DE10218392A1 - Pharmaceutical combination of tamsulosin and finasteride useful for treating benign prostatic hyperplasia - Google Patents
Pharmaceutical combination of tamsulosin and finasteride useful for treating benign prostatic hyperplasiaInfo
- Publication number
- DE10218392A1 DE10218392A1 DE2002118392 DE10218392A DE10218392A1 DE 10218392 A1 DE10218392 A1 DE 10218392A1 DE 2002118392 DE2002118392 DE 2002118392 DE 10218392 A DE10218392 A DE 10218392A DE 10218392 A1 DE10218392 A1 DE 10218392A1
- Authority
- DE
- Germany
- Prior art keywords
- finasteride
- tamsulosin
- pharmaceutical combination
- prostatic hyperplasia
- benign prostatic
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Withdrawn
Links
Classifications
-
- 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
- A61K31/16—Amides, e.g. hydroxamic acids
- A61K31/18—Sulfonamides
-
- 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
- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
-
- 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
Abstract
Description
Die vorliegende Erfindung betrifft eine Arzneimittelkombination enthaltend die Wirkstoffe Finasterid und Tamsulosin. Die erfindungsgemäße Kombination eignet sich zur langandauernden Behandlung von Prostatahyperplasie. The present invention relates to a pharmaceutical combination containing the active ingredients Finasteride and tamsulosin. The combination according to the invention is suitable for long-term treatment of prostate hyperplasia.
BPH, eine gutartige, nicht krebsartige Vergrößerung der Prostata, ist eine allgemein bekannte Störung bei Männern, die gewöhnlich ab einem Alter von 50 Jahren klinisch offenkundig zu Tage tritt. Etwa 50% aller Männer in einem Alter oberhalb von 50 Jahren und 95% aller Männer oberhalb von 70 Jahren sind davon betroffen. BPH, a benign, non-cancerous enlargement of the prostate, is a well-known one Malfunction in men, which is usually clinically evident from the age of 50 Days occurs. Around 50% of all men over the age of 50 and 95% of all Men over the age of 70 are affected.
Bei BPH handelt es sich um einen allgemein fortschreitenden Zustand, der in schwerwiegenderen Fällen die Nierenfunktion gefährden kann und einen chirurgischen Eingriff erforderlich macht. Die Zahl der unbehandelten Patienten beläuft sich weltweit auf über 37 Millionen. Durch die Wucherung der Prostata wird die Harnröhre zusammengedrückt oder verlangen, was Symptome einer Harnleiterblockade verursacht und zum Urinrückstau führen kann. BPH is a generally progressive condition that occurs in more serious cases can compromise kidney function and a surgical Intervention requires. The number of untreated patients is around the world over 37 million. The prostate overgrowth compresses the urethra or request what causes symptoms of ureter blockage and urinary retention can lead.
Die Prostata besteht aus epithelialen Drüsenschläuchen, die in fibromuskuläres Stroma eingebettet sind. Das hyperplastische Wachstum der Prostata beginnt etwa im 30. Lebensjahr in den periurethral gelegenen Drüsenabschnitten, der sogenannten Übergangszone. Neben dem Einfluß des Alterns bilden androgene Hormone einen entscheidenden Wachstumsstimulus in der postpubertären Drüsenvolumenregulation. In der normalen Prostata wandelt das Enzym 5α-Reduktase in den Epithelzellen das androgene Hormon Testosteron (T) in Dihydrotestosteron (DHT) um. DHT, ein aktiver androgener prostatischer Metabolit, bindet an zytoplasmatische Rezeptoren und wird in den Zellkern transportiert, wo es RNA- und Proteinsynthese sowie die Zellreplikation einleitet. Es wird angenommen, dass sich BPH in Antwort auf die Einwirkung von DHT auf die alternde Prostata und auf Veränderungen in den Stroma- und Epithelzellen bildet (Steers, Zorn, Dis. Mon., 41(7): 437-497 (1995)). The prostate is made up of epithelial glandular tubes that run into fibromuscular stroma are embedded. The hyperplastic growth of the prostate begins around the age of 30 in the periurethral gland sections, the so-called transition zone. Next androgenic hormones are a crucial factor in the influence of aging Growth stimulus in post-pubertal gland volume regulation. In the normal The enzyme 5α-reductase in the epithelial cells converts the androgenic hormone into the prostate Testosterone (T) to dihydrotestosterone (DHT). DHT, an active androgenic prostatic Metabolite, binds to cytoplasmic receptors and is transported to the cell nucleus where it initiates RNA and protein synthesis as well as cell replication. It is believed that BPH in response to DHT's effects on the aging prostate and on Changes in the stromal and epithelial cells form (Steers, Zorn, Dis. Mon., 41 (7): 437-497 (1995)).
