Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
  • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K31/00—Medicinal preparations containing organic active ingredients
  • A61K31/21—Esters, e.g. nitroglycerine, selenocyanates
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K31/00—Medicinal preparations containing organic active ingredients
  • A61K31/21—Esters, e.g. nitroglycerine, selenocyanates
  • A61K31/215—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P13/00—Drugs for disorders of the urinary system
  • A61P13/08—Drugs for disorders of the urinary system of the prostate
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P13/00—Drugs for disorders of the urinary system
  • A61P13/10—Drugs for disorders of the urinary system of the bladder
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P35/00—Antineoplastic agents
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Definitions

• This invention relates to a new active ingredient combination for the treatment of
• a pharmaceutical active ingredient combination comprising at least one beta-3 adrenoceptor agonist and at least one further active ingredient is selected, which is selected from the group of alpha antagonists (alpha adrenoceptor antagonist) and / or the 5-alpha reductase inhibitor.
• the combination according to the invention is preferably used in patients who have bladder dysfunction and pathological changes or irritations of the prostate at the same time. The bladder dysfunction can cause urinary incontinence.
• the incidence of genitourinary disorders is increasing due to the shift in the age structure.
• the symptoms of the disease are associated with a high level of psychological suffering for those affected.
• the lower urinary tract consists of the urinary bladder, the urethra, the corresponding muscles and the ligaments of the holding apparatus. In men, the prostate also falls into this area.
• the function of the bladder is to store and empty the urine.
• the smooth muscles of the urethra and the striated muscles of the urethra and the pelvic floor are important.
• urinary bladder emptying the detrusor muscle contracts while the urethra and pelvic floor relax or the urinary sphincter muscle opens.
• the prostate whose job it is, among other things, to produce secretions for the sperm fluid, lies between the urinary bladder and the area of the pelvic floor that forms the outer sphincter of the urethra.
• the prostate covers the beginning of the urethra.
• the muscles of the prostate and urinary bladder partially interlock functionally, 5 for example when urinating, when the injection tubules and the ducts of the prostate glands are closed by the muscles of the bladder and prostate so that no urine can penetrate.
• the prostate supports the bladder neck and thus the occlusion of the bladder.
• Men with prostate problems often experience irritation when urinating, 10 especially if they have benign prostatic hyperplasia (BPH).
• BPH benign prostatic hyperplasia
• prostatitis encompasses a heterogeneous clinical picture with multiple causes. One differentiates between acute and chronic, mostly unspecified inflammation or irritation of the prostate, and between bacterial or antibacterial causes. Both phenomena can overlap. Some forms of prostatitis are also referred to as non-inflammatory chronic pelvic pain syndrome, pelvic myoneuropathy, prostatodynia, or prostatopathy.
• Alpha antagonists or alpha reductase inhibitors are used to treat functional symptoms of benign prostatic hyperplasia (BPH).
• Alpha antagonists can bind selectively and competitively to the postsynaptic alpha 1 receptors, in particular to the subtypes alphal A and alphalD. This relaxes the smooth muscles of the prostate and urethra and reduces the tone of the smooth muscles of the prostate and urethra. As a result, the urine flow rate is increased.
• 5-alpha reductase inhibitors inhibit the 5-alpha reductase enzyme. This enzyme converts the body's testosterone into dihydrotestosterone, which directly stimulates the growth of prostate tissue.
• Prostate problems can be aggravated by the appearance of bladder dysfunction and vice versa.
• Hamblase dysfunction is a heterogeneous group of disorders that differ in terms of their etiology, diagnosis, and therapy.
• urinary incontinence is defined as involuntary urine loss, which is objectively demonstrable and represents a social and hygienic problem.
• urinary incontinence only occurs if there is an unintentional increase in pressure in the bladder during the storage phase. This can occur as a result of uninhibited contractions of the detrusor muscle (urge incontinence) or incompetence of the urethral occlusion mechanism (stress incontinence).
• OAB overactive bladder
• urinate associated with or without urge incontinence, usually with increased micturition frequency and nightly urination.
