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Stable pharmaceutical drug aerosols

A medicament, a technology for preparing a drug, applied in the field of stable drug products

Inactive Publication Date: 2010-02-17
SCHERING AG
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Any change in FSD or FPF may raise questions about the efficacy or safety of the drug product

Method used

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  • Stable pharmaceutical drug aerosols
  • Stable pharmaceutical drug aerosols
  • Stable pharmaceutical drug aerosols

Examples

Experimental program
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Effect test

other Embodiment approach

[0010] Other embodiments provide a pharmaceutical product comprising a metered dose inhaler container comprising at least one active agent, ethanol, a propellant. When stored under ambient conditions, the at least one active agent can maintain substantially the same fine particle size for a period of at least about 3 months from the date of manufacture. The at least one active agent may include mometasone furoate and optionally formoterol fumarate. Ambient conditions are considered to include temperatures between about 20°C and 25°C. Desirably, the fine particle fraction varies by no more than about 20%, or by no more than about 15%, or by no more than about 10%, or by no more than about 5%. Useful excipients include co-solvents, surfactants, carriers and combinations of two or more of them. More specifically, useful excipients include lactose, lecithin, oleic acid, and combinations of two or more thereof.

[0011] Various embodiments of the invention provide methods of sta...

Embodiment

[0049] The samples in Tables 1 and 2 were prepared according to the cold fill method. In the cold fill method, chilled propellant HFA 227 is added to a chilled batching vessel with constant agitation. In the concentrate vessel, a mixture of ethanol and oleic acid was prepared and added to the ingredient vessel to form the placebo mixture. Some of the placebo mixture was then transferred from the dosing vessel to a pre-chilled cold concentrate vessel. The active agent is added to the cooled contents in the cold concentrate vessel and mixed. Mix the concentrate in the cold concentrate vessel and transfer it back to the batch vessel. The resulting formulation was continuously mixed and maintained between about -50°C and about -60°C. Dispense the required amount of formulation into suitable canisters, such as aluminum containers coated with FEP on the inside, which are immediately sealed with metering valves. The cells were check weighed and heat stressed. The units were stor...

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Abstract

Various aspects of the present invention provide for methods of manufacturing a pharmaceutical drug product, which include storing a container at a temperature greater than ambient conditions for at least about seven days and conducting release testing on the container after storing. Products manufactured by this method have a more consistent fine particle size distribution (FSD) and fine particlefraction (FPF) at ambient conditions and at accelerated stability conditions over the life of the drug product. Advantageously, such products may more reliably and regularly pass testing requirementsas required for an approved drug product by regulatory authorities such as the United States Food and Drug Administration (USFDA).

Description

technical field [0001] The present invention relates to stabilized pharmaceutical products, such as stabilized metered dose inhalers comprising an active drug. Background technique [0002] Pharmaceutical compositions such as those found in inhalers may present stability issues. Stability issues may include degradation or alteration of the active pharmaceutical agent (APA) during delivery of the pharmaceutical composition, such as a change in particle size of the APA emitted from an inhaler. Changes in APA particle size distribution can be a significant problem as this can alter the potency of a drug product. For example, an increase in particle size of a drug product may alter the region of the lung where the drug product is delivered. As a result, the efficacy of the drug product may be reduced. [0003] It has been found that the fine particle size distribution (FSD) or fine particle fraction (FPF) of certain active agents in pharmaceutical products changes over time. ...

Claims

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Application Information

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IPC IPC(8): A61K9/00A61K31/58A61K9/12
CPCA61K31/167A61K31/58A61K9/008A61P11/06A61K2300/00A61K9/12
Inventor J·K·谢尔伍德J·塞凯拉B·A·多诺文
Owner SCHERING AG
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