim 1 or claim 2, further characterized in that it comprises a buffering agent selected from the group consisting of magnesium hydroxide, aluminum hydroxide, calcium carbonate and magnesium carbonate.

10. The composition according to claim 4, further characterized in that it comprises a buffering agent selected from the group consisting of magnesium hydroxide, aluminum hydroxide, calcium carbonate and magnesium carbonate.

11. The composition, according to claim 1 or claim 2, further characterized in that it comprises a dispersing agent selected from the group consisting of anhydrous lactose, microcrystalline cellulose and ACDI-SOL.

12. The composition according to claim 10, further characterized in that it comprises a dispersing agent selected from the group consisting of anhydrous lactose, microcrystalline cellulose and ACDI-SOL.

13. The composition, according to claim 1 or claim 2, further characterized in that it comprises a binder selected from the group consisting of nonionic detergents, mechanical adhesives and microcrystalline cellulose.

14. The composition, according to claim 10, further characterized in that it comprises a binder selected from the group consisting of nonionic detergents, mechanical adhesives and microcrystalline cellulose.

15. A method for inducing colon purgation in a patient, characterized in that it comprises the steps of: (a) preparing a non-aqueous mixture of a purging salt selected from the group consisting of magnesium and sodium phosphates, sulfates and tartrates, and mixtures of the same to constitute a purgative formulation; (b) constituting an orally administrable dosage form of the purging formulation; (c) orally administering an effective purging dose of the formulation to a patient; and (d) allowing the administered dose to induce purgation.

16. A method for inducing colon purgation in a patient characterized in that it comprises the steps of: (a) preparing a non-aqueous mixture of a purging salt selected from the group consisting of Mg 3 (P04) 2, MgHP04, Mg (H2P04) 2, MgSO4, MgCl2, Na2SO4, sodium tartrate, potassium tartrate, magnesium tartrate and mixtures thereof to form a purging formulation; (b) constituting an orally administrable dosage form of the purging formulation; (c) orally administering an effective purging dose of the formulation to a patient; and (d) allowing the administered dose to induce purgation.

17. The method according to claim 15 or claim 16, characterized in that step (a) further includes the step of adding to the purging formulation at least one member selected from the group consisting of buffering agents, dispersing agents and binding agents. .

18. The method according to claim 15 or claim 16, characterized in that the orally administrable dosage form is selected from the group consisting of gelatine capsules and tablets.

19. The method according to claim 15 or claim 16, characterized in that the mixture formed in step (a) includes a purging salt selected from the group consisting of dibasic magnesium phosphate, monobasic magnesium phosphate and mixtures thereof.

20. The method according to claim 19, characterized in that the purging salt is dibasic magnesium phosphate included in an amount ranging from about 0.2 grams per kilogram of body weight to 12.0 grams per kilogram of body weight.

21. The method according to claim 19, characterized in that the purging salt is a mixture of dibasic magnesium phosphate and monobasic magnesium phosphate included in an amount ranging from about 0.2 grams per kilogram of body weight to 12.0 grams per kilogram of body weight .

22. The method according to claim 20, characterized in that the dibasic magnesium phosphate is administered in a proportion from about 0.2 grams per diagram I of body weight to 0.7 grams per kilogram of body weight.

23. The method according to claim 15 or claim 16, characterized in that step c) is repeated at least once.

24. The method according to claim 19, characterized in that step c) is repeated at least once.

25. An orally administrable non-aqueous composition capable of inducing colon purge to a patient, characterized in that it comprises an effective purgative amount of a non-aqueous mixture of a salt selected from the group consisting of magnesium and sodium phosphates, sulfates and tartrates and mixtures thereof. same in combination with an effective purgative amount of at least one sodium phosphate salt selected from the group consisting of monobasic sodium phosphate, dibasic sodium phosphate and tribasic sodium phosphate.

26. The composition according to claim 25, characterized in that the composition further includes an effective amount of at least one composition selected from the group consisting of aqueous sodium phosphate salts, polyethylene glycol, aqueous polyethylene glycol, aqueous solutions of sodium sulfate, sodium bicarbonate, sodium chloride or potassium chloride, Mg (0H) 2, citrate salts such as magnesium citrate, lactate salts such as magnesium lactate, sorbitol, magnesium carbonate hydroxide, phenolphthalein, bisacodyl, methylcellulose, sodium carboxymethyl cellulose, psyllium, tragacanth, bran, sodium and potassium tartrate, castor oil, sena, cascara sagrada, aloe, dantrone, dioctyl sodium sulfosuccinate, dioctyl calcium sulfosuccinate, mineral oil and mixtures thereof.

27. An orally administrable non-aqueous composition capable of inducing colon purge to a patient, characterized in that it comprises an effective purgative amount of a non-aqueous mixture of a sodium phosphate salt selected from the group consisting of monobasic sodium phosphate, dibasic sodium phosphate and tribasic sodium phosphate in combination with an effective amount of at least a composition selected from the group consisting of aqueous sodium phosphate salts, polyethylene glycol, aqueous polyethylene glycol, aqueous solutions of sodium sulfate, sodium bicarbonate, sodium chloride or potassium chloride, Mg (0H) 2, citrate salts such as magnesium citrate, lactate salts such as magnesium lactate, sorbitol, magnesium carbonate hydroxide, phenolphthalein, bisacodyl, methylcellulose, sodium carboxymethylcellulose, psyllium, tragacanth, bran, sodium and potassium tartrate, castor oil, sena, cascara Saccharose, aloe, dantrone, dioctyl sodium sulfosuccinate, dioctyl calcium sulfosuccinate, mineral oil and mixtures thereof.