COMPOSITION FOR THE TREATMENT OF SKIN CONDITIONS

FIELD OF THE INVENTION

The present invention relates generally to a composition for topical application that comprises an active solution mixed with a pharmaceutically acceptable carrier, wherein the solution is produced by repeatedly filtering a liquid through a filter/extraction column housing crushed mollusk shell particles. This composition can be used for the treatment of a variety of skin conditions.

BACKGROUND OF THE INVENTION

The present invention is an improvement over Canadian Patent Application No. 2,566,562, wherein a process is disclosed for the preparation of a solution for use in the treatment of skin diseases. Further developments have been revealed that outline the use of the aforementioned solution for the production of a new composition. For a ready understanding of the solution itself, and the process of manufacture therefor, the reader is directed to Canadian Patent Application No. 2,556,562.

Shells derived from mollusks are generated as industrial waste from fisheries around the world. It is common practice to dump the shell waste into the ocean. However, shells have been efficiently used as a source of calcium and for obtaining antibacterial agents, as well as for purifying water. It has been shown that the powder obtained from shells of scallops, oysters, clams, and other mollusks, or a solution containing the powder, has antibacterial and antiviral properties, as well as a use as a water purifying agent. It has also been found that the aforesaid powder has demonstrated useful properties when applied as a deodorant for sterilization, as a preservative agent and for selected medicinal use. Medicinal properties of mollusk shell powder and extract are well proven and tested. For example, European Patent Application No. 1676583 describes atherapeutic agent for periodontal disease that is prepared by utilizing a scallop shell material, and which has antimicrobial activity against periodontal disease-inducing bacteria. In particular, the shells are crushed and are then subjected to calcination, to convert the calcium carbonate in the original shells to calcium oxide, by firing at a high temperature. An aqueous solution is then formed with the newly formed calcium oxide powder and the original calcium carbonate powder.

U.S. Patent Application No. 2004/0028748 describes a remedy for dermatophytosis, obtained from a product formed by grinding shells having a crystalline structure and forming an aqueous dispersion of the product. In particular, the ground shells are calcinated by heating the particles in excess of 1000 ⁰ C, and the aqueous solution is obtained by the use of both the originally ground shells and calcinated shells.

Japanese Patent Application No. 2004/256785 describes a soap which has an auxiliary therapeutic effect for relieving itching associated with atopic dermatitis and psoriasis. The primary active ingredient in the soap is a fine powder prepared by high temperature calcination of scallop shells, oyster shells, clam shells and the like. United States Patent No. 6,627,229 describes an antiviral agent produced by applying a heat treatment of between 700 ⁰ C to 1200 ⁰ C to the pulverized powder of a calcium-containing substance originating from animals, such as clamshell, crustacean shell, bone, coral and pearl.

U.S. Patent Nos.6,365,193 and 6,488,978 to Sasaki et al. disclose that burned shells can be used as antibacterial agents and water purifying agents. Sasaki et al. disclose heating a shell in an atmosphere of inactive gas and burning the shell. In particular, the antibacterial agent is obtained by burning a powder from the shell of a surf clam in an atmosphere of inactive gas. The powder can be easily dissolved into water and used as an antibacterial solution.

The above uses of shells demonstrate the vast area of applications in which shell properties can be exploited. Further developments directed to new uses of shell material are desired and needed to manage and reduce the great quantity of shell waste produced every year.

Most of the above-identified applications require the use of crushed shells or a powder obtained from the shells of mollusks, where in all instances, heat treatment under high temperatures are employed, in order to effect calcination upon the shell particles. All of these procedures consequently require expensive equipment and complex set-up procedures to achieve these high temperatures, when in fact, calcination may not be a necessary step in order to reveal the inherent medicinal properties of the shell particles.

Furthermore, a large proportion of therapeutic agents that are prescribed and/or recommended by physicians for skin conditions contain harsh chemicals, such as lower monohydric alcohols i.e. ethanol and isopropanol. However, the abundance of these alcohols in the therapeutic agents often contributes to drying and irritation of the skin where the agent is applied. The lack of these and other additives in the present invention will minimize the adverse

effects associated with these chemicals.

