Interferon-containing suppository

FIELD: pharmaceutical industry, pharmacy.

SUBSTANCE: invention relates to producing interferon-containing suppositories. Interferon-containing suppository comprises a fatty base, emulsifier and human lyophilized interferon purified from low-molecular and high-molecular components of the definite antiviral activity. Mixture of mono-, di- and triglycerides and saturated fatty acids from coconut oil and palm oil of sort "Vitepsol" H-15 and W-35 taken in equal ratio are used as a fatty base. Distilled monoglycerides taken in the definite ratio are used as an emulsifier. Above describes suppositories retain specific activity and effectiveness in treatment of viral and bacterial diseases for a long time and show stability against mechanical effects.

EFFECT: improved and valuable properties of suppository.

1 tbl, 1 ex

 

The invention relates to the manufacture of candles with interferon and can be used in the medical industry to obtain drugs for the treatment and prevention of viral and bacterial infections.

The closest technical solution of the present composition are suppositories containing interferon, the body's framework and emulsifier (RF Patent No. 2201212, CL AC 9/02, publ. 27.03. 2003).

The disadvantage of this drug is unstable forms to mechanical stress during packaging and transportation, the rapid decline in activity, low physical and biological properties, short term storage.

The present invention is to obtain suppositories with interferon with property preservation of physical and biological properties during long-term storage, as well as increased stability of the dosage forms to mechanical stress during packaging and transportation.

The technical result, which can be obtained by carrying out the invention, is in the long-term preservation specific activity and efficacy in the treatment of viral and bacterial diseases.

For this purpose, the suppositories as interferon is used lyophilized human leukocyte interferon purified from low molecular weight and a professional who cularly components with antiviral activity not less than 25000 ME/ as a fat basis use a mixture of tri-, di - and monoglycerides and saturated fatty acids from coconut and palm oils brand "Witepsol" H-15 and W-35 in equal proportions, and as an emulsifier used distilled monoglycerides in the ratio of 0.5% by weight of the candles.

The method of producing suppositories with interferon includes the following stages:

Obtaining a purified substance interferon, in particular natural, is as follows: prefabricated interferon (IFN) is tested for sterility, the presence of a regulated level of antiviral activity, the absence of infectious virus inductor, toxicity and non-specific impurities, as well as the lack of surface antigen of the hepatitis C virus (HCV), antibodies to HIV types 1 and 2. Prefabricated natural interferon clear one of the regulated methods using gelfiltration using Sephadex brand G-25 (coarse) (V.P. Kuznetsov "the Modern conception of the use and manufacture of medical preparations of interferon". Sat. "The interferon system in health and disease". Edited FI Ershov, Medicine, 1996, PP 156-171), or by ultrafiltration through the membrane polysulfone plate with a nominal cut-off 100-300 KD with subsequent clipping of low molecular weight compounds 10-20 KD.

Sterile prefabricated interferon activity not less than 25,000 IU/, bottled in sterilized the basic metallic cartridge. A cassette cover with a sterile drug of a napkin and then a metal cover. The process of freeze drying comprises freeze of the drug at low temperature and sublimation. Cassette with spilled product put on the freeze in low temperature counter NS-700/ 50 or ILICA-2000. In one of the cassettes with spilled product installed on the top shelf of the stack put the Pt-100 sensor for hourly temperature recording freezing of the drug. The freezing temperature not higher than minus 40°C for at least 16 hours with forced ventilation and not less than 24 hours without forced ventilation. The final freezing temperature of not higher than minus 45°C.

The drying is conducted at industrial installations for lyophilization TG 50.4 regime drying of the drug Interferon human leukocyte dry". When the condenser temperature not higher than minus 50°and the temperature of the shelves is not higher than 20°With metal cover to remove cassettes, tapes with frozen drug quickly loaded into the freeze-installing apparatus for freeze-drying, the camera is closed and vacuum pumps. At the end of the process, the vacuum in sublimator "extinguish" nitrogen through sterilizing filters up to full pressure equalization. The camera open, the cartridge tightly closed metal lids./p>

Collection of lyophilized IFN carried out in the zone of laminar air flow. Using a sterile metal spatula preparation of the cassette is transferred into a sterile container, which is closed by a stopper, seal with paraffin or balconywith. Store to use in the next stage of the technological process in the refrigerator at a temperature of plus (6±2)°C.

