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Dry powder inhaler of interferon

A dry powder inhaler and interferon technology, which is applied in powder delivery, antiviral agent, aerosol delivery, etc. It can solve the problems of dose discount, inability to accurately control the dose, and low effective inhalation dose.

Active Publication Date: 2016-07-20
BEIJING TRI PRIME GENE PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although the medicines for the treatment of respiratory and / or lung diseases are prepared into conventional dosage forms such as tablets, granules, capsules, and injections, they also have curative effects, but the characteristics of systemic metabolism make the actual dosage of these dosage forms greatly reduced; Targeted drug delivery forms such as nebulized inhalers and sprays still have the disadvantages of low effective inhalation dose and inability to precisely control the dosage

Method used

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  • Dry powder inhaler of interferon
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  • Dry powder inhaler of interferon

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0050] Example 1: Preparation of Interferon Dry Powder Inhaler Granules

[0051] Each spray-drying solution is prepared according to the formula in the following table 1 (wherein the main function of lysine is the interferon active protective agent, the main function of leucine is dispersibility auxiliary, disodium hydrogen phosphate-sodium dihydrogen phosphate The main function is pH stabilizer (adjusting pH is 7.0), and the main function of mannitol is diluent), and the solution is spray-dried with BuchiB-290 spray dryer according to the corresponding spray drying conditions in Table 2 (after all liquid sprays are completed) Continue to maintain the spray drying gas inlet temperature and flow rate for 15 minutes), thereby preparing the interferon dry powder inhaler particles.

[0052] Table 1 prepares the solution formula for spray drying of interferon dry powder inhaler particles

[0053]

[0054]

[0055] The spray drying conditions of table 2 interferon dry powder in...

Embodiment 2

[0057] Example 2: Quality evaluation of interferon dry powder inhaler particles

[0058] The moisture content in the prepared interferon dry powder inhaler granules of each formula was determined according to the provisions of the first method of "Moisture Determination Method" in the appendix of "Pharmacopoeia of the People's Republic of China 2010 Edition (Part Three)".

[0059] The average particle size of the prepared interferon dry powder inhaler particles of each formula was determined according to the provisions of the first method of "Particle Size and Particle Size Distribution Determination Method" in the appendix of "Pharmacopoeia of the People's Republic of China 2010 Edition (Part II)".

[0060] All measurement results are shown in Table 3 below.

[0061] The quality evaluation results of the interferon dry powder inhaler particles prepared by table 3 spray drying

[0062]

[0063]

Embodiment 3

[0064] Example 3: Preparation of Interferon Dry Powder Inhaler from Interferon Dry Powder Inhaler Granules

[0065] The interferon dry powder inhaler particles of formula 1-42 obtained by the method of Example 1 are mixed with commercially available large-size lactose carrier particles in a mass ratio of 1:1, respectively, and are packaged in an amount of 20 mg per capsule. The interferon dry powder inhalers of formula 1'-42' were then used for the research of Example 4 respectively.

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PUM

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Abstract

The invention belongs to the field of biotechnology pharmaceutical preparations, and relates to a dry powder inhaler of an interferon. The dry powder inhaler, having single dose of 1 mg, 2 mg, 5 mg, 10 mg, 20 mg, 40 mg or 60 mg, contains 1-100 [mu]g of interferon and an appropriate amount of a pharmaceutically acceptable adjuvant for the dry powder inhaler; the interferon is composed of an interferon alpha and an interferon lambda in a weight ratio of (1:19)-(19:1). The dry powder inhaler of interferon provided by the invention is used for treating viral pneumonia and can significantly improve the therapeutic effect in comparison with the dry powder inhaler of the interferon alpha or the dry powder inhaler of the interferon lambda used alone.

Description

technical field [0001] The present invention relates generally to formulations of interferon for respiratory and pulmonary administration, and in particular to dry powder inhalation formulations of interferon. Background technique [0002] Viral pneumonia is a common disease in infants and young children, which seriously endangers the life and health of infants and young children. According to incomplete statistics, more than 90% of infants and young children have been infected with viral pneumonia before the age of 2, and more than 80% of the cases are within 1 year of age. The peak age of onset is 2-6 months, and severe cases can be seen in 1-6 months. . The death rate of infants and young children caused by viral pneumonia is 0.5%-2.0% in developed countries and up to 7% in developing countries. In my country, it is the leading cause of infant and young children's death. In addition, viral pneumonia is highly contagious and reinfected. It has been reported that successi...

Claims

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Application Information

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IPC IPC(8): A61K38/21A61K9/12A61P11/00A61P31/12A61P31/14A61P31/16A61P31/22
CPCA61K38/21A61K38/212A61K47/26A61K9/0073A61K9/12
Inventor 周敏毅程永庆
Owner BEIJING TRI PRIME GENE PHARMA CO LTD
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