This invention concerns Pharmaceutical, Cosmetic Dermo-Cosmetic, Hygiene, Alimentary and Para-Alimentary (Food Supplements) Compositions (or Products or Compounds), characteristically containing Seal-Oil, its Components or Derivatives, associated with Active Ingredients (synergyzing them or compensating clinical or sub-clinical deficiencies) which said Compositions (Products or Compounds) deliver to the human organism; It also concerns the process(es) of preparation of said Compositions (Products or Compounds), which normally consist in mixing the necessary ingredients, eventually under heating and/or cooling, extraction of water, etc. An example of these processes is the following composition, involving : (a) Seal-Oil - with or without fish-oil; (b) Excipients : Distilled water; Glycerol; Emulgin; Myristol; Isopropyl-palmitate; Alcohol; Cutin; a Thickening Agent (modocoll); (c) Ubiquinone; (d) Liposomes - for a total of 100 %. This current invention also comprises the uses (utilisation) of these Compositions (or Products or Compounds) in the preparation of Pharmaceutical Products (whether Preventive or Therapeutic), which are useful in the Treatment of Illness and/or Deficiencies of the Active Ingredients and/or the consequences thereof (including signs and symptoms) elicited by said deficiencies), as well as the clinical and non-clinical uses of said Products.

CLAIMS

1. PHARMACEUTICAL, COSMETIC, DERMO-COSMETIC, HYGIENE, ALIMENTARY AND PARA-ALIMENTARY (FOOD SUPPLEMENTS) COMPOSITIONS (OR COMPOUNDS, OR PRODUCTS) characterised by the fact that they incorporate as active ingredient Seal-Oil and/or the respective#-3EFA's (whether extracted from seal-oil or of any other origin) and/or their physiologically acceptable salts, and/or the respective (seal-oil) phospholipidsand/or other (seal-oil) components isola ted thereof for TOPICAL and NON-TOPICAL USE, eventually enriched andpharmacologically synergized through (by) the use of Liposomes or Phitosomes and/or of (other) Active Ingredients(re- inforcing the effects elicited by the0-3EFA's and/or the other constituents of Seal-Oil and/or compensa-. ting simultaneous cellular deficiencies), in association with adequate, pharmaceutically acceptable exci pients.

2. COMPOSITIONS(OR COMPOUNDS, OR PRODUCTS) as perReivindication (1), characterised by the fact that they incorporate as active ingredient Seal-Oil and/or the respective#-3EFA's and/or their physiologically acceptable salts, eventually in association with other ingredients active in this field.

3. COMPOSITIONS(OR COMPOUNDS, OR PRODUCTS) as per Reivindications (1) and (2), chara cterised by the fact that they incorporate as active Ingredient Seal-Oil under the final forms of creams to counter (or prevent, or treat, or compensate) dry, squamous skin, nutritive creams, make-up creams, dermatoldgical hydrating lotions, dermatological hydrating sprays, hydrating restorative gels, mascara gels, lip products (whether shining or dull, in terms of light reflection), eye powders, shampoos, capil lary gels, etc..

4. COMPOSITIONS (OR COMPOUNDS, OR PRODUCTS) as perReivindications (1) (2) and (3), cha racterised by the fact that they incorporate as active ingredients two or more of the following substances (or groups of substances) hereinafter indicated, one of them being Seal-Oil :(1) Seal Oil (mostly under filtered and deodorised form) - and/or the respective#-3EFA's ; these should represent0, 5 % to 25 %(weight/weight) of the final product, more particularly 2, 5% to 15%, preferably 5% to 10% ; (2) Excipients, among which the following may be the chosen ones : Water (distilled or demineralized), which may amount to 40 to75 % (W: W or weight : weight) of the final product; Glycerol, which will amount to 2,5a 10% (W :W) of the final product ; Emulgin (productn 7450 in Merck Index), which will amount to 1,5 a 5% (W:W) of the final product ; Myristol (productn 6184Xin Merck Index), which will amount to 2,5 a 10 % (W: W) of the final product ; Isopropylpalmitate, which will amount to 2,5 a 10 % (W: W) of the final product ; Alcohol, which will amount to1, 5 a 5% (W : W) of the final product, Cutin (product n 2610 in Merck Index), which will amount to 4, 5 a 15 % (W: W) of the final product, a thickening agent (such as

(3) Fish Qils, (mostly of halibut, salmon, tunna, sardine, shark, cod, etc.) rich in#-3EFA's - and/or the re pective #-3EFA's ; such #-3EFA's (as any other #-3EFA's mentioned in this Patent) may eventually be produced by chemical synthesis and/or through techniques of genetic engineering ; they will represent 7, 5 to 15 % (W : W) of the final product; (4) Vegetable Oils (namely those of evening primrose or field borage, of grape seeds, etc.) rich in! D- 3EFA's - or the respective #-3EFA's ; they will represent 7,5 to 15 % (W: W) of the final product; (5) De-acylated glycerophospholipids (glycero-phosphoryl-choline ; glycero-phosphoryl-inositol; glycero phosphoiyl-serine ; glycero-phosphoryl-ethanolamine ; etc.) and/or their respective physiologically acce- ptable salts, in concentrations ranging from 0,1

(7) Ubiquinone(or ubidecarenone or Cd-enzymeQ-1Q)-a natural product acting as a potent andphysiolo- gicanti-oxidant which our experiments have revealed is capable of completely reverting inflammatory skin processes due to physical and chemical agents (burns, etc.).