SUMMARY OF THE INVENTION

It is an object of the present invention to provide a composition, comprising an extract from mollusk shells, containing mainly calcium, that is safe for the human body and environmentally friendly. Further, this composition inherits the antibacterial, antiviral and ancillary healing properties of the shells and as indicated heretofore may effectively be utilized for the treatment of skin diseases. Additionally, it is desired that the composition does not cause any significant drying or irritation of the skin. Moreover, the composition and process of manufacture thereof of the present invention are simple, and as such, are economically advantageous. Therefore, the composition of the present invention can be available to the general public at an affordable price.

According to an aspect of the present invention, there is provided a composition for topical application, comprising an active solution mixed with a pharmaceutically acceptable carrier, wherein the solution is produced by repeatedly filtering a liquid through a filter/extraction column housing crushed mollusk shell particles.

According to another aspect of the present invention, there is provided a composition for topical application, comprising fine crushed mollusk shell particles mixed with a pharmaceutically acceptable carrier. According to a further aspect of the present invention, there is provided a composition for topical application comprising dissolving fine crushed mollusk shell particles into a solution.

BRIEF DESCRIPTION OF THE DRAWINGS

The above and other features of the present invention will become more apparent from the appended drawings, wherein:

Figure 1 shows a cross-sectional view of the extraction column comprising an inlet, an outlet, and a housing member;

Figure 2a is an exploded cross-sectional view of the upper half of the extraction column and illustrates the empty column set-up; Figure 2b is an exploded cross-sectional view of the upper half of the extraction column and illustrates the column filled with the packing member;

Figure 3 is an exploded cross-sectional view of the lower half of the extraction column and illustrates the empty column set-up;

Figure 4 illustrates a cross-sectional view of the apparatus comprising two extraction columns in a tandem arrangement; Figure 5 illustrates the measured turbidity of the active solution with exposure time;

Figure 6 illustrates the increase of the amount of calcium determined in the active solution with exposure time;

Figure 7 illustrates the changes that occur in pH of the active solution with exposure time and also compares the effect utilizing different ratios of shell particles to solvent has on pH; Figure 8 illustrates the changes that occur in the conductivity of the active solution with exposure time and also compares the effect utilizing different ratios of shell particles to solvent has on conductivity;

Figure 9 illustrates the changes that occur of the amount of calcium recovered in the active solution with exposure time and also compares the effect utilizing different ratios of shell particles to solvent has on calcium.

DETAILED DESCRIPTION OF THE INVENTION

One component of an embodiment of the present invention is an active solution that is mixed with a pharmaceutically acceptable carrier. The process for production of the active solution is similar to that which is disclosed in the priority document of the present application, that being Canadian Patent Application No. 2,556,562, and is herein discussed with reference to the Figures.

Fig. 1, illustrates a filter/extraction column (10) comprising an inlet (11), an outlet (13), two screens (14), and a housing member (12). The housing member (12) defines a passageway (12a) that can be filled with crushed mollusk shells.

Fig 2a, illustrates an exploded view of the upper half of the filter/extraction column (10), comprising a top coupling (16), a screw-in stopper (15) and an outlet (13) placed in the stopper

(15). A screen (14) may be placed at the top of the housing member (12) in order to contain the crushed mollusk shells in the filter/extraction column (10). The top coupling (16) is fitted with a coupling inside lip (17) in order to attach the screen (14) to the housing member. An interchangeable seal (18), such as silicon can be used to inhibit leaking of the column.

Fig. 2b, illustrates an exploded view of the lower half of the extraction column, comprising the bottom coupling (16), stopper (15) and an inlet (11) placed in the stopper (15). The bottom coupling can also be fitted with the coupling inside lip (17) in order to attach the screen (14) to the housing member (12) so as to contain the crushed mollusk shells into the filter/extraction column. The inlet (11) is designed for connection to a plastic valve and a pump used to feed the column with a solvent. An interchangeable silicon seal (18) can be used to avoid leaking of the column.

