Roflumilast inhalation aerosol compound and preparation method thereof

A technology for roflumilast and aerosol, which is applied in the field of compound roflumilast inhalation aerosol and its preparation, can solve problems such as complicated devices, and achieve the effects of eliminating damage, improving lung deposition, and improving compliance.

Inactive Publication Date: 2015-07-29
成都英诺新科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] Although MDI is very easy to use, its device is complex, including the integrated structure of drug formulation, container, quantitative valve and actuator ( figure 1 )

Method used

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  • Roflumilast inhalation aerosol compound and preparation method thereof
  • Roflumilast inhalation aerosol compound and preparation method thereof
  • Roflumilast inhalation aerosol compound and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0048] 1. Formula (calculated based on 1000 bottles):

[0049] Roflumilast: 24.4g;

[0050] Salbutamol: 12.2g;

[0051] Lecithin: 4.8g;

[0052] Absolute ethanol: 1200g;

[0053] HFA: added up to 18000g.

[0054] 2. Preparation method:

[0055] 1) Micronization of API: pulverize albuterol sulfate to less than 7 μm;

[0056] 2) Weighing: Weigh the roflumilast, albuterol, lecithin, and absolute ethanol in the formula amount;

[0057] 3) Surfactant dissolution: first take 2 / 3 of the formula amount of absolute ethanol, add the formula amount of lecithin, and homogenize and stir for 20 minutes under a high-shear homogenizer;

[0058] 4) Preparation of medicinal solution: add the upper liquid to the formulated amount of salbutamol sulfate, stir for 30 minutes under a high-shear homogenizer; supplement the remaining anhydrous ethanol to the full amount, continue stirring for 20 minutes, turn on the circulation pump, and circulate for 15 minutes;

[0059] 5) Filling and pinchin...

Embodiment 2

[0066] 1. Formula (calculated based on 1000 bottles):

[0067] Roflumilast: 28g;

[0068] Salbutamol: 14g;

[0069] Mint ice: 50g;

[0070] Propylene glycol: 350g;

[0071] HFA: added up to 14000g.

[0072] 2. Preparation method:

[0073] See Example 1.

[0074] 3. Particle size determination

[0075] Particle size determination method is referring to embodiment 1, and measurement result is shown in Table 2 and figure 2 .

[0076] Table 2 Particle Size Distribution

[0077]

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Abstract

The invention discloses a compound aerosol for quick-acting treatment of COPD, and a preparation method thereof. The compound aerosol comprises roflumilast and salbutamol. The compound aerosol combines respective characteristics of the long-acting COPD medicine roflumilast and the quick-acting COPD medicine salbutamol, and realizes rapid effectiveness and long lasting time in order to reduce the oral spray frequency of patients and reduce toxic side effects. A propellent changes from CFCs to HFC in order to eliminate destroys to the earth's ozone layer. Lecithin selected in the invention is in favor of realizing immersion and penetration of medicines to lung cells in order to improve the bioavailability and realize quick acting. Mentholum is added into a dispersant, so the patients have refreshing and comfortable feeling after administration, thereby the patients' compliance is improved.

Description

technical field [0001] The invention relates to a formula, a dosage form and a preparation method of a compound preparation of roflumilast and albuterol, in particular to a compound roflumilast inhalation aerosol and a preparation method thereof, and belongs to the field of biochemical medicine. Background technique [0002] Chronic obstructive pulmonary disease (Chronic obstructive pulmonary diseases, COPD) is a progressive and life-threatening respiratory disease, which is one of the "killers" of human health. It makes patients have difficulty breathing, loses the ability to move, and reduces the quality of life. COPD patients after the acute exacerbation period. The clinical symptoms have been relieved, but the lung function continues to deteriorate, and due to the decrease of self-defense and immune function and the influence of various harmful factors outside, it often recurs, and gradually produces various cardiopulmonary diseases, usually including chronic Bronchitis...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/44A61K9/12A61K9/72A61P11/00A61K31/137
Inventor 李克江祝国华丁多浩王楠刘成吴晓波
Owner 成都英诺新科技有限公司
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