CA1112164A

CA1112164A - Therapeutic selenium compositions and the use thereof

Info

Publication number: CA1112164A
Application number: CA307,652A
Authority: CA
Inventors: Joseph R. Levitt
Original assignee: Lundy Research Laboratories Inc
Current assignee: Lundy Research Laboratories Inc
Priority date: 1977-08-02
Filing date: 1978-07-18
Publication date: 1981-11-10
Also published as: EP0000670A1; IT1107965B; IT7850509A0; JPS5459309A

Abstract

Abstract of the Disclosure There are provided therapeutic compositions comprising certain selenium-containing compounds which exhibit therapeutic benefits in mammal hosts including humans. The selenium compounds in accordance with this invention are preferably water soluble organic or inorganic compounds containing selenium such as alkali metal selenites and selenates. Among the therapeutic benefits exhibited by these compositions are the reduction in severity from and improvements in recovery from physically in-duced damage to body tissue which includes damage caused by surgical incisions, lacerations and burns.

Description

- ~1;Z164 .~ lg' ; 20 Background of the In~ention 21 This invention relates to therapeutic compositions 22 containing certain selenium compounds. These therapeutic 23 compositions have been found to exhibit surprising and unexpected 24 prope~ties in mammalian hosts. More particularly, the selenium compounds in accordance with the present in~ention are water 26 soluble organic or inorganic compounds containing selenium in a 27 form capable of being absorbed by the body tissue to be treated.
28 Preferably, the compounds are salts containing selenium in the 29 form of the selenite or selenate anions. In the practice of the present inventioll, the therapeutic compositions are formulated 31 so that ~aid selenium compounds are present in certain specific .. ..
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3 I Selenium is one of numerous elements found in trace

4 i amounts in many foods. The seleni~m is present in many

5 il chemicals and often in very complex forms. Many technical I studies have been carried out concerning its biological effects 7 1 although tl~e majority of the work has dealt with those adverse effects which occur by ingesting more than trace amounts of 9 selenium-containing compounds.
Research studies to date have indicated that selenium 11 doea hav~ beneficial physiological effects on mammals. For ; 12 examp~e, it is known that selenium, when ingested, reduces 13 the rat~ of oxidative damage caused by chemicals, such as, for 14 example, ozone in smog, by entering the membranes of the body's cells and protec~ing the contents of the cells from reacting 16 with oxygen in a manner that tamages the cells. It has also 17 been reported that selenium may be beneficial in the trea~ment 18 l of heart disease by reducing or decreasing coronary vascular 19 resistance in d~gs. Additional studie5 have Al80 shown some beneficial effects of 8elenium in cancer therapy. In combination 21 with Vitamin E, selenium has been reported to have a beneficial 22 effect in relief of arthritis and tendonitis.
23 ¦ On the other hand, there has been considerable 24 reluctance to prescribe usages of selenium because of its apparent toxic effects when present in large dosages. While 26 numerous medical and governmental reports have found selenium to ha~e general toxic properties in adult mammals, there i5 no 28 consensus as to specific toxicity levels nor toxicity effects.
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It is known r however, that deleterious effects on 2 1I the heart, lungs, liver and kidneys do occur, in addition to 3 ¦1 adverse e~fects on other body systems in mammals, both humans 4 I and animals, in cases where selenium is ingested. But the particular amounts ingested which cause such effects vary

6 ~ widely depending upon the form of the ingested seleniu~, and

7 ¦ the presence of other materials in the diet of the host. For ~ ! example, protein is reported to afford some protection against -; the toxic effects of selenium.
It is therefore surprising that in accordance with i 11 the pre8ent invention it has been discovered that pharmaceuti- I
12 cally safe compositions have been formulated which have ; 13 unexpected therapeutic and physiological properties and benefits ¦
14 which enable it to be easily formulated and administered to ! lS mammals, including humans. Also provided by this invention I -16 are methods of treating mammals, including humans, to reduce ~7 the severity from and to improve recovery from certain 18 physically induced injurie9 to ti8sue caused by physical l9 effect8 or irritating stimuli such as surgical operations, laceratio~s and ~urns including electrical, sun and thermal 21 burns, etc.