Altersabhängige Veränderungen hinsichtlich der Serumkonzentrationen des gesamten hormonalen Regelkreises (LH, FSH, SHGB, T und DHT) sowie anderer Hormone, die auf diesen Regelkreis Einfluß nehmen können (Östrogene, Prolaktin, Testosteronderivate), sind als mögliche Ursache untersucht worden. Eine Korrelation zwischen solchen altersabhängigen Hormonveränderungen im Serum und den intraprostatischen Hormonkonzentrationen fehlt allerdings. Es wird somit deutlich, dass die Prostata für die Regulation des hormonellen Milieus selbst verantwortlich ist. Age-related changes in total serum concentrations hormonal control loop (LH, FSH, SHGB, T and DHT) as well as other hormones that act on can influence this control loop (estrogens, prolactin, testosterone derivatives) has been investigated as a possible cause. A correlation between such age-dependent Hormone changes in the serum and intraprostatic hormone concentrations are missing Indeed. It thus becomes clear that the prostate is responsible for the regulation of hormonal Milieus is responsible.
Mögliche Angriffspunkte für die Steuerung des intraprostatischen Hormonmilieus sind die 5α-Reduktase (also der Androgenmatabolismus), die Hormonrezeptorexpression in Epithel und Stroma, Östrogene und andere Hormone. Daneben beeinflussen zahlreiche peptidale Wachstumsfaktoren parakrin oder autokrin den lokalen Stoffwechsel in den verschiedenen Kompartimenten der Drüse, wodurch das Gleichgewicht der Zellkinetik zwischen Proliferation und programmiertem Zelltod verschoben werden kann. Possible points of attack for the control of the intraprostatic hormone environment are 5α-reductase (i.e. androgen matabolism), the hormone receptor expression in epithelium and stroma, estrogens and other hormones. In addition, numerous peptidals affect Paracrine or autocrine growth factors affect the local metabolism in the various Compartments of the gland, creating a balance of cell kinetics between Proliferation and programmed cell death can be postponed.
Die klinischen Symptomen von BPH umfassen sowohl blockierende Symptome (z. B. Stocken des Harnstrahls, schwacher oder unterbrochener Strahl, Harnstauung), welche direkt aus der Einengung des Blasenhalses und der prostatischen Harnröhre durch die hyperplastische Prostata resultieren, als auch Symptome eines gereizten unteren Harntraktes (z. B. Harnfrequenz, Nykturie, Dysurie, Harndrang, Dranginkontinenz). Unbehandelt kann BPH zu schwerwiegenderen Komplikationen der Harnwege und Nieren führen, wie z. B. akute Harnstauung und Hydronephrose (Harnstauniere). The clinical symptoms of BPH include both blocking symptoms (e.g. stagnation of the urine jet, weak or interrupted jet, urinary congestion), which come directly from the Narrowing of the bladder neck and prostatic urethra through the hyperplastic Prostate result, as well as symptoms of an irritated lower urinary tract (e.g. Urinary frequency, nocturia, dysuria, urge to urinate, urge incontinence). If left untreated, BPH can lead to more serious complications of the urinary tract and kidneys, such as B. Acute Urinary stasis and hydronephrosis (urinary tract).
Tamsulosin hydrochlorid ist ein α-Rezeptorenblocker und wird als Monosubstanz zur Behandlung von funktionellen Symptomen der Prostatahyperplasie (BPH) angewendet. Tamsulosin hydrochloride is an α-receptor blocker and is used as a mono substance Treatment of functional symptoms of prostatic hyperplasia (BPH) applied.
Die Synthese von Tamsulosin und seinen Säureadditionssalzen wurde erstmals in der europäischen Patentschrift EP 34432 beschrieben, auf die hiermit Bezug genommen wird. The synthesis of tamsulosin and its acid addition salts was first described in the European patent EP 34432 described, to which reference is hereby made.
Eine geeignete Retardformulierung ist beispielsweise in der US-Patentschrift Nr. 4/772,475 offenbart, auf die ebenfalls Bezug genommen wird. A suitable sustained release formulation is, for example, in US Pat. No. 4 / 772,475 to which reference is also made.
