Tiotropium aerosol inhalant and its preparation method

A technique for inhaling powder and tiotropium bromide, which is applied to the pharmaceutical preparation and preparation of tiotropium bromide lung inhalation powder and aerosol, and in the field of medicine for treating chronic obstructive diseases, which can solve the problem of poor deposition effect, Unable to produce content uniformity powder and other problems, to achieve the effect of good compliance, accurate dosage and good fluidity

Inactive Publication Date: 2004-12-29
SHANGHAI PUKANG PHARMA +2
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

This patented technology solves problems associated with traditional medicines like pills but doesn't have any harmful chemical substances inside them due to their lack of stability during storage over time. These technical features include efficient delivery from the lungs into blood vessels without causing damage, rapid release at the target area while avoiding unwanted reactions, easy handling when administered via injection, low risk of adverse events related to ingestion (such as nausea), ease of use on children, ability to treat diseases affective disorders caused by various factors including stressors, alcohol consumption, etc., and reducing patient noncomplaints compared to current therapies.

Problems solved by technology

Technological Problem addressed in this patents relates to improving the accuracy and consistency of delivering drugs like tioconazole during therapy without causing harmful side effects such as bradycardia or heart failure when administered alone.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] Name of raw materials 10,000 capsules dosage

[0030] Tiotropium bromide 0.4334g

[0031] Serine 2.0g

[0032] Add lactose to 200.0g

[0033] According to the above formula, take 0.8668g tiotropium bromide and 4.0g serine, dissolve it in deionized water and make a 100ml solution. Control the inlet air temperature to 130°C, the outlet air temperature to 80°C, the airflow rate to 10%, and the sample rate 10%, spray-dried to obtain spray-dried micropowder, dried at 105°C for 2h and stored in a desiccator.

[0034] Weigh 300g of lactose, add 250ml of water in a water bath to dissolve it, pass through a No. 5 sand core funnel, and place the filtrate at room temperature for 24 hours to gradually precipitate crystals and dry under reduced pressure to obtain recrystallized lactose. Grind the lactose finely, pass a 200-mesh sieve, and store it in a desiccator.

[0035] Weigh 2.0 g of tiotropium bromide-serine spray-dried micropowder, add 198.0 g of lactose by an equal addition metho...

Embodiment 2

[0037] Name of raw materials 10,000 capsules dosage

[0038] Tiotropium bromide 0.4334g

[0039] Serine 10.0g

[0040] Add lactose to 200.0g

[0041] According to the above formula and the same method as above, each hard capsule contains about 20mg and contains 43.43μg of tiotropium bromide.

Embodiment 3

[0043] Name of raw materials 10,000 capsules dosage

[0044] Tiotropium Bromide 0.4334g

[0045] Serine 20.0g

[0046] Add lactose to 200.0g

[0047] According to the above formula and the same method as above, each hard capsule contains about 20mg and contains 43.43μg of tiotropium bromide.

[0048] Comparing the mixing ratios of different amino acids and lactose, the results show that as the ratio of amino acid micropowders increases, the amount of effective part deposits increases, but the ratio of amino acids is too high, and the fluidity of the powder is not good. The mixing ratio of amino acids and lactose is 5:95. Better.

[0049] Table 2 shows the results of the mixing ratio of different amino acids and lactose.

[0050] Table 2

[0051] Serine Lactose Serine / Lactose Active Parts Remarks

[0052] (g) (g) Deposit

[0053] (%)

[0054] Example 2 198 1 / 99 12 Since the content of the main drug is extremely l...

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Abstract

The tiotropium bromide inhalant is prepared through spray drying the mixture solution of tiotropium bromide and amino acid to form superfine powder, mixing with re-crystallized lactose, and capsulizing or preparing other proper preparation form. It is administrated with special device so that the dry medicine powder enters to the lung via respiratory tract to treat chronic obstructive diseases. The present invention has simple preparation process without organic solvent and preservative used, and the prepared powdered preparation has good flowability, accurate dosage, high effective part depositing amount and no irritation to mucous membrane. The preparation process of the present invention may be also used for preparing Salbutamol, salmeterol and other inhalant.

Description

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Claims

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Application Information

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Owner SHANGHAI PUKANG PHARMA
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