DE4316727A1 - Composition for the treatment of inflammatory disorders of the lower colonic region and of the skin with beclomethasone as active ingredient - Google Patents

Composition for the treatment of inflammatory disorders of the lower colonic region and of the skin with beclomethasone as active ingredient

Info

Publication number
DE4316727A1
DE4316727A1 DE19934316727 DE4316727A DE4316727A1 DE 4316727 A1 DE4316727 A1 DE 4316727A1 DE 19934316727 DE19934316727 DE 19934316727 DE 4316727 A DE4316727 A DE 4316727A DE 4316727 A1 DE4316727 A1 DE 4316727A1
Authority
DE
Germany
Prior art keywords
beclomethasone
active ingredient
treatment
skin
suspension
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Withdrawn
Application number
DE19934316727
Other languages
German (de)
Inventor
Eva Stoecker
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
LINDEN APOTHEKE APOTHEKERIN EV
Original Assignee
LINDEN APOTHEKE APOTHEKERIN EV
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by LINDEN APOTHEKE APOTHEKERIN EV filed Critical LINDEN APOTHEKE APOTHEKERIN EV
Priority to DE19934316727 priority Critical patent/DE4316727A1/en
Publication of DE4316727A1 publication Critical patent/DE4316727A1/en
Withdrawn legal-status Critical Current

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
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/57—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0031—Rectum, anus

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

The present invention relates to a composition for the treatment of inflammatory disorders of the lower colonic region and/or of the skin, containing beclomethasone which is in the form of a solution and/or suspension which contains 0.1 to 10% by weight of active ingredient as aqueous solution, forms a foam on release through a valve from a pressurized container and can be introduced rectally.

Description

Gegenstand der vorliegenden Patentanmeldung ist ein Mittel zur Behandlung von entzündlichen Erkrankungen des unteren Dick­ darmbereiches und/oder der Haut enthaltend Beclomethason sowie die Verwendung dieser Substanz zur Herstellung eines Arznei­ mittels.The subject of the present patent application is a means for Treatment of inflammatory diseases of the lower dick intestine and / or skin containing beclomethasone and the use of this substance in the manufacture of a medicament by means of.

Beclomethason ist ein bereits seit vielen Jahren bekanntes halogeniertes Glucocorticoid, mit antiphlogistischer und anti­ allergischer Wirkung. Der Wirkstoff wird in zahlreichen Arzneimitteln, insbesondere gegen Asthma, chronische Bronchi­ tis sowie gegen allergische Rhinitis verwendet. Als Applika­ tionsformen sind die inhalatorische Verabreichung von Suspensionen, Aerosolen oder auch Pulvern bekannt.Beclomethasone has been known for many years halogenated glucocorticoid, with anti-inflammatory and anti allergic effect. The active ingredient is used in numerous Medicines, especially for asthma, chronic bronchi used as well as against allergic rhinitis. As an applica tion forms are the inhaled administration of Suspensions, aerosols or powders are known.

Das technische Problem der Erfindung war es, Beclomethason mit neuer Indikation und als rektal zu verabreichenden Schaum zur Verfügung zu stellen.The technical problem of the invention was with beclomethasone new indication and as a rectal foam to be administered To make available.

Dieses technische Problem wird entsprechend dem kennzeichnen­ den Teil des Anspruchs 1 gelöst.This technical problem will identify accordingly solved the part of claim 1.

Dabei liegt Beclamethason als wäßrige 0,1 bis 10 Gew.-% Wirk­ stoff enthaltende, bei Freisetzung aus einem Druckbehälter über ein Ventil schaumbildende rektal einführbare Lösung und/ oder Suspension vor.Beclamethasone is an aqueous 0.1 to 10% by weight of active ingredient substance containing, when released from a pressure vessel Rectally insertable solution foamable via a valve and / or suspension before.

In einer besonderen Ausführungsform enthält das erfindungsge­ mäße Mittel verträgliche Lösungsmittel, Lösungsvermittler und Schaumbildner. In a particular embodiment, this contains fiction Compatible solvents, solubilizers and Foaming agent.  