Fig.3 , illustrates the filter/extraction column (10), comprising an inlet ( 11 ), an outlet (13), top and bottom identical screens (14), and a housing member (12). The housing member (12) contains crushed mollusk shell particles which may be of equal or different sizes. In one embodiment shown in Fig. 3 the housing member contains at the bottom portion crushed shell particles of sizes between 0.5 and 1 mm in diameter (20) and crushed shell particles of sizes between 3 and 4 mm in diameter (21 ) in the upper portion. However, the crushed mollusk shells can be comprised of particles of about equal size distributed evenly along the passageway according to the filter/extraction needs in one or a plurality of zones. A zone is defined as containing crushed shell particles of approximately the same diameter. The packing of the column with crushed shell particles can follow a regular distribution according to a desired gradient or an irregular distribution.

Fig. 4, illustrates a cross-sectional view of the apparatus (1) according to the present invention and comprises at least two filter/extraction columns (2,3), in a tandem arrangement. In the two-column apparatus (1) the filter/extraction columns are arranged linearly so that the outlet (13) of the first column (2) is connected to the inlet (11) of the second column (3) by a connecting tube (23). The housing member (12) of the first column (2) can contain at the bottom thereof crushed shell particles of sizes between 0.5 and 1 mm in diameter (20), and crushed shell particles of sizes between 3 and 4 mm in diameter (21) thereafter. The housing member (12) of the second column (3) may contain crushed shell particles coated with iron oxide or hematite (24). It is believed that coating the crushed shell particles with iron oxide or hematite may substantially improve the purifying properties of the filter/extraction columns by reducing the metal content in the solution passed through the apparatus (1). Analysis of the water passed through the filter/extraction columns apparatus ( 1 ) showed nearly zero content of aluminum and arsenic in the active solution.

In the practice of the process of the present invention for production of an active solution, shells are collected directly off the fishing boat and put in tote boxes for transportation to the manufacturing plant. The shells are then cleaned by electric drills and wire brushes and throughly washed with water under high pressure to ensure effective cleaning. The cleaning and washing steps may be followed by a cooling step in which the shells are left on a wire rack for an amount of time necessary to cool the shells to the ambient temperature. In the next step the shells are then subjected to a heat treatment, by any means known to one skilled in the art, e.g. boiling or baking, such that the shells reach a temperature in the range of about 100 ⁰ C to about 300 ⁰ C. The main purpose of the heat treatment is to remove any remaining mollusk tissue, to coerce the opening of the intrinsic pores of the shells, and to further expose the inner layer of the shells by eradicating the protective layer. This heat treatment makes the inner layer, which contains the majority of the active ingredients, more susceptible to leaching when used in the above-described apparatus.

At this point, the whole of the shells are crushed by any means known to one skilled in the art. The resulting particles are then separated and sorted according to size by the use of sieves, filters or the like. Scallop shell particles of a size about 1 mm to about 6 mm in diameter are preferably selected, more preferably is a size of about 2 mm to 5 mm in diameter, and most preferably is a size of about 3 mm to 4 mm in diameter. Although particles of a size ranging from about 10 μm to about 25 mm may be utilized while still remaining within the scope of the present invention. These particles are then introduced into the filter/extraction column.

Alternatively, particles of about the same diameter or a mixture of particles with a range of different diameters may be used in the filter/extraction column according to the present invention.

The effectiveness of the active solution, and hence, the composition itself, will be determined by several factors including the pH of the solvent used and the particle size of the crushed shells that form the packing members of the extraction column. Preferably, the solvent is water. More preferably, the solvent is distilled water or reverse osmosis purified water. By passing the water through the filter/extraction column (10) one can control, inter alia, the turbidity, the pH, the calcium content, the conductivity and the suspended solids of the active solution. The number of passes, the water flowrate and the ratio of water to shells in the column determine the properties of the active solution, and hence the composition itself. The particle diameter of the crushed shells has been shown to be relatively inversely proportionate to the

effectiveness of the composition. For example, it is preferred that the particle diameter of the crushed shell be between 1 mm and 6 mm, more preferably between 2 mm and 5 mm, and most preferably between 3 mm and 4 mm, in order to produce an active solution that is effective as a topical composition when combined with an acceptable carrier. Fig. 5, illustrates the Turbidity vs. Exposure time as determined in Example 1 detailed below. It will be noted that the measured turbidity of the active solution decreases as it is subject to exposure time to the filter/extraction column. The turbidity was measured after each pass of solvent through the extraction column. After an exposure time of 12 hours the measured turbidity of the active solution was about 2.2 NTU. The above measurements of turbidity are correlated with the measurements of the amount of suspended solids in the active solution after each pass. Accordingly, as is shown in Table 1 of Example 1 as time passes the amount of suspended solids decreases from 6 mg/L after the first pass of solvent through the filter/extraction column to about 0 mg/L after 12 hours.

