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Rhinocort aqua nasal spray : Cotrimoxazol dosierung harnwegsinfekt
Topical nasal treatment using desloratadine and mometasone furoate. The present invention relates to the treatment of nasal and more particularly to topical treatments using an antihistamine with a corticosteroid disorders. Allergic disorders are widespread throughout the world, causing very significant to society for therapy and in the form of absenteeism and decreased productivity labor cost.
These diseases are frequently manifest as acute or chronic rhinitis, sometimes also described, respectively, as seasonal and perennial rhinitis. Symptoms typically occur very quickly after exposure to allergens, of which the most common are grass, pollens and mold spores. The incidence of allergic rhinitis is higher during the spring and summer months, but some people suffer symptoms throughout the year, with exacerbations during spring and summer. When allergens airborne interact with membranes attached to the mast cell specific antibodies, mast cells react by releasing histamine, in a process called degranulation.
La histamina es un potente vasodilatador que incrementa la permeabilidad microvascular, permitiendo que el plasma fluya dentro de los espacios extravasculares provocando de ese modo edema. Histamine is a potent vasodilator that increases microvascular permeability, allowing plasma flow into extravascular spaces causing edema that mode.
Antihistamines, administered systemically alone or together with sympathomimetic decongestants, have traditionally been the drugs of choice for treating allergic rhinitis. Other forms of therapy have included the use of topically applied cromolyn sodium, hypertonic salt solutions or immunotherapy. Antihistamines have also been applied directly to nasal tissues. A currently available product provides azelastine commercially in a form of water-based nasal spray.
The European Patent Application 0,, A1 discloses nasal spray compositions containing both a glucocorticosteroid and an antihistamine possessing leukotriene inhibiting properties, for treating rhinoconjunctivitis. The present invention provides the use of desloratadine in the manufacture of a medicament for treating rhinitis by a combination therapy comprising topical application of desloratadine and mometasone furoate. In a second aspect, the invention provides the use of mometasone furoate in the manufacture of a medicament for treating rhinitis by a combination therapy comprising topical application of desloratadine and mometasone furoate.
Las substancias activas pueden administrarse conjuntamente o separadamente. The active compounds may be administered together or separately. However, it is preferred that they be administered together, most preferably in a single formulation. El tratamiento puede efectuarse usando composiciones intranasales que son acuosas o no acuosas. Treatment can be effected using intranasal compositions which are aqueous or nonaqueous. Thus according to a further aspect of the invention, a fluid composition characterized by containing desloratadine and mometasone furoate, in a pharmaceutically acceptable carrier it is provided.
Although it is possible that some portion of the topically applied drugs develop systemic concentrations, such as by absorption through after swallowing, the treatment effect desired nasal membranes or other mucous membranes or through the gastrointestinal tract at least initially results from an external contact of the applied drugs with the nasal tissues.
The symptoms of allergic rhinitis usually include ocular and palatal irritation, ocular secretions, red eyes, sneezing, mucus hypersecretion and itching. A further manifestation of the state is nasal congestion. Allergic rhinitis can be of the seasonal or perennial types. Other types of rhinitis, vasomotor rhinitis such as, exhibit some of the same symptoms and typically respond in varying degrees to similar treatment. Various "antihistamines" have been known since the Newer antihistamines have a very low potential to cross the blood-brain barrier so you do not have the potential sedation well known to many of the older agents.
Among the known antihistamines are three having a close chemical structure relationship: Their common structure is as follows: Azatadine is a potent topical antihistamines i. Togias paper and other presents sleepiness in one of the eight subjects tested. Both loratadine and desloratadine have a greatly reduced compared to azatadine, so that generally prefer sedation potential.
It is determined in the European Patent Application A1 0,, loratadine is useful in topical compositions, but the present inventors have not found a useful degree of topical activity for this drug.