Finasterid, ein 5α-Reduktasehemmer, wird ebenfalls zur Behandlung der BPH eingesetzt. Finasterid ist in der europäischen Patentschrift EP 155096 beschrieben. Finasteride, a 5α-reductase inhibitor, is also used to treat BPH. Finasteride is described in the European patent EP 155096.
Überraschenderweise ist die erfindungsgemäße Kombination aus Tamsulosin, sein Säureadditionssalz, insbesondere Tamsulosinhydrochlorid und Finasterid für die Langzeittherapie zur Behandlung der gutartigen Prostatahyperplasie geeignet. The combination of tamsulosin according to the invention is surprising Acid addition salt, especially tamsulosin hydrochloride and finasteride for the Long-term therapy suitable for the treatment of benign prostatic hyperplasia.
Die erfindungsgemäße Kombination enthält beide Wirkstoffe in einer Formulierung, die zwischen 0,1 und 0,6 mg Tamsulosinhydrochlorid und zwischen 1 und 8 mg Finasterid enthält. Bevorzugt ist eine feste Arzneimittelkombination mit 0,2 bis 0,4 mg Tamsulosinhydrochlorid und 0,3 bis 0,5 mg Finasterid. Die Wirkstoffe können oral verabreicht werden. The combination according to the invention contains both active ingredients in a formulation which between 0.1 and 0.6 mg tamsulosin hydrochloride and between 1 and 8 mg finasteride contains. A fixed drug combination with 0.2 to 0.4 mg is preferred Tamsulosin hydrochloride and 0.3 to 0.5 mg finasteride. The active ingredients can be taken orally be administered.
Geeignete übliche Darreichungsformen sind beispielsweise inerte übliche Trägerstoffen und/oder Verdünnungsmitteln, z. B. mit Maisstärke, Milchzucker, Rohrzucker, mikrokristalliner Zellulose, Magnesiumstearat, Polyvinylpyrrolidon, Zitronensäure, Weinsäure, Wasser, Wasser/Ethanol, Wasser/Glycerin, Wasser/Sorbit, Wasser/Polyethylenglykol, Propylenglykol, Cetylstearylalkohol, Carboxymethylcellulose oder fetthaltigen Substanzen wie Hartfett oder deren geeigneten Gemischen, in übliche galenische Zubereitungen wie Tabletten, Dragees, Kapseln, Pulver, Suspensionen oder Zäpfchen einarbeiten. Suitable customary dosage forms are, for example, inert customary carriers and / or diluents, e.g. B. with corn starch, milk sugar, cane sugar, microcrystalline cellulose, magnesium stearate, polyvinylpyrrolidone, citric acid, Tartaric acid, water, water / ethanol, water / glycerin, water / sorbitol, Water / polyethylene glycol, propylene glycol, cetylstearyl alcohol, Carboxymethyl cellulose or fatty substances such as hard fat or their suitable mixtures, in conventional pharmaceutical preparations such as tablets, coated tablets, Incorporate capsules, powder, suspensions or suppositories.
Die Wirkstoffe können oral in einer breiten Vielfalt von verschiedenen Dosierungsformen verabreicht werden, beispielsweise können sie zusammen mit verschiedenen pharmazeutisch annehmbaren inerten Trägern in Form von Tabletten, Kapseln, Pastillen, Plätzchen, harten Bonbons, Pulvern, wässrigen Suspensionen, Elixiren, Sirupen und dergleichen formuliert werden. Derartige Träger umfassen beispielsweise feste Verdünner oder Füllstoffe, sterile wässrige Medien und verschiedene nichttoxische organische Lösungsmittel. Zudem können derartige orale Formulierungen auf geeignete Weise mit Hilfe von verschiedenen, üblicherweise für diesen Zweck eingesetzten Agenzien gesüßt und/oder aromatisiert sein. Im allgemeinen sind die Wirkstoffe in solchen oralen Dosierungsformen mit Konzentrationsmengen vorhanden, deren Bereich, bezogen auf die Gesamtzusammensetzung, von etwa 0.5 Gew.-% bis etwa Gew.-90% reicht, in Mengen, die ausreichen, um die gewünschten Dosierungseinheiten zu ergeben. Andere geeignete Dosierungsformen für die Wirkstoffe umfassen Formulierungen zur kontrollierten Freisetzung und Vorrichtungen, die den Fachpersonen auf dem betreffenden Gebiet wohlbekannt sind. The active ingredients can be taken orally in a wide variety of different dosage forms can be administered, for example, together with various pharmaceuticals acceptable inert carriers in the form of tablets, capsules, lozenges, cookies, hard Formulated candies, powders, aqueous suspensions, elixirs, syrups and the like become. Such carriers include, for example, solid diluents or fillers, sterile aqueous media and various non-toxic organic solvents. You can also such oral formulations in a suitable manner with the aid of various Agents commonly used for this purpose may be sweetened and / or flavored. in the in general, the active ingredients are in such oral dosage forms Concentration quantities available, the range of which, based on the total composition, ranges from about 0.5% by weight to about 90% by weight, in amounts sufficient to achieve the to give desired dosage units. Other suitable dosage forms for the Active ingredients include controlled release formulations and devices that are well known to professionals in the field.
