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
  • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
  • A61K31/19—Carboxylic acids, e.g. valproic acid
  • A61K31/192—Carboxylic acids, e.g. valproic acid having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic acid 
• • 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
  • A61K31/216—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acids having aromatic rings, e.g. benactizyne, clofibrate
• • 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
  • A61K31/22—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acyclic acids, e.g. pravastatin
  • A61K31/222—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acyclic acids, e.g. pravastatin with compounds having aromatic groups, e.g. dipivefrine, ibopamine
• • 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
  • A61K31/235—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids having an aromatic ring attached to a carboxyl group
  • A61K31/24—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids having an aromatic ring attached to a carboxyl group having an amino or nitro group
• • 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
  • A61K31/33—Heterocyclic compounds
  • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
  • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
  • A61K31/415—1,2-Diazoles
• • 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
  • A61K31/33—Heterocyclic compounds
  • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
  • A61K31/54—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one sulfur as the ring hetero atoms, e.g. sulthiame
  • A61K31/5415—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one sulfur as the ring hetero atoms, e.g. sulthiame ortho- or peri-condensed with carbocyclic ring systems, e.g. phenothiazine, chlorpromazine, piroxicam
• • 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
  • A61K31/60—Salicylic acid; Derivatives thereof
• • 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
  • A61P25/00—Drugs for disorders of the nervous system

Definitions

• This invention describes a new combination of active ingredients for the treatment of painful bladder dysfunction.
• a pharmaceutical active ingredient combination comprising at least one beta-3 adrenoceptor agonist and at least one active ingredient which intervenes in prostaglandin metabolism is presented.
• urinary incontinence is increasing due to the shift in the age structure. However, most of those affected are still not being treated or are being treated inadequately. In addition to the medical complications, such as chronic urinary tract infections, urinary incontinence is associated with a high level of psychological suffering for those affected. An estimated 100 million older people are affected by urinary incontinence.
• the lower urinary tract consists of the urinary bladder, the urethra, the corresponding muscles and the ligaments of the holding apparatus.
• the function of the bladder is to store and empty the urine.
• For the fulfillment of the memory function is not only the relaxation of the bladder muscle (detrusor muscle), but also closing mechanisms through the bladder neck, the smooth muscles of the urethra and the striated muscles of the urethra and the
• Bladder 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
• Contractions during the filling phase are based, the cause of which may 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.
• the WHO recommends treatment with
• 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).
• ⁇ -adrenoceptor agonists such as pseudoephedrine and phenylpropanolamine
• ⁇ -adrenoceptor agonists have an extremely moderate effect in the treatment of mild stress incontinence.
• 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.
• Prostaglandins seem to play an important role in the endogenous modulation of the micturition reflex. An increase in prostate glandin biosynthesis was also observed in chronic bladder obstruction. Based on these and other observations, active substances that intervene in prostaglandin biosynthesis are becoming increasingly important. A significant group of active substances in this regard are the non-steroidal, anti-inflammatory compounds, NSAID for short. These interact with the enzymes cyclooxygenase (COX), which are important for the synthesis of prostaglandins and are present as COX-1 and COX-2. Really important is the enzyme COX-2 and accordingly with it COX-2 inhibitors for intervening in prostaglandin biosynthesis.
• COX cyclooxygenase
• the present invention is intended to provide such a contribution to the therapy of urinary incontinence.
• the invention is preferably suitable for the treatment of stress incontinence, urge incontinence, mixed incontinence or hyperactive bladder (hyperactive bladder without urge incontinence or with urge incontinence).
• a pharmaceutical combination is presented which is intended to combine the advantages of the NSAIDs or cyclooxygenase inhibitors as well as those of the beta-3-adrenoceptor agonists with one another in a manner which favors the therapy of the underlying disease.
• a new pharmaceutical composition which comprises (a) an NSAID and / or cyclooxygenase inhibitor in a pharmaceutically effective amount and (b) at least one beta-3-adrenoceptor agonist 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,
• Glucon glutamine, hydrogen bromide, hydrogen chloride, hydrogen iodide, isethione, milk, maleic, apple, almond, methane sulfone (mesylate), mucin, saltpetre, oxal, pamoa, pantothes -, Phosphoric, amber, sulfuric, 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, hexin-1,6-dioate, hydroxybenzoate, iodide, lactate, maleate, malonate, mandelate, metaphosphate, methanesulfonate, methoxybenzoate, methylbenzoate, monohydrogen phosphate, naphthalene-1-sulfonate, naphthalene-2-sulfonate, oxalate, phenylproutionate , Phosphate, phthalate, phenylacetate, propanesulfonate, propiolate, propionate, pyrophosphate, pyr
• COX-2 inhibitors are particularly preferred as cyclooxygenase inhibitors.
