WO2022045994A1 - Procédé de préparation de compositions en poudre sèche pour inhalation - Google Patents

Procédé de préparation de compositions en poudre sèche pour inhalation Download PDF

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Publication number
WO2022045994A1
WO2022045994A1 PCT/TR2020/050779 TR2020050779W WO2022045994A1 WO 2022045994 A1 WO2022045994 A1 WO 2022045994A1 TR 2020050779 W TR2020050779 W TR 2020050779W WO 2022045994 A1 WO2022045994 A1 WO 2022045994A1
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WO
WIPO (PCT)
Prior art keywords
dry powder
active agent
powder compositions
compositions according
manufacturing dry
Prior art date
Application number
PCT/TR2020/050779
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English (en)
Inventor
Fatih CAN
Devrim CELIK SAKIZCI
Emine Yilmaz
Original Assignee
Arven Ilac Sanayi Ve Ticaret Anonim Sirketi
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
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Application filed by Arven Ilac Sanayi Ve Ticaret Anonim Sirketi filed Critical Arven Ilac Sanayi Ve Ticaret Anonim Sirketi
Priority to PCT/TR2020/050779 priority Critical patent/WO2022045994A1/fr
Publication of WO2022045994A1 publication Critical patent/WO2022045994A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/13—Amines
    • A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
    • A61K31/137—Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/007—Pulmonary tract; Aromatherapy
    • A61K9/0073—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
    • A61K9/0075—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy for inhalation via a dry powder inhaler [DPI], e.g. comprising micronized drug mixed with lactose carrier particles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A61P11/06—Antiasthmatics

