Zambon S.p.a.

Eratech S.r.l.

Zambon Group

Cristina Veneziani

Giovanni Caponetti

Loretta Maggi

Laura Zanellotti

Paolo Ventura

Heike Butti

The present invention relates to inhalation formulations of drugs in the form of dry powder for inhalation administration deliverable as such with an inhaler and provided with high deliverability, respirability and stability. In particular, the invention relates to a pharmaceutical composition for inhalation in the form of powder comprising at least a first and a second powder, in which at least said first powder contains an active agent in an amount greater than 1% by weight with respect to the weight of said first powder. Both the powders comprise leucine in an amount ranging from 5 to 70% by weight with respect to the weight of each powder and a sugar in an amount ranging from 20 to 90% by weight with respect to the weight of each powder. The composition has a fine particle fraction (FPF) greater than 60% and a delivered fraction (DF) greater than 80.

Composition comprising at least two dry powders obtained by spray drying to increase the stability of the formulation

The present invention relates to inhalation formulations of drugs in the form of dry powder for inhalation administration deliverable as such with an inhaler and provided with high deliverability, respirability and stability. In particular, the invention relates to a pharmaceutical composition for inhalation use in powder form comprising a first powder comprising at least a powder (a1) comprising an active agent or a pharmaceutically acceptable salt thereof, in an amount greater than 1% by weight of the powder, leucine in an amount from 5 to 70% by weight of said powder, a sugar in an amount from 20 to 90% by weight of the powder; and a second powder comprising a mixture of a first lactose which has an X50 from 35 to 75 &#x3bc;m, with a second lactose which has an X50 from 1.5 to 10 &#x3bc;m, the content of the first and second lactose in the mixture are respectively from 85% to 96% and from 4% to 15%. The ratio by weight between the first powder and the second powder is from 1/5 to 1/100, and the composition has a fine particle fraction (FPF) greater than 60% and a delivered fraction (DF) greater than 85%.

Composition comprising at least one dry powder obtained by spray drying to increase the stability of the formulation

Provided is an inhalatory pharmaceutical composition that comprises a drug, a soluble excipient and a surfactant, wherein the soluble excipient is present in an amount between 10% and less than 100% by weight; and the solid excipient forms a solid matrix in which the drug is dispersed; the weight ratio between the surfactant and drug is between 0.01 and 10; the particle size of at least 50% of the particles of the powder is below 5 &#x3bc;m; the bulk density dof the powder is between 0.1 and 0.3 g/cc; the tapped density dof the powder is between 0.15 and 0.7 g/cc and the ratio d/dis between 0.2 and 0.65. Also provided is the method for fabricating the composition.

Inhalatory pharmaceutical compositions in form of dry powders, solutions or suspensions obtained from the same and process for their preparation

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Castel San Giovanni, Italy

Cristina Veneziani