• cyclooxygenase inhibitors or COX inhibitors are used in parallel.
• COX-1 inhibitors or COX-2 inhibitors are used in parallel.
• Selective COX-2 inhibitors are understood to mean compounds whose inhibitory effect on the enzyme COX-2 is greater than on the enzyme COX-1.
• acetylsalicylic acid ab) indomethacin, ac) sulindac, ad) etodolac, ae) mefenamic acid, af) tolmetin, ag) ketorolac, ah) Diclofenac, ai) ibuprofen, aj) naproxen, ak) fenoprofen, al) ketoprofen, am) oxaprozine, an) flurbiprofen, ao) nitroflurbiprofen, ap) piroxicam, aq) tenoxicam, ar) phenylbutazone, as) apazone, at) nimesul their pharmacologically acceptable salts.
• Preferred representatives are acetylsalicylic acid, i
• Each of these compounds listed above can be used for the treatment of urinary incontinence including at least one of the subindications listed at the outset, in particular stress incontinence, urge incontinence, mixed incontinence or hyperactive bladder.
• the second component comprises one or more beta-3 adrenoreceptor agonists. This is preferably selected from the following group:
• 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, its enantiomers, other stereoisomers thereof, and pharmacologically active salts thereof.
• Particularly preferred combinations include each of the following combination options from (a) and (b):
• the invention comprises each of the following combinations: (aa, 1); (ab, 1); (ac, 1); (ad, 1); (ae, 1); (Af,
• the dosages given below expressly include all numerical values, whole or fractional, within the range given.
• the information relates to adult people. Pediatric doses may be lower.
• Administrations more than once a day or twice a day are also expressly considered herein.
• the oral dose of the cyclooxygenase inhibitor preferred for humans is 0.1 mg to 200 mg per day and kg body weight, preferably it is between 1 mg and 50 mg per day and kg body weight and very particularly preferably it is between 1 mg and 10 mg per day and kg body weight.
• the intravenous administration of each of the compounds mentioned can be 10 times, preferably 100 times lower than the oral dose.
• 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 selection of the dosage of this first component (a) is the one that can provide relief for the patient.
• the daily dose of the combination according to the invention desirably contains it in an amount of about 0.5 mg to about 50 mg. More preferably, each dose of the component contains about 1 to about 25 mg of the active ingredient.
• the preferred daily dose is 0.1 mg to 4000 mg, preferably 10 mg to 2000 mg.
• the preferred daily dose for ibuprofen is 0.1 mg to 6000 mg, preferably 10 mg to 3000 mg.
• the preferred daily dose is 0.1 mg to 500 mg, preferably 10 mg to 250 mg.
• 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 dosages and the regimen i.e. one, two, three or more.
• Administrations per day) of the second component depends on the factors which have already been referred to in connection with the dosage choice of the first component.
• the average daily dose of the second component (beta-3 agonist) for an adult human is about 1 mg to 1000 mg, preferably 10 mg to about 750 mg per day, preferably 5 to 120 mg, more preferably 10 to 100 mg, administered in one or more cans. This dose is preferably administered orally.
• the intravenous dose is preferably a factor of 10, particularly preferably 100, below the oral dose.
• 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, intravaginally, 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. Enteric capsules or enteric tablets are therefore preferred, which in both cases e.g. can be realized with an enteric coating.
• enteric-coated formulations in the prior art.
• composition of the invention can be combined with one or more carriers and in the form of ingestible ones
• Tablets buccal tablets, sublingual tablets, sugar-coated tablets, powders, powders, lozenges, dragees, granules, capsules, elixirs, suspensions, solutions,
• Syrups, wafers, chewing gums, foods and the like can be used.
• a powder can be made, for example, in which the particles of the active
• the substance can be brought to a suitable size by grinding.
• Diluted powders can be produced by finely grinding the powdery substance with a non-toxic carrier material, such as lactose, and as Powder is applied.