(8)Lipgsomes orPhitosomes made so as to containand/4r help deposit said#-3EFA's and/or Q-10 and/or Ingredients such as'those in this list on the surface of cell membranes of those cell we aim at enriching with these Active Ingredients. We aim at enriching the Liposomes or Phitosomes in question in those Ingredients referredto ; they may eventually contain Seal Oil itself inside their membranes, but even in such eventuality they shall in principle contain other Ingredients ; (9) Silver Salts (those metabolically more active and directed at cell Sections more specifically involved in cellular respiration and in energy production and control) - because we confirmed that silver is one oligo-element capable of augmenting. the efficacy of Q-10; said salts are, forexample, orqtate, gluconate, picoli-nate, and all those capable of easy penetration into cell structures-butyrate and its immediate derivatives and other salts of ammo or fatty acids of low molecular weight-can be used to alter energy metabolism at cellularmitochondrial and nuclear level ; (10) vitaminaBl (cocarbpxylase, if possible understabilised form) and/or ATP (Adertosine-tri-phosphate- dissodic or other) under a form capable of promoting and activating energy production and/or liberation even in visibly deficient cells or those under aggression or intoxication decreasing such processes signifi cantly ; (11) other vitamins of B complex, and above all B5(Panthenol), B6,B12 andFolic Acid, which areimpli- casted in cell respiration processes and in those controlling cellular energy ; (12) otherAnti-oxidants-such as vit.A, C and E,glutathion andglutathion reductase,catalase, supero xyde-dismuthase, poliphenols (including picmogenol) and catechmes and their elements and polimers ; (13)Aiiti-Ageing Products and antagonists of collagen and elastin cross-linking, such asanti-oxidants, po liphenols andcatechines, and their elements and polimers, as well as Products rich in silicium (such as the garlic derivatives and extracts of plants with similar properties); glucosaminoglycans ;hyaluronic acid; amino-acidsand/or bio-stimulins ; collagen, elastic and placentahydrolysates and extracts ; and/or the extensine proteins; (14) certainoligo-saceharides of vegetable origin, namely those extracted from algaeand/or DMSO (of ve getable and non-vegetable origin), inducing membrane de-stabilisation and, therefore, increased mem brane permeability to the chosen Active Ingredients used in the Products contemplated in this Patent,(15) soluble calcium carbonate and other soluble salts of (mostly soluble calcium carbonate known as "coral calcium" (CC, extracted inOkinawa andTokunpshimo Islands, inIapan, and mvarketed outside Japan, by the Swedish firm PMG - Preventive Medical Group) ; other oligo-elements, including chromium and or selenium and/or germaniumand/or zinc (assans-orotate, picolinate,gluconate and other salts derived of fatty-and amino-acids) with great importance in the processes related to tissue healing and cellular reparation (systemic, epithelialand/or occurring in other structures related to the Skin and the Mucous Membranes, etc).

(16)Chelanting agents and ion-exchange substances (as, for example, calcium-EDTA) ;(17) Chromoglyeate (disodic or not) and/or other anti-allergic and/or membrane-stabilising products.

(18) Different Vegetable or Animal Products, capable of inducing metabolic recovery in cells, such as cen trophenoxine and certain Vegetable Extracts(as, for example,tepescohuite or mimosa tenuflora poir, tabernanthine, gingkobiloba, aloe vera, and other extracts, such as those rich in VegetableAuxins) (19) Epidermal Growth Factor (EGF) ;(20) Interferon - alpha, beta and / or gamma; (21) Enzymes, specially enzymes capable of digesting and mobilising blood components (a good example is hirudin) or components of connective or elastic tissue (for example, collagenase and elastase) ; (22) Xanthine derivatives (including caffeine) and vegetable extracts containing them (as is the case of guarani) ;iddo-thyrosine and/or tri-iodo-thyro-acetic or tri-iodo-thyro-propionic acids ; (23) To these Active Ingredients other may be added, such as certain Active Vegetable, or Animal, princi ples, allowing for Formulations & Preparations (mixtures) endowed with-specially desired effects, such as (a) Vegetable or Animal Products active against penile ageing and the loss of male erectile poten cy due to local vascularand/or muscular deficits (as those related to muscles which compress veins drai ning the urethra corpus cavernosus) ; (b) certain substances and certain animal extracts, namely male-seal penile extract, which may be obtained (for example) by sonic & mechanical destruction of the organ at stake,. followed by differential centrifugation to separate the respective constituents; one of the objectives involves the use total extract having as Ingredients all elements with MW not superior the 200.000 D (therefore including hormone receptorsand/or ADN andARN of cells of this organ reputed for its permanent growth until the seal's death-these substances probably corresponding to nucleic acids and/or their precursors(DNA, RNA, puric apd pyrimidic bases).