Therefore, it is considered that topical antihistaminic efficacy ie, local is not a predictable property of compounds having this general chemical structure. Corticosteroids that are useful in the present invention have potent glucocorticoid activity and weak mineralocorticoid activity.
These agents affect the inflammatory condition that eventually results from the allergic response. The currently preferred in the invention is mometasone corticosteroid agent, specifically including the mention of any base drug hydrates other addition compounds thereof, and pharmaceutically acceptable salts thereof. Due to its very low systemic bioavailability, mometasone generally used in the form of its furoate, or as the furoate monohydrate is particularly advantageous.
Mometasone furoate and desloratadine will each be administered in a pharmaceutically acceptable intranasal carrier. Preferably, the active substances are present in an aqueous carrier, dissolved therein to provide an easily attainable physical stability during storage and dose reproducibility.
Sin embargo, ciertos corticosteroides son bastante insolubles en medios acuosos. However, certain corticosteroids are quite insoluble in aqueous media. Desloratadine also has limited solubility in aqueous media. If not feasible preparing a solution, then the aqueous carrier will be used to form a suspension formulation having one or more active ingredients uniformly dispersed therein, in the form of a micronized powder.
It is highly desirable to use such devices to deliver reproducible amounts of the formulation, since the drugs are quite potent. The desired isotonicity of the aqueous compositions of this invention grade can be achieved using, for example, sodium chloride or other pharmaceutically acceptable agents such as dextrose, boric acid, citric acid, sodium tartrate, sodium phosphate, potassium phosphate, propylene glycol or other inorganic solutes or organic or mixtures thereof.
Sodium chloride is preferred particularly for buffers containing sodium ions. Further examples of sodium chloride equivalents described in Gennaro AR, Ed. La viscosidad de las composiciones puede mantenerse al nivel seleccionado usando un agente espesante. The viscosity of the compositions may be maintained at the selected level using a thickening agent.
Suitable thickeners include, for example, xanthan gum, carrageenan, and combinations of crystalline sodium carboxymethyl cellulose, and the like, including pharmaceutically acceptable salts thereof. Also mixtures of thickeners used. The concentration of the thickener will vary, depending upon the agent selected. The important consideration is to use an amount that achieves the desired viscosity. Viscous compositions are normally prepared from solutions or suspensions by the addition of such thickening agents.
Preferred compositions within the scope of this invention will contain from about 0. Is useful a variety of pharmaceutically acceptable humectants, including, for example, sorbitol, propylene glycol, glycerol or mixtures thereof. As with the thickeners, the concentration will vary with the selected agent, although the presence or absence of these agents, or their concentration is not an essential feature of the invention.
A pharmaceutically acceptable preservative is generally employed to increase the shelf life of the compositions of the invention. Benzyl alcohol is suitable, although a variety of other preservatives may be employed including, for example, parabens, phenylethyl alcohol, thimerosal, chlorobutanol, phenylmercuric acetate and benzalkonium chloride. A suitable concentration of the preservative will be from 0.
Also mixtures of preservatives used. A variety of additional optional ingredients may be added to the topical nasal compositions of the present invention. These additional ingredients include various polymers for aiding the film-forming properties and substantivity of the formulation, antioxidants, and agents suitable for aesthetic, such as fragrances purposes.
Another preferred form for nasally administered drugs is the pressurized metered dose inhaler. These products usually utilize a chlorofluorocarbon or fluorohydrocarbon propellant of low boiling point, which can be dissolved drug substances sometimes with the help of a cosolvent such as an alcohol or suspended.
Puesto que los propelentes de clorofluorocarbono se consideran peligrosos para el medio ambiente, actualmente se prefiere usar una alternativa de fluorohidrocarbono tal como 1,1,1,2-tetrafluoroetano "HFCa" o 1,1,1,2,3,3,3-heptafluoropropano "HFC". Since chlorofluorocarbon propellants are considered hazardous to the environment, it is presently preferred to use a fluorohydrocarbon alternative such as 1,1,1,2-tetrafluoroethane "HFCa" or 1,1,1,2,3 , 3,3-heptafluoropropane "HFC".