Fig. 6 illustrates the amount of calcium measured after each pass of water through the extraction column versus the exposure time. The final active solution contains approximately 121 times more calcium than the starting solvent. It is preferred that the calcium content of the active solution is higher than 14 mg/L, and more preferably is higher than 20 mg/L. Other factors that can impact upon the effectiveness of the active solution, and hence the composition, are the pH and the turbidity of the active solution, hi order to optimize the effectiveness of the active solution, while still making it tolerable to topical application, the pH of the active solution is preferably between 6.0 and 10.0, more preferably between 6.5 and 9.0 and most preferably between 7.0 and 8.0. The turbidity should be less than 6 NTU Units.

According to an embodiment of the present invention, a composition is formed when the active solution, wherein the active solution is produced by repeatedly filtering a liquid through a filter/extraction column housing crushed mollusk shell particles, after having attained all of its desired properties through this filtration process, is in admixture with a pharmaceutically acceptable carrier. Specific methods or processes that are used to combine the active solution with the pharmaceutically acceptable carrier are not limited, and any sort of mixing method utilizing any sort of known mixing apparatus is contemplated within the scope of the present invention.

A preferred process of mixing the active solution with an acceptable carrier comprises

utilizing a common kitchen mixing apparatus. The active solution, in it's entirety, is added incrementally to half of the total weight of the acceptable carrier at the beginning of the process. After thorough mixing has occurred, the remaining carrier is added and incorporated into the composition. The benefit to this process is that the development of air bubbles within the composition is significantly reduced and it also helps to ensure constant consistency of the product.

The pharmaceutically acceptable carrier of the present invention can be, but is not limited to, a cream, a lotion, a gel, an ointment and a paste. Preferably, the carrier is petrolatum, a base emulsifying ointment or Eucerin™. More preferably, the carrier is a base emulsifying ointment or Eucerin™. In an alternate embodiment of the present invention, the carrier may include any combinations of the above-mentioned compounds.

According to an embodiment of the present invention, when the acceptable carrier is Eucerin™, the active solution is mixed with the Eucerin™ at a ratio of about 1:1 to about 7:1, by weight. Preferably, the ratio of active solution to Eucerin™ is 7: 1 , by weight. The upper limit of these ratios is defined by the ability of the active solution to be incorporated into the Eucerin™. At the upper limit of the stated ratios, that being 7:1, the Eucerin™ becomes saturated, and subsequent addition of active solution is no longer incorporated. Accordingly, any ratio of active solution to Eucerin™ that allows for supersaturation of Eucerin™ with the active solution resides within the scope of the present invention. These ratios produce a cream that is easy to apply onto the skin.

According to an embodiment of the present invention when the acceptable carrier is a base emulsifying ointment, the active solution is mixed with the base emulsifying ointment at a ratio of about 0.5:1 to about 7:1, by weight. Preferably, the ratio of active solution to base emulsifying ointment is 5 : 1 , by weight. The upper limit of these ratios is defined by the ability of the active solution to be incorporated into the base emulsifying ointment. At the upper limit of the stated ratios, that being 7:1, the base emulsifying ointment becomes saturated, and subsequent addition of active solution is no longer incorporated. Accordingly, any ratio of active solution to base emulsifying ointment that allows for the supersaturation of base emulsifying ointment with the active solution resides within the scope of the present invention. These ratios produce a cream that is smooth, easy to apply onto the skin and appears to be absorbed with ease through the pores of the skin.

According to another embodiment of the present invention, a composition is formed when fine crushed mollusk shell particles are added to a pharmaceutically acceptable carrier. In the present invention, "fine crushed mollusk shell particle" is defined as a crushed mollusk shell particle that is less than or equal to 250 μm in diameter. More preferably, a fine crushed mollusk shell particle is less than or equal to 150 μm in diameter. The pharmaceutically acceptable carrier is as defined above.

