ALGINATE, POLYLYSINE, AND SEED PRESERVATIVE NUTRITIONAL PRODUCT AND DIGESTIVE AID

Abstract

An alginate-based nutritional product (“AP”) comprising a composition and digestive aid. AP includes alginate as a demulcent (protective), raft-forming, stabilizing agent, polylysine, dextrose and grapefruit seed extract preservatives. The pharmaceutical composition is intended for the relief or prophylaxis of acid reflux and other forms of indigestion in mammals. In some embodiments, dextrose and polylysine are combined to form a preservative for the alginate-based nutritional supplement. In other embodiments, dextrose (or other common sugars known in the art), grapefruit seed extract, and polylysine are combined to form a preservative for the alginate-based nutritional supplement.

Claims

1. A composition for mitigating the harmful effects of stomach acid in a subject, said composition comprising an alginate-based product (AP), wherein AP comprises alginate, a stabilizer, an alkaline salt, a secondary alkaline agent, and a salt comprising calcium.

2. The composition of claim 1, wherein alginate comprises an alkaline metal alginate, and wherein AP further comprises a preservative.

3. The composition of claim 2, wherein the stabilizer comprises polylysine, and wherein AP further comprises at least one flavoring agent.

4. The composition of claim 3, further comprising grapefruit seed extract, cofactors, excipients, and/or combinations thereof.

5. The composition of claim 4, wherein the preservative comprises dextrose, and wherein AP further comprises at least one suspending agent.

6. The composition of claim 5, wherein AP is formulated as a powder, aqueous suspension, tablet, pill, gummy, soft gel, and/or capsule.

7. The composition of claim 6, wherein AP is formulated such that it benefits from enhanced pourability, the formulation with enhanced pourability comprising liquid potassium bicarbonate, at least 10% w/v sodium alginate, at least 5 g calcium carbonate, and at least 100 g dextrose.

8. The composition of claim 2, wherein the alkaline metal alginate is mixed in combination with a binder and/or lubricant.

9. The composition of claim 8, wherein AP further comprises an alkaline salt mixed with a surfactant.

10. A solid or powderized composition for mitigating the harmful effects of stomach acid and/or for forming a reflux preventing raft in a subject, said composition comprising AP, wherein AP comprises sodium alginate, polylysine, an alkaline salt, and an agent comprising calcium, wherein the raft floats on top of stomach contents.

11. The composition of claim 10, the composition further comprising a carrier and wherein the alkaline salt is a disintegrating agent.

12. The composition of claim 11, wherein the disintegrating agent is selected from the group consisting of sodium bicarbonate (NaHCO.sub.3), potassium bicarbonate (KHCO.sub.3), and/or mixtures thereof.

13. The composition of claim 12, wherein AP further comprises at least 2% by weight of a further alkaline agent selected from the group consisting of magnesium hydroxide (Mg(OH).sub.2), potassium hydroxide (KOH), sodium hydroxide (NaOH), sodium acetate (C.sub.2H.sub.3O.sub.2Na), and mixtures thereof.

14. The composition of claim 13, wherein AP comprises less than 10% by weight, based on the weight of the sodium alginate, of a salt comprising calcium.

15. The composition of claim 14, wherein the further alkaline agent is magnesium hydroxide.

16. The composition of claim 14, wherein the composition further comprises an amount of either potassium bicarbonate or sodium bicarbonate, or some combination totaling 15% by weight or more, based on the weight of the sodium alginate.

17. The composition of claim 15, wherein the amount of magnesium hydroxide is 3% by weight or more, based on the weight of the sodium alginate.

18. The composition of claim 10, wherein the agent comprising calcium further comprises Vitamin B5 and/or another B complex vitamin.

19. A composition for mitigating the harmful effects of stomach acid in a subject, said composition comprising AP, wherein AP comprises sodium alginate, polylysine, dextrose or another sugar, grapefruit seed extract, and at least one flavoring agent, wherein the grapefruit seed extract comprises natural seed antioxidants, fibers, and resveratrol.

20. The composition of claim 19, wherein said at least one flavoring agent comprises vanilla, caramel, mint chocolate, and or other natural flavors; and wherein the composition further comprises an alkaline salt, the alkaline salt comprising a cross-linking polyvalent metal ion and is non hormone-disrupting in the human body.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0026] In order to enhance clarity and improve understanding of the various elements and embodiments of the invention, elements in the figures have not necessarily been drawn to scale. Furthermore, elements that are known to be common and well understood to those in the industry are not depicted in order to provide a clear view of the various embodiments of the invention. Thus, the drawings are generalized in form in the interest of clarity and concision.