5. COMPOSITIONS (OR COMPOUNDS, OR PRODUCTS) as per Reivindications (1) through (4), characterised by the fact that they incorporate as active ingredients three or more of the indicated subs tances (or groups of substances), one of them being Ubiquinone (Co-Enzyme QIC) ; 6. PHARMACEUTICAL PREPARATIONS, COMPOSITIONS (OR COMPOUNDS, OR PRO DUCTS) for Medical-and Non-Medical) Dermatological, Cosmetic,Oermo-Cosmetic Use, Characteri sed by the fact that they incorporate mixtures with the compositions indicated in any ofReivindications (1) through (5); 7. The use of PHARMACEUTICAL PREPARATIONS, COMPOSITIONS (OR COMPOUNDS, OR PRODUCTS) as per Reivindications (1) through (6), characterised by the fact that they containpharma- ceutic products meant to treat deficiencies inQ-3EFA's and other dysfunctional or deficiency states and/or diseases and/or lesions associated with them at topic (cutaneous, dermic, mucous orsubmucous) level or at a deeper level in the human body, with a preventive or therapeutic purpose in dermatology, and the cosmetic ordermo-cosmetic fields; 8. Process (es) for-the preparation of pharmaceutical compositions (or compounds or products) as per rei vindications (1) through (5), characterised by the fact that they contain mixtures of (all percentages represent W: W proportions of the final product): a) Seal-oil-0, 10 to 50,0% ; or seal-oil-0,10 to30, 0 % + fish-oil 0,10 to 25,0 %; b) Excipients: Distilled water 30,0 to 90,0 %; Glycerol 0-4 %; Emulgin 0-3 %; Myristol0-5 % ; Isopropyl-palmitate0-4 % ; Alcohol0-3% ; Cutin 0-6 %; a thickening agent (modocoll)0-2 %; c) Ubiquinone-0, 10 to 55,0 %; d) Liposomes or Phitosomes 0,10 to 30,0% ;for a total of 100 %. or characterised by the fact that they contain mixtures of the substances indicated in the following exam ples (already referred to illustrate this current invention, which they nevertheless do not limit in any way whatsoever the scope of application and use of this.inventidn) : Example # 1 NUTRITIVE CREAM(I) weight/weight (a) seal-oil-10 %; ou seal-oil-5 % + fish-oil-5 % ; total : 10 % (b) Glycerol 04% (c) Emulgin 03% (d) Myristol 05% (e) Isopropyl-Palmitate 04% (f) Alcohol 03% (g) Cutin 06% (h) Thickening Agent (modocoll) 02% (i)Ubiquinone 05 % (j) Liposomes 10% (k) Distilled Water 48% for a total of100 %.

Preparation : Mix the indicated ingredients at40'C temperature, under stirring and allow cooling.

Example 2 NUTRITIVE CREAM(II) (p/p)(I) a Seal-oil 10,0% or Seal-oil (5,0 %) + Fish-oil (3,0%) + Vegetable Oil (2, 0 %) 10.0 % b Gliyerol Monoestearate emulsified withPoliethilene-glycol 05,0 % c Stearic Acid of origin vegetable 08,0 % d. Sweet almonds oil 07,0 % eMiristyl Ethoxi-miristate 06,0 % f Cetyl Alcohol 01, 0 % g Lauryl Pyroglutamate 01,0 % h Silicone00, 5 % i Demineralized Waterq. s.

(H) a Glycerol 02, 0% b Glycerophosphorylcholinae 03,0 % c Zinc Pyroglutamate 00, 2% d Pyroglutamate ofcrhomium 00, 2% e PyrogXutamate of copper 00,2 % f Demineralized Water q. s.

Preparation : Mix the components of phase(1) with water and heat up to54 C ; Mix'the components of phase(II) with water and heat up to 54 C, Add as phases (I) and(II) stirring slowly; Add the products of this phase(III) to Triethanolamineq. s. up to pH 6,4-6,6 Add b Perfume q. s. c Demineralized Water (diluting) q. s. up to 100, 0% Allow cooling up to 35 C, stirring slowly.

Example3 DERMO-COSMETIC HYDRATING LOTION(I) (p/p) a Seal-oil 10, 0% ou Seal-oil (5,0 %) +Fish-oil (3, 0 %) + Oleo vegetable (2,0 %) 10.0 % methyl p-oxybenzoate 00,7 % c propylp-oxybenzoate 00,3 % dGlycerylphosphorylcholine 35,0 % eDerdineralized Water (diluting) q. s. up to 100,0% Preparation. :

Dissolve Seal-oil (or amixture of oils indicated above) and os conservantes in water tepid de-ionized ; Add aGlycerylphosphorylcholine, stirring slowly : EXample 4 LOTION HYDRATING DERMO-COSMETIC (II) (p/p) Seal-oil 07, 0 % or Seal-oil (5,0 /O) + Fish-oil (3,0%) + Vegetable Oil (2, 0%) 07.0% bGlyceryl Stearate 00, 5 % c Isocethyl Stearate 10,0 % d Lanolin Ether PPG-10 00,3 % e Lanolinic Alcohol00, 7% fAcido oleic 02, 0 % g Triethanolamine 01,3 % h Carbomer 941 00,1% Glycerol 04, 0 % j Conservative Agent (s) 00,4 % k5% Solution of carrot extensin 05, 0% 1 Polipeptides of 5% extensinahydrolisate ("Vegagen" Centerchem8) 05,0 % e Demineralized Water (diluting) q. s. up to 100, 0% Preparation;

Dissolve Seal-oil (or the mixture of oils indicated above) and the conservative agents in tepid de-ionized water ; Add the other elements, under stirring.

Example MAKE-UP CREAM(A) :(p/p) (I) a Seal-oil 10, 0% or Seal-oil (5,0 %) + Fish-oil (3,0%) + Oleo vegetable (2,0O/o) 10. 0 % b Bees Wax 03,0% cPolyglyceryl-4-oleate 02, 0% d Silicones(ciclomethicone and dimethiconecoliopol) 08,0 % e. Silicone(cyclomethicone) 08, 0% fGlycerylphosphorylethanolamine 01,0 % g Pigments 15,0% (II) a Sodium Citrate 03, 0% b Conservative agents q.s. e Demineralized Water (diluting) q. s. up to 100, 0% Preparation :

Mix Seal-oil (or the mixture of oilsindicada above), silicones, Polyglyceryl-4-oleate and Bees Wax and conservative agents, heating up to 54 C ; Add the other elements of phase (I), dissolving them in de-ionized water, adding Glycerylphosphorylethanolamine last, under slow stirring ;

Mix phase (II) in de-ionized water ; Mix phases (I) and(II) under slow stirring ; allow cooling ; Homogenise the resulting CREAM.