Ein weiterer Gegenstand der Erfindung ist die Verwendung von Beclomethason zur Herstellung eines Arzneimittels zur Behand­ lung von entzündlichen Erkrankungen des unteren Dickdarmberei­ ches, insbesondere Colitis ulcerosa, Morbus Crohn und Prokto­ sigmoiditis, welches dadurch gekennzeichnet ist, daß es als wäßrige 0,1 bis 10 Gew.-% Wirkstoff enthaltende rektal ein­ führbare schaumbildende Lösung/Suspension vorliegt.Another object of the invention is the use of Beclomethasone for the manufacture of a medicament for treatment treatment of inflammatory diseases of the lower colon ches, especially ulcerative colitis, Crohn's disease and procto sigmoiditis, which is characterized in that it as aqueous rectally containing 0.1 to 10% by weight of active ingredient feasible foam-forming solution / suspension is present.

Ein weiterer Gegenstand der Erfindung ist die Verwendung von Beclomethason zur Herstellung eines Arzneimittels zur Behand­ lung von entzündlichen Erkrankungen der Haut, insbesondere Nesselfieber, Sonnenbrand, Hautjucken, welches dadurch gekenn­ zeichnet ist, daß es als wäßrige 0,1 bis 10 Gew.-% Wirkstoff enthaltende äußerlich anwendbare schaumbildende Lösung/Suspen­ sion vorliegt.Another object of the invention is the use of Beclomethasone for the manufacture of a medicament for treatment inflammatory diseases of the skin, in particular Nettle fever, sunburn, itchy skin, which is known is that it is an aqueous 0.1 to 10 wt .-% active ingredient containing externally applicable foam-forming solution / Suspen sion is present.

Durch die leichte rektale Applizierbarkeit des erfindungsge­ mäßen Mittels kann es leicht und praktisch dosiert und einge­ führt werden, wobei die Nachteile von Klistieren vermieden werden.Due to the easy rectal applicability of the fiction it can be easily and practically dosed and absorbed the disadvantages of enemas are avoided become.

Das erfindungsgemäße Mittel kann mit Hilfe eines speziellen Applikators, der jeweils zuvor mit Schaum gefüllt wird, rektal eingeführt werden. Als weitere Möglichkeit der Applikation be­ steht die Aufnahme mit Hilfe eines Druckbehälters mit einem Dosierventil, welches bei einmaliger Auslösung jeweils dosiert ca. 1 ml Lösung und/oder Suspension freigibt. Auf dieses Do­ sierventil kann weiterhin ein geeignetes Verlängerungsstück aufgesteckt oder aufgeschraubt werden, welches ebenfalls zur rektalen Einführung geeignet ist.The agent according to the invention can with the help of a special Applicator, which is filled with foam beforehand, rectally be introduced. As a further possibility of application be is the recording with the help of a pressure vessel with a Dosing valve, which doses when triggered once releases approx. 1 ml of solution and / or suspension. On this Thursday Sierventil can continue to be a suitable extension piece be plugged on or screwed on, which is also used for rectal introduction is suitable.

Das folgende Beispiel soll die Erfindung näher beschreiben.The following example is intended to describe the invention in more detail.

Beispielexample

1 g des erfindungsgemäßen Mittels enthalten:1 g of the agent according to the invention contain:

0,1 bis 10 Gew.-% Beclomethason,
200 mg Propylenglykol,
50 mg Ethoxystearylalkohol,
2 mg Cetylalkohol,
3 mg Macrogolstearyläther,
1,1 mg Konservierungsmittel (Parabene)
673 mg Wasser
Mittel zur Einstellung des pH-Wertes
50 mg Polysorbel (20/80).0.1 to 10% by weight beclomethasone,
200 mg propylene glycol,
50 mg ethoxystearyl alcohol,
2 mg cetyl alcohol,
3 mg macrogol stearyl ether,
1.1 mg preservative (parabens)
673 mg water
Means for adjusting the pH
50 mg polysorbel (20/80).

Der Behälter, in dem der erfindungsgemäße Schaum gefüllt wird, kann als Treibmittel Preßluft, Propan/Isobutan (Gemisch 1 : 1) oder Propan/Stickstoff (Gemisch mit einem Stickstoffanteil von 1 bis 10%) enthalten.The container in which the foam according to the invention is filled compressed air, propane / isobutane (mixture 1: 1) or propane / nitrogen (mixture with a nitrogen content of 1 to 10%) included.