• OAB overactive bladder
• this disease can be based on involuntary contractions during the filling phase, the cause of which can be neurogenic or non-neurogenic (idiopathic) in nature.
• Urge incontinence is characterized by irresistible urge to urinate and involuntary loss of urine.
• Stress incontinence is characterized by the involuntary loss of urine, which usually occurs when increased intra-abdominal pressure occurs. This can occur, for example, when lifting, coughing, sneezing, running and when there is no detrusor activity.
• the loss of urine occurs as a result of a variable combination of insufficiency of the urinary sphincter muscles and pelvic floor as well as an anatomical defect in the holding apparatus. As a result, the urethra's occlusion pressure becomes too low and incontinence is the result. In men, this form of urinary incontinence is usually only observed after prostatectomies or other small pelvic surgery.
• the WHO recommends treatment with anticholinergics (antimuscarinics).
• anticholinergics antimuscarinics
• their use is limited due to their moderate effectiveness and above all the considerable side effects such as dry mouth, accommodation disorders, constipation, central nervous effects (dizziness, tiredness, confusion).
• Alpha agonists such as pseudoephedrine and phenylpropanolamine have been shown to treat mild stress incontinence a very moderate effect.
• the disadvantage is that these have no selectivity for the urethral muscles and are associated with frequent side effects such as hypertension, tachycardia, arrhythmia, sleep disorders, headaches and tremors.
• beta-3-adrenoceptor agonists are also promising in the treatment of urinary incontinence (EP 0 958 835). Since the stimulation of beta-3 receptors is extremely important for the relaxation of the detrusor muscle, the use of selective beta-3 adrenoceptors in patients with urge incontinence should result in a reduction or prevention of involuntary detrusor contractions during the urinary storage phase. Experiments with beta-3 adrenoceptor agonists promise high effectiveness with good tolerability. In addition, their effect should be limited to the storage phase of the bladder and an undisturbed emptying of the bladder without residual urine should be guaranteed.
• the present invention is intended to contribute to better therapy for the patients concerned. It is therefore an object of the invention to provide medication for patients with prostate problems, in particular benign prostatic hyperblasia or prostatitis.
• Another task is to provide medication for patients with prostate problems that will help to better control bladder function.
• Another object relates to medication for the treatment of benign prostatic hyperplasia and / or prostatitis in the presence of a bladder dysfunction such as stress incontinence, urge incontinence, mixed incontinence or hyperactive bladder without urge incontinence or with urge incontinence.
• a bladder dysfunction such as stress incontinence, urge incontinence, mixed incontinence or hyperactive bladder without urge incontinence or with urge incontinence.
• a pharmaceutical composition which is to combine the advantages of the alpha antagonists for the treatment of benign prostatic hyperplasia or prostatides as well as those of the beta-3-adrenoceptor agonists for the control of the bladder function in a manner which favors the associated irritations.
• a novel pharmaceutical composition which comprises (a) at least one alpha antagonist in a pharmaceutically effective amount and / or a 5-alpha reductase inhibitor in a pharmaceutically effective amount and (b) at least one 3-adrenoceptor agonists in a pharmaceutically effective amount as active ingredients.
• Examples of pharmaceutically active salts for each of the compounds that are the subject of this description include, but are not limited to, salts made from pharmaceutically acceptable acids or bases, including organic and inorganic acids and bases. If the compound preferred for use is basic, salts can be prepared from pharmaceutically acceptable acids. When choosing the most preferred salt, or to clarify whether a salt or the neutral compound is used, properties such as bioavailability, manufacturability, processability and storability are taken into account.
• Suitable pharmaceutically acceptable acids include acetic, benzenesulfonic (besylate), benzoic, p-bromophenylsulfonic, camphor sulfonic, carbon, citric, ethanesulfonic, fumaric, gluconic, glutamine, hydrogen bromide, hydrogen chloride, Hydrogen iodide, isethione, milk, maleic, apple, almond, methanesulfone (mesylate), mucin, saltpetre, oxal, pamoa, pantothene, phosphorus, amber, sulfur, wine -, p-toluenesulfonic acid and the like.
