SILVA POLIANA EMILIA BOTELHO (BR)
| JP2006117613A | 2006-05-11 | |||
| JP2003212728A | 2003-07-30 | |||
| JP2005200353A | 2005-07-28 | |||
| RO96600A2 | 1989-03-30 | |||
| RO116522B |
| Claims PHARMACEUTICAL COMPOSITION COMPREHENDING VEGETAL EXTRACT AND HEMOSTATIC AGENT AND ITS MANUFACTURING PROCESS 1. Pharmaceutical composition characterized by: a) at least one vegetal extract of one the plants selected among Calendula genus; b) at least one hemostatic agent; c) at least one optional ingredient; e d) an suitable pharmaceutical vehicle. 2. Composition, as claim 1, characterized for the fact that the vehicle provides an ointment. 3. Composition, as claim 1 , characterized for the fact of that the vegetal extract is extract of Calendula officinalis. 4. Composition, as claim 1 , characterized for the fact of that the vegetal extract is present in concentrations that vary from 5% v/w to 30% v/w. 5. Composition, as claim 4, characterized for the concentration of the vegetal extract to be approximately 14.4% v/w. 6. Composition, as claim 1 , characterized for the fact of that the hemostatic agent is aluminum potassium sulphate. 7. Composition, as claim 1, characterized for the fact of that the hemostatic agent is present in concentrations that vary of 0.01 to 3% w/w. 8. Composition, as claim 7, characterized for the concentration of the hemostatic agent to be approximately 0.5% w/w. 9. Composition, as claim 1 , characterized for the fact of the optional agents are to be chosen of the group comprehending thickeners, preservatives, thixotropic agents, coloring agents, metallic oxides, flavor agents, and mixes of them. 10. Composition, as claim 9, characterized for the fact of the optional agent is zinc oxide. 11. Composition, as claim 1 , characterized for the optional ingredient is present in concentrations that vary of 0.5% w/w to 25% w/w. 12. Composition, as claim 1 , characterized for the fact of the optional ingredient is zinc oxide and is present in a concentration of approximately 13.3% w/w. 13. Composition, as claim 1 , characterized for being used in animal and/or human beings. 14. Composition, as claim 13, characterized for the animals to be chosen of the group that includes canines, felines, bovines, equines. 15. Process of preparation of the pharmaceutical composition, characterized for including the following stages: a) To prepare a mixture including: i at least one vegetal extract from one herb of Calendula genus; ii at least one hemostatic agent; and iii at least an optional ingredient; and b) to incorporate the mixture of the item (a) to an suitable pharmaceutical vehicle. 16. Process, as claim 15, characterized for the fact of that the related vegetal extract is extract of Calendula officinalis. 17. Process, as claim 15, characterized for the fact of that the related vegetal extract is present in concentrations that vary from 5% v/w to 30% v/w. 18. Process, as claim 17, characterized for the concentration of the vegetal extract to be approximately 14.4% v/w. 19. Process, as claim 15, characterized for the fact of that the related hemostatic agent is aluminum potassium sulphate. 20. Process, as claim 15, characterized for the fact of that the related hemostatic agent is present in concentrations that vary from 0.01% to 3% w/w. 21. Process, as claim 20, characterized for the concentration of the hemostatic agent to be approximately 0.5% w/w. 22! Process, as claim 15, characterized for the fact of the optional are to be chosen of the group comprehending thickeners, preservatives, thixotropic agents, coloring agents, metallic oxides, flavor agents, and mixes of them. 23. Process, as claim 22, characterized for the fact of the optional agent to is zinc oxide. 24. Process, as claim 15, characterized for the optional ingredient is present in concentrations that vary of 0.5% w/w to 25% w/w. 25. Process, as claim 15, characterized for the fact that the optional ingredient is zinc oxide and to be present in a concentration of approximately 13.3% w/w. |
Pharmaceutical composition comprising an extract of Calendula subspecies
Field of the Invention
The present invention is placed in the field of the pharmaceutical compositions that comprehend vegetal extract, a hemostatic agent and at least one optional ingredient possessing cicatrization, antiseptic and hemostatic action. Specifically, the pharmaceutical composition of the present invention is of topical use and contains extract of Calendula Officinalis, aluminum potassium sulphate (Alum Potassium) and zinc oxide in a pharmaceutically suitable vehicle. The pharmaceutical composition of the present invention is presented preferentially in the form of an ointment that can be used in human beings as well as in animals such as canines, felines, bovines and/or equines.
