WO2010066437A2 - Aqueous composition containing dexpanthenol and sodium chloride - Google Patents
Aqueous composition containing dexpanthenol and sodium chloride Download PDFInfo
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- WO2010066437A2 WO2010066437A2 PCT/EP2009/008855 EP2009008855W WO2010066437A2 WO 2010066437 A2 WO2010066437 A2 WO 2010066437A2 EP 2009008855 W EP2009008855 W EP 2009008855W WO 2010066437 A2 WO2010066437 A2 WO 2010066437A2
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- 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
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- 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
- A61K31/164—Amides, e.g. hydroxamic acids of a carboxylic acid with an aminoalcohol, e.g. ceramides
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/02—Inorganic compounds
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- 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
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- A61P11/00—Drugs for disorders of the respiratory system
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- Y02E10/00—Energy generation through renewable energy sources
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- the invention relates to an aqueous pharmaceutical composition containing dexpanthenol and sodium chloride, characterized in that the osmolality of the composition is 200 to 400 mosmol / kg, and their use for a medical device for the treatment and / or care of the nasal mucosa.
- the invention also relates to a container containing the aqueous composition according to the invention.
- Nasal sprays consisting of dexpanthenol and NaCl and their synergistic effect on the wound healing process of the nasal mucosa are known from EP 0 366 888.
- the compositions described in the examples can be counterproductive in dry and inflamed mucous membranes, as they usually promote dehydration of the nasal mucosa. This is based on EP 0366888 market product Nasicur ® may therefore no longer than 4 weeks are applied.
- the compositions shown as preferred in the examples also include benzalkonium chloride as a preservative. Preservatives have per se an allergic potential and an irritant effect.
- the object of the present invention was therefore to provide a pharmaceutical composition, in particular in the form of a nasal spray, wherein the composition has a beneficial effect on the treatment and / or care of the nasal mucosa and exhibits good tolerability in the patient.
- a composition is to be provided, which leads to a moistening of the nasal mucous membranes and prevents them from drying out.
- a composition is to be provided which can also be used as a long-term use (i.e., over a period of more than 4 weeks).
- the invention therefore relates to an aqueous pharmaceutical composition containing dexpanthenol and sodium chloride, characterized in that the osmolality of the composition is 200 to 400 mosmol / kg.
- the invention further provides a container containing the aqueous pharmaceutical composition according to the invention.
- the invention relates to the use of the aqueous composition according to the invention for a medical device for the treatment and / or care of the nasal mucosa.
- composition of the invention contains water, dexpanthenol and sodium chloride (NaCl, also known in the art as “saline”). All components preferably satisfy the requirements of the European Pharmacopoeia. In particular, the water used meets the requirements of the European Pharmacopoeia for "water for injection”.
- dexpanthenol (+) - (R) -2,4-dihydroxy-N- (3-hydroxypropyl) -3,3-dimethylbutyramide.
- Dexpanthenol has the following structure:
- Dexpanthenol is also referred to in the art as pantothenol or panthenol.
- the osmolality of the composition is from 200 to 400 mosmol / kg, preferably from 250 to 350 mosmol / kg.
- the osmolality indicates the number of osmotically active particles per kg of solution and is thus a measure of the osmotic pressure.
- the osmolality is determined by measuring the freezing point depression. Between osmolality and freezing point depression ⁇ T, the relationship is as follows:
- the device (osmometer) consists of a cooling device for the Meß duenis; - A temperature measuring device consisting of a temperature-dependent
- a resistor having a device capable of measuring a current or a potential difference and having a display on which the freezing point depression or osmolality is to be read; and a mixing device.
- aqueous composition of the invention is preferably in the form of a
- aqueous composition according to the invention may also be present in the form of a dispersion.
- the determination of the osmolality is carried out using the reference solutions and instructions for execution shown in the pharmacopoeia.
- the composition according to the invention contains from 0.5 to 2.5% by weight, more preferably from 0.7 to 1.5% by weight of dexpanthenol, based on the total weight of the composition.