Example6 CREAM of MAKE-UP(B) : (I)(p/p) a Seal-oil 10, 0% or Seal-oil (5,0 %) + Fish-oil (3,0 %) +6leo vegetable (2, 0%) 10.0% b BeesWax'03, 0 % cPolyglyceryl-4-oleate 02,0 % d Silicones (cyclomethieone and coliopol of Dimethicone) 08, 0% 8Centerchem Inc. - Stamford, CT, USA e Silicone (cyclomethicone) 08,0% fGlycerylphosphorylethanolamine 01,0 % g Pigments 15,0% (II) a Citrate of sodium 03,0% b Conservative agents q. s. e Demineralized Water (diluting) q. s. up to 100, 0% Preparation : Mix Seal-oil (or the mixture of oils indicated above), silicones, Polyglyceryl-4-oleate and Bees Wax and the conservative agents, heating up to 54 oC ; Add the other elements of phase (I), disolving them in de-ionized water, adding

Mix phase (II) in de-ionized water ; Mix phases (I) and(II) under slow stirring ; allow cooling ;Homqgenise the resulting CREAM.

Example 7 HYDRATING GREAM (I) : (p/p) , Seal-oil 10, 0% or Seal-oil (5, 0 %) + Fish-oil (3, 0 %) + Oleo vegetable (2,0 %) 10.0 % + Mineral Oil 02,0% b Stearateofglyceryl 05, 0% c Stearate of isopropyl 04, 0% d Cethylic Alcohol 02,0% e Steatylic Alcohol 02,0 % fPolysorbate 60 01,0 % g Gum of xatitane 00,3 % h Glycerol 08,0% i Conservative Agent(s) 00,6 % j 5 Solution of carrot extensin 05,0% k Polipeptides of 5 % extensina hydrolisate ("Vegagen" Centerchem9) 05,0 % 1 Demineralized Water (diluting) q. s. up to100, 0% Preparation :

Dissolve Seal-oil(or a mixture of oils indicated above) and the conservative agents in tepid, de-ionized water; Add the other elements, under stirring.

Example 8 MAKE-UP CREAM (C) : (p/p) a Seal-oil (5%) or or Seal-oil (2,5 %) + Fish-oil (1,5 %) + Vegetable Oil (1,0 %) 05, 0 % b Octildodecyl-stearyl Stearate04, 0 % cIsocetyl Stearate 01,0 % d Propilene-glycol 03,0 % e Iron Oxyde 02,0 % f Titanium Dioxyde 08, 0% g TensioactiveAgehts' (lecithin,polisorbate 20, sorbitan laurate) 01,0 % h Triethanolamine 01,5 % i Conservative agents 00,6 % j Aglutinating and Thickening Agents 01,8 % k 1,5 % Solution of tomato extensine 01,0 % Demineralized Water (diluting) q. s. up to 100, 0% Preparation :

Dissolve Seal-oil (or the mixture of oils indicated above) and the conservative agents in tepid de-ionized water; Add the other elements, under stirring.

Examples 9 and 10 MAKE-UP CREAMS (D) and (E): (p/p) (p/p) a Seal-oil 05, 0% 05,0% or Seal-oil (2,5 %) + Fish-oil (1,5 %) + Vegetable Oils (1,0%) 05.0 % 05,0 % b Bentone Gelllyfying Agente 05,0% ----c "Laureth 7" 00,5% ----d Propylene-glycol 06,0% 08,0% e Iron Oxyde 03,1 /d 02, 4% 9 Centerchem Inc. - Stamford, CT, USA 10Aninicos f TitaniumDiOxyjde 12, 0% 08,5 %g Tensioactive Agent(s) 16,0% 20,0% h Cyclomethicone22, 5 % 12, 0% i Dimethicone ----- 05,0%j Conservative agent (s)00, 5% 00,5%k Talcum powder 04,5 % 03,3 % 1 Sodium Chloride0220 % 02, 0% m 1, 5% Solution of potato extensine 00, 5% 00,5% n Demineralized Water (diluting) q. s. up to 100, 0% 100, 0% Preparation :

Dissolve Seal-oil (or the mixture of oils indicated above) and the conservative agents in tepid de ionized water. Add the other elements, under stirring.

Example 11 MASCARA GEL :(p/p) a Seal-oil 10,0 % or Seal-oil (5,0 %) + Fish-oil (3,0 %) + Vegetable Oils (2,0%) 10,0% b 1,2-propanodiol 02,0 % c Glycerylphosphorylcholine (at 85 in Demineralized Water) 00,2 % d Carbomer 940 00, 2% e Triethanolamine 00,2 % f 95"Ethyl Alcohol 10, 0% PVP (polivinylpyrrolidone K 30) 01, 0% h Conservative agents q. s. i Pigments q. s. e Demineralized Water (diluting) q. s. up to 100, 0% Preparation :

Mix Seal-oil (or the mixture of oils indicated above),1, 2-propanodiol, Glycerylphosphoryl choline in Demineralized Water ; Add, under strong stirring, Pigments and catbomer ; Neutralize with Triethanolamine in aquous solution ; Add 95 Ethyl Alcohol and PVP (polivinylpyrrolidone K 30) under stirring.

