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Inhalable medicaments

A technology for drugs and inhalers, applied in the field of inhalable drugs, can solve problems such as narrow treatment window and cardiac side effects

Active Publication Date: 2016-08-31
PHARMACHEMIE BV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, beta 2 -Agonists are more of a problem because of the narrow therapeutic window and, as mentioned, beta 2 -Agonists have been associated with serious adverse effects, including cardiac side effects

Method used

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Examples

Experimental program
Comparison scheme
Effect test

example 1

[0120] Two samples of formoterol fumarate dihydrate were micronized by jet milling. These two lots are designated by codes 7544MA (normal mill) and 7544MO (invention). Micronization conditions are given in Table 1.

[0121] Table 1. Micronization conditions

[0122]

[0123]The process for Lot 7544MO used a lower milling pressure and higher feed rate than Lot 7544MA. Therefore, the process for batch 7544MO utilized lower energy to micronize formoterol than batch 7544MA. This is why the batches made from the 7544MO treatment had a consistently higher d90 diameter than the batches made from the 7544MA treatment.

[0124] The particle size of the two batches was measured using laser light scattering and dry particle dispersion methods, e.g. in air, e.g. by Sympatec HELOS / BF equipped with a RODOS disperser, the results are given in Table 2 and Figure 24 given in.

[0125] Table 2. Particle Sizes of Formoterol Batches

[0126]

[0127] The particle size distribution of...

example 2

[0129] Pharmacokinetic (PK) clinical studies were performed. PK studies utilize a stepwise approach to assess multiple key formulation parameters, metered dose (dose cup volume of device), formulation mixing intensity, drug particle size, and lactose particle size. PK studies were performed on the medium strength product (160 / 4.5 μg). Batch A contained Formoterol 7544MA and Batch B contained Formoterol 7544MO. The inhaler, budesonide and lactose were the same for batch A and batch B.

[0130] exist Figure 25 The key findings of the PK study are highlighted in . The data show that the coarser particle size formoterol significantly lowers Cmax, ie by more than 20%.

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Abstract

The present invention provides a dry powder inhaler comprising: a reservoir containing a dry powder formulation and an arrangement for delivering a metered dose of the medicament from the reservoir; a cyclone deagglomerator for breaking up agglomerates of the dry powder medicament; and a delivery passageway for directing an inhalation-induced air flow through a mouthpiece, the delivery passageway extending to the metered dose of medicament, wherein the formulation comprises an inhalable [beta]2-agonist having a particle size distribution of d10<1 [mu]m, d50=1-3 [mu]m, d90=3.5-6 [mu]m and NLT 99%<10 [mu]m and a lactose carrier.

Description

technical field [0001] The present invention relates to inhalable medicaments, in particular to inhalable beta 2 - agonists, such as formoterol. Background technique [0002] respirable beta 2 Adrenoceptor agonists (often abbreviated as beta 2 - agonists) are widely used in the treatment of respiratory diseases, especially asthma and COPD. They are usually classified as short-acting beta 2 - Agonist (SABA) and long-acting beta 2 - Agonist (LABA). Examples of SABAs include salbutamol, levosalbutamol, terbutaline, pirbuterol, procaterol, clenbuterol, orcina Lin (metaproterenol), fenoterol (fenoterol), bitolterol (bitolterol), ritodrine (ritodrine), and isoproterenol. Examples of LABS include formoterol, salmeterol, bambuterol, indacaterol, and carmoterol. Many are used as pharmaceutically acceptable salts. An example of particular interest is formoterol fumarate. [0003] respirable beta 2 - Agonists are usually administered using a dry powder inhaler (DPI), pressur...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/00A61M15/00A61K31/167A61K31/58
CPCA61K9/0075A61K9/145A61K31/137A61K31/165A61K31/167A61K31/24A61K31/44A61K31/4704A61K31/58A61K45/06A61K47/26A61K2300/00A61M15/0008A61M15/0021A61M15/0026A61M15/0028A61M15/0078A61M15/0086A61M15/009A61M15/0091A61M2202/064A61M2206/16A61M2206/20A61P11/00A61P11/06A61P43/00A61M15/0065
Inventor E·范阿克索文J·基格斯特拉M·I·格勒尔
Owner PHARMACHEMIE BV
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