[0027] FIG. 1 shows the chemical structure for polylysine in accordance with the preferred embodiment of the present invention;

[0028] FIG. 2 shows the chemical structure for dextrose in accordance with the preferred embodiment of the present invention;

[0029] FIG. 3 shows the chemical structure for alginic acid (“alginates”) in accordance with the preferred embodiment of the present invention; and

[0030] FIG. 4 shows a diagrammatic image of an alginate raft precipitate.

DETAILED DESCRIPTION OF THE INVENTION

[0031] In the following discussion that addresses a number of embodiments and applications of the present invention, reference is made to the accompanying drawings that form a part hereof, and in which is shown by way of illustration specific embodiments in which the invention may be practiced. It is to be understood that other embodiments may be utilized and changes may be made without departing from the scope of the present invention.

[0032] Various inventive features are described below that can each be used independently of one another or in combination with other features. However, any single inventive feature may not address any of the problems discussed above or only address one of the problems discussed above. Further, one or more of the problems discussed above may not be fully addressed by any of the features described below.

[0033] As used herein, the singular forms “a”, “an”, and “the” include plural referents unless the context clearly dictates otherwise. “And” as used herein is interchangeably used with “or” unless expressly stated otherwise. As used herein, the term “about” means +/−5% of the recited parameter. All embodiments of any aspect of the invention can be used in combination unless the context clearly dictates otherwise.

[0034] Unless the context clearly requires otherwise, throughout the description and the claims, the words “comprise”, “comprising”, and the like are to be construed in an inclusive sense as opposed to an exclusive or exhaustive sense; that is to say, in the sense of “including, but not limited to”. Words using the singular or plural number also include the plural and singular number, respectively. Additionally, the words “herein,” “wherein”, “whereas” “above,” and “below” and words of similar import, when used in this application, shall refer to this application as a whole and not to any particular portions of the application.

[0035] The description of embodiments of the disclosure is not intended to be exhaustive or to limit the disclosure to the precise form disclosed. While the specific embodiments of, and examples for, the disclosure are described herein for illustrative purposes, various equivalent modifications are possible within the scope of the disclosure, as those skilled in the relevant art will recognize.

[0036] In some embodiments, the use of polylysine 10, dextrose 20 and grapefruit seed extract as preservatives in an alginate-based product is contemplated. In the preferred embodiment, the alginate-based product (hereafter referred to as “AP” or “alginate supplement”) is a composition that includes an alginate-based product using alginate 30 as a stabilizing agent, in addition to polylysine 10, dextrose 20 and grapefruit seed extract preservatives. In some embodiments, dextrose 20 (or other common sugars known in the art) and polylysine 10 are combined to form a preservative for the alginate-based nutritional supplement. In other embodiments, dextrose 20 (or other common sugars known in the art), grapefruit seed extract, and polylysine 10 are combined to form a preservative for the alginate-based product.

[0037] In some embodiments, the dextrose 20 sugars, and/or other sugars, contribute to desiccation of the product which facilitates its action as a preservative. In addition, in some embodiments AP forms a demulcent (protective) barrier on the mucosal lining of the throat and esophagus of a user in order to provide relief against the partially regurgitated low pH constituents of the small intestine and stomach characteristic of gastroesophageal reflux. Once in the stomach, and as shown in FIG. 4, AP forms a stable protective raft 40 of foam-like composition (also referred to herein as a “gel raft”, “foam”, or “foam raft”) that serves as a pH neutral mechanical barrier reducing gastric regurgitation from the stomach to the esophagus and throat.

[0038] Reduction in regurgitation reduces exposure of the throat of a user to the low pH contents of the stomach, which otherwise contributes to local inflammation, DNA damage, pain, halitosis, and poor sleep.