Antecedents of the Invention
Vegetal extracts have been widely used in the composition of pharmaceutical formulations. The active principles of vegetal origin can be obtained from leaves, flowers, rinds and roots of the plants. The general process of obtaining a vegetal extract involves grinding of the chosen plant in the solvent, agitation, maceration (period of rest where a solid substance is dived in a liquid, to extract the characteristics) and, finally, the filtration of the liquid.
Calendula (Calendula officinalis L) is a plant of European origins, belonging to the Asteraceae family. The plants of Calendula officinalis found in Brazil produce heterogeneous flowers of varied size (3 to 9 cm) and colors. Calendula officinalis is spread out in the world and is well acclimatized to Brazil, being commercialized in pharmacies and drugstores where it is used in diverse phytotherapy and cosmetic preparations. The extract of calendula flowers is indicated in the treatment of skin and mucosa inflammations, in wound cicatrization and light burns. Some studies with calendula have correlated its biological activity with its chemical structure: triterpene saponines have anti- tumoral activity; triterpenoids have topic anti-inflammatory activity, flavonoids present anti-inflammatory activity and triterpenodiol ester present anti-edema activity.
Besides, inorganic composites such as metallic oxides are usually used as hemostatic agents in pharmaceutical compositions as some studies demonstrate its effectiveness and reveal components with cicatrization purpose.
Considering these facts, the inventors of the present invention have considered opportune the possibility to develop formulations containing extracts of Calendula officinalis combined with hemostatic agents in a pharmaceutical composition for topical use. it has not been found in the state of the technique documents concerning to the pharmaceutical compositions for topical use with cicatrization action and/or antiseptic action containing the combination of Calendula officinalis extract and at least one hemostatic agent, as considered in the present Invention. The most relevant documents will be described to follow.
Document WO 1998/50055 describe an ointment for treatment of burnings and other illnesses of the skin containing extract of Calendula officinalis, edible sunflower oil, edible olive oil, incense, colophony, white beewax, subgallic bismuth and camphor. In this document, the extract of Calendula officinalis is used in ratios that vary from 1 % to 2% and at no moment it is considered or suggested the use of hemostatic agents.
Document WO 1997/42963 describes a "green ointment" used in the treatment of burnings and skin diseases that includes some types of plants such as Chelidonium majus, Plantago major, Matricaria chamomilla, Achillea millefolium, Calendula officinalis, Hypericum perforatum, Eucalyptus globus, Oleum olivarum e yellow beewax of Cera flava. In this document, the concentration of C. officinalis used varies from 1.5% to 2.5% and at no moment it is considered or suggested the use of hemostatics agents.
Document WO 2006/117516 describes a composition for topical use with bactericidal function against Staphylococcus aureus e Escherichia coli that uses extract of Calendula officinalis. However, in this document, the extract of C. officinalis has the function of being a perfuming agent, and not, a cicatrization and antiseptic agent as considered in the present invention. Still at no moment it is considered or suggested the use of hemostatics agents.
Document WO 2005/063266 describes a composition for topical use that uses the extract of Calendula officinalis and Hypericum perforatum that they snclude peptides of low molecular weight and free aminoacids. The composition still includes unsaturated fatty acids, vitamins, minerals and microelements. It does not have mention the use of hemostatic agent, as considered in the present invention. Specifically, the described composition in this document is destined for the treatment of psoriasis.
Document EP 1 707 213 reports a composition for pharmaceutical use that includes the extract/tincture of Calendula officinalis, Matricaria recutita and Salvia officinalis, suitable pharmaceutical vehicles such as ointments, creams, emulsions or gels that are destined to the cutaneous treatment of eritematoses. However at no moment it is considered or suggested the use of hemostatics agents.
The metallic oxides have diverse known uses. They can be used as physical solar filters, as described in documents US 6,749,838, US 6,267,949, EP 786982, WO 07/048057, US 2008/031832, WO 94/24998; used as pigments in inks as described in documents US 6,700,112,. EP 379746, US 5,916,947, US 5,656,074, WO 05/071032, US 4,407,997; used as zinc source in food, as described in documents US 6,156,355, WO 05/058052; used also in the manufacture of electronic components, due to its high conductivity, as described in documents US 6,813,137, EP 1770074, WO 06/138071. However, few documents describe its use in cicatrization compositions.
One of these documents is WO 2007/022264, that describes a composition using metallic oxides for the cicatrization of wounds. Amongst described oxides are diverse oxides such as silicon oxide, titanium oxide and zinc oxide. The document clearly states that acid oxides, as silicon oxide and titanium oxide possess protrombotic characteristics, diminishing the coagulation time, while basic oxides, such as zinc oxides and aluminum oxide possess antitrombotic characteristics ^ thus increasing the coagulation time. The present invention differs from this document due to the fact it uses a vegetal extract in combination with other elements, amongst them metallic oxides, especially zinc oxide, that presents a different behavior of the described in the state of the technique, thus promoting cicatrization.