Definitions

  • the invention relates to processes for the preparation of dry powder pharmaceutical compositions and compositions obtained by said process which are used in the treatment of chronic obstructive pulmonary disease (COPD), asthma and other obstructive airway diseases.
  • COPD chronic obstructive pulmonary disease
  • Dry powder inhalers are well known devices for administering pharmaceutically active agents to the respiratory tract to treat respiratory diseases such as asthma and chronic obstructive pulmonary disease (COPD). Desirable performance characteristics expected form them are physical and chemical stability, ease of processing, accurate and reproducible delivery to the target organ, and availability at the site of action. These goals can be achieved primarily with a homogenous and stable powder formulation.
  • compositions for inhalation used in the treatment of obstructive airway diseases can comprise various active agents such as long acting muscarinic antagonists (LAMA), long acting beta agonists (LABA), short acting beta-2 agonists (SABA) and corticosteroids.
  • LAMA long acting muscarinic antagonists
  • LABA long acting beta agonists
  • SABA short acting beta-2 agonists
  • corticosteroids corticosteroids
  • Corticosteroids are a class of drug that lowers inflammation in the body. They also reduce immune system activity. Inhaled corticosteroids reduce inflammation in the airways that carry air to the lungs (bronchial tubes) and reduce the mucus made by the bronchial tubes which makes easier to breathe.
  • Fluticasone is the most commonly used corticosteroid in the dry powder formulations for inhalation.
  • Fluticasone furoate which is a salt of fluticasone, is a synthetic trifluorinated corticosteroid with potent anti-inflammatory activity.
  • Fluticasone furoate is available as a combination product with vilanterol, under the tradename Breo Ellipta®. Its use is indicated for the long-term, once-daily maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and emphysema.
  • long-acting beta2-agonists are bronchodilators taken routinely in order to control and prevent bronchoconstriction. They are not intended for fast relief.
  • These medications may take longer to begin working but relieve airway constriction for up to 12 hours. They are used in combination with a corticosteroid to treat asthma in a metered-dose or dry powder inhaler. They relax the smooth muscles lining the airways that carry air to the lungs (bronchial tubes). This allows the tubes to stay open longer and makes breathing easier.
  • Salmeterol is a selective long-acting beta2-adrenergic agonist (LABA) used in the maintenance and prevention of asthma symptoms and maintenance of chronic obstructive pulmonary disease (COPD) symptoms. Symptoms of bronchospasm include shortness of breath, wheezing, coughing and chest tightness. It is also used to prevent breathing difficulties during exercise.
  • LPA beta2-adrenergic agonist
  • DPI formulations consist of micronized drug blended with larger carrier particles, which enhance flow, reduce aggregation, and aid in dispersion.
  • a combination of intrinsic physicochemical properties, particle size, shape, surface area, and morphology effects the forces of interaction and aerodynamic properties, which in turn determine fluidization, dispersion, delivery to the lungs, and deposition in the peripheral airways.
  • Small drug particles are likely to agglomerate. Said agglomeration can be prevented by employing suitable carrier or carrier mixtures. It also assists in controlling the fluidity of the drug coming out of the carrier device and ensuring that the active ingredient reaching to lungs is accurate and consistent.
  • inhalation device delivers sufficient amount of the medicament to the patient for inhalation.
  • the homogeneity of the discharge is basically dependent on the agglomeration tendency of the dry powder in the capsule or in the blister and the agglomeration tendency is related to both the content of the formulation (such as selected carriers and their hygroscopicity etc.) and the particle size distribution (the ratio of fine particles and coarse particles) of this content.
  • Fine-particle dose (FPD) is defined as the dose of the aerosolized drug particles with an aerodynamic diameter ⁇ 5 microm and fine particle fraction (FPF) is the ratio of FPD to the total recovered dose.
  • FPF is an essential factor which directly effects the amount of the drug which reaches to the lungs of the patient.
  • Drug particles less than 5 pm have the greatest probability of deposition in the lung, whereas those less than 2 pm tend to be concentrated in the alveoli.
  • the dose emitted from an inhaled product contains a large proportion of particles within the 2-5 pm range ensuring a fairly even distribution throughout the lungs.
  • Selection of the carrier and optionally other excipients is one the main approaches to adjust FPF.
  • the preparation process of the dry powder composition is as important as the carrier selection to maintain FPF at a desirable range. The process can comprise several steps such as mixing/blending, sieving and filling the powder mixture into capsules or blisters.
  • Blending is the step in which distinct bulk material particles are brought into close contact to produce a homogenous powder mixture.
  • a mixture can be defined as homogeneous if every sample of the mixture has the same composition and properties as any other.
  • the phenomena of particle segregation and agglomeration present a challenge in developing a reproducible blending process.
  • blending parameters such as blending speed and blending volume are just as important as carrier selection to achieve both homogeneity and uniformity of the composition.
  • the duration of blending is also important to assure stability of the composition since the longer blending lasts, the greater the dry powder absorbs atmospheric moisture. Moisture is the primary cause of agglomeration; thus, it is preferable to keep the blending time short but enough to assure uniformity.
  • blending step is performed via shaker mixers with low speed which require long blending times to achieve a desirable uniformity.
  • the patent application numbered WO2018206618 (A1) relates to a process for preparing a powder formulation for inhalation for use in a dry powder inhaler.
  • low shear mixer Trobula mixer
  • the rotation speed is preferably 16 to 32 rpm for a period of 60 to 300 minutes.
  • the main object of the present invention is to provide a novel process for manufacturing dry powder compositions for inhalation which eliminate all aforesaid problems and bring additional advantages to the relevant prior art.
  • Another object of the present invention is to provide a novel process for manufacturing dry powder compositions for inhalation with increased stability, enhanced fine particle dose (FPD) and fine particle fraction (FPF).
  • FPD fine particle dose
  • FPF fine particle fraction
  • Another object of the present invention is to provide a novel process for manufacturing dry powder compositions for inhalation with enhanced uniformity and homogeneity.
  • Another object of the present invention is to provide a novel process for manufacturing dry powder compositions for inhalation which decreases the required blending duration to provide a homogeneous composition and the risk of caking accordingly.
  • Another object of the present invention is to provide a novel process for manufacturing dry powder compositions for inhalation which eliminates the requirement of using a sieving, saves time and provides a one-pot manufacturing accordingly.