[0039] In the preferred embodiment, AP comprises 200 mg sodium alginate, 170 mg Vitamin B5, 200 mg sodium bicarbonate, dextrose 20, polylysine 10, and grapefruit seed extract. In the preferred embodiment, the alginate gel coats the tissues of the throat and esophagus, providing relief against acid reflux and other forms of indigestion described above. Notably, the 200 mg Sodium Alginate is used as a food additive, forming a foam-like and/or viscous solution or gel. In addition, the 170 mg Vitamin B5 (calcium pantothenate) enhances the strength and cohesiveness of the foam-like raft. Calcium increases raft strength by cross-linking alginic acid polymers 30. In some embodiments, Vitamin B5 provides the unexpected result of enhanced raft strength and reduced acid reflux. Further, Vitamin B5 helps the body convert masticated carbohydrates into glucose, which the body uses to produce Adenosine Triphosphate (ATP) via aerobic metabolism. These B vitamins, often referred to as B complex vitamins, also help the body metabolize fats and protein and contribute to improved nervous system function. The AP further serves to fill the stomach and can be used as a diet aid.

[0040] Further to the above, 200 mg Sodium Bicarbonate enhances the utility and potency of the raft formation. Notably, in the presence of gastric acid, the bicarbonate forms carbon dioxide bubbles within the alginate gel matrix, in the process, buffering acid. This feature induces foaming action in the raft and further allows the gel to float on the surface of the gastric contents. Carbon dioxide also contributes to the acid mitigating effect of AP. In some embodiments, dextrose 20 serves as an all-natural sweetener and essential preservative. As described above, dextrose 20 also reduces the water content of AP which is essential to the preservative function of AP. The unique combination of alginate 30 and dextrose 20 significantly enhances the acid reflux-dampening effect of AP in a manner not contemplated by the art. As described above, polylysine 10 also serves as an essential all-natural preservative. In some embodiments, grapefruit seed extract (“GSE extract”) serves as an essential all-natural preservative, antifungal, and sweetener providing a unique high concentration of antioxidants.

[0041] In some embodiments, AP is a low sodium, iodine-free, potassium-free alternative to many anti-reflux compositions known in the art. Other products known in the art contain potential carcinogens such as paraben, a known hormone disruptor, high salt content, high concentrations of potassium, contributing to high blood pressure and kidney injury in some patients. In contrast, all ingredients of AP are non-synthetic, thus ameliorating digestive and organ filtering issues. In another embodiment, AP serves as a dieting aid with the utility of AP largely derived from its fibrous compounds. In the stomach of a user, said compounds expand, making the user feel satiated while contributing to a well-balanced pH environment. In other embodiments, the composition may be used in connection with weight loss strategies and programs due to the effect of reduction of hunger pains associated intermittent fasting and hunger generally.

[0042] Expanding on the utility of Vitamin B5, aside from its digestive functions, the compound is highly water soluble and is critical to the manufacture of red blood cells. Further, Vitamin B5 acts as a substrate for the synthesis of stress-related hormones produced in the adrenal glands. In some embodiments, Vitamin B5 in AP facilitates maintenance of a healthy digestive tract and helps the body use other vitamins, particularly B2 (also called riboflavin). Notably, the miscibility of calcium and Vitamin B5 were contemplated by the present inventors. In some embodiments, the ideal composition of ingredients (optimized for solubility) included a Chilean seaweed sourcing of alginate 30 (specifically, lessonia nigrescens) formulated at a ratio of 60/40 (M/G) ratio.

[0043] In some embodiments, various dosages of each of the above ingredients are contemplated, with each optimized for buffering, antioxidant capacity, and the like, tailored to each particular foodstuff. As described above, in the preferred embodiment AP comprises 200 mg sodium alginate, 170 mg Vitamin B5, 200 mg sodium bicarbonate, dextrose 20, polylysine 10, and grapefruit seed extract. In another embodiment, AP comprises a range of 75-400 mg sodium alginate, 100-350 mg Vitamin B5, 100-300 mg sodium bicarbonate, with dextrose 20, polylysine 10, and grapefruit seed extract included at non-specific dosages.

[0044] In some embodiments, AP relates to the relief of reflux esophagitis using alginates 30 specifically formulated to inhibit proteolytic enzymes. In some embodiments, the invention relates to inhibiting the proteolytic activity of pepsin and/or gastric juices. In other embodiments, one or more dextrose molecules 20 with a preferred molecular weight of less than 500 kDa are used in combination with polylysine 10, dextrose 20 and grapefruit seed extract preservatives. The composition may be in the form of a dry powder, which can be admixed with water. Furthermore, the preparations may be composed in liquid form preferably containing the amount of from 0.1 to 15% w/v of dextrose 20. In some embodiments, the composition further comprises a neutralizing agent for neutralizing gastric acid such as sodium hydroxide.