Example 1 CAPILLARY TONIC in CREAM FOR WASHING : (p/p) a Seal-oil 05,0% or Seal-oil (2,5 %) + Fish-oil(1, 5%) + Vegetable Oils(1, 0 %) 05.0 % b Stearalconium Cloride 02, 0 % c "Ceteareth 20" 02,0% d Citric Acid 00,3 % e Dimethicone 00, 2% f Gumoixantano 00,5 % g Cethyl Alcohol 01,0 % hStearilic Alcohol 00,5 % i 1% Solution of maize extensine 00,2 % j Demineralized Water (diluting) q. s. up to 100, 0% Preparation :

Dissolve Seal-oil (or the mixture of oils indicated above) and the conservative agents in tepid de-ionised water; Add the other elements, under stirring.

9. The use (utilisation) of the compositions prepared as per the processes in accordance withReivindication 8, characterised by the obtention of Dermatological, Cosmetic and Dermo-Cosmetic Products.

DESCRIPTION:

PATENT

PHARMACEUTICAL, COSMETIC,DERMO-COSMETIC, HYGIENE, ALIMENTARY AND PARA-ALIMENTARY (FOOD-SUPPLEMENTS) PRODUCTS INCORPORATINGSEAL-QIL AND/OR THE RESPECTIVE COMPONENTS THEREOF, ENRICHEDBY LIPOSOMES OR PHITOSOMES AND/OR ACTIVE INGREDIENTS REINFORCING THE EFFECTS OF SEAL OIL COMPONENTS OR THEIR DERIVATIVES. METHODS, PROCESSES AND PROCEDURES FOR PREPARING. SAID PRODUCTS USES OF THE ABOIE PRODUCTS, ACTING AS PREVENTIVE OR AS THERAPEUTIC AGENTS.

DESCRIPTION

This current invention is related to Compositions (Compounds, or Products) for topical and non-topical use, characteristically containing seal-oiland/or the respective essential fatty acids (EFA's) of the Omega3(Q-3) series and/orphysiologically-and-therapeutically-acceptable saltsthereof ; and/or any seal-oil-derived phospholipidsand//or the respective derivatives;and/or other components of seal-oil and the derivatives thereof ; these Compositions (Compounds) can be enriched withLiposomes or Phitosomes, and /or other Active Ingredients (reinforcing the effects elicited by the Seal-Oil Q-3EFA's or by other Components typical of Seal-oil ;and/or compensating simultaneously existing cellular deficiencies); the usages of said Compositions or Products, as well as to their methods or processes of preparation.

In particular, this invention is also related to the use, either as preventive or as therapeutic agents, of said Compositions (Compounds, or Products), which make use ofQ-3EFA's and/or any seal-oil-derived phospholipids and/or the respective derivatives;and/or other components typical of seal-oil) or their respective derivatives, which will be found useful and adequate in the perspective outlined here.

In this particular invention said Compositions (Compounds, or Products) can be used either isolated or in different combinations. TheQ-3EF 's and/or their acceptable salts, the phospholipids and/or their acceptable derivatives,and/or other seal-oil components and/dr their acceptable derivatives can be obtained by extraction from seal-oil, but they can also be extracted from other natural sources or be obtained through chemical or bio-technological or bio-engineering synthesis.

ANTECEDENTS OF THIS INVENTION

Cosmetic products laboratories, enterprises and firms are particularly interested in formulating treatment cometics and/of treatments endowed with beneficial effects upon the skin, the mucosal membranes and their associated, allied structures(phanerae)-such as hair and nails. It is widely known that animal-derived products-exert beneficial effects upon the skin, the mucosal membranes and the associated, allied structures(phanerae) and this has rendered the incorporation of substances of this type in cosmetics and personal-care products, as well as inderino-cosmetics and pharmaceutical products, including those with a decidedly thrapeutic vocation.

TheS2-3EFA's (and/or their physiologically acceptable salts) are widely distributed in the vegetable andani- malkingdoms, where they play ubiquitous, frequent and relevant roles, namely in the realms of cellular fuctions and the functional regulation of cellular and intra-cellular membranes. Phospholipids also are essential constituents of the cell structures (whether these are part of the different membranes or not) and they can be

The administration (or use) of seal oil or of its elements (and/or of their respective derivatives) by oral or parenteral route, under formulations such as food supplements orpharrnaceutical preparations, has been shown to be useful in the prevention or the reversion. of dysfunctionaland/or involutive (ageing) processesinciding in the cellular (and intra-cellular) membranes, since they carry out functions which are of great importance for the biochemical regulations in the cell-membrane, intra-cellular and inter-cellular spaces.

It has been shown that seal-oil (as well as itsQ-3EFA's and/or their acceptable salts, its phospholipids and/ or their acceptable derivatives,and//or other seal-oil componentsand/or their acceptable derivatives are very well absorbed by the topical route when presented in an adequate formulation, such absorptionbeing, a valuable"exogenous"alternative for supplying them to epithelial and sub-epithelial cells via an endogenous (oral or parenteral) route.

Thus, seal-oil (or, rather, Seal-Oils, since different compositions are known to exist for different species or even for different strains of seals), as well as its52-3EFA's and/or their acceptable salts, its phospholipids and/or their acceptablederivatives ? and/or other seal-oil components an/or their acceptable derivatives, possess properties'and characteristics which are most interesting and useful to be exploited, once adequately formulated, in the domains of cosmetic, dermo-cosmetic and pharmaceutical prevention and therapy, as well as in Alimentary, Para-Alimentary. and Hygiene (Consumer) Products Said use and exploitation is based on the fact that the referred Compositions (or Compounds) have properties which induce humidifying, anti-dehydration, emollient,elastifying, restorative, and allied or similar effects.