- the composition according to the invention contains from 0.2 to 0.6% by weight, more preferably from 0.3 to 0.55% by weight, of sodium chloride, based on the total weight of the composition.
- composition of the invention may consist of water, dexpanthenol and sodium chloride.
- inventive aqueous composition contains (in addition to water, dexpanthenol and sodium chloride) a buffer substance.
- Buffer substances are substance mixtures whose pH in aqueous solutions are essentially insensitive to small amounts of acid or base additive. For this purpose, preferably equimolecular mixtures of weak acids and their alkali metal salts are suitable. The same applies to the bases.
- Suitable buffer substances are, for example, an acetate buffer, citrate buffer or phosphate buffer.
- the acetate buffer is preferably a mixture of CH 3 COOH and CH 3 COOM.
- the phosphate buffer is preferably a mixture of H 2 PO 4 M and HPO 4 M 2 .
- M is an alkali metal, preferably potassium.
- the phosphate buffer is particularly preferred. In particular, a potassium phosphate buffer is used as the buffer substance.
- the buffer substance is preferably used in an amount of from 0.2 to 0.8% by weight, based on the total weight of the aqueous composition.
- the aqueous composition of the invention is substantially free of preservatives.
- the aqueous composition according to the invention consists of dexpanthenol, sodium chloride, buffer substance and water, in particular water for injection purposes.
- the pH of the aqueous composition according to the invention is 6.0 to 7.0.
- the aqueous composition according to the invention is preferably designed such that it is suitable for nasal application.
- it is a sterile, aqueous composition.
- a sterile composition is preferably achieved by sterile filtration.
- filters of the type "Ultipor N66” or “N66 Posidyne” are suitable for sterile filtration.
- composition of the invention is usually used as a medical device, preferably for the treatment and / or care of the nasal mucosa.
- this is a dry and / or inflamed nasal mucosa.
- the application is preferably carried out in the form of a nasal spray.
- the aqueous composition according to the invention is filled into a container. It is preferably a multi-dose container system. In the multi-dose container system, after dispensing a dose, the remaining aqueous composition does not come into contact with air. Furthermore, the multi-dose container system, after dispensing a dose, the remaining aqueous composition does not come into contact with air. Furthermore, the multi-dose container system, after dispensing a dose, the remaining aqueous composition does not come into contact with air. Furthermore, the
- Container in particular the product-contacting part of the spray head, preferably designed such that it can release silver ions.
- composition according to the invention comprised the following steps:
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Abstract
Description
Wässrige Zusammensetzung enthaltend Dexpanthenol und Natriumchlorid Aqueous composition containing dexpanthenol and sodium chloride
Die Erfindung betrifft eine wässrige pharmazeutische Zusammensetzung, enthaltend Dexpanthenol und Natriumchlorid, dadurch gekennzeichnet, dass die Osmolalität der Zusammensetzung 200 bis 400 mosmol/kg beträgt, sowie deren Verwendung für ein Medizinprodukt zur Behandlung und /oder Pflege der Nasenschleimhaut. Ebenfalls betrifft die Erfindung einen Behälter, enthaltend die erfindungsgemäße wässrige Zusammensetzung.The invention relates to an aqueous pharmaceutical composition containing dexpanthenol and sodium chloride, characterized in that the osmolality of the composition is 200 to 400 mosmol / kg, and their use for a medical device for the treatment and / or care of the nasal mucosa. The invention also relates to a container containing the aqueous composition according to the invention.
