Sour cherry topical biotherapeutic formulations, method of manufacture and method of treatment of human osteoarthritis symptoms

Abstract

A biotherapeutic anti-inflammatory composition, its method of manufacture and method of treatment of various diseases, the composition having an efficacious amount of solid sour cherry seed extract and sour cherry seed oil sufficient to inhibit production of disease-associated inflammatory cytokines by CD3+ T lymphocytes in a vertebrate mammal.

We claim: 
     
         1 . A biotherapeutic anti-inflammatory composition produced by a process comprising the steps of:
 (a) providing a lipophilic component comprising at least some ingredients not present naturally in sour cherry seeds;   (b) providing a hydrophilic component comprising at least some ingredients not present naturally in sour cherry seeds;   (c) providing solid flavonoid-rich sour cherry seed extract in powdered form;   (d) providing sour cheery seed oil;   (e) heating said lipophilic component to a sufficient temperature to melt or liquefy said lipophilic component and separately heating said hydrophilic component to a sufficient temperature to melt or liquefy said hydrophilic component;   (f) mixing said melted or liquefied lipophilic component and said melted or liquefied hydrophilic component;   (g) allowing said mixed heated lipophilic and hydrophilic components to cool to form a cream base; and   (h) mixing said sour cheery seed oil and said solid flavonoid-rich sour cherry seed extract in powdered form into said cream base.   
     
     
         2 . The comnposition of  claim 1 , wherein said step of mixing said sour cherry seed oil and said solid flavonoid-rich sour cherry seed extract in powdered form into said cream base comprises mixing an amount of said sour cherry seed oil and an amount of said solid flavonoid-rich sour cherry seed extract in powdered form such that said sour cherry seed oil is approximately 3-5 wt % of said composition and said solid flavonoid-rich sour cherry seed extract in powdered form is approximately 3-5 wt % of said composition. 
     
     
         3 . The composition of  claim 1 , wherein said step of providing a lipophilic component comprises the step of mixing lanolin, cetylic and stearylic alcohol, stearin and isopropyl myristate; and
 wherein said step of providing a hydrophobic component comprises the step of mixing vitamin C, sodium lauryl sulphate, glycerin, propylene glycol and water.   
     
     
         4 . The composition of  claim 3 , wherein said step of providing a lipophilic component comprises the step of mixing approximately 20 wt % lanolin, approximately 20 wt % cetylic and stearylic acid, approximately 40 wt % stearin and approximately 20 wt % isopropyl myristate to form said lipophilic component; and
 wherein said step of providing a hydrophilic component comprises the step of mixing approximately 1.2 wt % vitamin C, approximately 3.1 wt % sodium lauryl sulphate, approximately 7.7 wt % glycerin, approximately 7.7 wt % propylene glycol, and approximately 80.3 wt % water to form said hydrophilic component.   
     
     
         5 . The composition of  claim 3 , wherein said steps of providing a lipophilic component, providing a hydrophobic component, providing solid flavonoid-rich sour cherry seed extract in powdered foiiii, and providing sour cheery seed oil comprise providing approximately 5 wt % lanolin, approximately 5 wt % cetylic and stearylic alcohol, approximately 10 wt % stearin, approximately 5 wt % isopropyl myristate, approximately 0.8 wt % vitamin C, approximately 2 wt % sodium lauryl sulphate, approximately 5 wt % glycerin, approximately 5 wt % propylene glycol, approximately 52.2 wt % water, approximately 5 wt % solid flavonoid-rich sour cherry seed extract and approximately 5 wt % sour cherry seed oil relative to said composition. 
     
     
         6 . The composition of  claim 1 , wherein said step of heating said lipophilic component and separately heating said hydrophilic component comprises heating each in a water bath at a temperature of approximately 50-60° C. 
     