Bevorzugt ist eine retardierte Formulierung der beiden Wirkstoffe. A delayed-release formulation of the two active compounds is preferred.
Erfindungsgemäß wird unter dem Begriff Langzeittherapie eine medizinische Anwendung der Kombination beider Wirkstoffe in einer Darreichungsform von mindestens 3 Monaten und länger. According to the invention, the term long-term therapy is used for medical purposes Combination of both active ingredients in a dosage form of at least 3 months and longer.
Besonders geeignet erscheint die erfindungsgemäße Kombination zur Behandlung einer besonders vergrößerten Prostata. The combination according to the invention appears particularly suitable for the treatment of a particularly enlarged prostate.
Claims (3)
Priority Applications (28)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
DE2002118392 DE10218392A1 (en) | 2002-04-24 | 2002-04-24 | Pharmaceutical combination of tamsulosin and finasteride useful for treating benign prostatic hyperplasia |
NZ536514A NZ536514A (en) | 2002-04-24 | 2003-04-17 | Pharmaceutical combination for the treatment of benign prostatic hyperplasia or for the long-term prevention of acute urinary retention |
PCT/EP2003/004034 WO2003090753A1 (en) | 2002-04-24 | 2003-04-17 | Pharmaceutical combination for the treatment of benign prostatic hyperplasia or for the long-term prevention of acute urinary retention |
MXPA04010408A MXPA04010408A (en) | 2002-04-24 | 2003-04-17 | Pharmaceutical combination for the treatment of benign prostatic hyperplasia or for the long-term prevention of acute urinary retention. |
EP06122312A EP1743656A3 (en) | 2002-04-24 | 2003-04-17 | Pharmaceutical combination for the treatment of benign prostatic hyperplasia or for the long-term prevention of acute urinary retention |
EP03725053A EP1501517B1 (en) | 2002-04-24 | 2003-04-17 | Pharmaceutical combination for the treatment of benign prostatic hyperplasia or for the long-term prevention of acute urinary retention |
PT03725053T PT1501517E (en) | 2002-04-24 | 2003-04-17 | Pharmaceutical combination for the treatment of benign prostatic hyperplasia or for the long-term prevention of acute urinary retention |
CA002479992A CA2479992A1 (en) | 2002-04-24 | 2003-04-17 | Pharmaceutical combination for the treatment of benign prostatic hyperplasia or for the long-term prevention of acute urinary retention |
PL03371430A PL371430A1 (en) | 2002-04-24 | 2003-04-17 | Pharmaceutical combination for the treatment of benign prostatic hyperplasia or for the long-term prevention of acute urinary retention |
IL16397603A IL163976A0 (en) | 2002-04-24 | 2003-04-17 | Pharmaceutical combination for the treatment of benign prosttic hyperplasia or for the long-term prevention of acute urinary retention |
DE60313603T DE60313603T2 (en) | 2002-04-24 | 2003-04-17 | PHARMACEUTICAL COMBINATION FOR THE TREATMENT OF BENIGNER PROSTATE HYPERPLASIA OR FOR THE LONG-TERM PREVENTION OF ACUTE HARN RESUME |
DK03725053T DK1501517T3 (en) | 2002-04-24 | 2003-04-17 | Pharmaceutical combination for the treatment of benign prostate hyperplasia or for long-term prevention of acute urinary retention |
AT03725053T ATE361075T1 (en) | 2002-04-24 | 2003-04-17 | PHARMACEUTICAL COMBINATION FOR THE TREATMENT OF BENIGAN PROSTATE HYPERPLASIA OR FOR THE LONG-TERM PREVENTION OF ACUTE URINARY RETENTION |
CNA038089300A CN1646135A (en) | 2002-04-24 | 2003-04-17 | Pharmaceutical combination for the treatment of benign prostatic hyperplasia or for the long-term prevention of acute urinary retention |
AU2003227643A AU2003227643A1 (en) | 2002-04-24 | 2003-04-17 | Pharmaceutical combination for the treatment of benign prostatic hyperplasia or for the long-term prevention of acute urinary retention |
