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US 2026/0083711 A1Published application
Capsule inhaler for the administration of a phosphodiesterase-4 inhibitor
AssigneeChiesi Farmaceutici S.p.A.
InventorsFrancesca BUTTINI, Giada VARACCA, Romina OSELLO
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Abstract
The present invention relates to a drug product comprising a single-dose dry powder inhalation device and a pharmaceutical composition filled in a capsule, the pharmaceutical composition comprising micronized particles of the compound of formula (I) and a carrier. The present invention also relates to a drug product or a pharmaceutical composition for use for the treatment of a respiratory disease and to a method for the treatment of a respiratory disease.
Claims13
1:
- A drug product, comprising a single-dose dry powder inhalation device, comprising an inhaler body (2) defining a recess (3) for a capsule (4), wherein the capsule (4) holds therein a pharmaceutical composition to be inhaled, a nosepiece or mouthpiece (5) communicating with the recess (3), at least one rupturing element (7) coupled to the inhaler body (2) and configured for rupturing the capsule (4) to allow an outside airflow to be mixed with the pharmaceutical composition of the capsule (4) and inhaled through the nosepiece or the mouthpiece (5), and a pharmaceutical composition filled in a capsule,
- the pharmaceutical composition comprising micronized particles having a size of from 0.1 to 15 microns of the compound of formula (I)
- and lactose carrier particles,
- wherein the inspiratory flow rate of said inhalation device is from 30 l/min to 65 l/min and
- wherein the lactose carrier particles have an equivalent volume diameter lower than 110 microns, measured by means of laser diffraction or sieve analyzer.
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2:
- The drug product according to claim 1, wherein said carrier particles are made of alpha-lactose monohydrate.
3:
- The drug product according to claim 1, wherein said lactose carrier particles have an equivalent volumediameter of from 1 to 95 microns.
4:
- The drug product according to claim 3, wherein the lactose carrier particles have a dv(10) of from 1 to 5 microns, a dv(50) of from 18 to 30 microns and a dv(90) of from 65 to 95 microns.
5:
- The drug product according to claim 1, wherein the inspiratory flow rate of the inhalation device is from 40 l/min to 65 l/min.
6:
- The drug product according to claim 1, wherein the unitary nominal dose of the compound of formula (I) is from 400 to 800 μg.
7:
- The drug product according to claim 6, wherein the unitary nominal dose of the compound of formula (I) is 800 μg.
8:
- The drug product according to claim 6, wherein the unitary nominal dose of the compound of formula (I) is 400 μg.
9:
- A method for the treatment of a respiratory disease, comprising administering to a subject in need thereof an effective amount of a pharmaceutical composition, comprising micronized particles having a size of from 0.1 to 15 microns of the compound of formula (I)
- and lactose carrier particles,
- wherein said composition is administered using a single-dose dry powder inhalation device,
- wherein the inspiratory flow rate of said inhalation device is from 30 l/min to 65 l/min, and
- wherein the lactose carrier particles have an equivalent volume diameter lower than 110 microns, measured by means of laser diffraction or sieve analyzer.
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10:
- The method according to claim 9, wherein the respiratory disease is asthma or chronic obstructive pulmonary disease (COPD).
11:
- The method according to claim 9, wherein the total daily dose of the compound of formula (I) is from 800 to 4800 μg.
12:
- The method according to claim 11, wherein the total daily dose of the compound of formula (I) is from 1600 to 3200 μg.
13:
- A process for the preparation of the drug product according to claim 1, said process comprising:
- i) sieving the compound of formula (I) through a suitable mesh,
- ii) adding the lactose carrier particles to the compound of formula (I), to obtain a final blend,
- iii) sieving the final blend and mixing to obtain the final pharmaceutical composition,
- iv) filling the final pharmaceutical composition in a capsule, and
- v) loading the capsule into the medicament chamber of single dry powder inhalation device.
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