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Tiotropium bromide respirable dry powder composition

A technology of tiotropium bromide and composition, which is applied in the field of dry powder composition for inhalation and its preparation, can solve the problems such as the adsorption and fluidity of drugs and carriers that are not completely solved, and achieves improved bioavailability, improved stability, The effect of promoting drug absorption

Active Publication Date: 2009-05-06
CHIA TAI TIANQING PHARMA GRP CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] The above-mentioned tiotropium bromide dry powder inhalation does not completely solve the adsorption and fluidity between the drug and the carrier, the adsorption problem between the drug and the capsule or vesicle, and the resulting flow of the inhalation composition powder. issues of stability, uniformity, emptying rate and stability

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036] Raw material name Prescription (1000 capsules)

[0037] Anhydrous tiotropium bromide 18mg (calculated as tiotropium)

[0038] Lactose 20.5g

[0039] Phospholipids (polyene phosphatidylcholine) 43.2mg

[0040] Preparation:

[0041] 1) The coarse-grained carrier is INHALAC 230 lactose produced by MEGGLE, Germany, and used to prepare microparticles and fine-grained fractions.

[0042] 2) The raw material and 9 times the amount of carrier lactose were mixed uniformly in equal increments, and then air-jet milled to less than 10 μm to make a particle part.

[0043] 3) Mix the phospholipid and an appropriate amount of carrier lactose evenly, put it into a ball mill jar, and ball mill it to a particle size below 20 μm to prepare a fine particle carrier containing 2.35% phospholipid.

[0044] 4) Add the fine powder obtained in 2) into the fine particles obtained in 3) at one time, and the ball milling time is 30 minutes together.

[0045] 5) Add the powder obtained in 4) in...

Embodiment 2

[0047] Raw material name Prescription (1000 capsules)

[0048] Tiotropium bromide monohydrate 18mg (as tiotropium)

[0049] Lactose 33.3g

[0050] Phospholipids (hydrogenated lecithin for injection) 538.3mg

[0051] Preparation:

[0052] 1) The coarse-grained carrier lactose is INHALAC 230 lactose produced by MEGGLE, Germany, and is used to prepare microparticles and fine-grained fractions.

[0053] 2) The raw material and 0.5 times the amount of carrier lactose are mixed uniformly in equal increments, and then air-jet crushed to a size below 10 μm to make a particle part.

[0054] 3) Mix the phospholipids and an appropriate amount of carrier lactose evenly, put them into a ball mill jar, and ball mill them to a particle size below 20 μm to prepare a fine particle fraction containing 8.0% phospholipids.

[0055] 4) Add the fine powder obtained in 2) to 100 times the amount of fine particles obtained in 3) at one time, sieve and mix well.

[0056] 5) Add the rest of the fi...

Embodiment 3

[0059] Raw material name Prescription (1000 capsules)

[0060] Anhydrous tiotropium bromide 18mg (calculated as tiotropium)

[0061] Lactose 21.6g

[0062] Phospholipids (Soy Lecithin) 48.7mg

[0063] Preparation:

[0064] 1) Lactose monohydrate with a particle size of 80-120 μm is screened as a coarse carrier and used to prepare microparticles and fine particles.

[0065] 2) The raw material and 9 times the amount of carrier lactose are mixed uniformly in equal increments, and then air-jet crushed to a size below 10 μm to make a particle part.

[0066] 3) Mix the phospholipid and an appropriate amount of carrier lactose evenly, put them into a ball mill jar, and ball mill to a particle size below 20 μm to prepare a fine particle carrier containing 2.5% phospholipid.

[0067] 4) Add the micropowder obtained in 2) into the lactose granules obtained in 3) at one time, and ball mill together for 30 minutes.

[0068] 5) Add the powder obtained in 4) into 9 times the amount of...

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Abstract

The invention provides a Tiotropium Bromide dry powder compound used for suction, and a preparation method thereof. The dry powder compound used for suction contains micronized Tiotropium Bromide, a micro-particle vector part, a granule vector part modified by phospholipid, and a coarse particle vector part. The dry powder compound can be used for preparing medicaments for curing chronic obstructive pulmonary disease and asthma.

Description

technical field [0001] The invention relates to a dry powder composition for inhalation and a preparation method thereof, in particular to a dry powder composition for tiotropium bromide inhalation and a preparation method thereof. The dry powder composition can be used to prepare medicines for treating chronic obstructive pulmonary disease and asthma. Background technique [0002] Tiotropium Bromide is an anticholinergic bronchodilator for the treatment of chronic obstructive pulmonary disease (COPD). It selectively acts on the muscarinic receptor subtypes M1 and M3 receptors of parasympathetic nerves, which improves the selectivity to M1 and M3 receptors and prolongs the action time, thereby avoiding the damage caused by the blockage of M2 receptors. Salivation and side effects such as mydriasis. [0003] Dry powder inhalation (dry powder inhalations, DPI), also known as inhalation powder aerosol, refers to the dry powder for inhalation composed of micronized drugs and c...

Claims

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Application Information

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IPC IPC(8): A61K31/381A61K9/14A61K9/72A61K47/24A61P11/00
Inventor 董平谢华许易张喜全
Owner CHIA TAI TIANQING PHARMA GRP CO LTD
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