The concentrations of seal-oil, itsn-3EFA's and/or their acceptable salts, its phospholipids and/or their acceptable derivatives,and//or other seal-oil componentsand/or their acceptable derivatives, in this current invention may vary within very ample limits, according to the intended aims and goals and the formulation : for example, they can be used within the interval comprised between 0,01 % and 99,50 %weight/weight, preferably between 0,1% and40 % weight/weight.

Seal oil, itsQ-3EFA's and/or their acceptable salts, its phospholipids and/or their acceptable derivatives, and/or other seal-oil components and/or their acceptable derivatives all have an extremely low systemic toxicity and a topicaltoxicity close to nihil, according to tests carried out in animals. Besides, it is important to state that seal oil has been shown to contain theQ-3EFA's in proportions which match those of the human bodya characteristic which immediately makes seal-oil a preferential source ofsaid Q-3EFA's for human use.

Olive Oil is, of all those which are known, the natural fat most suited for human consumption in what concerns the preparation of food at hightemperatu-re. In fact, not only have scientific, modern, clinical studies demonstrated that Olive Oil lowers total cholesterolemia and raisesHDI-chQlesterol (the "goocolesterol"), but also Olive Oil has been shown to be the only edible fat which will go through heating to200 C without significant generation of products harming health. In fact, in recent investigations, carried outwitlrdifferent edible fats easily found in supermarkets or food shops ; all experimental animals (rats, mice and guinea-pigs) after a 6 months period of ingestion of said edible fats (after being heated to200 C during sufficiently long periods of time),exhibi-ted cancerous lesions-the exception was the group of animals fed Olive Oil. With the exclusion of all other fats. Besides, Olive Oil is most probably the edible fat mostgeneralizedly appreciated (liked) all over the world.

Umbrtunartely, Olive Oil is insufficiently rich in those AGE (orEFA's)-which the human organism is unable to synthesize Out of other fats (this being the reason forEFA's really beingESSENTIAI for human heath...). It would therefore be ideal if Olive Oil was endowed with said EFA's in proportions covering the daily needs of each Consumer. This being so, by adding natural oils (or fats), rich in EFA's (or even the adding purifiedEFA's) to Olive Oil, it will be possible to obtain mixtures which are non-existing in Nature butwinch shall have great higher dietetic value to guarantee feeding habits ensuring good, equilibrated health to those who adopt them.

The ingestion of said fats enriched with the EFA's needed to avoid all and every stateof carency (in EFA's) of the organism shall be capable of doingtjhe correc ao and,a fortiori, the prevention of many illnesses, among which the following deserve being mentioned : arteriosclerosis (and platelethiperg- gregability and hiper-adhesiveness,hiper-coagulability and low bloodthrombo-lyic activity) ; doencas detipo rheumathoid: states of excessive dryness of the skin and/or the mucosal membranes, and skin diseases triggered or aggravated by said states ofcarency ; illnesses (of the intestines and other organs, as it happens in the eyes and in feminine genital organs) involving mucosal inflammation andimmunitary ; neurologic and psychologic dysfunctional processes.

Among the natural fats to be added to Olive Oil, the following must be counted: (a) vegetable oils rich in EFA's(also known as"fats rich inomega-3")-Cold-pressed Oils EXTRACTED fromborhage, grape seeds, linnseed, carthamus, sunflower,etc. ; (b) fish oils-mostly and preferably : from fat fish (salmon, sardine,halib, ut, shart thunafish, etc., etc.) ; (c) animal oils-as much as possible they must be Cold-Pressed, preferably Seal-Oil, particularly rich inEFA's (ilSclunding DPA) in proportions closely mimicking those found in the human organism, a reason why such oils are the most adequate, in terms. of physiology, for human consumption !.

On the other hand, enriching Olive Oil as suggested above, not with complete natural fats, rather (only) with the essentials fatty acids of the omega-3 seriesand/or the phisiologically acceptable salts thereofand/or other of their componentsand/or derivatives considered to be desirable, to say nothing of any other active ingredients referred to in this Patent and adequate for human feeding ingestion.

Thus alimentary products shall be prepared (through mixing Olive Oil with with other fats) capable of supplying to the human body healthier alimentary fats (exemptoftoxicity), and being complete (through containing the Essential Fatty Acids or EFA's, whose want trigger states of carency). Said enriched fats are therefore preventive ofphisiopatologically seroius carencies, which induce the loss of health and of immunity against illnesses) and superior to those usually proposed for sale to the public, avoiding carences of serious consequences for the maintenance of a healthy state and of the capacity to defend himself. (directly ou indirectly) of multiple diseases.

