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Interferon spray for lung administration and its prepn process

A technology for pulmonary drug delivery and interferon, which can be used in pharmaceutical formulations, aerosol delivery, medical preparations containing active ingredients, etc. To achieve the effect of convenient medication, large dosage, high chemical stability and microbial stability

Inactive Publication Date: 2005-09-28
TIANJIN INSTITUTE OF PHARMA RESEARCH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Since protein and polypeptide drugs are easily inactivated, most of them are administered by injection. For example, interferon α-2b is injected 3-5 times a week for the treatment of hepatitis, so it has the following insurmountable shortcomings: poor patient adaptability, The risk of needle infection, high cost, etc.; in addition, human serum albumin (HSA) is often used as a stabilizer in interferon aqueous solution, so there is inevitably a potential risk of contamination and disease transmission; patients are often accompanied by fever, chills, Side effects such as muscle pain may also be related to injection administration, so the clinical application of interferon is greatly limited
However, the chlorofluorocarbon propellant used as the power source in the spray can destroy the ozone layer of the atmosphere and pose a great threat to the environment; Inhalation, clinical use is limited due to expensive equipment and complicated operation

Method used

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  • Interferon spray for lung administration and its prepn process
  • Interferon spray for lung administration and its prepn process
  • Interferon spray for lung administration and its prepn process

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0052] This example describes a method for preparing highly active interferon spray-dried powder by adding lecithin as an active protective agent.

[0053] Used as the liquid phase for spray drying, its composition is: citric acid 0.38mg / ml, disodium hydrogen phosphate 3.8mg / ml, soybean lecithin 1.34mg / ml, lactose 66.7mg / ml, and each milliliter emulsion contains interferon α-2b is about 40,000 international units, and the measured pH value of the solution is 7.05. Gained emulsion is spray-dried with Buchi minispray dryer B-191 (the same below, no longer mentioned), and the spray conditions are as follows:

[0054] Solution temperature 6°C-8°C

[0055] Inlet temperature 110℃

[0056] Outlet temperature 70°C-80°C

[0057] Nozzle air flow rate 500l / h

[0058] Spray speed 1.8ml / min

[0059] Once the solution is sprayed, reduce the inlet temperature to maintain the outlet temperature at about 60°C-70°C for about 10 minutes, and perform secondary drying on the interferon spray-...

Embodiment 2

[0063] This example describes a method for preparing highly active interferon spray-dried powder by adding HPCD as an active protective agent.

[0064] Used as the liquid phase for spray drying, its composition is: citric acid 0.076mg / ml, sodium citrate 1.8mg / ml, disodium hydrogen phosphate 0.76mg / ml, HPCD 0.67mg / ml, lactose 66.7mg / ml, Each milliliter of the solution contains about 200,000 international units of interferon alpha-2a, and the measured pH value of the solution is 6.92.

[0065] The spray conditions are as follows:

[0066] Solution temperature 4°C-6°C

[0067] Inlet temperature 110℃

[0068] Outlet temperature 60°C-70°C

[0069] Nozzle nitrogen flow rate 570l / h

[0070] Spray speed 2.1ml / min

[0071] Spray Gun Condensation System On

[0072] Once the solution is sprayed, reduce the inlet temperature to maintain the outlet temperature at about 60°C-70°C for about 10 minutes, and perform secondary drying on the interferon spray-dried powder to further reduce ...

Embodiment 3

[0076] This example describes a method for preparing highly active interferon spray-dried powder using lysine as a stabilizer.

[0077] Used as the liquid phase for spray drying, its composition is: 0.38mg / ml citric acid, 3.8mg / ml disodium hydrogen phosphate, 0.67mg / ml lysine, 66.7mg / ml lactose, and interferon per milliliter emulsion α-2a is about 40,000 international units, and the measured pH value of the solution is 6.81.

[0078] The spray conditions are as follows:

[0079] Solution temperature 7℃-9℃

[0080] Inlet temperature 110℃

[0081] Outlet temperature 60°C-70°C

[0082] Nozzle air flow rate 500l / h

[0083] Spray speed 1.8ml / min

[0084] Once the solution is sprayed, reduce the inlet temperature to maintain the outlet temperature at about 60°C-70°C for about 10 minutes, and perform secondary drying on the interferon spray-dried powder to further reduce the water content.

[0085] Spray-dried powder form: see image 3 . It can be seen from the figure that th...

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Abstract

The present invention discloses one kind of interferon spray for lung administration and its preparation process. Liquid composition is first constituted with interferon in 0.0002-0.8 % and corresponding medicinal supplementary material, and then dried in proper process, such as spray drying process, to prepare efficient stable interferon spray. The present invention adopts active protecting agent to ensure no damage of the interferon activity during drying or serve as stabilizer. The interferon spray of the present invention contains no human serum albumin and absorption promoter and thus has no blood contamination and damage to lung.

Description

technical field [0001] The invention relates to a high-efficiency interferon powder formulation and a preparation method thereof. In particular, the interferon powder mist formula and its preparation method can be absorbed in the nasal cavity, oral cavity, trachea and lungs after being inhaled through the oral cavity or nasal cavity. Background technique [0002] Interferon (INF) is a highly active and multifunctional cytokine produced by animal cells under the stimulation of inducers. It has strong antiviral activity, and an interferon can inhibit the proliferation of various viruses. , is a class of broad-spectrum antiviral drugs in medicine. Interferon can treat common viral diseases such as hepatitis and influenza, and also has anti-proliferation effects on cancer cells, and has been used in the treatment of breast cancer, bone marrow cancer and other cancers. [0003] Since protein and polypeptide drugs are easily inactivated, most of them are administered by injectio...

Claims

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Application Information

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IPC IPC(8): A61K9/12A61K38/21A61P11/00A61P31/12
Inventor 江荣高刘衡王春龙杨颖
Owner TIANJIN INSTITUTE OF PHARMA RESEARCH
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