The fine crushed mollusk shell particles are prepared according to the crushed mollusk shell particles of the present invention. That is, after the shells have been adequately cleaned, the shells are then subjected to a heat treatment, by any means known to one skilled in the art, e.g. boiling or baking, such that the shells reach a temperature in the range of about 100 ⁰ C to about 300 ⁰ C. The shells are then crushed by any means known to one skilled in the art. The resulting particles are then separated and sorted according to size by the use of sieves, filters or the like. It is during this sorting step that the fine crushed mollusk shell particles are identified. These fine crushed mollusk shell particles are then incorporated into a composition comprising a pharmaceutically acceptable carrier. Preferably, the fine particles are incorporated into the composition at about 0.01% to 0.5%, by weight. More preferably, the fine particles are incorporated into the composition at about 0.03%, by weight. The limitation in regard to the addition of the fine particles to the composition is that even though the particles are fine, they are still quite granular in nature. Accordingly, if the fine particles are incorporated into the composition at a higher percentage by weight than the above-mentioned range, it has been found that the use of the composition is limited as it will become excessively abrasive and has an overwhelming tendency to severely dehydrate the skin when applied.

According to a preferred embodiment of the present invention, a composition is formed when the active solution of the present invention is in admixture with a pharmaceutically acceptable carrier, and wherein fine crushed mollusk shell particles are subsequently added to this composition. Similar to the parameters listed above, when the carrier is Eucerin™, the ratio of active solution to carrier is about 1 :1 to about 7:1, by weight. Preferably, the ratio of active solution to Eucerin™ is 7:1, by weight. When the carrier is the base emulsifying ointment, the ratio of active solution to carrier is about 0.5: 1 to about 7: 1, by weight. Preferably, the ratio of active solution to base emulsifying ointment is 5:1, by weight. The fine particles are identical to those defined above. Preferably, the fine particles are incorporated into the composition of the present embodiment at about 0.01% to 0.5%, by weight. More preferably, the fine particles are incorporated into the composition at about 0.03%, by weight. The limitation in regard to the

addition of the fine particles to the composition is that even though the particles are fine, they are still quite granular in nature. Accordingly, if the fine particles are incorporated into the composition at a higher percentage by weight than the above-mentioned range, it has been found that the use of the composition is limited as it will become excessively abrasive and has an overwhelming tendency to severely dehydrate the skin when applied.

A further embodiment of the present invention is the use of any of the above-described compositions for topical application. Preferably, the use of any of the compositions according to the present invention is for the treatment of at least one skin condition. More preferably, the use of the compositions according to the present invention are for the treatment of at least one skin condition, where the at least one skin condition is selected from the group consisting of psoriasis, acne, herpes-zoster, skin diseases associated with varicella-zoster virus, insect bites, insect stings, blisters, xeroderma, burns, sunburns, rashes, athlete's foot, eczema and dermatitis, including contact dermatitis and atopic dermatitis.

According to yet another embodiment of the present invention, fine crushed mollusk shell particles are dissolved into an aqueous solution. Preferably, the fine particles are incorporated into the solution at about 5% to 20%, by weight. The aqueous solution may be any solution that is capable of dissolving the above-mentioned amount of fine crushed mollusk shell particles, provided that it is also safe for topical application. Preferably, the aqueous solution is water or the active solution. It is contemplated within an embodiment of the present invention that this solution that contains dissolved fine crushed mollusk shell particles can be used for the treatment of at least one skin condition. Preferably, the at least one skin condition is selected from the group consisting of hyperhidrosis and pitted keratolysis.

According to yet another embodiment of the present invention, the active solution is treated with sodium hydroxide (NaOH). Preferably, the NaOH is introduced into the active solution of about 0.1% to 4%, by weight. Preferably, the active solution has a calcium concentration of about 30 mg/L to ≥ 1000 mg/L. The addition of the NaOH, upon being thoroughly dispersed through the solution, will cause an increase in the pH of the solution, resulting in the concomitant precipitation of some of the calcium. This active solution, including the precipitated calcium, may be used interchangeably with any of the active solutions as described according to the compositions of the present invention.

Example 1

An extraction column (10) was constructed with a 6 inch diameter 4 feet long PVC pipe

with two couplings (16) closing each end as described in Figure 1. The top coupling (16) had a 90 ° elbow screw- in with a 3/4 inch plastic tube connected thereto. The top coupling (16) and the plastic tube connected to it represent the outlet (13) according to the present invention.