  • Another object of the present invention is to provide a novel process for manufacturing dry powder compositions for inhalation in which the active agent(s) and carrier are added in more than one portions together or separately.
  • Another object of the present invention is to provide a novel process for manufacturing dry powder compositions for inhalation which decrease contamination in the powder mixture depending on the process time and steps.
  • Another object of the present invention is to obtain dry powder inhalation compositions provided by the above-mentioned process comprising at least one active agent selected from the group comprising corticosteroids, long-acting beta2-adrenergic agonists (LABAs), short acting beta-2 agonists (SABA) and long-acting muscarinic antagonists (LAMAs).
  • active agent selected from the group comprising corticosteroids, long-acting beta2-adrenergic agonists (LABAs), short acting beta-2 agonists (SABA) and long-acting muscarinic antagonists (LAMAs).
  • a further object of the present invention is to obtain dry powder inhalation compositions comprising a corticosteroid and a selective long-acting beta2-adrenergic agonist (LABA) in combination.
  • a corticosteroid and a selective long-acting beta2-adrenergic agonist (LABA) in combination.
  • LAA beta2-adrenergic agonist
  • Another object of the present invention is to obtain inhalation compositions having appropriate particle size and ratios of both carriers and active agents ensuring that effective doses of active agents reach the alveoli.
  • a further object of the present invention is to obtain inhalation compositions which can be administered in blister pack or in capsule using an inhaler.
  • a further object of the present invention is to obtain a blister pack filled with the above- mentioned dry powder inhalation combinations.
  • a further object of the present invention is to obtain a capsule filled with the above-mentioned dry powder inhalation combinations.
  • a further object of the present invention is to obtain an inhaler which is applicable with the above-mentioned blister pack or the above-mentioned capsule.
  • the present invention relates to process for manufacturing dry powder compositions for inhalation wherein a first active agent with lower amount in mass and at least one second active agent with greater amount in mass comparing with the first active agent each separately selected from the group comprising corticosteroids, long-acting beta2-adrenergic agonists (LABAs), short acting beta-2 agonists (SABA) and long-acting muscarinic antagonists (LAMAs) comprising the steps of adding the first active agent and the second active agent with at least one carrier are in a high shear mixer and mixing with an impeller of the mixer with a rotational speed of 75-1000 rpm wherein each of the first active agent and the second active agent with carrier is added to the mixer in separate steps and each adding step of the first active agent and the second active agent with the carrier into the mixer is followed by at least one blending step for a duration of is at least 3 minutes.
  • a first active agent with lower amount in mass and at least one second active agent with greater amount in mass comparing with the first active agent each
  • the present invention relates to a process for manufacturing dry powder compositions for inhalation in which at least one active agent and at least one carrier are added in a mixer comprising an impeller with a rotational speed of 75-1000 rpm, together or separately in more than one portions.
  • said mixer is a high shear mixer.
  • the process is carried out by dry granulation and free of any liquid.
  • the process is free of sieving and time-saving accordingly.
  • each active agent is added in separate portions.
  • carrier addition per portion is performed only with at least one active agent.
  • the rotational speed of said impeller is in the range of 100-1500 rpm, more preferably in the range of 150-800 rpm.
  • each addition of active agent and/or carrier into the mixer is followed by at least one blending step.
  • the duration of said blending step is at least 3 minutes.
  • the addition of active agent and/or carrier is repeated 10 times at most.
  • the process is carried out for 10-120 minutes, more preferably 15-60 minutes. This duration is far shorter than the duration required in the prior art.
  • said impeller is bottom-driven.
  • Said impeller comprises at least one blade, preferably three blades.
  • said mixer further comprises a chopper located on the internal side wall of the mixer with a rotational speed of 1-2200 rpm, preferably 50-1000 rpm, more preferably 100-500 rpm.
  • said chopper is in the form of a hook.
  • said active agent is selected from the group comprising corticosteroids, long-acting beta2-adrenergic agonists (LABAs), short acting beta-2 agonists (SABA) and long-acting muscarinic antagonists (LAMAs).
  • LAMAs long-acting beta2-adrenergic agonists
  • SABA short acting beta-2 agonists
  • LAMAs long-acting muscarinic antagonists
  • the dry powder composition comprises a corticosteroid or pharmaceutically acceptable salt thereof and a selective long-acting beta2- adrenergic agonist (LABA) or pharmaceutically acceptable salt thereof in combination.
  • a corticosteroid or pharmaceutically acceptable salt thereof and a selective long-acting beta2- adrenergic agonist (LABA) or pharmaceutically acceptable salt thereof in combination.
  • LAA beta2- adrenergic agonist
  • Said corticosteroid is selected from the group comprising ciclesonide, budesonide, fluticasone, aldosterone, beklometazone, betametazone, chloprednol, cortisone, cortivasole, deoxycortone, desonide, desoxymetasone, dexametasone, difluorocortolone, fluchlorolone, flumetasone, flunisolide, fluquinolone, fluquinonide, flurocortisone, fluorocortolone, flurometolone, flurandrenolone, halcynonide, hydrocortisone, icometasone, meprednisone, methylprednisolone, mometasone, paramethasone, prednisolone, prednisone, tixocortole, triamcynolondane or mixtures thereof.
  • said corticosteroid is fluticasone.
  • said fluticasone salt is fluticasone propionate.
  • Said long-acting beta-2-adrenergic agonist is selected from the group comprising salmeterol, formoterol, arformoterol, salbutamol, indacaterol, terbutaline, metaproterenol, vilanterol, carmoterol, olodaterol, bambuterol, clenbuterol or mixtures thereof.
  • said long-acting beta-2-adrenergic agonist is salmeterol.
  • said salmeterol salt is salmeterol xinafoate.
  • said carrier is selected from the group comprising lactose, mannitol, sorbitol, inositol, xylitol, erythritol, lactitol and maltitol.
  • said carrier is lactose monohydrate.
  • Particle size distribution of the carrier plays a crucial role for the qualification of the composition subjected to the invention.
  • particle size distribution means the cumulative volume size distribution as tested by any conventionally accepted method such as the laser diffraction method (Malvern analysis).
  • Laser diffraction measures particle size distributions by measuring the angular variation in intensity of light scattered as a laser beam passes through a dispersed particulate sample. Large particles scatter light at small angles relative to the laser beam and small particles scatter light at large angles. The angular scattering intensity data is then analyzed to calculate the size of the particles responsible for creating the scattering. The particle size is reported as a volume equivalent sphere diameter.
  • the D50 value is the size in microns that splits the distribution with half above and half below this diameter.