Nasensprays bestehend aus Dexpanthenol und NaCl sowie deren synergistische Wirkung auf den Wundheilungsprozess der Nasenschleimhaut sind aus EP 0 366 888 bekannt. Die in den Beispielen beschriebenen Zusammensetzungen können sich jedoch bei trockenen und entzündeten Schleimhäuten kontraproduktiv auswirken, da sie üblicherweise das Austrocknen der Nasenschleimhaut fördern. Das auf EP 0 366 888 basierende Marktprodukt Nasicur® darf deshalb nicht länger als 4 Wochen angewandt werden. Zusätzlich beinhalten die in den Beispielen als bevorzugt dargestellten Zusammensetzungen auch Benzalkoniumchlorid als Konservierungsmittel. Konservierungsmittel haben per se ein allergisches Potential und eine reizende Wirkung.Nasal sprays consisting of dexpanthenol and NaCl and their synergistic effect on the wound healing process of the nasal mucosa are known from EP 0 366 888. However, the compositions described in the examples can be counterproductive in dry and inflamed mucous membranes, as they usually promote dehydration of the nasal mucosa. This is based on EP 0366888 market product Nasicur ® may therefore no longer than 4 weeks are applied. In addition, the compositions shown as preferred in the examples also include benzalkonium chloride as a preservative. Preservatives have per se an allergic potential and an irritant effect.
Aufgabe der vorliegenden Erfindung war es daher, eine pharmazeutische Zusammensetzung, insbesondere in Form eines Nasensprays, bereit zu stellen, wobei die Zusammensetzung eine vorteilhafte Wirkung bei der Behandlung und /oder Pflege der Nasenschleimhaut zeigt und eine gute Verträglichkeit beim Patienten aufweist.The object of the present invention was therefore to provide a pharmaceutical composition, in particular in the form of a nasal spray, wherein the composition has a beneficial effect on the treatment and / or care of the nasal mucosa and exhibits good tolerability in the patient.
Im Speziellen soll eine Zusammensetzung bereit gestellt werden, die zu einer Befeuchtung der Nasenschleimhäute führt und ein Austrocknen dieser verhindert. Insbesondere soll eine Zusammensetzung bereit gestellt werden, die auch als Daueranwendung (d.h. über einen Zeitraum von mehr als 4 Wochen) eingesetzt werden kann.In particular, a composition is to be provided, which leads to a moistening of the nasal mucous membranes and prevents them from drying out. In particular, a composition is to be provided which can also be used as a long-term use (i.e., over a period of more than 4 weeks).
Die Aufgaben konnten unerwartet durch eine spezielle Wahl der Osmolalität der Zusammensetzung gelöst werden.The tasks could be solved unexpectedly by a special choice of the osmolality of the composition.
Gegenstand der Erfindung ist daher eine wässrige pharmazeutische Zusammensetzung, enthaltend Dexpanthenol und Natriumchlorid, dadurch gekennzeichnet, dass die Osmolalität der Zusammensetzung 200 bis 400 mosmol/kg beträgt.The invention therefore relates to an aqueous pharmaceutical composition containing dexpanthenol and sodium chloride, characterized in that the osmolality of the composition is 200 to 400 mosmol / kg.
Ferner ist Gegenstand der Erfindung ein Behälter, enthaltend die erfindungsgemäße wässrige pharmazeutische Zusammensetzung. Schließlich ist Gegenstand der Erfindung die Verwendung der erfindungsgemäßen wässrigen Zusammensetzung für ein Medizinprodukt zur Behandlung und /oder Pflege der Nasenschleimhaut.The invention further provides a container containing the aqueous pharmaceutical composition according to the invention. Finally, the invention relates to the use of the aqueous composition according to the invention for a medical device for the treatment and / or care of the nasal mucosa.
Die erfindungsgemäße Zusammensetzung enthält Wasser, Dexpanthenol und Natriumchlorid (NaCl, im Fachgebiet auch als "Kochsalz" bekannt). Alle Bestandteile genügen bevorzugt den Anforderungen des Europäischen Arzneibuchs. Insbesondere genügt das eingesetzte Wasser den Anforderungen des Europäischen Arzneibuchs an "Wasser für Injektionszwecke".The composition of the invention contains water, dexpanthenol and sodium chloride (NaCl, also known in the art as "saline"). All components preferably satisfy the requirements of the European Pharmacopoeia. In particular, the water used meets the requirements of the European Pharmacopoeia for "water for injection".