• Such pharmaceutically acceptable salts include, but are not limited to, acetate, benzoate, hydroxybutyrate, bisulfate, bisulfite, bromide, butyne-1,4-dioate, caproate, chloride, chlorobenzoate, citrate, dihydrogen phosphate, dinitrobenzoate, fumarate, glycolate , Heptanoate, hexine-1,6-dioate, hydroxybenzoate, iodide, lactate, maleate, malonate, mandelate, metaphosphate, methanesulfonate, methoxybenzoate, methylbenzoate, monohydrogenphosphate, naphthalene-1-sulfonate, naphthalene-2-sulfonate, oxalate, phenylproutionate , Phosphate, phthalate, phenylacetate, propane sulfonate, propiolate, propionate, pyrophosphate, pyr
• the alpha antagonist is preferably selected from the following group: aa) alfuzosin, ab) bunazosin, ad) doxazosin, ae) indoramine, af) naftopidil, ag) prazosin, ah) tamsulosin, ai) terazosin, aj) urapidil and ak) silodosin (KMD 3213), am) Moxisylyte, an) Metazosin, ao) Fiduxosin, ap) Upidosin, aq) SNAP-5089 (5- (N- (3- (4,4-Diphenylpiperidin-l-yl) propyl) carbamoyl) -2,6-dimethyl-4 (R) - (4-nitrophenyl) - 1, 4-dihydropyridine-3-carboxylic acid methyl ester), ar) AIO-8507L, as) SL
• Tamsulosin is preferably used in the form of the hydrochloride.
• Au) finasteride and / or av) dutasteride can preferably be used as the 5-alpha reductase inhibitor.
• the second component comprises one or more beta-3 adrenoreceptor agonists. This is (are) preferably selected from the following group:
• n 0 or 1
• n 0 or 1
• beta-3-adrenoceptor agonists are (-) - ethyl-2- [4- (2- ⁇ [(1 S, 2R) -2-hydroxy-2- (4-hydroxyphenyl) ⁇ 1 -methylethyl ] amino ⁇ ethyl) -2,5-dimethylphenyloxy] acetate or (-) - 2- [4- (2- ⁇ [(IS, 2R) -2-hydroxy-2- (4-hydroxyphenyl) -l-methylethyl] -amino ⁇ ethyl) -2,5-dimethylphenyloxy] acetic acid, the enantiomers, other diastereosomers of the same and pharmacologically active salts thereof.
• Particularly preferred combinations include a combination of (a) tamsulosin, either in its enantiomeric or racemic form, or pharmacologically acceptable salts thereof, or any active metabolite thereof, and (b) at least one of the following compounds: (-) - ethyl-2- [4- ( 2- ⁇ [(IS, 2R) -2-hydroxy-2- (4-hydroxyphenyl) -1-methylethyl] amino ⁇ ethyl) -2,5-dimethylphenyloxy] acetate, (-) - ethyl 2- [4- (2- ⁇ [(IS, 2R) -2-hydroxy-2- (4-hydroxyphenyl) -1-methylethyl] amino ⁇ ethyl) -2,5-dimethylphenyloxy] acetate monohydrochloride, (-) - 2- [4 - (2- ⁇ [(IS, 2R) -2-Hydroxy-2- (4-hydroxyphenyl)
• compositions include a combination of (a) finasteride, either in its enantiomeric or racemic form, or pharmacologically acceptable salts thereof, or any active metabolite thereof, and (b) at least one of the following compounds: (-) - ethyl-2- [4- (2- ⁇ [(IS, 2R) -2-hydroxy-2- (4-hydroxyphenyl) -1-methylethyl] amino ⁇ ethyl) -2,5-dimethylphenyloxy] acetate, (-) - ethyl-2- [4- (2- ⁇ [(1 S, 2R) -2-hydroxy-2- (4-hydroxyphenyl) -1-methylethyl] amino ⁇ ethyl) -2,5-dimethylphenyloxy] acetate monohydrochloride, (-) - 2- [4- (2- ⁇ [(1 S, 2R) -2-Hydroxy-2- (4-hydroxyphenyl) -l