The bottom coupling (16) as constructed had a straight adapter screwed in the coupling stopper and connected to a plastic tube representing the inlet (11) according to the present invention. A 12 V, 360 gallon/hour pump was connected to the inlet ofthe column (10) and was used to pump distilled water through the column (10). The top and the bottom ofthe column (10) were designed in the same way except that the bottom coupling (16) had a 3/4 nipple with a 3/4 plastic tube connected to a plastic valve and the 12 V pump. Two screens (14) as shown in Fig. 1 were used to keep the crushed scallop shells inside the passageway (12a).

The composition of the crushed shells was comprised of a mixture of 0.5 and 1 mm diameter scallop shell particles. The mass ofthe smaller particles was approximately 10 kg and the column (10) was filled to within two inches ofthe screen (14) ofthe upper coupling. The rest ofthe column (10) was filled with larger diameter particles of 3 and 4 mm. After the first pass of distilled water the active solution had a high suspended solids concentration. The suspended solids concentrations were found to diminish with exposure time. Table 1 shows the suspended solids concentration in the solution as measured by the Hach Company DR- 2400 Spectrometer. This method of determining suspended solids is a simple, direct measurement which does not require the filtration or ignition/weighing steps as do gravimetric procedures. While the USEPA specifies the gravimetric method for solids determinations, this method is often used for checking in-plant processes. Test results are measured at 810 nm. This method is documented in the Hach Water Analysis Handbook, method 8006 page 963.

The accuracy of the spectrometric method of measuring the suspended solids concentration was compared against the gravimetric method as described in the Hach Water Analysis Handbook, method 8271 page 947. The mass ofthe aluminum dish was measured with a Scientech 120 analytical balance to the nearest 1 mg. A 100 ml sample from the solution was taken in situ and placed into the aluminum dish. The dish with sample was placed in a preheated oven and evaporated at 103-105 °C for approximately six hours. The dish was then taken out ofthe oven and allowed to cool at room temperature in a desiccator. The dish with sample was then taken out ofthe desiccator and mass measurements were effected to the nearest 0.1 mg with the Scientech 120 analytical balance. This was the first mass measurement ofthe sample. The dish and sample were put into the preheated oven again for a period of one hour and mass measurements were effected until the results did not differ by more than 0.4 mg. A second

measurement of the mass was done in the same manner as above. Table 2 below shows the suspended solids concentration in the solution as measured by the gravimetric method.

Total Solids Analysis

Table 2

Total Solids Calculations

Equation: mg/L Total solids= ( A - B) X lOOO

Sample volume ml

Where:

A = Weight (mg) of sample + tray

B = Weight (mg) of dish

% Error of Results

% of error = (Dh - Dl) x 100 = ( 0.15 mg - 0.124mg) x 100 = 0.5 % error

# of data points 5

Where:

Dh = Highest numerical data results obtained Dl = Lowest numerical data results obtained

Example 2

Two extraction columns (10) were constructed as indicated above in Example 1 (see Fig.

4). The two columns (10) were arranged in tandem with the outlet of the first column (10) directly connected to the inlet of the second column (10). A 12 V, 360 gallon/hour pump was connected to the inlet of the first column (10) and was used to pump distilled water through the first and second column (10).

The packing member of the first column (10) was made of a mix of smaller 0.5 and 1 mm in diameter scallop shell particles. The mass of the smaller particles was about 10 kg while the column should be filled two inches below the screen (14) of the upper coupling (16). The rest of the column (10) was filled with larger diameter particles of 3 and 4 mm as described in Example 1.

The packing member of the second column (10) was made of crushed scallop shell

particles coated with iron oxide or hematite (Fe ₂ O ₃ ). The coating of the crushed shell particles with iron oxide can be effected by any process known to a person skilled in the art. In the present invention, the coating of the scallop shells is effected by soaking the shells in iron oxide or hematite for 4 hours, then baking the shells and solution for 4 hours at 200 °C. The shells should then be washed with distilled water and dried in an oven at 200 °C for three hours.

Contaminated water with a high content of aluminum and arsenic was passed through the apparatus comprising the two extraction columns arranged in tandem. It has been found in practice that the aluminum and arsenic content of the resulting active solution was reduced to 0 mg/L.