  • the process comprises the use of coarse lactose of which d50 value in the range 25-250 pm. According to one embodiment, the process further comprises the use of fine lactose of which d50 value is in the range of 0-25 pm.
  • Coarse carrier particles are used to prevent agglomeration of the active agent particles having mean particle size lower than 10 pm.
  • shape and surface roughness of the carrier particles are especially important. Particles having smooth surface will be separated much easier from the active agents compared to the particles in the same size but having high porosity.
  • Active agent particles will tend to concentrate on the regions having higher energy as the surface energy does not dissipate on the coarse carrier particles evenly. This might prevent separation of the active agent particles from the coarse carrier after pulmonary administration, especially in low dose formulations. In this sense, fine carrier particles are used to help the active agents to reach to the lungs easier and in high doses. As the high- energy regions of coarse carrier particles will be covered by fine carrier particles, the active agent particles will be attaching to low energy regions; thus, the amount of active agent particles detached from the coarse carrier particles will potentially increase. This preferred selection of carrier and its particle size distribution eliminates agglomeration of active agent particles and assures the enhanced stability, moisture resistance, fluidity, content uniformity and dosage accuracy.
  • the process comprises the following procedural steps: i. plastering the inner wall of the mixer with coarse lactose by blending for at least 3 minutes
  • coarse lactose mentioned in step (i) and (iii) have a d50 value in the range 25-250 pm, preferably in the range of 30-80 pm.
  • the invention also defines dry powder inhalation compositions obtained by the process mentioned above.
  • the amount of fluticasone propionate is between 0.1-10%, preferably 0.3-8%, more preferably 0.5-5% by weight of the total composition.
  • the amount of salmeterol xinafoate is between 0.01-5%, preferably 0.05-3%, more preferably 0.1-2% by weight of the total composition.
  • the amount of total lactose is between 85-99.89%, preferably 89-99.65%, more preferably 93-99.4% by weight of the total composition.
  • the amount of coarse lactose is between 90-100%, preferably 96-99% by weight of the total lactose.
  • the amount of fine lactose is between 0-20%, preferably 1-10 % by weight of the total lactose.
  • the process comprises the following procedural steps: a. plastering the inner wall of the mixer with coarse lactose by blending for at least 3 minutes b. adding salmeterol xinafoate and blending for at least 5 minutes c. adding salmeterol xinafoate and coarse lactose and blending for at least 5 minutes d. adding fluticasone propionate and coarse lactose and blending for at least 10 minutes
  • coarse lactose mentioned in step (a) has a d50 value in the range 25-250 pm, preferably in the range of 30-80 pm.
  • the amount of coarse lactose mentioned in step (a) is 20-40% by weight of the coarse lactose in the final dry powder composition. According to this embodiment, the amount of coarse lactose mentioned in step (c) is 20-40% by weight of the coarse lactose in the final dry powder composition. And accordingly, the amount of coarse lactose mentioned in step (d) is 30-50% by weight of the coarse lactose in the final dry powder composition.
  • the amount of salmeterol xinafoate mentioned in step (b) is half by weight of the salmeterol xinafoate in the final dry powder composition. According to this embodiment, the amount of salmeterol xinafoate mentioned in step (c) is the other half by weight of the salmeterol xinafoate in the final dry powder composition.
  • the invention also defines dry powder inhalation compositions obtained by the process mentioned above.
  • the amount of fluticasone propionate is between 0.1-10%, preferably 0.3-8%, more preferably 0.5-5% by weight of the total composition.
  • the amount of salmeterol xinafoate is between 0.01-5%, preferably 0.05-3%, more preferably 0.1-2% by weight of the total composition.
  • the amount of coarse lactose is between 85-99.89%, preferably 89-99.65%, more preferably 93-99.4% by weight of the total composition.
  • the dry powder composition subjected to the invention comprises;
  • the below given formulations can be used for the dry powder composition subjected to the invention. These examples are not limiting the scope of the present invention and should be considered under the light of the foregoing detailed disclosure.
  • Example 1 Dry powder composition for inhalation
  • Example 2 Dry powder composition for inhalation
  • Example 3 Dry powder composition for inhalation Unlike processes in the art in which sieving is essential to assure stable and uniform dry powder compositions, these suggested processes don’t require any sieving step to provide such compositions.
  • the process subjected to the invention only requires a mixer defined as in any embodiment above.
  • the composition is free of all types of amino acids such as leucine and all types of stearates such as magnesium stearate. It means that required moisture resistance, stability, fluidity, content uniformity and dosage accuracy are ensured even in absence of a further excipient apart from carrier. It is significantly important considering the prior art and scientific observations in which the use of an amino acid or stearate, especially magnesium stearate, is shown as indispensable to ensure these qualifications.
  • the dry powder compositions subjected to the invention is suitable for administration in dosage forms such as capsules, cartridges or blister packs.
  • the one-unit dose of the composition in the dosage form is ranging between 100 to 500 mcg for fluticasone propionate and 10 to 100 mcg for salmeterol xinafoate.
  • the dry powder composition is presented in one dose capsule.
  • the said capsule may be a gelatin or a natural or synthetic pharmaceutically acceptable polymer such as hydroxypropyl methylcellulose and it is arranged for use in a dry powder inhaler and the composition is configured to be delivered to the lungs by the respiratory flow of the patient via the said inhaler.
  • one dose capsule contains 13 mg dry powder composition.
  • the dry powder composition subjected is suitable for administration in a multi-dose system, more preferably in a multi-dose blister pack which has more than one blister with air and moisture barrier property.
  • the said blister pack comprises an aluminum material covering them to prevent moisture intake.
  • Each blister is further encapsulated with a material resistant to moisture. By this means, blisters prevent water penetration and moisture intake from outside into the composition.
  • Each blister contains the same amount of active agent and carrier which is provided via content uniformity and dosage accuracy of the composition. For this invention, it is ensured by the specific selection of carriers, their amounts and their mean particle sizes. In a preferred embodiment, a blister contains 13 mg dry powder composition.
  • the said blister pack is arranged to be loaded in a dry powder inhaler and the composition subjected to the invention is configured to be delivered to the lungs via the said inhaler.
  • the inhaler has means to open the blister and to provide respective delivery of each unit dose.
  • dry powder composition subjected to the invention is used in the treatment of the respiratory diseases selected from asthma and chronic obstructive pulmonary disease and other obstructive respiratory diseases.