• Other particularly preferred combinations include a combination of (a) dutasteride, either in its enantiomeric or racemic form, or pharmacologically acceptable salts thereof, or any active metabolite thereof, and (b) at least one of the following compounds: (-) - ethyl-2- [4- (2- ⁇ [(IS, 2R) -2-hydroxy-2- (4-hydroxyphenyl) -l-methylethyl] amino ⁇ ethyl) -2,5-dimethylphenyloxy] acetate, (-) - ethyl-2- [4 - (2- ⁇ [(IS, 2R) -2-hydroxy-2- (4-hydroxyphenyl) -1-methylethyl] amino ⁇ ethyl) -2,5-dimethylphenyloxy] acetate-monohydrochloride, (-) - 2- [ 4- (2- ⁇ [(IS, 2R) -2-Hydroxy-2- (4-hydroxyphenyl)
• tamsulosin or its hydrochloride and finasteride either in their enantiomeric or racemic form or pharmacologically acceptable salts thereof or any active metabolites thereof and (b) at least one of the following compounds: (-) - ethyl 2- [4- (2- ⁇ [(IS, 2R) -2-hydroxy-2- (4-hydroxyphenyl) -1-methylethyl] amino ⁇ ethyl) -2,5-dimethylphenyloxy] acetate, (- ) -Ethyl-2- [4- (2- ⁇ [(1 S, 2R) -2-hydroxy-2- (4-hydroxyphenyl) -1-methylethyl] amino ⁇ ethyl) -2,5-dimethylphenyloxy] acetate- monohydrochloride, (-) - 2- [4- (2- ⁇ [(IS, 2R) -2-hydroxy-2- (4-hydroxy)
• the invention comprises each of the following combinations: (aa, 1); (ab, 1); (ac, 1); (ad, 1); (ae, 1); (Af, 1); (ag, 1); (ah, 1); (ai, 1); (aj, 1); (Ak, l); (al, 1); (Am, l); (An, l); (Ao, l); (Ap, l); (Aq, l); (Ar, l);
• the dosages given below expressly include all numerical values, whole or fractional, within the range given.
• the information relates to adult people.
• Pediatric dosing racks can be lower.
• this first component (a) is the one that can provide relief for the patient. In some cases a smaller amount than specified may be sufficient, while in other cases a larger total amount may be necessary.
• the daily total dose can be taken in one piece or within several servings, depending on the therapy regimen.
• the therapy regiment can also prescribe intervals between receipts that are longer than a day.
• the preferred dose of the alpha antagonist for humans is between 0.001 mg and 5 g per day, preferably between 0.001 mg and 100 mg and very particularly preferably between 0.1 mg and 50 mg.
• the daily dose of the combination according to the invention desirably contains it in an amount of about 0.05 mg to about 5 mg. More preferably, each dose of the component contains about 0.1 to about 1 mg of the active ingredient.
• This dosage form allows the full daily dose to be administered in half or whole, single or multiple doses. Administrations more than once a day or twice a day (e.g. 3, 4, 5 or 6 administrations per day) are also expressly contemplated herein.
• the average daily adult dose of the other possible representatives of the alpha antagonists is as follows.
• the average daily dose of the component (mg / day / patient) is:
• Alfuzosin (1 mg to 15 mg, preferably approx.7.5 mg), bunazosin (0.5 mg to 20 mg preferably 5.5 mg), doxazosin 0.5 to 15 mg, preferably up to 4 mg), indoramine (1 to 50 mg, preferably up to 25 mg), naftopidil (1 mg to 100 mg, preferably less than 50 mg), prazosin (1 mg to 10 mg), terazosin (0.1 mg to 5 mg, preferably 2 mg), urapidil ( 10 mg to 150 mg, preferably 30 mg to 90 mg). If a 5-alpha reductase inhibitor is used, the average daily dose for an adult is: 0.1 mg to 10 mg, preferably 5 mg finasteride, 0.01 mg to 2 mg, preferably 0.5 mg dutasteride.