Different phenomena and processes must be taken in consideration in the amplest context, within which only really self-sustainable decisions can be taken in the long run-that is, only biologically andecologically sound decisions must be underwritten. In that perspective, a somewhat surprising phenomenon (or process) hasbee# taking place and the public opinion which does not follow this specific field has not been aware of its importance-the exponential increase of the seal population, after this species was considered by the world press, to be an endangered one, after the campaigns that ecologists and other well-intended entities organise to stop the killing of baby-seals, whose skins were used to make fur coats or women. The hunting restrictions thus elicited by these legitimate preoccupations(more"humalaitarian", if such word can be used in relation to non-human animals, than ecological) allowed for a significant shift of the then existingequili- brium and the consequent expansion of the number of existing seals. Significantly safe data are now available (from theGovernment of Canada) which demonstrate that this seal population is the largest wildmam- mal population in the world (provided that the human is not considered) - with over 6 (six) milli) seals in Canada alone. Some consequences of an equilibrium shift should have been expected-but they were not all anticipated or set in a perspective taking into account immediate human problems andpriorities. One rather striking illustration of this last statement pertains to the fact that each seal eats an average of14 Kg of cod (and similar) fish per dAy, a fact which, albeit not being probably not the sole factor responsible for the current scarcity of that fish species, nevertheless probably contributed significantly to the"palmeta" (cod fish) war, which had as a consequence that Portuguese (and other) fishermen were forbidden from carrying out their traditional activity of fishing cod in Newfoundland.

The census carried out estimate that the current annual seal hunting kills 250.000 to 300.000 animals in Cnada, and that it would be necessary to kill 600.000 animals per year to reach a zero-growth equilibrium in thismammal population (in Canada alone). The annual production of seal-oil-in Canada alone, which has about 80 % of the world production of seal-oil-3, 000 metric tons, It is therefore of importance (it urges) toBnd added value uses for a product which, otherwise, shall be discarded away and lost-or shall be indiscrminately used in purposes of no special interest, depriving populations (mainly Eskimo) of a compensation which is legitimately due to them and which shall be able to sustain themselves through them instead of having to resort to charity and welfare. Different potential uses have been studies and what follows should be considered as part of that perspective.

Essential Fatty Acids(EFA's) are dietery (or alimentary) factors whose ingestion is essential for the body to keep healthy. They were discovered in 1929 by George and Mildred Burr- (University of Minnesota, USA). There are two series ofEFA's, the n-6 (or omega-6), derived ofcis-linoleic acid ; and the n-3 (or6mega-3), derived ofalfa-linolenic acid The digits indicate the position of the first double link (C=C) in the molecule counted from the omega terminal. As for certain vitamins, cis-linoleic andalia-linolemc acids are devoid of activity (except that of serving as energysubstrates-being"burnt"in cellular metabolism to generate energy for the cell) while they have not been specifically bio-transformed in the human body, as shown hereafter' : EMI4.1

S ries 11-6 S Bise n-3 cis-linoleic acid alfa-linolenic acid delta-6-desaturase (D6D) gama-lmolemc acid (AGL) 18: 4, n-3 1 elongation 1 dihomo ; gamma-linol nic acid (da) 20 4 :, n-3 delta-5-desaturase (D5D) PG's series 1 arachid6nic acid eicosa-pentaenoic acid (20: 5, n-3) PG's serie 3 PG's s rie 2 longer EFA's longer EFA's TheEFA's of these two series (n-6 and n-3) are not interchangeable in animals. It is worthy noting the low activity ofdelta-5-desaturase no Man and the guinea-pig, while it is high in mice and rats.

EFA's are important for twofoundanlental reasons : (a) they are constituents of all membranes in all tissues of the body, playing a role which is vital for determining the characteristics and the biological capacities of their respective membranes-it is therefore logic that EFA's deficiencies trigger great dysfunctions in all body tissues; and (b) EFA's are the precursors of a group of highly reactive and very efemerous substances - prostaglandins (PG's), leuco-trienes (LT's) and other related molecules, such as thrpmboxanes (TX's), which intervene in an infinity of cell and organ processes. More than 50PG's, LT's and related molecules with biologicalmportance have been identified, acting as local messangers in the regulation of the activity of different tissues and organs where they are produced.Arachidonic acid (AA) has very different and varied effects through the products it generates. Thus, for example, it both originates PGI2 (prostaciclin), with desirable effects of inhibition of platelet aggregation and vasodilatation, andthromboxane A2 (TXA2) and PGF2a, which promotevasospasm, thrombosis and inflammation. After AA,PG's andthromboxahes (TX's) are due to the intervention of a ciclo-oxigenase, whileLT's are due to a completely differentenzime-a lipo-oxigenase : EMI4.2

AA in membrane deposit 10 (inhibitedby NSAI's and PGE1) free AA 10 (inldbited by vit and and bt Lipooxigenaseo Ciclooxigenase (inhibited by NSAI's and aOH-acid derived from DGLA) LT's PG's and IXAt (After Horrobin, 1982) NSAI's (non-steroidal anti-inilammatories) andAAS (acetyl-sallicilic acid, or aspirin), do notinterfete directly with the productionof LT's, while inhibiting the productionof PG's and related products(TX's, etc.), make available a greater quantity of AA thelipo-, oxigenase, a change which can exacerbate inflammatory processes regulated byLT's. This is what happens, apparently, in the causes of asthma induced or aggravated by AAS.Cortico-ster6ids, far more potent thanNSAI's and AAS, block the liberation of AA from the membrane deposits and, therefore, the production of both LT's and PG's.

Sincedelta-5-des turase is very little active in the human species, diet may have an important impact in the (quantitative and qualitative) regulation of the equilibrium of the series ofPG's referredabove. Thus, for example, linoleic acid (which originate$ DGLA) is ingested mainly in vegetables (and in minor quantity in certain animal organs), while AA is found nainly in meats and sealed (shrimos being particularly rich in AA).

Horrobin, 1982 All that has been said implies that states of deficiency of EFA's cause dysfunctions more or less intense (depending largely on the intensity of the deficiency) in animals (human or not) where they occur.