     
         7 . A biotherapeutic anti-inflammatory topical composition in the foini of a phase-stable emulsion, said composition comprising a mixture of solid flavonoid-rich sour cherry seed extract in powdered form previously separated from sour cherry seeds and sour cherry seed oil previously separated from sour cherry seeds, wherein said solid flavonoid-rich sour cherry seed extract in powdered form and said sour cherry seed oil are present in amounts producing an anti-inflammatory effect, said composition altering the underlying pathomechanisms caused by dysregulated inflammatory processes by inhibiting production of disease-associated inflammatory cytokines by CD3+ T lymphocytes, inhibiting the inflammation-associated serum biomarker c-reactive protein, and increasing expression of heme oxygenase-1 by peripheral blood leukocytes, when topically applied, produced by a process comprising the steps of:
 (a) providing a lipophilic component comprising at least some ingredients not present naturally in sour cherry seeds;   (b) providing a hydrophilic component comprising at least some ingredients not present naturally in sour cherry seeds;   (c) providing solid flavonoid-rich sour cherry seed extract in powdered form;   (d) providing sour cheery seed oil;   (e) heating said lipophilic component to a sufficient temperature to melt or liquefy said lipophilic component and separately heating said hydrophilic component to a sufficient temperature to melt or liquefy said hydrophilic component;   (f) mixing said melted or liquefied lipophilic component and said melted or liquefied hydrophilic component;   (g) allowing said mixed heated lipophilic and hydrophilic components to cool to form a cream base; and   (h) mixing said sour cheery seed oil and said solid flavonoid-rich sour cherry seed extract in powdered form into said cream base.   
     
     
         8 . The composition of  claim 7 , wherein said step of mixing said sour cherry seed oil and said solid flavonoid-rich sour cherry seed extract in powdered form into said cream base comprises mixing an amount of said sour cherry seed oil and an amount of said solid flavonoid-rich sour cherry seed extract in powdered form such that said sour cherry seed oil is approximately 3-5 wt % of said composition and said solid flavonoid-rich sour cherry seed extract in powdered form is approximately 3-5 wt % of said composition. 
     
     
         9 . The composition of  claim 7 , wherein said step of providing a lipophilic component comprises the step of mixing lanolin, cetylic and stearylic alcohol, stearin and isopropyl myristate; and
 wherein said step of providing a hydrophobic component comprises the step of mixing vitamin C, sodium lauryl sulphate, glycerin, propylene glycol and water.   
     
     
         10 . The composition of  claim 9 , wherein said step of providing a lipophilic component comprises the step of mixing approximately 20 wt % lanolin, approximately 20 wt % cetylic and stearylic acid, approximately 40 wt % stearin and approximately 20 wt % isopropyl myristate to form said lipophilic component; and
 wherein said step of providing a hydrophilic component comprises the step of mixing approximately 1.2 wt % vitamin C, approximately 3.1 wt % sodium lauryl sulphate, approximately 7.7 wt % glycerin, approximately 7.7 wt % propylene glycol, and approximately 80.3 wt % water to form said hydrophilic component.   
     
     
         11 . The composition of  claim 9 , wherein said steps of providing a lipophilic component, providing a hydrophobic component, providing solid flavonoid-rich sour cherry seed extract in powdered form, and providing sour cheery seed oil comprise providing approximately 5 wt % lanolin, approximately 5 wt % cetylic and stearylic alcohol, approximately 10 wt % stearin, approximately 5 wt % isopropyl myristate, approximately 0.8 wt % vitamin C, approximately 2 wt % sodium lauryl sulphate, approximately 5 wt % glycerin, approximately 5 wt % propylene glycol, approximately 52.2 wt % water, approximately 5 wt % solid flavonoid-rich sour cherry seed extract and approximately 5 wt % sour cherry seed oil relative to said composition. 
     
     
         12 . The composition of  claim 1 , wherein said step of heating said lipophilic component and separately heating said hydrophilic component comprises heating each in a water bath at a temperature of approximately 50-60° C.