[0045] In some embodiments, the composition preferably comprises divalent or trivalent metal cations to strengthen the formation of the foamy alginate raft. The cations may be calcium or aluminum ions, for example. For instance, the composition may contain from 10 to 80 g of calcium carbonate per 100 g dextrose 20. In some embodiments, AP exercises its effect by dissolving solid calcium carbonate salt in the stomach under the influence of the acid gastric fluid, in addition to polylysine 10, dextrose 20 and grapefruit seed extract. The increasing calcium concentration will stimulate the alginate gelation as calcium ions and the polysaccharides form a rigid matrix. Furthermore, the dissolving of calcium carbonate and sodium bicarbonate liberates CO.sub.2 gas which will be entrapped in the alginate matrix thereby forming foam. Apart from the potential carcinogens and known hormone disruptors in the art in addition to the inconvenience of the consumption an inhomogeneous product, products known in the prior art have the disadvantage that the consumer may not obtain the calcium salt in a proper dose for an optimal gelation to progress. More importantly, the sodium alginate salts used in the prior art are not available to react with the acid present in the stomach because it is occupied with calcium ions in a cage-like structure.

[0046] To remedy this problem, in some embodiments AP can act as both an antacid and a foam barrier or raft where the esophagus empties into the top of the stomach. When the tablet is swallowed or the liquid is ingested, the antacid, polylysine 10, dextrose 20 and grapefruit seed extract reduce stomach acid and the foaming agent creates a physical barrier that helps provide relief from acid reflux. The compositions may be administered orally in the form of a dry powder or aqueous suspension which may also contain a suspending agent and/or a preservative. The antacid/foam formulation reacts with gastric acid to form a raft on the contents of the stomach. In some embodiments, AP comprises a foam formulation with a 2.0 to 12.0% weight/volume of a low viscosity grade dextrose admixed a secondary preservative sugar. Relatedly, a liquid formulation of the antacid/foam formulation comprises an aqueous medium containing 1.5 to 10.0% weight/volume of a low viscosity grade dextrose 20 admixed with other sugars known in the art. To suspend the calcium carbonate particles in the aqueous medium a suspending agent like acrylic polymer cross-linked with 1% dextrose 20 may be used.

[0047] In other embodiments, improved pourability is obtained in an AP formulation wherein a liquid composition comprising potassium bicarbonate instead of other bicarbonates and at least 10% w/v sodium alginate is used in combination with polylysine 10, dextrose 20 and grapefruit seed extract as preservatives. The composition obtains a viscosity which does not possess thickening problems even when stored at low temperatures. Salt of divalent metal ions, such as calcium carbonate, are generally included in the compositions described above in an amount of 5 to 40 g/100 g dextrose 20 in order to obtain an optimal foam-like raft formation.

[0048] In some embodiments, a method for providing relief from reflux esophagitis as well as dyspepsia using all natural polylysine 10, dextrose 20 and grapefruit seed extract as preservatives is contemplated. As described above, this method further relates to the preparation of a pourable liquid sodium alginate composition. The composition preferably comprises a dextrose 20 content of 8 to 15% w/v. In this example, the composition further comprises an amount of bicarbonate. Bicarbonate may be required in order to produce adequate carbon dioxide in the stomach to obtain a proper raft formation 20.

[0049] In some embodiments, the composition of the invention may contain a minor amount of an alkaline salt comprising a cross-linking polyvalent metal ion to support the foam-like raft, if desired, when contacted with the gastric juice. The cross-linking polyvalent metal ion may be ions of calcium and aluminum and the salt may as an example be selected among calcium carbonate, CaHPO.sub.4, aluminum carbonate and aluminum hydroxide. The salt comprising the cross-linking polyvalent metal ion is usually present in an amount of less than 12% weight, such as less than 5% by weights, such as less than 1% by weights, such as less than 0.3% by weights, preferably less than 0.1% weight, based on the weight of the alginate. The salt is generally solid in the composition but is suitable highly dissolvable at a pH present in the stomach. In an aspect of the invention the salt provides less than 200 ppm polyvalent metal ions when the pH of the composition is changed to about pH=2. In one aspect the amount of calcium salt in the composition provides less than 50 ppm dissolved calcium ions when the pH is changed to about pH=2.