JP2003587387A JP2005524693A (en) | 2002-04-24 | 2003-04-17 | Pharmaceutical composition for the treatment of benign prostatic hyperplasia or long-term prevention of acute urinary retention |
BR0309435-9A BR0309435A (en) | 2002-04-24 | 2003-04-17 | Pharmaceutical combination for the treatment of benign prostatic hyperplasia or for the long term prevention of acute urinary retention |
SI200330899T SI1501517T1 (en) | 2002-04-24 | 2003-04-17 | Pharmaceutical combination for the treatment of benign prostatic hyperplasia or for the long-term prevention of acute urinary retention |
EA200401340A EA008377B1 (en) | 2002-04-24 | 2003-04-17 | Pharmaceutical combination for the treatment of benign prostatic hyperplasia or for the long-term prevention of acute urinary retention |
YU92304A RS92304A (en) | 2002-04-24 | 2003-04-17 | Pharmaceutical combination for the treatment of benign prostatic hyperplasia or for long-term preservation of acute urinary retention |
ES03725053T ES2287474T3 (en) | 2002-04-24 | 2003-04-17 | PHARMACEUTICAL COMBINATION FOR THE TREATMENT OF BENIGN PROSTATIC HYPERPLASIA OR FOR THE LONG-TERM PREVENTION OF ACUTE URINARY RETENTION. |
UA20041109632A UA79116C2 (en) | 2002-04-24 | 2003-04-17 | Pharmaceutical combination for the treatment of benign prostatic hyperplasia or for the long-term prevention of acute urinary retention |
US10/422,509 US20030225118A1 (en) | 2002-04-24 | 2003-04-24 | Pharmaceutical combination for the treatment of benign prostatic hyperplasia or for the long-term prevention of acute urinary retention |
ZA200407057A ZA200407057B (en) | 2002-04-24 | 2004-09-03 | Pharmaceutical combination for the treatment of benign prostatic hyperplasia or for the long-term prevention of acute urinary retention |
NO20044333A NO20044333L (en) | 2002-04-24 | 2004-10-12 | Pharmaceutical combination for the treatment of benign prostate hyperplasia or for long-term prevention of acute urinary retention |
HR20040994A HRP20040994A2 (en) | 2002-04-24 | 2004-10-22 | Pharmaceutical combination for the treatment of benign prostatic hyperplasia or for the long-term prevention of acute urinary retention |
US11/697,470 US20070197666A1 (en) | 2002-04-24 | 2007-04-06 | Pharmaceutical combination for the treatment of benign prostatic hyperplasia or for the long-term prevention of acute urinary retention |
CY20071100794T CY1107674T1 (en) | 2002-04-24 | 2007-06-14 | PHARMACEUTICAL COMBINATION FOR THE THERAPEUTIC TREATMENT OF BENEFICIAL PROTECTION OF THE PROTECTOR OR FOR LONG-TERM VIOLENCE PREVENTION |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
DE2002118392 DE10218392A1 (en) | 2002-04-24 | 2002-04-24 | Pharmaceutical combination of tamsulosin and finasteride useful for treating benign prostatic hyperplasia |
Publications (1)
Publication Number | Publication Date |
---|---|
DE10218392A1 true DE10218392A1 (en) | 2003-11-06 |
Family
ID=28798766
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
DE2002118392 Withdrawn DE10218392A1 (en) | 2002-04-24 | 2002-04-24 | Pharmaceutical combination of tamsulosin and finasteride useful for treating benign prostatic hyperplasia |
Country Status (3)
Country | Link |
---|---|
DE (1) | DE10218392A1 (en) |
UA (1) | UA79116C2 (en) |
ZA (1) | ZA200407057B (en) |
-
2002
- 2002-04-24 DE DE2002118392 patent/DE10218392A1/en not_active Withdrawn
-
2003
- 2003-04-17 UA UA20041109632A patent/UA79116C2/en unknown
-
2004
- 2004-09-03 ZA ZA200407057A patent/ZA200407057B/en unknown
Also Published As
Publication number | Publication date |
---|---|
UA79116C2 (en) | 2007-05-25 |
ZA200407057B (en) | 2006-06-28 |
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8141 | Disposal/no request for examination |