Carrier mixed with additives having lubricant properties for preparing powdery pharmaceutical compositions for inhalation
AssigneeChiesi Farmaceutical S.p.A.
InventorsRossella Musa, Paolo Ventura, Paolo Chiesi
Life of this patent
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Abstract
Powdery pharmaceutical compositions including an active ingredient and carrier particles containing only a small amount of lubricant, 0.1-0.5% by weight, are used to prepare dry powder inhalers in order to increase the fine particle dose. A process for coating the surface of the carrier particles with such little amount of lubricant is also provided. Use of limited amount of lubricant is safe and provides ordered stable mixtures without segregation of the active particles during handling and before use.
Claims19
A powder for use in a dry powder inhaler, the powder consisting of an active ingredient and a carrier, the carrier consisting of one or more crystalline sugars in the form of particles of size within the range 20 and 1000 μm mixed with a lubricant selected from the group consisting of magnesium stearate, stearic acid, sodium stearyl fumarate, stearyl alcohol, and sucrose monopalmitate, wherein the lubricant coats the carrier particles to an extent such that the coated particles have a water contact angle of at least 36° and is present in an amount within the range of 0.1-0.5 percent by weight of the composition.
A carrier for use in making a powder for use in a dry powder inhaler, said carrier consisting of one or more crystalline sugars and being in the form of particles of a size within the range 20 and 1000 μm mixed in a mixer apparatus with a lubricant selected from the group consisting of magnesium stearate, stearic acid, sodium stearyl fumarate, stearyl alcohol, and sucrose monopalmitate, wherein the lubricant coats the carrier particles to an extent such that the coated particles have a water contact angle of at least 36° and is present in an amount within the range of 0.1-0.5 percent by weight of the composition.
A method for producing a carrier for use in making a powder for use in a dry powder inhaler, such carrier consisting of one or more crystalline sugars and being in the form of particles of a size within the range 20 and 1000 μm mixed with a lubricant selected from the group consisting of magnesium stearate, stearic acid, sodium stearyl fumarate, stearyl alcohol, and sucrose monopalmitate, wherein the lubricant coats the carrier particles to an extent such that the coated particles have a water contact angle of at least 36° and is present in an amount within the range of 0.1-0.5 percent by weight of the composition,
- the method including the step of mixing in a mixer apparatus carrier particles of a size within the range 20 and 1000 μm with 0.1-0.5 percent by weight of a lubricant to provide a coating on the carrier particles to an extent such that the coated particles have a water contact angle of at least 36°.
Dependencies are inferred from the claim text.