Therefore, it's clear the association of Calendula extract with hemostatic agents and optional ingredients has never been described before, being therefore the present new invention and its combination neither suggested, proving the present invention inventive.
Summary of the Invention
It is the object of the present invention to provide a pharmaceutical composition including: a) at least one vegetal extract of one of the plants selected in the
Calendula genus; and b)at least one hemostatic agent; and c) at least one optional ingredient d) a vehicle pharmaceutical suitable.
The pharmaceutical composition of the present invention presents cicatrizating, antiseptic and hemostatic action.
In an optional concretion of the present invention to the pharmaceutical composition of the present invention can be incorporated acceptable vehicles for the presentation in the form of, creams, lotions, amongst others. it is also object of the present invention to provide a process of preparation of the pharmaceutical composition, including the stages of: a) mix a vegetal extract of a selected plant of the Calendula genus with a hemostatic agent and an optional ingredient; and b) to incorporate the mixture of item (a) to an suitable pharmaceutical vehicle.
The use of the pharmaceutical composition is still another object of the present invention in dermic cicatrization processes in human beings and animals.
These and other objects of the invention will be evaluated and better understood for the experts in the art from of the detailed description to follow. Detailed description of the Invention
The following examples do not have the intention to limit the invention, but only to exemplify one in the innumerable ways to materialize it. Diverse variants of the composition/pharmaceutical formulation can be prepared from the teachings of the present invention.
The pharmaceutical composition described in the present invention it uses below at least one component of the related composite classes:
Vegetal extract of plants of the Calendula genus
The used vegetal extract in the present invention is taken from methods of extraction widely known that use any part of the pertaining plants of Calendula genus. Specifically, in the present invention, parts of plants of the species Calendula officinalis are used.
The vegetal extract of the present invention can be used in ratios that vary from 5% to 30%. The present invention uses extract of Calendula officinalis in a 14.46% concentration v/w.
Hemostatic agent
The chosen hemostatic agent of the present invention is in sulphate form and is present in concentrations that vary of 0.01% to 3% w/w. Preferentially, the composition of the present invention defines as hemostatic agent the aluminum potassium sulphate (Alum Potassium), in a 0.5% concentration w/w.
Optional ingredients
Useful optional ingredients in the present invention include but are not limited to thixotropic agents, colorings, thickeners, preservatives, flavoring, metallic oxides, as for example zinc oxide, amongst other possible ones as well as the mixture of them. Specifically, the optional ingredients are used in concentrations that vary from 0.5 to 25% w/w.
Specifically, the present invention uses zinc oxide in a 13% concentration w/w. Pharmaceutically suitable vehicle
The term "pharmaceutical suitable" is used here for those compounds, materials and compositions and/or dosage forms considered safe to be administered to the patient without causing undesirable adverse effects as toxicicity, irritation, allergic reaction or other problem or complication with a reasonable risk of occurrence. The pharmaceutical vehicles and the cosmetic vehicles are included in this definition.
The suitable pharmaceutical vehicle to be used in the present invention can be presented in diverse pharmaceutical or cosmetic forms for topical use as, for example, ointments, sprays, creams, amongst other possible ones.
The used amount of vehicle is enough to supply the desired amounts of the essential components of the present invention.
In a preferential form, the composition of the present invention is an ointment with cicatrizating,, antiseptic and hemostatic action, indicated to the treatment of superficial injuries as wound and dermic ulcerations of canines, felines, bovines and/or equines, as well as human beings who present after- surgical bleed of aural hematoma (otohematoma), escrotal orquiectomy, neoplasias and extensive tumors, diminishing and preventing the bleeding.
Example 1. Ointment for veterinarian use
In this preferential form, 100g of the ointment contains:
Tincture of Calendula, Calendula officinalis L 14.46 ml_
Zinc oxide 13.30 g
Alum Potassium 0.50 g
Excipient s.q.f. 100.00 g
(glycerol monostearate, cetostearyl alcohol, etoxilated cetostearyl alcohol, mineral oil, white petroleum jelly, methylparaben, propylparaben, ethylic alcohol, essence of Melissa, purified water).
The wise in the art will immediately value the important benefits of the use of the present invention. Small variations in the form to materialize it must be understood as inside of the spirit of the invention and the attached claims.