The main signs and symptoms to be found in (ACUTE & CRONIC) EFA's DEFICIENCIES were the following;

1. Hair loss; skin lesionspf eczematoustype ; hypertrophy of sebaceous glands.

Dry, scaly skin, eczematous or psoriatic, erithematous, very sensitive and hyper-reactive.

2. Great general and cutaneous irritability, higher apetite and caloric consumption.

3. Delayed and deficient healing, mainly due to collagen deficiency.

4. Delayed or arrested growth.

5. Hyperpermeability of all body membranes to water. Excessive loss of water through the pele, causing paradoxal dehydration, with thirst and hyper-concentrated urine.

6. Loss of reproductive activity, particularly in the male ; females usually develop complicated pregnancies and miscarriages.

7. Kidney hypertrophy andhaemorrhagess with renal insufficiency.

8.Hepatic steatosis.

9. Atrophy of execrine salivary, lacrimal and pancreatic glands 10. Inhibition of immune system, with great susceptibilidty to infections.

In what concerns cronicEFA's deficiency states, alimentarysupplementation in EFA's improved Patients with cardio-vascular problems, diabetes, breast problems and multiple sclerosis. Mosy relevant was the discovery by the Brenner group of the progressive disappearance ofactividade ofdelta-6-desaturase with ageing, which renders animals (humans included) functionally deficient in EFA's as age increases.

The loss of activity of this enzyme occurs first in the gonads. EFA's administration has systematically been able to increase the concentration of EFA's in tissues-accompanied by clinical benefits widely documented in the medical literature during the last years.

Nevertheless, ageing is not the sole cause of the loss of enzymatic activity of delta-6-desaturase. Other factors contribute to that effect :1., Saturated fats inhibit thisenzyma.

2."trans"fatty acids(v. infra), formed during industrial extraction and processing of alimentary fats, inhibitdelta-6-desaturase.

Diabetes has low activity ofdlta-6*desaturase.

4. Alcohol (ethyl) inhibits the activity ofdelta-6-desatwzrase (D6D,).

5. Adrenalin (and, therefore, stress) inhibit the activityof D6D, which beta-blockers antagonize 6. Fasting inhibits the activity of D6D, but a hypocaloric diet increases its activity 3 fold.

7. (yluco-corticoids (high in long-lasting stress) inhibit the activity of D6D.

8.Hypoproteic diets inhibit the activity of D6D andhyperproteic diets raiseit.

9 : The ingestion of glucose inhibits the activityof D6D.

10.Oncogenicos viruses and ionizing radiation inhibit the activity of D6D.

Seal Oil is particularly endowed with (Omega-3) Essential Fatty Acids(Omega-3 EFA's or simplyf3-3EFA 's) necessary (and, above all, well suited) to the human organism, particularly because it contains allQ-3 EFA's which are known to exist in (and are needed by) the human species and because those sameQ-3 EFA 's are found in the same proportions in the tissues of the human body.

Nonvu it has been shown thatwhen these f2-3EFA's (essential, as their name clearly indicates, to many meta bolic processes-among which the synthesis and the renovation of different cellular membranes structures, because the body can not function well without said Q-3EFA's, and is unable (and incapable1 of synthesising them, if and when suchS2-3EFA's are not present in sufficient quantity in the organism, the body replaces them with the most similar Fatty Acids(FA) it can find in its existing reserves. Such deficiency states nor mally involve serious cellular dysfunctions, affecting different organs, not only because said EFA intervene directly in metabolic chains as substracts or regulators (an example of that being themetabolism of prosta- glandins), but also because, inadequate FA overloads alter significantly the permeability and the selectivity of different cellular membranes, thus excessively impeding and/or facilitating the passage of substances across cell membranes. This causes ill functioning (with clinical symptoms ranging from light to intense) related with deficiency (relative or not) and/or overload (relative or not) of metabolites and products (which may be , essential as, for example, water) states which are detrimental for the good functioning of cells. When this occurs, organs which are important for bodily equilibrium tend to suffer, as, for example, happens with the Central Nervous System(CNS), the Peripheral Nerves, the Blood Vessels, the Immune Cells, the-Joints, the Mucosal Membranes (Ocular, Nasal, Intestinal,Genito-Urinary, etc.) and the Skin-to mention only some ofthem.

They display dysfunctions of varying intensity which are a function of the intensity of the #-3EFA's deficiencies, on the one hand, and of deficiencie's and/or excesses which it secondarily results in or, at least, accompanies, such as those of certainnon-essentiai FA which act asS2, 3EFA's antagonists. Therefore, one of the consequences systematically found in persons with prolonged and intense

The consequences appear easily,, among which the following deserve mentioning : (a) edematous fluid collections-very often"of lymphatic type" ; and (b) the different types of the"inadequate secretion of anti-diuretic hormone syndrome", usually associated with"lymphatic edema"and"orange skin cellulitis".

Then-3 EFA's considered most beneficial for human health (specifically, in what concerns the system cardio-vascular) are identified in he following table(from Ackman, 1997) : EMI6.1

oleos marinhos: n-3 EFA's Seal Oil (Harp Seal) Fish Oil from :

(Acidos gords Essenciais) Sardine Menhaden Cod Liver peso: peso % EPA (20 : 5 n-3) 5,9 11,7 13,7 (eicosa-pentaenoic acid) DPA (22:5 n-3)* 3,6 1,6 1,1 1, 6 (docosa-penfaenoic acid) DHA (22 : 6 n-3) 7,9 11,5 9,1 12, 5 (doco‹-hexaenoic acid)

Total