Die chemische Bezeichnung von Dexpanthenol ist (+)-(R)-2,4-Dihydroxy-N-(3- hydroxypropyl)-3,3-dimethylbutyramid. Dexpanthenol weist folgende Struktur auf:The chemical name of dexpanthenol is (+) - (R) -2,4-dihydroxy-N- (3-hydroxypropyl) -3,3-dimethylbutyramide. Dexpanthenol has the following structure:
Dexpanthenol wird im Fachgebiet auch als Pantothenol oder Panthenol bezeichnet.Dexpanthenol is also referred to in the art as pantothenol or panthenol.
Es ist ein wesentliches Merkmal der erfindungsgemäßen wässrigen Zusammensetzung, dass die Osmolalität der Zusammensetzung 200 bis 400 mosmol/kg, bevorzugt von 250 bis 350 mosmol/kg, beträgt.It is an essential feature of the aqueous composition according to the invention that the osmolality of the composition is from 200 to 400 mosmol / kg, preferably from 250 to 350 mosmol / kg.
Die Osmolalität gibt die Anzahl der osmotisch aktiven Teilchen pro kg Lösung an und ist damit ein Maß für den osmotischen Druck.The osmolality indicates the number of osmotically active particles per kg of solution and is thus a measure of the osmotic pressure.
Im Rahmen dieser Erfindung gilt für den Ausdruck "Osmolalität" stets die imIn the context of this invention, the term "osmolality" always applies to the term "osmolality"
Europäischen Arzneibuch angegebene Definition und die dort beschriebeneDefinition given in the European Pharmacopoeia and those described therein
Messmethode zur Bestimmung der Osmolalität (siehe Ph. Eur., 4. Ausgabe, Grundwerk 2002, 2.2.35 Osmolalität).Measuring method for the determination of osmolality (see Ph. Eur., 4th ed., Basic text 2002, 2.2.35 osmolality).
Gemäß Europäischem Arzneibuch wird die Osmolalität durch Messung der Gefrierpunktserniedrigung bestimmt. Zwischen der Osmolalität und der Gefrierpunktserniedrigung ΔT besteht folgende Beziehung:According to the European Pharmacopoeia, the osmolality is determined by measuring the freezing point depression. Between osmolality and freezing point depression ΔT, the relationship is as follows:
AT ξm - r-s2 * 10°3 mosmo] - kg-1 ' l M Die Bestimmung erfolgt mittels Osmometer.AT ξ m - r-s2 * 3 10 ° mosmo] - kg- 1 'l M The determination is carried out by means of an osmometer.
Das Gerät (Osmometer) besteht aus einer Kühlvorrichtung für das Meßbehältnis; - einer Temperaturmeßeinrichtung bestehend aus einem temperaturabhängigenThe device (osmometer) consists of a cooling device for the Meßbehältnis; - A temperature measuring device consisting of a temperature-dependent
Widerstand (Thermistor) mit einer zur Messung eines Stroms oder einer Potentialdifferenz geeigneten Vorrichtung, welche eine Anzeige besitzt, auf der die Gefrierpunktserniedrigung oder die Osmolalität abzulesen ist; und einer Mischvorrichtung.A resistor (thermistor) having a device capable of measuring a current or a potential difference and having a display on which the freezing point depression or osmolality is to be read; and a mixing device.
Die erfindungsgemäße wässrige Zusammensetzung liegt bevorzugt in Form einerThe aqueous composition of the invention is preferably in the form of a
Lösung vor. Alternativ kann die erfindungsgemäße wässrige Zusammensetzung auch in Form einer Dispersion vorliegen.Solution. Alternatively, the aqueous composition according to the invention may also be present in the form of a dispersion.
Die Durchführung der Bestimmung der Osmolalität erfolgt unter Verwendung der im Arzneibuch dargestellten Referenzlösungen und Ausführungsvorschrift.The determination of the osmolality is carried out using the reference solutions and instructions for execution shown in the pharmacopoeia.
In einer bevorzugten Ausführungsform enthält die erfindungsgemäße Zusammensetzung 0,5 bis 2,5 Gew.-%, mehr bevorzugt 0,7 bis 1,5 Gew.-% Dexpanthenol, bezogen auf das Gesamtgewicht der Zusammensetzung.In a preferred embodiment, the composition according to the invention contains from 0.5 to 2.5% by weight, more preferably from 0.7 to 1.5% by weight of dexpanthenol, based on the total weight of the composition.