• the dosages and regimen (i.e., one, two, three or more administrations per day) of the second component will depend on the factors already referred to in connection with the dosage choice of the first component.
• the average daily adult dose of the second component (beta-3 agonist) is about 1 mg to 1000 mg, preferably 10 mg to about 750 mg per day, preferably 50 to 500 mg, more preferably 80 to 200 mg, administered in one or more doses ,
• compositions of the present invention may conveniently be administered in a pharmaceutical composition containing the active components in combination with a suitable carrier.
• a pharmaceutical composition containing the active components in combination with a suitable carrier.
• Such pharmaceutical compositions can be prepared by methods and contain carriers that are well known in the art. Generally recognized frameworks are available to the specialist in this regard.
• compositions of the present invention can be administered parenterally (e.g., by intravenous, intraperitoneal, subcutaneous or intramuscular injection), topically, orally, intranasally, transdermally, rectally, pulmonally by inhalation or nasally by inhalation, with oral administration being particularly preferred.
• Enteric formulations are preferred among the oral forms of administration. Therefore enteric capsules or enteric tablets are preferred, which in both Cases can be realized, for example, with an enteric coating. The person skilled in the art will find instructions for enteric-coated formulations in the prior art.
• composition of the invention may with one or more carriers are combined and in the form of ingestible tablets, buccal tablets, sublingual tablets, sugar-coated tablet, powders, Pudem, lozenges, coated tablets, granules, capsules, elixirs, suspensions, 'solutions, Syrups, wafers, chewing gums, foods and the like can be used.
• a powder can be produced by grinding the particles of the active substance to a suitable size.
• Diluted powders can be produced by finely grinding the powdery substance with a non-toxic carrier material, such as lactose, and applying it as a powder.
• suitable carrier materials in this regard are other carbohydrates, such as starch or mannitol.
• these powders can contain flavoring agents, preservatives, dispersing agents, colorants and other pharmacological auxiliaries.
• Capsules can be produced from a powder of the type mentioned above or other powders which are introduced into a capsule, preferably a gelatin capsule, and the capsule is then closed.
• lubricants known from the prior art can be introduced into the capsule or for the closure of the two capsule parts.
• the effectiveness of a capsule when taken orally can be enhanced by adding disintegrating or solubilizing substances, such as, for example, carboxymethyl cellulose, low-substituted carboxymethyl cellulose calcium Hydroxy propyl cellulose, calcium carbonate, sodium carbonate and other substances.
• the active ingredient can be present in the capsule not only as a solid, but also in suspension, for example in vegetable oil, polyethylene glycol, glycerol with the aid of surface-active substances, etc.
• Tablets can be made by pressing the powdered mixture and then e.g. is processed into granules.
• the tablets can contain various excipients, e.g. Starches, milk sugar, cane sugar, glucose, sodium chloride, urea for solution u. Injection tablets, amylose, various types of cellulose as described above and others.
• glycerin or starch can be used as a humectant.
• starch alginic acid, calcium alginate, pectic acid, powdered agar agar, formaldehyde gelatin, calcium carbonate, sodium bicarbonate, magnesium peroxide, amylose can be used as disintegrants.
• cane sugar, stearin, solid paraffin (preferably with a melting range of 50-52 ° C) are used as counter-disintegrants or solution retarders; Cocoa fat, hydrogenated fats into consideration.
• disintegrants can be: corn starch, potato starch, alginic acid and the like.
• Quaternary ammonium compounds, sodium lauryl sulfate and saponins are suitable as absorption accelerators.
• ether can be used as a binder distributor and cetyl alcohol, glycerol monostearate, starch, maize starch, lactose, wetting agents (e.g. Aerosol OT, Pluronics, Tweens), tragacanth, gum arabic, gelatin and others as a hydrophilizing agent or as a disintegration accelerator.