• a non-toxic carrier material such as lactose
• suitable carrier materials are other carbohydrates, such as starch or mannitol.
• these powders can contain flavorings, preservatives, dispersing agents, colorants and other pharmacological adjuvants.
• 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 carboxymethyl cellulose, carboxymethyl cellulose calcium, low-substituted hydroxyprophyl 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 (e.g. for vaginal tablets), 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, come as counter-disintegrant or solution retarder; 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.
• a binder distributor e.g. Ether are used and as a hydrophilizing agent or as a disintegration accelerator cetyl alcohol, glycerol monostearate, starch, corn starch, milk sugar, wetting agents (e.g. Aerosol OT, Pluronics, Tweens), tragacanth, gum arabic, gelatin and others.
• a binder distributor e.g. Ether are used and as a hydrophilizing agent or as a disintegration accelerator cetyl alcohol, glycerol monostearate, starch, corn starch, milk sugar, wetting agents (e.g. Aerosol OT, Pluronics, Tweens), tragacanth, gum arabic, gelatin and others.
• Sucrose, fructose, lactose or aspartame can be used as sweeteners or peppermint, wintergreen oil, cherry flavor and much more as flavoring agents.
• 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.
• Tableting aid K M25
• 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.
• отно ⁇ coatings or to otherwise modify the physical form of the solid unit dosage form can be present as coatings or to otherwise modify the physical form of the solid unit dosage form.
• tablets, pills or capsules can be coated with gelatin, wax, shellac or sugar and the like.
• enteric formulations are preferred for the oral dosage forms. Enteric coatings for tablets or capsules are therefore preferred.
• sucrose or fructose can be used as a sweetener, methyl and 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.
• 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.
• 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 time or at different times, as long as both active ingredients are administered at the same time over a 24-hour period in the patient come into effect. 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 treatment or prophylaxis and others.
• Each of the following clinical pictures can be used as a single clinical picture as well as in combination with another of the named clinical pictures, but without being limited to it: urinary incontinence, in particular stress incontinence, urge incontinence, mixed incontinence or hyperactive bladder of neurogenic or non-neurogenic origin, neurogenic
• Incontinence detrusor hyperreflexia, suburethral diverticulitis, urinary tract infections and their other subindications.
• a further embodiment of the present invention 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 for bladder dysfunction mentioned in the previous paragraph.
• Treatment of the above diseases or disorders is accomplished by delivering a therapeutically effective amount of the composition of the invention to a mammal. In most cases this is a human, but the treatment of food animals (e.g. cattle) and pets (e.g. dogs, cats and horses) is expressly covered here.
• the dosages to be used may be different from the dosages given herein.
• the new composition with a minimal level of deleterious side effects is expected to provide rapid relief to those suffering from the above diseases and disorders.
• Example No. 1 composition containing (-) - ethyl-2- [4- (2- ⁇ [(IS, 2R) -2-hydroxy-2- (4-hydroxyphenyl) -1-methylethyl] amino ⁇ ethyl) -2 , 5 -dimethylphenyloxy] acetate and acetylsalicylic acid - tablet 40 mg / 500 mg
• Example N ° 2 - composition containing (-) - ethyl 2- [4- (2- ⁇ [(IS, 2R) -2-hydroxy-2- (4-hydroxyphenyl) -l-methylethyl] amino ⁇ ethyl) - 2,5-dimethylphenyloxy] acetate and meloxicam - tablet 80 mg / 7.5 mg
• Example N ° 3 composition containing (-) - ethyl-2- [4- (2- ⁇ [(IS, 2R) -2-hydroxy-2- (4-hydroxyphenyl) -1-methylethyl] amino ⁇ ethyl) -2 , 5-dimethylphenyloxy] acetate and ibuprofen - film-coated tablet 40 mg / 200 mg core
• Example N ° 4 composition containing (0-ethyl-2- [4- (2 - ⁇ [(IS, 2R) -2-hydroxy-2- (4-hydroxyphenyl) -l-methylethyl] amino ⁇ ethyl) -2, 5-dimethylphenyloxy] acetate and diclofenac sodium - enteric-coated tablet 80 mg / 50 mg core

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  • 2003-11-27 DE DE10356112A patent/DE10356112A1/de not_active Withdrawn
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