23 Summary of the Invention 24 In accordance with the present invention, there are 25 ¦ ¦ provided therapeutic compositions for treating mammals, including 26 1 humans, comprising a therapeutically effective but non-toxic i 27 ¦ amount of a water 901uble organic or inorganic selenium compound 28 combined with a pharmaceutically acceptable carrier or vehicle 29 therefor. In general, such compositions comprise about 0.05 mg to about 1.0 mg and prefer~bly 0.5 to 1.0 mg of elemental .
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3 ¦ The selenium compound is preferably a water soluble 4 ¦ organic or inorganic selenite or selenate such as i~lkali 5 ¦ metal selenites or selenates. The composition may be 6 ~ fomulated for oral, injectable, topical or suppository 7 ¦ administration. For example, tablets, capsules, solutions,

8 ¦ creams and the like may be made where the selenium compound

9 ¦ is dispersed substantially homogeneously throughout a suitable ¦ ;

10 ¦ pharmaceutically acceptable carrier or vehicle in such finished

11 ¦ dosage form.

12

13 ¦ Description of the Preferred Embodiments ; I Compositions in accordance with the present invention which contain certain selenium compounds in therapeutically 16 effective but non-toxic dosages can be administered to mammals 17 for the purpose o~ reducing the severity from and improving 18 the recovery from physically induced tamage to the host's 19 tissue. By phys~.cally induced damage is meant vari~us types of damage to the tissue of a mammal including, for example, L
21 surgical incisions, lacerations, burns, etc. Accompanying such 22 damage are the likelihood of infection, edema, ecchymosis 23 and other in~la~atory responses. It has been found that 24 where the therapeutic compositions of the present invention are administered prior to such physically induced damage to 26 ¦ tissue, such as prior to surgery, an observable improvement 27 ¦ in the patient's healing of the tissue and a reduced degree of 28 ¦ infection, edema, ecchymosis and other inflammatory responses 29 1 are noted.

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; 1 It has also been found that the therapeutic 2 composition of the present invention can be administered subse-3 quent to the physically induced damage to tissue and improve 4 the recovery of the tissue and affected areas. For example, 5 the compositions of the present invention may be applied 6 topically to the specifically affected areas of the skin to 7 reduce scarring, etc.
8 It is also intended that physically induced damage 9 in accordance with the present invention should include damage due to burns. It has been found thiat lesions and scars 11 to the skin due to burning and other tissue damage is reduced 12 and in some cases eliminated and that recovery is accelerated 13 by use of the composition of the present invention.

14 The anti-inflammatory properties of the selenium ! 15 ¦ compositions of this invention provide useful advantages 16 ¦ when employed alone or with other materials utilized, for 17 ¦ example, in pre-operative or post-operative surgical 18 ¦ procedures. For example, various compounds such as steroids 19 ¦ have been allege~ to possess anti-inflammatory properties.
20 ¦ Included among these are, for example, cortisone and hydro-21 ¦ cortisone.
22 ~ The selenium compositions of this invention used 23 alone exhibit effective anti-inflammatory properties without 24 the detrimental side effects of some known materials which exhibit anti-inflammatory properties. The selenium compounds 26 of the present invention may be combined with materials having 27 compatible properties to form compositions exhibiting the 28 beneficial effects of the selenium compounds, as well as 29 enhan d beneficial effects of these other materials.