• wetting agents e.g. Aerosol OT, Pluronics, Tweens
• tragacanth e.g. Aerosol OT, Pluronics, Tweens
• tragacanth e.g. Aerosol OT, Pluronics, Tweens
• gum arabic e.g., tragacanth
• disintegration accelerator e.g., tragacanth
• Sucrose, fructose, lactose or aspartame can be used as sweeteners or peppermint, wintergreen oil, cherry flavor and much more as a flavoring agent
• auxiliaries are generally considered: Aerosil, Aerosol OT ethyl cellulose, amberlite resin, XE-88, Amijel, Amisterol, Amylose, Avicel microcrystalline cellulose, bentonite, calcium sulfate, Carbowax 4000 u.
• auxiliaries can be found in the examples, but other auxiliaries from the prior art can also be used.
• tablets can be manufactured by direct compression.
• connection can be microencapsulated.
• Parenteral administration can be achieved by dissolving the compound in a liquid and injecting it subcutaneously, intramuscularly or intravenously.
• suitable solvents are water or oily media.
• the compound can be formulated with low-melting and water-soluble or water-insoluble materials such as polyethylene glycol, cocoa butter, higher esters (for example moerysthyl, palmitate) or mixtures thereof.
• Propylparaben as a preservative a colorant and a flavoring such as cherry or orange flavor may be included.
• auxiliary substances mentioned are not limited to the use of the application form in the context in which they were mentioned, but can also be transferred to the other application forms.
• any material used in the manufacture of any unit dosage form should be pharmaceutically acceptable and substantially non-toxic in the amounts used.
• the active components can be incorporated into sustained release preparations and devices that include, but are not limited to, those based on osmotic pressures to achieve a desired release profile. Once-daily formulations for each of the active components are specifically included. Such compositions and preparations should contain at least 0.001% active compound. The percentage of compositions and preparations can, of course, be varied and may conveniently be between about 0.1 to about 100% by weight of a given unit dosage form. The amount of active compound in such therapeutically useful compositions is such that an effective dosage amount is obtained.
• composition of the invention containing the two active components can be administered in the same physical form or simultaneously in accordance with the dosages described above and in the delivery vehicles described above.
• the dosages for each active component can be measured separately and can be administered as a single combined dose or administered separately. They can be administered at the same or different times, as long as both active ingredients are effective in the patient at one time over a 24-hour period. It is preferred if the two components come into effect in such a way that an effect is achieved which is improved compared to the respective individual effect.
• Simultaneous or co-administration means that the patient takes one drug within about 5 minutes after taking the other drug. For reasons of simple handling, formulations are preferred in which the two drugs are administered to the patient close together and typically at the same time.
• the pharmaceutical composition according to the invention can preferably be used for the treatment or prophylaxis, inter alia, of any of the clinical pictures mentioned below, as a single clinical picture or in combination with another of the named clinical pictures, but without being limited thereto: prostate diseases such as benign prostatic hyperblasia, prostatitis, in particular chronic abacterial prostatitis, neurogenic, muscular or bacterial origin, chronic pelvic pain syndrome, pelvic myoneuropathy, prostatodynia or Prostatopathy, bladder dysfunction, such as urinary incontinence, especially stress incontinence, urge incontinence, mixed incontinence or hyperactive bladder of neurogenic or non-neurogenic origin and their other subindications.
• the invention is preferably used in the presence of one of the above-mentioned prostate diseases and one of the above-mentioned bladder dysfunction.
• both those clinical pictures are included, the cause of which is an organ dysfunction or illness, and also those which are attributable to diseases or disorders of the central nervous system.
• composition according to the invention can thereby alleviate the symptoms of the disease (s) and / or cause the disease.
• a further embodiment of the present invention thus comprises the use of the composition according to the invention for the manufacture of a medicament for the treatment or prevention of any of the indications mentioned in the preceding paragraph.
• food animals e.g. cattle
• pets e.g. dogs, cats and horses
• the dosages to be used may be different from the dosages given herein.
• Example 1 Composition from (-) - ethyl-2- [4- (2- ⁇ [(IS, 2R) -2-hydroxy-2- (4-hydroxyphenyl) -1-methylethyl] amino ⁇ ethyl) -2.5 -dimethylphenyloxy] acetate / tamsulosin: prolonged-release capsule 80 mg / 0.367 mg

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• 2004
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