In einer weiteren bevorzugten Ausführungsform enthält die erfindungsgemäße Zusammensetzung 0,2 bis 0,6 Gew.-%, mehr bevorzugt 0,3 bis 0,55 Gew.-% Natriumchlorid, bezogen auf das Gesamtgewicht der Zusammensetzung.In a further preferred embodiment, the composition according to the invention contains from 0.2 to 0.6% by weight, more preferably from 0.3 to 0.55% by weight, of sodium chloride, based on the total weight of the composition.
Die erfindungsgemäße Zusammensetzung kann aus Wasser, Dexpanthenol und Natriumchlorid bestehen. In einer bevorzugten Ausführungsform enthält die erfindungemäße wässrige Zusammensetzung jedoch (neben Wasser, Dexpanthenol und Natriumchlorid) eine Puffersubstanz.The composition of the invention may consist of water, dexpanthenol and sodium chloride. In a preferred embodiment, however, the inventive aqueous composition contains (in addition to water, dexpanthenol and sodium chloride) a buffer substance.
Unter Puffersubstanzen versteht man Substanzgemische, deren pH-Wert in wässrigen Lösungen im Wesentlichen unempfindlich gegen geringe Mengen an Säure- oder Basezusatz sind. Hierfür eignen sich bevorzugt äquimolekulare Mischungen schwacher Säuren und ihre Alkalisalze. Analoges gilt für die Basen. Geeignete Puffersubstanzen sind beispielsweise ein Acetatpuffer, Citrat- oder ein Phosphatpuffer. Bei dem Acetatpuffer handelt es sich bevorzugt um ein Gemisch aus CH3COOH und CH3COOM. Bei dem Phosphatpuffer handelt es sich bevorzugt um ein Gemisch aus H2PO4M und HPO4M2. M ist ein Alkalimetall, bevorzugt Kalium. Der Phosphatpuffer ist besonders bevorzugt. Insbesondere wird als Puffersubstanz ein Kaliumphosphatpuffer verwendet. Die Puffersubstanz wird bevorzugt in einer Menge von 0,2 bis 0,8 Gew.-%, bezogen auf das Gesamtgewicht der wässrigen Zusammensetzung, eingesetzt.Buffer substances are substance mixtures whose pH in aqueous solutions are essentially insensitive to small amounts of acid or base additive. For this purpose, preferably equimolecular mixtures of weak acids and their alkali metal salts are suitable. The same applies to the bases. Suitable buffer substances are, for example, an acetate buffer, citrate buffer or phosphate buffer. The acetate buffer is preferably a mixture of CH 3 COOH and CH 3 COOM. The phosphate buffer is preferably a mixture of H 2 PO 4 M and HPO 4 M 2 . M is an alkali metal, preferably potassium. The phosphate buffer is particularly preferred. In particular, a potassium phosphate buffer is used as the buffer substance. The buffer substance is preferably used in an amount of from 0.2 to 0.8% by weight, based on the total weight of the aqueous composition.
Es ist ferner bevorzugt, dass die erfindungsgemäße wässrige Zusammensetzung im Wesentlichen frei von Konservierungsstoffen ist. Insbesondere besteht die erfindungsgemäße wässrige Zusammensetzung aus Dexpanthenol, Natriumchlorid, Puffersubstanz und Wasser, insbesondere Wasser für Injektionszwecke.It is further preferred that the aqueous composition of the invention is substantially free of preservatives. In particular, the aqueous composition according to the invention consists of dexpanthenol, sodium chloride, buffer substance and water, in particular water for injection purposes.
In einer bevorzugten Ausführungsform beträgt der pH-Wert der erfindungsgemäßen wässrigen Zusammensetzung 6,0 bis 7,0.In a preferred embodiment, the pH of the aqueous composition according to the invention is 6.0 to 7.0.