Dried powder of IFN before making a suppository is controlled by the following parameters: antiviral activity of interferon, solubility, pH, sterility.

To provide the necessary structural-mechanical properties and uniform distribution of IFN in suppozitornyj based emulsifiers are used distilled monoglycerides (MHD) in the ratio of 0.5% by weight of the candles. The melting point of suppositories thus does not increase, and its structural and mechanical properties streamline the packing of suppositories with IFN.

In addition, the data for the study of experimentally produced series of suppositories prepared on the basis of witepsol two kinds - N-15 and W-35 in different variants showed that the best structural-mechanical properties are suppositories that witepsol N-15 and W-35 taken in 1:1 ratio.

The capacity to melt the basics of load-weighted number monagle is erodov distilled, at the same time into the second tank fat basis and melted for 20 minutes at a temperature of plus (60±1)°With the bath water laboratory with electric heating. Heat-resistant vessel with a fat basis and MHD cover with foil, paper and sterilized in an autoclave at a pressure of 0.5 kgf/cm2temperatures above 110°C for 30 minutes. Sterile witepsol and MHD melted in a water bath at a temperature of (38±2)°and mix them into one of the tanks. Then load the powder interferon and mix until smooth. The temperature of the process must be within plus (38±2)°that is achieved by temperature control of the container for preparing suppozitornoj mass. Suppozitornyj the masses poured into the socket of the metal molds. The mold is cooled at a temperature of minus 12±2)°C.

Example

1100 suppository average weight of 1.35 g weight suppozitornoj mass taking into account losses (0.2% - when filtering witepsol and distilled monoglycerides, 9.8 percent - when filling suppozitornoj mass in the mold of 2.7% when filling in the contour packaging without cells) will be 1,673 kg

Powder interferon - 18 l (0,072 kg).

Weight basis 1,673-0,072=1,601 kg

Of distilled monoglycerides - 0.5% of suppozitornoj mass, i.e. 0,0083 kg

Comparative evaluation of physical properties and specifications the practical activity of suppositories with IFN, prepared on various lipophilic bases, are presented in the table.

The data presented show that the optimum is the seventh option to obtain suppositories with a long shelf-life, specific activity, and also provides sufficient strength, crack resistance and shape retention of the drug in the packaging, transportation and storage.

Comparison of quality indicators suppositories with IFN prepared with different lipophilic bases, during storage
Options used suppozitornyj bases with IFNShelf life Lek. shape, mo.Indicators
Melting point, °CThe full deformation, minThe activity of IFN, IU/St.Appearance
1. Solid confectionery fat T-20407,040000

30000

20000
When packaging laminated paper partially melted
127,0
276,0
2. Solid confectionery fat Paraffin, is -2 0528,040000

30000

30000
When packaging laminated paper partially melted
128,0
276,0
H. Witepsol N -150377,540000

40000

40000
Partly on the suppositories are formed cracks
127,5
277,0
4. Witepsol N-15 + Witepsol W-35 (2:1)0376,040000

40000

40000
Very fragile, broken
126,0
276,0
5. Witepsol W-35037,57,040000

40000

40000
Partly on the suppositories are formed cracks
127,0
277,0
6. Witepsol-15+ Witepsol W-35 (1:1)037,58,040000

40000

40000
Partly on the suppositories are formed cracks
128,0
278,0
7. Witepsol N-15 + Witepsol W-35 (1:1)+MHD0388,040000

40000

40000
Cracks, breakage and fusion during the packaging is not marked
128,0
278,0

Suppositories with interferon containing fat-based and emulsifier, characterized in that the composition is administered lyophilized human leukocyte interferon, purified from low molecular weight and high molecular weight components with antiviral activity not less than 25,000 IU/g, as a fat basis use a mixture of tri-, di - and monoglycerides and saturated fatty acids from coconut and palm oils brand "Witepsol" H-15 and W-35 in equal proportions, and as an emulsifier use distilled monoglycerides, and interferon take in the amount of 4.3%, fat basis is 65.5%and monoglycerides - 0.5% of the weight suppozitornoj mass.



 

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