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tt~ 4 1 The primary active ingredient in the therapeutic 2 compositions of the present invention is the selenium compounds.
3 It is to be noted that selenium occurs in a number varying 4 valence forms. For example, selenium compounds in which the selenium has a +4 valence, usually as the selenite and 6 selenate ions, may be utilized in the compositions of this 7 invention. Among the selenite and selenate forms, the preferred 8 compounds utilized in the compositions of this invention are 9 the water soluble alkali metal salts thereof, and particularly, the sodium and potassium salts, that is, sodium and potassium 11 selenite and selenate. On the other hand, organic compounds of 12 selenium may also be uti.~ized in the compositions of this 13 invention. For example, selenium compounds of cystine and 14 methionine, as well as the aliphatic mono- and di-selenodi-carboxylic acids having about 7 to 11 carbons in the carbon 16 chain may be used. Particularly useful acids of this group 17 include monoseleno-ll,ll'~di'n-undecanoic acid, diseleno-4,4'-18 di-n-valeric aci~ and diseleno-ll,ll'-di-n-undecanamide. It 1~ is to be understood, however, that the particular organ~c forms of selenium compounds set forth herein are not to be considered 21 limitati~e. Other organic selenium compounds which exhibit 22 the desired actici.t.y and are compatible and non-toxic can 23 be used in the pr~ctice of this invention.
24 It is a critical aspect o this invention that the selenium in the form present in the composition be capable of 26 being absorbed by the tissue of the body to be treated. It is 27 noted that water insoluble selenium compounds are not generally 28 ~ ¦ absor ~d on this ] evel.

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The compositions of this invention can be made by 2 ¦I mixing a suitably appropriate carrier and the sel~nium compound 3 1~ together and agitating the mixture until homogeneity is attained.
4 ¦~ The concentration of the seleni~m compound to be 5 ~ present in a particular composition will depend upon the means ';
¦ of administration and nature of the composition. For exampLe, 7 ¦ compositions for topical administration should have generally 8 1 a lower concentration of elemental selenium than compositions ¦ for other types of administration.
10 1 The selenium compound can be present in such an 11 ¦ amount 80 that the elemental selenium concentration of the 12 1 therapeutic composition is in the order of from about 0.005 to 13 ¦ about 2 mg per gram of the total weight of the composition.
14 1 The concentration, of course, depends upon the therapeutic i 15 l¦ activity desired and toxicity maximum levels.
16 ¦ As the daily dosage range is of the order of about 17 0.05 to 1.0 mg and preferably 0.5 to about 1.0 elemental 18 selenium, it i9 convenient as a practical matter to formulate 19 the composition so that about 0.5 mg to about 1.0 mg of ; 20 elemental selenillm is present in a given dosage amoun~ of the 21 composition.
22 The compositions of the present invention are quite 23 stable and can bc pre-mixed in the form of subsequent 24 administration. ~rt recognized techniques for packaging, 2S storing and preparing medicinal compositions for administration ¦
26 are generally applicable to these compositions.
27 ¦ As noted above, the therapeutic compositions in 28 1~ accordance with the present invention may be made in various 29 ¦I physical forms for well known methods of administration. For 30 ,1 example, the composition can be in a suitable form for injectable ~, ' i1 ' I .

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1 ¦ topical, suppository and oral administration. The choice of ¦ -2 the particular carrier or vehicle and other additives present 3 li will depend upon the form desired. Said compositions may 4 l¦ also be combined with other materials such as cleansing and 5 ¦l antiseptic-type a~,ents.
6 ¦~ In carrying out the practice of this invention, a 7 1 wide variety of carriers or vehicles for the selenium can be 8 1 utilized and the terminology "pharmaceutically acceptable 9 carrier or vehicle" as employed throughout this specification and in the appended claims is to be understood to include any 11 known carriers or vehicles generally employed in the pharmaceuti-12 cal field including inert and active carriers or vehicles. The 13 vehicles or carriers should not detrimentally affect any of 14 the active ingredients of the composition.

15 1 Exemplary inert carriers or vehicles include: sugars 1~ ¦ and milk sugars, such as lactose; liquids, such as water, 17 ¦ isotonic aqueous solutions, saline solutions and alcohol; and 18 I inert powders, creams, salves, ointments, cleansing and 19 I antisep~ic agen~s and the like.
20 I Pharm~ceutically active carriers or vehicles may 21 also be used. Tllese may include physiologically active powders, 22 liquids, salves, creams and ointments as weLl as materials such 23 as vitamins, 8 tcloids including cortisone and hydrocortisone.
24 Other materials include proteolytic enzymes, such as those obtained from the pineapple plant and sold under the trade name 26 I of Ananase by William H. Rorer, Inc. of Fort Washington, Pa., 27 ¦¦ USA, proteolytic enzymes obtained from the papaya plant and 28 1l sold under the trade name of Papase by Warner/Chilcott, Division 29 ~ of Warner-Lambert Company of Morris Plains, New Jersey, USA, 30 1! and others, such as animal pancreas extracts which contain li ' I', .

