Two-part capsule to accept pharmaceutical preparations for powder inhalers

Abstract

The present invention relates to capsules for holding pharmaceutical preparations for powder inhalers with increased drug safety and capsules for pharmaceutical preparations for powder inhalers with improved adaptation to their use in powder inhalers. The capsules consist of water-insoluble hydrophobic synthetic materials which do not significantly affect the pharmaceutical quality of the contents themselves, but which improve the usability of the filled capsules with regard to their function, their longevity and / or the geographic location of their use, and are advantageous at various stages from manufacture up to utilisation.

Description

[0001] The invention relates to new two-part capsules for holding pharmaceutical preparations for use in powder inhalers.THE PRIOR ART[0002] Capsules with pharmaceutical preparations are often used in the therapy and diagnosis of illnesses. The capsules can be orally administered or are used in certain medical apparatus such as powder inhalers. Generally, the capsules consist of two parts, a capsule body (body) and a capsule cap (cap), which are pushed together telescopically. However, multi-part capsules are also known. The capsules generally consist of gelatine, especially hard gelatine. In the case of some special applications, the capsules occasionally consist of water-soluble synthetic materials easily digested by humans, in order for example to release the active ingredients in certain compartments of the gastrointestinal tract in the case of oral administration. Examples of various capsule materials are listed hereinafter.[0003] EP 0143524 discloses a two-part capsule of mate...

AI Technical Summary

Benefits of technology

The present invention relates to a capsule for holding pharmaceutical preparations for powder inhalers with improved safety and usability. The capsule is made of a water-insoluble, hydrophobic synthetic material that does not affect the quality of the contents and is stable for use in powder inhalers. The capsule can be opened easily and the contents can be fully released for inhalation. The capsule is stable and can withstand stress during manufacture, filling, packaging, and transportation. It is also stable in high-humidity environments and can be locked closed for temporary or final closure. The capsule is advantageous for use in powder inhalers and can be opened without leaving any residue.

Problems solved by technology

The materials which are used are often not very resistant to air humidity, which is why the pharmaceutical quality of the contents cannot be guaranteed for all climatic zones.

However, these materials are not specially perfected for use in powder inhalers.

Hence materials used in construction of the capsules can alter their characteristics dependent on the ambient air humidity and / or do not always have sufficient inherent stability.

As a result, such a capsule cannot for example be used in climatic zone 4 as a result of the high air humidity, since the capsule material absorbs the humidity to such a degree that the inherent stability is seriously affected and / or the humidity penetrates into the interior of the capsule.

This has a negative effect on the pharmaceutical quality of the capsule's contents.

The said materials also have diverse disadvantages in other various stages in the life of the capsule from manufacturing up to utilisation, which affect the suitability of the capsule as a carrier for pharmaceutical preparations, the manner of administration of the contents, the perishability of the contents and / or the usability of the capsule in certain countries.

A further disadvantage of conventional capsule materials is that e.g. they tend to bind powder materials to themselves, especially when coated with a mould release agent which is often necessary for production of the capsule.

In the case of capsules for inhalation purposes, this leads to difficulty in accurately metering the fine fraction which is to enter the lungs.

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