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  • Health & Medical Sciences (AREA)
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Abstract

L'invention concerne un procédé de préparation de compositions pharmaceutiques en poudre sèche et des compositions obtenues par ledit procédé, qui sont utilisées pour traiter la bronchopneumopathie chronique obstructive (MPOC), l'asthme et d'autres maladies obstructives des voies respiratoires.
PCT/TR2020/050779 2020-08-28 2020-08-28 Procédé de préparation de compositions en poudre sèche pour inhalation WO2022045994A1 (fr)

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PCT/TR2020/050779 WO2022045994A1 (fr) 2020-08-28 2020-08-28 Procédé de préparation de compositions en poudre sèche pour inhalation

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PCT/TR2020/050779 WO2022045994A1 (fr) 2020-08-28 2020-08-28 Procédé de préparation de compositions en poudre sèche pour inhalation

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WO2022045994A1 true WO2022045994A1 (fr) 2022-03-03

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Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2011093818A2 (fr) * 2010-01-29 2011-08-04 Mahmut Bilgic Compositions pharmaceutiques comprenant du salmétérol et du fluticasone
WO2019060604A1 (fr) * 2017-09-20 2019-03-28 Teva Branded Pharmaceutical Products R&D, Inc. Médicament inhalable

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2011093818A2 (fr) * 2010-01-29 2011-08-04 Mahmut Bilgic Compositions pharmaceutiques comprenant du salmétérol et du fluticasone
WO2019060604A1 (fr) * 2017-09-20 2019-03-28 Teva Branded Pharmaceutical Products R&D, Inc. Médicament inhalable

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