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, ~t~ 1Z164 1 ! trypsin and chymotrypsin, one form of such extract being sold 2 ¦ under the trade name of Chymoral by Armour Pharmaceutical Co. of 3 ¦ Phoenix, Arixona, USA.
4 ¦~ For oral administration, the therapeutic composition 5 ~l of the present invention can be prepared in dosage form as 6 ¦¦ capsules, tablets, powders, syrups, oral solutions and the like.
: 7 1I These orally administrable compositions may contain such addi-¦ tives as diluents, fillers, lubricants and glidants. Where they 9 ¦ are in the form of a liquid, they should be suitably prepared I so that the ingredients including the liquid pharmaceutical 11 carrier are bland to the gastric mucosa.
12 In the case of the injectable form of the composition, 13 ¦ the therapeutic selenium compound may be dissolved in distilled 14 or sterilized water to form a parenteral preparation, or it can I be mixed with intravenous infusions such as glucose or saline.
16In accordance with this invention, selenium can be 17 utilized in compositions suitable for topical, dermatological 18 applications. In this regart, the selenium compounds can be used 19 for skin treatmcnts and maintenance in dermatological creams, ; salves, and the like. Such compositions can be effective in 21 treating skin irritations, certain rashes, dermatit~s, eczema o~
22 and pruritus. Such compositions also have properties making them 23 useful in reducing the rate of cell aging due to exposure to u 24 light and oxygen which generally results in an oxidizing condi-tion that weakens the cell membranes, thus causing the cells to 26 deform. In this regard, it is to be noted that the number o 27 damaged cells generally increases rapidly with the time of 28 exposure to light and oxygen. However, the use of dermatological 29 preparations containing selenium in accordance with this inven-~0 t tion dramatically interrupts or stops such damaging effects.

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1 The topical forms of the compositions of the present 2 invention are also particularly effective in improving and 3 accelerating the healing of tissue damaged by burns, which 4 includes burns caused by the sun, heat, electricity, ¦ radioactive exposure and chemicals. .
6 ¦ It is also to be noted that selenium compositions 7 I in accordance with the invention prevent distortion or adverse 8 ¦ bio-chemical effects in cells which are subjected to ultraviolet 9 ¦ light which greatly damages the membrane of such cells.
10 ¦ T~e composition of the present invention may be 11 admin~stered as eye drops in the form of a very dilute isotonic 12 aqueous solution, that is, from about 0.1 mg to 0.5 mg of 13 elemental selenium per cc solution and properly buffered to 14 substantially neutral pH of about 6-7. Such eye drop solutions 1 15 are useful in relieving eye irritation and redness caused by

16 dust, smoke, smog, wind and sun glare, swimming, strain due to

17 readin~ and television viewing or in the problems encountered

18 1 in adapting to thc utilization of contact lenses. A daily dosage of such an eye drop solution would be in the order of 1/20 to 20 1 1/5 cc.
21 ¦ It i9 to be understood that the particular carriers 22 ¦ or vehicles set out above are illustrative only and other known 23 ¦ pharmaceu~ically acceptable materials can be utilized in the 24 compositions o this invention so long as they do not react 25 with the seleniu~ and other active ingredients to destroy the , 26 identity thereo~. Moreover, the particular carrier or vehicle 27 chosen for use will depend upon the form of the composition 28 needed for the particular method o~ administration and the 29 host to receive the composition.