[0050] In some embodiments, AP further comprises an alkaline salt, wherein the alkaline salt is a disintegrating agent selected from the group consisting of sodium bicarbonate (NaHCO.sub.3), potassium bicarbonate (KHCO.sub.3), and mixtures thereof. In some embodiments, AP further comprises at least 2%, 4%, 8%, 10% by weight or more, based on the weight of the sodium alginate, of a further alkaline agent selected among the group consisting of magnesium hydroxide (Mg(OH).sub.2), potassium hydroxide (KOH), sodium hydroxide (NaOH), sodium acetate (C.sub.2H.sub.3O.sub.2Na), and mixtures thereof. In some embodiments, AP further comprises less than 10%, 8%, 6%, or 4% by weight based on the weight of the sodium alginate of a salt comprising calcium. In some embodiments, the composition further comprises an alkaline agent such as magnesium hydroxide.

[0051] Further to the above, in some embodiments, the composition further comprises an amount of sodium bicarbonate that is 10%, 12%, 15%, or 20% by weight or more, based on the weight of the sodium alginate. In other embodiments, the amount of magnesium hydroxide is 1%, 2%, or 3% by weight or more, based on the weight of the sodium alginate. As described above, in the preferred embodiment the alginate-based product (“AP”) is a composition that includes alginate 30 as a stabilizing agent, in addition to polylysine 10, dextrose 20, grapefruit seed extract preservatives, with an optional minor amount of salt. In other aspects, however, the composition of the invention (“AP”) does not contain an added salt comprising a cross-linking polyvalent metal ion, such as a calcium salt, said salt being capable of dissolving at a pH present in the stomach. Insignificant amounts of calcium salts may be present in, for example, the tap water ingested by a user of the composition. In one embodiment, at least 70%, such as 80%, preferably at least 90% of the alkali metal carboxylic acid groups of the alkali metal alginate are available for reaction with the stomach acid, i.e., is not reacted with a cross-linking polyvalent metal ion. In some embodiments, the agent comprising calcium is Vitamin B5. Calcium pantothenate is alternately known as pantothenic acid or vitamin B5 or panthenol, which is a composition of 8% calcium and 92% pantothenic acid.

[0052] The compositions according to the present invention may comprise one or more acceptable carriers in addition to the active constituent(s) described above. The carrier(s) must be “acceptable” in the sense of being compatible with the other ingredients of the composition and not deleterious to the recipients thereof. In a certain embodiment, the alginate is purified. The composition may be formulated as tablets, pills, syrups, capsules, powders, gummies, gels, etc.

[0053] The term “carrier” refers to a diluent, adjuvant, excipient, or vehicle with which the active components are administered. The carriers in the composition may comprise a binder, such as microcrystalline cellulose, polyvinylpyrrolidone (polyvidone or povidone), gum tragacanth, gelatin, starch, lactose or lactose monohydrate; a lubricant or surfactant, such as magnesium stearate, or sodium lauryl sulphate; a glidant, such as colloidal silicon dioxide; a sweetening agent, such as dextrose 20, sucrose or saccharin; and/or a flavoring agent, such as peppermint, methyl salicylate, or orange flavoring.

[0054] In some embodiments, the AP formulation further comprises one or more enzyme cofactors, and/or one or more essential nutrients. Exemplary cofactors include vitamin C, biotin, vitamin B5, vitamin E, and vitamin K. Exemplary essential nutrients are amino acids, fatty acids, etc. AP may also comprise one or more excipients known in the art, such as dispersing agents, wetting agents, and suspending agents. Solutions, suspensions, or emulsions of AP may also contain one or more excipients known in the art, such as dispersing agents, wetting agents, and suspending agents.

[0055] Therapeutic formulations suitable for oral administration, e.g., tablets and pills, may be obtained by compression or molding, optionally with one or more accessory ingredients. Compressed tablets may be prepared by mixing the constituent(s) and compressing this mixture in a suitable apparatus into tablets having a suitable size. In one embodiment, prior to the mixing, an alkaline metal alginate may be mixed with a binder, a lubricant, an inert diluent and/or a disintegrating agent and the alkaline salt may be mixed with a diluent, a lubricant and/or a surfactant.

[0056] In some embodiments, when one or more carriers are present, free-flowing alkaline metal alginate powder may be mixed with a binder, such as microcrystalline cellulose, and a surfactant, such as sodium lauryl sulphate, until a homogeneous mixture is obtained. Subsequently, another binder, such as polyvidone, may be transferred to the mixture under stirring. When a uniform distribution is obtained the alkaline salt is added under constant stirring. This mixture is passed through granulating sieves and dried by desiccation before compression into tablets in a standard compressing apparatus. Alternatively, the tablets are prepared without the addition of carriers. According to this alternative embodiment the free-flowing alkaline metal alginate is mixed with an alkaline salt before the mixture is compressed into tablets. Conventional methods for producing a solid form of the composition may be found in the European Pharmacopoeia, which is included herein by reference. A tablet may be coated or uncoated. An uncoated tablet may be scored. A coated tablet may be coated with sugar, shellac, film or other enteric coating agents.

