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Process for providing a filled canister for an inhaler

A technology for filling canisters, inhalers, applied in the field of pressurized metered dose inhalers, supplying canisters and filling said canisters with pharmaceutical components, capable of solving expensive and time-consuming problems

Inactive Publication Date: 2013-01-02
ASTRAZENCA UK LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This step has disadvantages because introducing any additional step is time consuming and more expensive and further requires release of excess propellant into the environment

Method used

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  • Process for providing a filled canister for an inhaler
  • Process for providing a filled canister for an inhaler
  • Process for providing a filled canister for an inhaler

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0090] The three canisters for the three inhalers were assembled and filled with drug in a conventional manner, ie using a decontamination step in which the canisters were purged with propellant, after which the canisters were sealed with metering valves and filled with drug. Test each inhaler as follows:

[0091] 1. Actuate in the conventional manner to dispense an aerosol.

[0092] 2. Actuate again and hold in the actuated position (ie, where the metering valve remains open) for a first predetermined period of time (recorded in column 1 of Table 1).

[0093] 3. Weighing.

[0094] 4. Actuate again and hold in the actuated position (ie, where the metering valve remains open) for a first predetermined period of time (recorded in column 1 of Table 1).

[0095] 5. Weighing.

[0096] 6. Drive in the usual way.

[0097] 7. Weighing.

[0098] Drive weight over hold time was calculated as follows: inhaler weight of step 5 minus inhaler weight of step 3 and inhaler weight of step...

Embodiment 2

[0104] For comparison with Example 1, a canister for an inhaler was assembled and filled with propellant according to aspects of the invention. The canister was configured and filled by the same method as Example 1, except that there was no decontamination step, whereby the canister of the inhaler in Example 2 was not decontaminated. As described in Example 1, the inhaler was tested in Example 2 in the following manner:

[0105] 1. Actuate in the conventional manner to dispense an aerosol.

[0106] 2. Re-actuate and hold in the actuated position (ie, where the metering valve remains open) for a first predetermined period of time (recorded in column 1 of Table 2).

[0107] 3. Weighing.

[0108] 4. Actuate again and hold in the actuated position (ie, where the metering valve remains open) for a first predetermined period of time (recorded in column 1 of Table 2).

[0109] 5. Weighing.

[0110] 6. Drive in the usual way.

[0111] 7. Weighing.

[0112] Drive weight over hold...

Embodiment 3

[0118] As discussed above, the aerosol actuation weight has a direct effect on the active pharmaceutical ingredient in the delivered dose of drug, and thus the patient receives a potential drug dose with each actuation. To confirm this, 90 purified tanks and 30 unpurified tanks (for comparison) were configured in the same manner as above. Each canister contains the same predetermined and known number of doses of the selected drug, thus allowing the beginning, middle and end of the canister's useful life to be determined.

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PUM

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Abstract

There is disclosed a process for providing a filled canister (138) for an inhaler (1), in particular a process for supplying a canister (138) and filling the canister (138) with components of a medicament, which canister (138) is suitable for use in a pressurised metered dose inhaler, preferably a breath-actuate inhaler (1). The process comprises providing a canister (138) that is substantially filled with air at ambient conditions and sealing the opening of the canister (138), for example with a metering valve (134). A filling device dispenses a pressurised liquid and / or gas into the sealed, air-filled canister (138) through the metering valve (134). The pressurised liquid and / or gas comprises at least a propellant. The sealed, air-filled canister (138) is substantially devoid of propellant prior to the step of dispensing the pressurised liquid and / or gas. Thereafter the sealed canister (138) is substantially filled with at least some propellant and some air. Preferably the sealed canister (138) also contains a medicament. In the art, pressure-filled canisters are purged with propellant immediately before sealing to remove the air. The present process excludes the purging step and the sealed canisters (138) contain air and no propellant prior when sealed.

Description

technical field [0001] The present invention relates to a method of providing a filling canister for an inhaler, in particular providing a canister and filling said canister with a pharmaceutical composition, wherein the canister is suitable for use in a pressurized metered dose inhaler. Background technique [0002] Inhalers, such as dry powder inhalers (DPIs) and pressurized metered dose inhalers (pMDIs), are commonly used to deliver a wide range of drugs. A pMDI includes at least one drug canister that is actuated, for example by opening a metering valve, to deliver a dose of drug to the user through a mouthpiece. The inhaler may be manually actuated and / or may have an actuation mechanism to automatically actuate the canister, for example with a breath actuation mechanism that operates in response to a user's inhalation. The Breath-Actuated Inhalers (BAIs) ensure that the dose of drug dispensed when used to actuate the canister is provided when the user inhales, which is...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): B65B31/00A61K9/00B65B37/06
CPCB65B31/003A61M15/009B65B37/06A61K9/008A61M15/0091A61M2207/00A61P11/00A61M11/04A61M16/12
Inventor S.C.贝里A.C.M.P.科洛姆巴尼D.C.迪基I.M.弗莱彻D.J.霍德森R.B.詹森K.J.李A.J.朱德奇克T.佩奇
Owner ASTRAZENCA UK LTD
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