Claims (4)

1. Mittel zur Behandlung von entzündlichen Erkrankungen des unteren Dickdarmbereiches, insbesondere Colitis ulcero­ sa, Morbus Crohn und Proktosigmoiditis und/oder entzünd­ lichen Erkrankungen der Haut enthaltend Beclomethason, dadurch gekennzeichnet, daß es als wäßrige 0,1 bis 10 Gew.-% Wirkstoff enthaltende, bei Freisetzung aus einem Druckbehälter über ein Ventil schaumbildende rektal ein­ führbare Lösung und/oder Suspension vorliegt.1. Agent for the treatment of inflammatory diseases of the lower colon, in particular ulcerative colitis, Crohn's disease and proctosigmoiditis and / or inflammatory skin diseases containing beclomethasone, characterized in that it contains 0.1 to 10% by weight of active ingredient , when released from a pressure vessel via a valve foam-forming rectally a feasible solution and / or suspension is present. 2. Mittel gemäß Anspruch 1, dadurch gekennzeichnet, daß diese wäßrige Lösung und/oder Suspension physiologisch verträgliche Lösungsmittel, Lösungsvermittler und Schaumbildner enthält.2. Composition according to claim 1, characterized in that this aqueous solution and / or suspension physiologically compatible solvents, solubilizers and Contains foaming agents. 3. Verwendung von Beclomethason zur Herstellung eines Arz­ neimittels zur Behandlung von entzündlichen Erkrankungen des unteren Dickdarmbereiches, insbesondere Colitis ulcerosa, Morbus Crohn und Proktosigmoiditis, dadurch gekennzeichnet, daß es als wäßrige 0,1 bis 10 Gew.-% Wirkstoff enthaltende schaumbildende rektal einführbare Lösung und/oder Suspension vorliegt.3. Use of beclomethasone to make a doctor Needy for the treatment of inflammatory diseases of the lower colon, especially colitis ulcerative disease, Crohn's disease and proctosigmoiditis, thereby characterized in that it is aqueous 0.1 to 10 wt .-% Active ingredient-containing foam-forming rectally insertable Solution and / or suspension is present. 4. Verwendung von Beclomethason zur Herstellung eines Arz­ neimittels zur Behandlung von entzündlichen Erkrankungen der Haut, insbesondere Nesselfieber, Sonnenbrand, Haut­ jucken, welches dadurch gekennzeichnet ist, daß es als wäßrige 0,1 bis 10 Gew.-% Wirkstoff enthaltende äußer­ lich anwendbare schaumbildende Lösung und/oder Suspen­ sion vorliegt.4. Use of beclomethasone to make a doctor Needy for the treatment of inflammatory diseases the skin, especially nettle fever, sunburn, skin itch, which is characterized in that it is as aqueous 0.1 to 10 wt .-% active ingredient containing outside Lich applicable foam-forming solution and / or Suspen sion is present.
DE19934316727 1993-05-19 1993-05-19 Composition for the treatment of inflammatory disorders of the lower colonic region and of the skin with beclomethasone as active ingredient Withdrawn DE4316727A1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
DE19934316727 DE4316727A1 (en) 1993-05-19 1993-05-19 Composition for the treatment of inflammatory disorders of the lower colonic region and of the skin with beclomethasone as active ingredient

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
DE19934316727 DE4316727A1 (en) 1993-05-19 1993-05-19 Composition for the treatment of inflammatory disorders of the lower colonic region and of the skin with beclomethasone as active ingredient

Publications (1)

Publication Number Publication Date
DE4316727A1 true DE4316727A1 (en) 1994-11-24

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2012150130A1 (en) * 2011-05-04 2012-11-08 Chiesi Farmaceutici S.P.A. A topical formulation comprising a corticosteroid as active ingredient

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2012150130A1 (en) * 2011-05-04 2012-11-08 Chiesi Farmaceutici S.P.A. A topical formulation comprising a corticosteroid as active ingredient
US8679512B2 (en) 2011-05-04 2014-03-25 Chiesi Farmaceutici S.P.A. Topical formulation comprising a corticosteroid as active ingredient

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