[0057] In other embodiments, grape seed compounds comprise natural seed antioxidants, fibers, and MTOR compounds (e.g., compounds shown to act on MTOR gene signaling pathways including resveratrol). In other embodiments, inclusion and concentration of resveratrol enhances both the potent antioxidant features of AP but may also contribute neuro-protective and life-extension benefits to user. Notably, resveratrol is highly concentrated in grape skins and has been shown to extend the life span of certain laboratory mice by up to 50% when administered in high concentrations. This observation is likely linked both to the potent antioxidant action of resveratrol along with a gene-signaling/gene-regulatory effects acting through the MTOR signaling pathways, for example.

[0058] In some embodiments, there are multiple flavors of AP including vanilla caramel, mint chocolate, and other natural flavors. These flavors derive in part from natural antioxidant components and sugars inherent to the natural ingredients. In the preferred embodiment, AP also has a basic pH and/or infuses pH buffering compounds such that acid reflux is lessened for users. In this manner, AP can be taken as both a flavorful foodstuff and a remedy for acid reflux by a user. One of the unique advantages of AP is the highly flavorful product (intensity of flavor), in addition to the variety of flavors (wide range of flavors).

[0059] In some embodiments, the reflux preventing raft (“raft”) is produced by the steps: a) providing a functionalized natural or synthetic calcium carbonate comprising mineral, wherein said functionalized natural or synthetic calcium carbonate is a reaction product of natural or synthetic calcium carbonate with carbon dioxide and one or more acids, wherein the carbon dioxide is formed in situ by the acid treatment and/or is supplied from an external source; b) providing at least one polylysine-containing ingredient; c) providing at least one formulating agent comprising alginate; d) mixing the compounds provided in steps a) b) and c); e) granulating the mixture obtained in step d) by way of melt, dry or wet granulation or roller compaction. Notably, step “c” may include the addition of dextrose, preservatives, grapefruit seed extract, and other secondary compounds.

[0060] Further to the above, in some embodiments, parts of the formulation aid of step c) is first mixed with the functionalized calcium carbonate of step a) and the at least one polylysine-containing ingredient of step b), and the remaining portion of the formulation aid is then added to the mixture, followed by the granulation step e). Further to the above, in some embodiments, the source of natural calcium carbonate for preparing the functionalized calcium carbonate is selected from the group of marble, calcite, chalk, Vitamin B5, limestone and dolomite and/or mixtures thereof. In other embodiments, the synthetic calcium carbonate for preparing the functionalized calcium carbonate is precipitated calcium carbonate comprising aragonitic, vateritic or calcitic mineralogical crystals forms, especially prismatic, rhombohedral or scalenohedral precipitated calcium carbonate or mixtures thereof. In still other embodiments, the acids are selected from the group of hydrochloric acid, sulfuric acid, sulfurous acid, hydrosulfate, phosphoric acid, phosphoric acid in combination with acetic, formic or citric acid or acid salts thereof, and mixtures thereof, preferably is phosphoric acid.

[0061] In some embodiments, the functionalized natural or synthetic calcium carbonate has a specific surface area of from 5 m.sup.2/g to 200 m.sup.2/g, preferably 20 m.sup.2/g to 150 m.sup.2/g, more preferably 40 m.sup.2/g to 100 m.sup.2/g, measured using nitrogen and other methods known in the art. In some embodiments, the functionalized natural or synthetic calcium carbonate has a weight median grain diameter of from 0.2 to 40 μm, preferably from 0.6 to 25 μm, more preferably from 0.9 to 18 μm, still more preferably from 1 to 15 μm, measured using standard means known in the art such as the Malvern Mastersizer™ X long bed.

[0062] The foregoing description of the preferred embodiment of the present invention has been presented for the purpose of illustration and description. It is not intended to be exhaustive or to limit the invention to the precise form disclosed. Many modifications and variations are possible in light of the above teachings. It is intended that the scope of the present invention not be limited by this detailed description, but by the claims and the equivalents to the claims appended hereto.