Example 3

An extraction column (10) was constructed with a 5.08 cm diameter, 79 cm long clear acrylic pipe with two couplings (16) closing each end as described in Figure 1. The top coupling (16) had a 90° elbow screw-in with a 3/4 inch plastic tube connected thereto. The top coupling (16) and the plastic tube connected to it represent the outlet (13) according to the present invention.

The bottom coupling (16) as constructed had a straight adapter screwed in the coupling (16) stopper and connected to a plastic tube representing the inlet (11) according to the present invention. A 12 V, 360 gallon/hour pump was connected to the inlet of the column (10) and was used to pump distilled water or reverse osmosis-derived water, through the column (10). The top and the bottom of the column (10) were designed in the same way except that the bottom coupling (16) had a 3/4 nipple with a 3/4 plastic tube connected to a plastic valve and the 12 V pump. Two screens (14) as shown in Fig. 1 were used to keep the crushed scallop shells inside the passageway (12a). Scallop shells were washed and cleaned with distilled water and then dried such that the shells reached a temperature of 100 ⁰ C. The shells were then crushed, and after sorting based upon size, the composition utilized was comprised of a mixture of 3 and 4 mm diameter scallop shell particles. The volume and type of the solvent loaded onto the column (10) was 1 L of water. Two distinct scenarios were tested in regard to the amount of crushed shells in order to optimize running conditions. The amount of shells that was utilized was either A) about 0.35 Ib, providing for a ratio of water to scallop shells of about 1 to 0.35 (w/w), or B) about 1 Ib, providing for a ratio of water to scallop shells of about 1 to 1 (w/w). The column was filled to within two inches of the screen (14) of the upper coupling (16). The water was then successively

run through the column. In both scenarios, the solvent outflow was about 2.16 L/minute.

When the resulting active solution was analyzed, there was some variation in the measured parameters according to which ratio of scallop shells to water was utilized. As can be seen from Fig. 7, pH of the solutions are fairly close in value. Referring now to Fig. 8, the conductivity, measured in micro Siemens, is presented for both of the above-mentioned scenarios. The latter scenario (B) where a greater proportion of shells are utilized produced a higher conductivity. The maximum conductivity attained over the observed time frame for both scenarios was (A) 58.9 μs/cm and (B) 95.8 μs/cm.

In order to understand the relationship between the two different scenarios and conductivity, calcium concentration was measured. As can be seen from Fig. 9, the latter scenario (B) contained a considerably higher calcium concentration than the former scenario (A). After the final pass of the solution from scenario A through the column, the solution contained 20.83 times more calcium than the initial solution, whereas after the final pass of the solution from scenario B through the column (10), the solution contained 32.5 times more calcium than the initial solution.

Referring now to Figure 10, the turbidity, measured in NTU Units, is presented for both of the above-mentioned scenarios. There is a general overall decrease in measured turbidity over time, however, there is very little difference, if any, when a comparison is made between the solutions that were made with different ratios of shell particles to solvent. Both scenarios were able to achieve values of less than one NTU Unit.

This series of Examples illustrates that the extraction of calcium from the crushed shell particles continues to be more efficient in accordance with an increase in the ratio of crushed shell particles to solvent. It should be noted that ratios of crushed shell particles to solvent other than those listed here are all contemplated within the scope of the invention, and should be based upon the desired properties of the resulting active solution.

The embodiments of the invention described herein are exemplary and numerous modifications, variations and rearrangements can be readily envisioned to achieve substantially equivalent results, all of which are intended to be embraced within the spirit and scope of the invention.

INDUSTRIAL APPLICABILITY

The invention provides a topically applied composition for the treatment of various skin

conditions, where an active solution is prepared by repeatedly filtering a liquid through a filter/extraction column housing crushed mollusk shell particles and is then in admixture with a pharmaceutically acceptable carrier. The resulting composition has numerous properties. In particular, this composition can be effectively implemented as treatment for a plethora of skin- associated maladies. Further, the present invention provides an application for an industrial waste product, mollusk shells, that are generated in large quantities from fisheries around the world, and it is believed that it would be fiscally and environmentally sound to implement uses of this waste product that is beneficial to the public.