Die erfindungsgemäße wässrige Zusammensetzung ist bevorzugt derart ausgestaltet, dass sie sich zur nasalen Anwendung eignet. Insbesondere handelt es sich um eine sterile, wässrige Zusammensetzung. Eine sterile Zusammensetzung wird bevorzugt durch Sterilfiltration erzielt. Beispielsweise sind für die Sterilfiltration Filter des Typs "Ultipor N66" oder "N66 Posidyne" (PaIl GmbH, Dreieich) geeignet.The aqueous composition according to the invention is preferably designed such that it is suitable for nasal application. In particular, it is a sterile, aqueous composition. A sterile composition is preferably achieved by sterile filtration. For example, filters of the type "Ultipor N66" or "N66 Posidyne" (PaIl GmbH, Dreieich) are suitable for sterile filtration.
Die erfindungsgemäße Zusammensetzung wird üblicherweise als Medizinprodukt, bevorzugt zur Behandlung und/oder Pflege der Nasenschleimhaut verwendet. Insbesondere handelt es sich hierbei um eine trockene und /oder entzündete Nasenschleimhaut. Die Anwendung erfolgt hierbei bevorzugt in Form eines Nasensprays.The composition of the invention is usually used as a medical device, preferably for the treatment and / or care of the nasal mucosa. In particular, this is a dry and / or inflamed nasal mucosa. The application is preferably carried out in the form of a nasal spray.
Zur Anwendung wird die erfindungsgemäße wässrige Zusammensetzung in einen Behälter gefüllt. Bevorzugt handelt es sich um ein Mehrdosis-Behältnissystem. Bei dem Mehrdosisbehältnissystem kommt nach dem Abgeben einer Dosis die verbleibende wässrige Zusammensetzung nicht in Kontakt mit Luft. Ferner ist derFor use, the aqueous composition according to the invention is filled into a container. It is preferably a multi-dose container system. In the multi-dose container system, after dispensing a dose, the remaining aqueous composition does not come into contact with air. Furthermore, the
Behälter, insbesondere der produktberührende Teil des Sprühkopfs, bevorzugt derart ausgestaltet, dass er Silberionen freisetzen kann.Container, in particular the product-contacting part of the spray head, preferably designed such that it can release silver ions.
Ein Beispiel für ein geeignetes Mehrdosis-Behältnissystem ist das "3K-System" vonAn example of a suitable multi-dose containment system is the "3K system" of
Ursapharm Arzneimittel GmbH, Saarbrücken.Ursapharm Arzneimittel GmbH, Saarbruecken.
Die Erfindung soll anhand der nachfolgenden Beispiele veranschaulicht werden. BEISPIELEThe invention will be illustrated by the following examples. EXAMPLES
Folgende erfindungsgemäße Rezepturen wurden eingesetzt:The following formulations according to the invention were used:
Die Herstellung der erfindungsgemäßen Zusammensetzung umfasste folgende Schritte:The preparation of the composition according to the invention comprised the following steps:
1. 50 % des Wassers für Injektionszwecke vorlegen;1. submit 50% of the water for injections;
2. unter Rühren mit N2 durchgasen, auf 500C erhitzen;2. pass through with stirring with N 2, heated to 50 0 C;
3. unter weiterem Rühren und Durchgasen nacheinander zugeben und lösen: a) Dexpanthenol,3. with further stirring and throughgassing, add successively and dissolve: a) dexpanthenol,
Natriumchlorid ; b) KH2PO4 und 90% von K2HPO4 in 40% von Wasser für Injektionszwecke lösen; c) Lösung aus b) zu Lösung aus a) geben; d) pH-Wert nach 10 min Rührzeit und vollständigem Auflösen mit restlichem K2HPO4auf pH 6,6 bzw. 6,9 einstellen; Verbrauch K2HPO4 feststellen;Sodium chloride; b) dissolve KH 2 PO 4 and 90% of K 2 HPO 4 in 40% of water for injections; c) give solution from b) to solution from a); d) adjust the pH to pH 6.6 or 6.9 after stirring for 10 minutes and complete dissolution with residual K 2 HPO 4 ; Determine consumption K 2 HPO 4 ;
4. Auffüllen auf das Endvolumen mit restlichem Wasser für Injektionszwecke; 5. Ansatz sterilfiltrieren durch 0,2 μm Sterilfilter;4. make up to the final volume with residual water for injections; 5. filter sterilize through 0.2 μm sterile filter;
6. Abfüllen von 20,7 ml in Behältnisse. In nachstehender Tabelle werden die Osmolalitäten der erfindungsgemäßen Rezepturen 1 und 2 mit den Osmolalitäten der Rezepturen des Standes der Technik verglichen.6. Filling 20.7 ml in containers. In the table below, the osmolality of formulations 1 and 2 according to the invention are compared with the osmolalities of the formulations of the prior art.