The formulation is contained in a pressure resistant container such as a pot polymer, glass or aluminum, and equipped with a metering valve which releases a fixed volume of the composition with each drive. Of course, additives commonly used to provide valve lubrication, assist in maintaining a stable solution or suspension and other functions. Surfactants are frequently incorporated into pressurized aerosol formulations to help maintain a stable dispersion of components and to help maintain proper valve function measuring.
Since always it desired to minimize the amounts of inactive substances in a medication, the lowest concentration that gives the desired effect is used. Other surfactants include, without limitation thereto, sorbitan trioleate, cetylpyridinium chloride, soya lecithin, polyoxyethylene 20 sorbitan, polyoxyethylene 20 -esteraril ether, polyoxyethylene 2 oleyl ether, block copolymers polyoxyethylene-polyoxypropylene-ethylenediamine, polyoxyethylene 20 sorbitan, block copolymers of polyoxyethylene-polyoxypropylene, castor oil ethoxylate and mixtures of any two or more.
In choosing a surfactant system, it is generally preferable that the surfactant is soluble in the propellant or a propellant-alcohol solution. The choice of suitable carrier forms will depend on the exact nature of the nasal dosage form particularly required, for example if the drug or drugs will be formulated as a nasal solution for use as drops or as a spray , a nasal suspension, nasal ointment, a nasal gel or another nasal form. Some of these forms, however, are less susceptible to reproducible dose measure and uniform application to the nasal mucosa.
In making the choices of dosage form, it should be noted that the objective of treatment is to affect allergic and inflammatory processes in nasal tissues, and not provide maximized systemic levels of the drugs. In the present invention, mometasone furoate is typically present in a topical nasal dosage at concentrations of about 0. Desloratadine is typically present in concentrations of about 0.
Preferably, the composition is applied to the nasal mucosa via topical application of a safe and effective for treating nasal symptoms unwanted amount. The amount of desloratadine and mometasone furoate and frequency of topical application to the nasal mucosa may vary, depending on personal and medical needs, but it is suggested as an example, that the application ranges from about once daily to about four times daily, preferably no more than twice daily and most preferably once daily.
A typical dose comprises one to four sprays per nostril. For convenience considerations, it is generally preferred that each dose of the two drugs is administered at the same time point, more preferably with both present in a single formulation. However, Mometasone furoate may require different intervals dosed desloratadine, so different formulations can and dose schedules used.
Optional ingredients which are useful in the present invention include topically active decongestants. Also useful are mixtures of such decongestants. When used in the compositions of the present invention, the sympathomimetic agents may be incorporated in concentrations from about 0. The compositions of the present invention may also optionally contain an antiallergic.
Suitable antiallergics include, but are not limited to, cromolyn, which is believed to inhibit mast cell degranulation. Moreover, they are optional use in the compositions of the present analgesics invention nonopioid such as oxaprozin, acetaminophen, acetylsalicylic acid, ibuprofen, etedolac, fenbuprofeno, fenoprofen, flurbiprofen, indomethacin, ketoprofen, naproxen, their pharmaceutically acceptable salts, racemates optically active and mixtures thereof.
They can beneficially incorporated analgesics such as oxycodone synthetic opioids, buprenorphine, meperidine, methadone, propoxyphene, pentazocine, pharmaceutically acceptable salts and mixtures thereof.
Also mixtures of such aromatic products used. They also frequently desired to incorporate any of the well known natural or synthetic flavoring agents, including, without limitation, mint or fruit flavors.
In the following examples, Examples 1 and 2 describe and demonstrate embodiments within the scope of the present invention. Examples 3 and 4 are not within the scope of the invention and are provided by way of illustrative formulations analogous to those of the invention. Ejemplo 1 Example 1. This suspension may be administered using a spray device typical pump preferably provides a volume of microliters per actuation.