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Pharmaceutical preparation

Inactive Publication Date: 2011-12-01
NORDMARK-WERKE GMBH 2000 HAMBURG
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0010]It could surprisingly be shown that lipase without coating is active in the aggressive environment of stomach and duodenum and that the enzyme is stable in an aqueous solution over several months at ambient temperature. Additionally, it has been stated that bacterial lipase is able to reduce steatorrohea for mucoviscidosis patients.

Problems solved by technology

Excessive expression or lack of effective enzymes often lead to metabolism or gastro-intestinal illnesses.
Imbalance of the lipase level can, for example, cause a multitude of digestion illnesses, including the malabsorption of fat.
The disadvantage of these administering forms consists in the discomfort of the administering to patients who have to swallow big tablets or capsules.
The crushing of the tablets cannot assure any homogeneous distribution of the enzymes to the chymus and the low solubility of the product can lead to the occlusion of the feeding tube.
However, in both cases, the enzyme solutions have to be prepared fresh before administration which is less convenient than a ready-made liquid preparation.
In a few medical applications, the accompanying proteolytic or amylolytic enzyme activities are not desired.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

example 1

Cumulated Fat Quantity In the Patient's Stool During the Treatment With Placebo Or Verum—FIG. 1

[0031]Bacterial lipase has been tested during a clinical study with mucoviscidosis patients. As shown in FIG. 1 and in the following table with the indication of coefficients of fat absorption of patients under placebo and verum, considerable differences are to be seen in the fat quantity in the stool of the patient under verum as well as the coefficient of fat absorption (CFA). The bacterial lipase significantly improves the resorption of fat during digestion.

PatientCFAPlacebo 173.00%Placebo 264.00%Placebo 365.00%Verum 192.00%Verum 296.00%Verum 393.00%

example 2

Activity of lipase under conditions of a low pH value (imitation of the pH value in the stomach)—FIG. 2

[0032]Bacterial lipase has been dissolved and adjusted to the pH value of 1.0, 2.0, 3.0, 4.0 and 5.0. Lipase activities have been measured by applying the tributyrin test after 15, 30 minutes and 1, 2, 4 and 18 hours with the test pH value (8.0).

[0033]It has been stated that the pH value increases to pH 4 in the stomach of patients who suffer from mucoviscidosis when swallowing. Bacterial lipase shows under these circumstances a sufficient activity (FIG. 2) while the activity of porcine lipase (made of pancreatin) is reduced by 85% after 2 hours and by 96% after 4 hours at pH 4 (not represented).

example 3

Stability of Bacterial Lipase In An Aqueous Solution—FIG. 3

[0034]Bacterial lipase has been dissolved in water and incubated at 4° C., ambient temperature and 40° C. The activity has been measured after 1, 2, 3, 4, 5, 10 and 14 weeks. No considerable loss of activity has been stated during this time.

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Abstract

The pharmaceutical preparation for the treatment of pancreatic insufficiency comprises a liquid administering form of enzymes.

Description

[0001]This application claims priority from PCT / EP2009 / 000566, filed Jan. 29, 2009, and the entire contents of that prior application are incorporated by reference.[0002]The invention relates to pharmaceutical preparations for the treatment of pancreatic insufficiency, for example mucoviscidosis or other pancreatic illnesses. In particular, this invention relates to liquid pharmaceutical preparations of digestive enzymes which have no coating and which are active in the aggressive environment of stomach and duodenum. Moreover, these liquid pharmaceutical preparations are stable and can be stored at high temperatures.BACKGROUND OF THE INVENTION[0003]Excessive expression or lack of effective enzymes often lead to metabolism or gastro-intestinal illnesses. Imbalance of the lipase level can, for example, cause a multitude of digestion illnesses, including the malabsorption of fat. For patients who suffer from mucoviscidosis, chronic pancreatitis and other pancreatic illnesses, fat malab...

Claims

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Application Information

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IPC IPC(8): A61K38/46A61P1/18
CPCA61K38/465A61P1/00A61P1/18
Inventor RÄMSCH, CHRISTIANKURFÜRST, MANFREDFRIEDEL, RAINERFRIEDRICH, OLAFHÜTTLER, SILKE
Owner NORDMARK-WERKE GMBH 2000 HAMBURG
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