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1~ 4 ~:t-l ~ I ' 1 ¦ In those cases where the composition contains more 2 I tl~an about 1.0 mg by weight, the composition may be employed 3 in the form of divided dosages when being administered whether 4 it be in the form of a tablet, a capsule or a liquid solution.
I Moreover, a particular dosage in this respect can be administered 6 several times a day so long as the total amount of selenium 7 compound does not exceed the generally accepted maximum of 8 about 1 0 mg per day.
9 In some instances, the composition of this invention can be made by simply mixing the selenium compound in proper 11 proportion with an appropriate carrier. For example, in 12 preparing tablets, an alkali metal selenite or selenate salt 13 in its dry form may be mechanically mixed with a powdered 14 carrier or vehicle and shaped or pressed into tablets or lS encapsulated by known art recognized techniques. On the other 16 hand, if desirable, such salts can be dissolved in water and 17 then mixed with A powdered carrier and shaped or pressed into 18 tablets.

19 As an alternative, liquid compositions can be prepared simply by disso].ving the selenium compounds in water and using 21 the composition in tllat form with recognized additives for 22 either external or oral application. The materials as mixed 23 shoult contain at least a 0.05 mg dosage of selenium to achieve 24 most therapeutic benefits and may contain up to an amount conveniently combinable with the carrier to provide a daily 26 dosage of selenium in a range of from about .05 mg to about 27 1.0 mg ? and preferably from about 0.5 mg to about 1.0 mg.

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1 ¦~ While t~le stated range is generally a beneficially 2 ~ useful amount of selenium in accordance with this invention, ¦it is also to be understood that this range is normally the 4 amount given to an adult mammalian individual. However, 5 dependent upon the weight and age of an adult mammalian host, 6 the amount ingested by such a host may be adjusted accordingly within the stated range or somewhat outside the minimum and 8 maximum thereof. The total overall amount to be ingested per 9 day by a relatively small or young individual, or example, is preferably near the lower end of the range and for 11 larger or older individuala, toward or in the area of the 12 upper end of the stated range. A general range for daily 13 treatment dosages, again based upon the purpose of treatment 14 and other factors of the individual, would be in the range 0.005 - 0.02 mg per kg weight of the host.
16 In using the selenium compositions of this invention 17 with the view to obtaining the pre-operative and post-operati~e 18 benefits thereof, the compositions may simply be administered 19 orally to an adult patient or host in divided doseY for several days, e.g., ~rom 1-7 days,preceding surgery in the 21 stated concentrations or for several days, e.g., from 1-7 days 22 following tlle sur~lcal procedure or other trauma. For example, 23 an aqueous .solutiotl of sodium selenate or sodium selenite 24 can be made in a concentration to provide 5.0 mg of selenium and then sub-divided by dilution to provide an equivalent amount 26 of selenium of 0.5 to 1 mg and administered in daily amounts 27 orally or otherwise for a period of 1-5 days preceding and 2~ 1! ' 30 !¦/
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1 ll following surgery. On the other hand, the selenium may also be 2 ~ administered orally, intraveneously or subcutaneously, for 3 !¦ example, by dissolving sodium selenate or sodium selenite in 4 ¦! water in an amount such that one drop of the solution yields 1 0.33 mg of selenium. The concentration may be based upon one 6 ¦ drop of the solution~being equal to l/20 of a cc. More dilute 7 and concentrated solutions may also be used.
8 In accordance with the present invention, the 9 effectiveness of selenium is generally enhanced by administering ¦ the same simultaneously with other physiologically active 11 ¦ materials. For example, compositions in accordance with this 12 invention can comprise small amounts of selenium combined with 13 Vitamin E, wherein the Vitamin E is present in the range from 14 about 10 I.U. to about 1000 I.U., and preferably from about 200 I.U. to about 800 I.U. The combination permits advantageous 16 beneficial effects due to the presence of selenium with the 17 vitamin, it being understood that in use further appropriate 18 dilution takes place so that the daily amount of elemental 1~ ¦ selenium atministered toes not exceed 1.0 mg.
The selenium can also be combined with ascorbic 21 acid, i.e., Vitamin C and utilized in the pre-treatment of 22 patients undergoing elective surgery. Due to the fact that 23 some selenium does form a precipitate with the Vitamin C, an 24 appropriate method of administration should be used to minimize this precipitation effect.