* Prozent Substanz in 100 ml * Percent substance in 100 ml
Claims
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| DE202008016517U DE202008016517U1 (en) | 2008-12-12 | 2008-12-12 | Aqueous composition containing dexpanthenol and sodium chloride |
| DE202008016517.2 | 2008-12-12 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| WO2010066437A2 true WO2010066437A2 (en) | 2010-06-17 |
| WO2010066437A3 WO2010066437A3 (en) | 2011-02-24 |
Family
ID=40418672
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PCT/EP2009/008855 Ceased WO2010066437A2 (en) | 2008-12-12 | 2009-12-10 | Aqueous composition containing dexpanthenol and sodium chloride |
Country Status (2)
| Country | Link |
|---|---|
| DE (1) | DE202008016517U1 (en) |
| WO (1) | WO2010066437A2 (en) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP2822537B1 (en) | 2012-05-14 | 2015-12-09 | Maria Clementine Martin Klosterfrau Vertriebsgesellschaft mbH | Combination therapy agent for treating rhinitis |
| WO2017005398A1 (en) * | 2015-07-06 | 2017-01-12 | Maria Clementine Martin Klosterfrau Vertriebsgesellschaft Mbh | Composition for treating rhinitis |
Families Citing this family (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE102011114094A1 (en) * | 2011-09-21 | 2013-03-21 | F. Holzer Gmbh | Stimulating and invigorating nasal spray and nose drops |
| DE202021103126U1 (en) | 2021-06-09 | 2021-06-23 | Alexander Leiser | Aqueous composition for preventive medical applications |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP0366888A1 (en) | 1988-09-23 | 1990-05-09 | CASSELLA Aktiengesellschaft | Pharmaceutical preparation for treating inflammations of the nasal mucous membranes |
Family Cites Families (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE29807223U1 (en) * | 1998-04-21 | 1998-09-17 | STADA Arzneimittel AG, 61118 Bad Vilbel | Pharmaceutical preparation, including sea water and pantothenol |
| DE10161110A1 (en) * | 2001-12-12 | 2003-06-26 | Ursapharm Arzneimittel Gmbh | Pharmaceutical composition for ophthalmic and rhinological use |
| DE102008036725B4 (en) * | 2008-08-07 | 2021-01-28 | Maria Clementine Martin Klosterfrau Vertriebsgesellschaft Mbh | Pharmaceutical composition for nasal application |
-
2008
- 2008-12-12 DE DE202008016517U patent/DE202008016517U1/en not_active Expired - Lifetime
-
2009
- 2009-12-10 WO PCT/EP2009/008855 patent/WO2010066437A2/en not_active Ceased
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP0366888A1 (en) | 1988-09-23 | 1990-05-09 | CASSELLA Aktiengesellschaft | Pharmaceutical preparation for treating inflammations of the nasal mucous membranes |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP2822537B1 (en) | 2012-05-14 | 2015-12-09 | Maria Clementine Martin Klosterfrau Vertriebsgesellschaft mbH | Combination therapy agent for treating rhinitis |
| WO2017005398A1 (en) * | 2015-07-06 | 2017-01-12 | Maria Clementine Martin Klosterfrau Vertriebsgesellschaft Mbh | Composition for treating rhinitis |
Also Published As
| Publication number | Publication date |
|---|---|
| WO2010066437A3 (en) | 2011-02-24 |
| DE202008016517U1 (en) | 2009-03-05 |
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