The pharmaceutical composition used in diseases of the pancreas

 

The invention relates to medicine, more specifically to pharmaceutical compositions for the treatment of diseases of the pancreas and digestive disorders associated with liver disease. The invention lies in the fact that the pharmaceutical composition is a tablet, which contains the nucleus, containing as active ingredient Pancreatin, as the target additives, sugar, milk, calcium stearate, methylcellulose (MC) or oksipropilmetiltselljuloza (OPMC) and is enteric-soluble shell, which consists of acetylcellulose (AFC), titanium dioxide, tween-80, acid red 2C at a specific ratio of ingredients. The invention provides improved allocation of pancreatitis tablets, the composition is stable during storage. 1 C.p. f-crystals, 1 table.

The invention relates to medicine, more specifically to pharmaceutical compositions for the treatment of diseases of the pancreas and digestive disorders associated with liver disease.

When intestinal disorders infectious nature a key element of treatment is correction of digestive processes in the gut, which is achieved by taking enzyme preparations.

To permanex enzymes of the gastrointestinal tract. [1] currently, domestic enzyme preparations used in the treatment of pancreas and digestive disorders, on the Russian market presents a narrow group of medicines. Basically presents the products of foreign manufacture: Mezim Forte (Germany), Festal (India, Germany), Ponzini Forte (Yugoslavia) [2, 3]. Drugs are expensive in our country, their production is not established, it is necessary to buy abroad.

There are various dosage forms containing Pancreatin capsules, granules, pills. In the Japan patent 4-257525 describes how to obtain granules containing Pancreatin, lactose, agent raspadaemosti, silicon oxide, binder agents. In U.S. patent 5378462 described composition micropellet containing Pancreatin, PEG and liquid paraffin. In the United Kingdom patent 1561613 described capsules containing Pancreatin, swelling and alkaline agent.

In the patent RU 206898 described the medicinal product for the treatment of patients with reduced exocrine function of the pancreas, containing Pancreatin, oraz, dried bile, and auxiliary substances. The disadvantages of this tool are the large size and weight of the tablets. To the enzyme preparation had an effect and the large size is difficult passage of the pellets through the pyloric sphincter, separating the stomach from the intestine.

In the patent RU 2172170 (prototype) described the drug to improve digestion, containing the enzyme, stabilizing additives, excipients and polymeric membranes. As enzyme medication contains Pancreatin, as stabilizing additive is magnesium oxide, calcium carbonate or calcium citrate, as an auxiliary substance use interpolymer complex of poly (methacrylic acid with polyethylene glycol (CPN-1) or polypropylenglycol (CPN-2). This medicinal product is covered by a shell of CPN-1. The disadvantage of this drug is that used in the composition of poly (methacrylic polymers have a high price. The high content of this polymer in tablets (over 50%) makes its use as a filler in industrial scale uneconomical. The polymer CPN-1 slows down the release of the active substance. I.e., Pancreatin tablets is excreted very slowly, and its concentration is not sufficient for the efficient breakdown of food.

This drug get direct extrusion or granulation with subsequent pressing.

Task izobreteny is to be placed, associated with liver disease, on the basis of Pancreatin, which eliminates the above disadvantages.

This objective is achieved in that the proposed pharmaceutical composition is a tablet, which contains the nucleus, containing as active ingredient Pancreatin, as the target additives, sugar, milk, calcium stearate, methylcellulose (MC) or oksipropilmetiltselljuloza (OPMC) and enteric-soluble shell, which consists of acetylcellulose (AFC), titanium dioxide, tween-80, acid red 2C.

The ingredients in the following ratio, g: Composition of tablets-kernel: Pancreatin - 0,0560 - 0,1 Sugar milk 0,2115 - 0,2560 Calcium stearate 0,0032 MC or OPMC - 0,0048 the shell tablet: AFC - 0,01386 titanium Dioxide - 0,00100
Acid red 2C - 0,0001
Tween-80 - of 0.00006
The claimed ratio of ingredients is best found experimentally and provides the required quality of the composition.

The way to obtain a new composition involves mixing powder of Pancreatin with filler, moisture, keeping in tightly closed containers, drying, granulation, powder, tableting and coating film coating.

Kolichestvo. When using the substance of Pancreatin with proteolytic activity above 250 U/g of the sugar content of the milk is increased, and the content of Pancreatin decreases (table).

Shell AFC protects Pancreatin from present and degrades the action of gastric juice and quickly dissolves in the gut.

To reduce microbial contamination tablety masses and produced from these tablets, we offer you to use as solvent humidifier ethyl alcohol, as well as to withstand moist tabletow mass in a tightly closed container for 246) hours.

The invention is illustrated by the following examples (see table).

Example 1. Pre-sifted and weighed substance of Pancreatin (31,3 g with an activity of 250 U/g) is mixed with sugar of milk (66,2 g). A dry mixture of the substance filled with moistened with a solution of 1.5 g OPMC in 50 ml of ethyl alcohol. Then to remove microbial contamination moistened mass is kept in a hermetically closed vessel for 246) hours. After exposure the mass is dried for 1 hour at a temperature of 40oC to a residual moisture content (51)% and granularit. The granulate op who ssoi 0,335 g, that meet the requirements of the pharmaceutical agent (in appearance, raspadaemosti and other indicators), the pharmaceutical composition is stable during storage and has a shelf life of 2 years.

Example 2. Pre-sifted and weighed substance of Pancreatin (25,2 g activity 310 U/g) is mixed with sugar of milk (72,3 g). A dry mixture of the substance filled with moistened with a solution of 1.5 g OPMC in 50 ml of ethyl alcohol. Then to remove microbial contamination moistened mass is kept in a hermetically closed vessel for 246) hours. After exposure the mass is dried for 1 hour at a temperature of 40oC to a residual moisture content (51)% and granularit. The granulate optivault calcium stearate (1 g), tabletirujut and applied film coating. Obtain 97 g of tablets with an average weight 0,335 g, which satisfy the requirements of the pharmaceutical agent (in appearance, raspadaemosti and other indicators), the pharmaceutical composition is stable during storage and has a shelf life of 2 years.

Examples 3-4. Carried out analogously to example 1.

The proposed composition was tested in different ratios of the starting components within the pre is to "Drugs, You choose", CJSC "SIA international LTD., JSC "TF "WORLD".

2. Mashkovsky M. D. Medicines. H 2, M, 1993.

3. Radbill O. S. Pharmacological basis for the treatment of diseases of the digestive system. M, S. 78, 1976.1


Claims

1. Pharmaceutical composition for the treatment of diseases of the pancreas and digestive disorders associated with liver disease, containing the active ingredient Pancreatin, targeted supplements, and with enteric-soluble shell, characterized in that as the target additives contains milk sugar, methylcellulose (MC) or oksipropilmetiltselljuloza (OPMC), calcium stearate in the following ratio of ingredients:
The composition of the tablet core:
Pancreatin - 0,0560-0,1
Milk sugar - 0,2115-0,2125
Calcium stearate - 0,0032
MC or OPMC - 0,0048
and the shell consists of acetylcellulose (AFC), titanium dioxide, tween-80, acid red 2C.

2. The pharmaceutical composition under item 1, characterized in that the shell contains these ingredients in the following ratio, g:
The composition of the shell tablet:
AFC - 0,01386
Titanium dioxide - 0,00100
Acid red 2C - 0,0001
Tween-80 - of 0.00006 l

 

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