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~t-l 1 l¦ The present invention presents many advantage5 both 2 I in its therapeutic effects and in the ability to formulate 3 I administrable compositions. When ingested, selenium is 4 ~ distributed to all of the cells in the body and is stored non-I selectively but not uniformly, as is the case with several 6 11 other elements such as chromium, iodine, and calcium.
7 Compositions of this invention are relatively simple 8 I to prepare. The water soluble sodium and potassium salts of 9 I selenium are readily available and are easily incorporated into a suitable pharmaceutical carrier or vehicle without the 11 neet for extraordillary and elaborate manu~acturing equipment.
12 Moreover, if desirable, the selenium salts can be distributed 13 in a suitable carrier and stored for long periods of time 14 without loss of effectiveness. On the other hand, if desired, ! 15 the salts can be marketed separately and simply mixed or com-16 pounded with a carrier just prior to use. Numerous other 17 ¦ advantages of this invention will be readily apparent to those 18 ¦ skilled in the art.
1~ Numerou9 ulodifications oE this invention may be made without departin~ from the spirit and scope thereof. Accordingly, 21 it is to be understood that this invention is not to be 22 limited to the illustrative embodiments set forth herein.

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1 'I EXAMPLE 1 2 ! This example is presented to illustrate the tolerance j and effect of compositions of the present invention as adminis-tered to humans. The patient chosen for this example was 1 22 years old. Some four years prior to receiving the treatment 6 ¦ in accordance with the present invention, he had undergone a 7 ¦ rhinoplasty surgery which resulted in severe and alarming 8 1 post-operative ecchymosis, edema and blood red eyes. The 9 rhinoplasty surgical procedure involved the fracture of the patient's nose and associated trauma associated with the 11 surrounding tissues. This prior treatment and recovery of the 12 patient acts as a control to the instant exam~le.
13 Four years after the aforementioned rhinoplasty 14 ~ surgery and after some three and a half years following 15 ~¦ complete recovery, the patient received the treatment in accord-16 ¦ ance with the present invention which contained 0.65 mg of 17 I selenium. This oral dosage was prepared as follows:
18 ¦ One ounc~ of sodiu~ selenite as obtained 14 from City Chemical Corp., of New York, 21 Mew York, was added to ordinary tap water to yield a concentration of 28~35 mg of 22 sodium selenite (~a2SeO3) to 1 cc of 23 water. This is equivalent to 13.0 mg 24 of elemental selenium per cc of water.
The foregoing solution was ingested in an amount daily to yield 26 a daily dosage of 0.65 mg per day. The daily dosage was 27 ¦ continued for a period of seven days. On the evening of the 28 seventh day of treatment, the patient was involved in an ¦ automobile acci~ent in which he suffered head, nose and facial 30 ! iRjuries. This included a fracture of his nose and associated !l " - 1 5 -tt~ 4 1 ¦¦ trauma to the surrounding tissue. The patient received 2 ,11 emergency hospital treatment including examination and 3 treatment by a plastic surgeon. During the course of the 4 patient's recovery, there was no observed ecchymosis or edema 5 ¦ of the nose, eyes or face, although trauma had been sustained 6 ¦ as a result of the accident. `~' 8 I E~AMPLE 2 g 1l This example illustrates the effect of orally ¦
ingesting the therapeutic composition of the present invention 11 on the irritation of the eyes of a human patient. The patient 12 was a wearer of contact lenses and for many years suffered 13 ¦ regular inflammation and irritation due to the wearing o 14 1 contact lenses. The patient received by oral ingestion the 15 1I therapeutic composition prepared in accordance with Example 1 16 ¦¦ 'in an amount equivalent to a daily dosage of 0.5 mg of selenium.
17 ! A~ter a period of S days the redness and inflammation that was 18 I normal,ly present in his ~yes subsided and discontinued.
19 After his eyes reached an optimum improvement, he discontinued the ingestion of the therapeutic composition for a period of 21 seven days. Ater those seven days, the patient's eyes became 22 'inflamed, red alld irritated to the same extent as existed 23 prior to the original treatment with the therapeutic composition 24 ¦ as noted above. A subsequent resumption in the ingestion of 25 ¦ the therapeutic compositlon again improved the patient's eyes 26 1 as during the prior treatment period. No side effects from 27 this treatment have been observed. ¦
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Claims

THE EMBODIMENTS OF THE INVENTION IN WHICH AN EXCLUSIVE
PROPERTY OR PRIVILEGE IS CLAIMED ARE DEFINED AS FOLLOWS:

1. A therapeutic composition for administration to humans and other animals for the purpose of reducing the severity from and accelerating the recovery from physically induced damage to body tissue, said composition comprising a water soluble organic or inorganic therapeutic compound containing selenium whereby the selenium is in such a form as to be capable of being absorbed by the tissue of the host being treated together with a non-toxic pharmaceutically acceptable carrier or diluent therefor, whereby the therapeutic composition is formulated so as to provide the equivalent of 0.05 mg - 1.0 mg of elemental selenium per day to the host in single or multiple dose form.

2. The therapeutic composition as defined in claim 1 wherein the selenium is present in the form of a water soluble inorganic salt.

3. The therapeutic composition of claim 1 wherein said salt contains selenium in the form of selenate or selenite anions.

4. The therapeutic composition of claim 1 wherein said selenium compound is an organic selenium compound.

5. The therapeutic composition of claim 1 wherein said carrier is an orally administrable pharmaceutical carrier.

6. The therapeutic composition of claim 1 in the form of an injectable preparation.

7. The therapeutic composition of claim 1 in the form of a topical preparation.

8. The topical preparation of claim 7 further containing an ingredient selected from the group consisting of perfumes, emollients, emulsifying agents, stabilizers, and physiologically acceptable coloring agents.

9. The therapeutic composition of claim 1 in the form of a suppository.

10. The therapeutic composition of claim 1 wherein the carrier includes water.

11. The therapeutic composition of claim 1 wherein the carrier is in liquid form.

12. The therapeutic composition of claim 1 wherein the carrier is in solid form.

13. The therapeutic composition of claim 1 in the form of a tablet.

14. The therapeutic composition of claim 1 in the form of a capsule.

15. The therapeutic composition of claim 11, 13 or 14, wherein said capsule contains a material selected from the group consisting of colloidal silica, magnesium stearate, calcium phosphate, calcium sulphate, lactose, mannitol, sodium stearyl fumarate and mixtures thereof.

16. The therapeutic composition of claim 1 in dosage form wherein said carrier is an orally administrable liquid pharmaceutical carrier bland to the gastric mucosa.

17. The therapeutic composition according to claim 1 further comprising Vitamin C or ascorbic acid.

18. The therapeutic composition of claim 1 which contains a steroid.

19. The therapeutic composition of claim 1 which contains a proteolytic enzyme.

20. The therapeutic composition of claim 19 wherein said proteolytic enzyme is selected from the group consisting of extracts from pineapple plants, extracts from papaya plants, and extracts containing trypsin and chymotrypsin.

21. The therapeutic composition of claim 20 wherein said proteolytic enzyme is selected from Ananase, Papase and Chymoral.

22. A cleansing composition having therapeutic properties in improving the healing and maintaining of skin tissue, said composition containing a cleansing agent and the therapeutic composition of claim 1.

23. An eye drop solution for alleviating irritation and redness in the eyes of humans as well as other mammals, said solution comprising a water soluble organic or inorganic therapeutic compound containing selenium whereby the selenium is in such a form as to be capable of being absorbed by the tissue of the eye being treated, said compound dissolved in a suitably buffered isotonic aqueous solution whereby the con-centration of the compound in solution is in the range of about 0.1 mg to 0.5 mg of elemental selenium per cc of solution.

24. The eye drop solution of claim 23 wherein said solution comprises a water soluble inorganic selenium salt.