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(12) Patent Application Publication (10) Pub. No.: US 2014/0302147 A1 HARTMAN Et Al

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(12) Patent Application Publication (10) Pub. No.: US 2014/0302147 A1 HARTMAN Et Al US 20140302147A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2014/0302147 A1 HARTMAN et al. (43) Pub. Date: Oct. 9, 2014 (54) RESPRABLEAGGLOMERATES OF POROUS Publication Classification CARRIER PARTICLES AND MICRONIZED DRUG (51) Int. Cl. A619/16 (2006.01) (71) Applicants: Michael HARTMAN, Millbrae, CA A619/00 (2006.01) (US); Thomas ETARARA, A613 L/40 (2006.01) Burlingame, CA (US); Patrick TEUNG, A613 L/4704 (2006.01) Sunnyvale, CA (US); Jeffry G WEERS, A613 L/58 (2006.01) Belmont, CA (US) (52) U.S. Cl. CPC ........... A61 K9/1617 (2013.01); A61 K3I/4704 (72) Inventors: Michael HARTMAN, Millbrae, CA (2013.01); A61 K3I/58 (2013.01); A61K 31/40 (US); Thomas ETARARA, (2013.01); A61 K9/1682 (2013.01); A61 K Burlingame, CA (US); Patrick TEUNG, 9/0075 (2013.01) Sunnyvale, CA (US); Jeffry G WEERS, USPC ............................ 424/489: 514/312: 514/171 Belmont, CA (US) (57) ABSTRACT Embodiments of the present invention provide a dry powder Assignee: composition comprising porous carrier particles associated (73) NOVARTIS AG, Basel (CH) with one, two, three or more micronized drugs or APIs wherein an ordered mixture between the micronized drug or (21) Appl. No.: 14/202,262 drugs and the carrier particle results, such that the micronized drug or drugs adhere strongly to the carrier particles forming a stable ordered mixture of respirable agglomerates. Embodi (22) Filed: Mar 10, 2014 ments of the present invention further comprise a spray-dry ing process to create the respirable agglomerates. Embodi ments of the present invention further relate to the use of the Related U.S. Application Data dry powder formulation comprising respirable agglomerates (60) Provisional application No. 61/784,842, filed on Mar. for the treatment of a patient having a disease or condition 14, 2013. which is treatable thereby. Patent Application Publication Oct. 9, 2014 Sheet 1 of 7 US 2014/0302147 A1 Patent Application Publication Oct. 9, 2014 Sheet 2 of 7 US 2014/0302147 A1 8 :---------rSingie Capsule Funifornity, Ovivot 105A-7-6 : NvA237 Dose & w (A843 base xx 88: 8; 3. & xx x88: 88 « » « » « » . 8 . » « » - 3. r- - - - - - - - - - . « » vis: 8 Patent Application Publication Oct. 9, 2014 Sheet 3 of 7 US 2014/0302147 A1 Patent Application Publication Oct. 9, 2014 Sheet 4 of 7 US 2014/0302147 A1 A5 im. im actose Biend a. 3 Standard PinoSphere Respirable aggotterate rea 888 4s 2.82 SS 94 . ,34. re PreSep NG Stage EC (a Fig. 4 Patent Application Publication Oct. 9, 2014 Sheet 5 of 7 US 2014/0302147 A1 Asraex S. Mono Corbo -------------------------------------------------------------------------------------------------------------------------------------------------------------- S at 8.8 4.46 2,82 166 94. 8s ,34 r PreSep is Stage ECO a Fig 5 Patent Application Publication Oct. 9, 2014 Sheet 6 of 7 US 2014/0302147 A1 (SunOO) (ISueu Patent Application Publication Oct. 9, 2014 Sheet 7 of 7 US 2014/0302147 A1 (SunOO) (ISueu US 2014/0302147 A1 Oct. 9, 2014 RESPIRABLEAGGLOMERATES OF POROUS interactions can lead to variability in aerosol performance, CARRIER PARTICLES AND MICRONIZED with differences observed for each drug as a mono-compo DRUG nent or in the fixed dose combination, and with differences in dose strength. The complex interactions between the various FIELD OF THE INVENTION formulation components leads to difficulty in meeting the “combination rule', which relates that the in vitro aerosol 0001. The disclosure relates to physically stable and sub performance of each drug should be equivalent for the drug stantially uniform dry powder medicament formulations of alone and in combination. In order to overcome potential one, two, three, or more active ingredients that are useful for issues with meeting the combination rule with lactose blends, pulmonary administration, and in particular for administering Some groups have turned to Sophisticated devices, where medicaments to treat diseases of the lung. blends of each drug in the fixed dose combination is present in its own receptacle, and the two receptacles are aerosolized BACKGROUND concurrently (see for example, Anderson et al., WO 2003/ 0002 Active pharmaceutical ingredients (APIs) that are 061743). useful for treating respiratory diseases are often formulated for administration pulmonarily, to wit: by inhalation, such as SUMMARY OF THE INVENTION with portable inhalers. Pulmonary drug delivery methods and 0008 Accordingly, embodiments of the present invention compositions that effectively provide the pharmaceutical overcome the complexity observed with standard blends of compound at the specific site of action (the lung) potentially coarse lactose and micronized drug by creating ordered mix serve to minimize toxic side effects, lower dosing require tures of respirable agglomerates comprising Small porous ments, and decrease therapeutic costs. The development of carrier particles and micronized drug. Such systems for pulmonary drug delivery has long been a 0009 Embodiments of the present invention further pro goal of the pharmaceutical industry. vide a method for creating uniform ordered mixtures of respi 0003. Inhalation systems commonly used to deliver drugs rable agglomerates of Small porous particles and micronized locally to the pulmonary air passages are dry powder inhalers drug, comprising preparing a suspension of drug and carrier (DPIs), metered dose inhalers (MDIs), and nebulizers. DPIs in an anti-solvent, followed by removal of the anti-solvent in generally rely entirely on the patients inspiratory efforts to a drying process. introduce a medicament in a dry powder form to the lungs. 00.10 Embodiments of the present invention thus com 0004 To achieve good deposition of aerosolized particles prise a dry powder composition comprising carrier particles in the lungs, the particles should have an aerodynamic diam associated with one, two, three or more micronized drugs or eter in the respirable size range from 1 to 5um. However, fine APIs wherein an ordered mixture between the micronized particles of this size are highly cohesive with poor bulk pow drug or drugs and the carrier particle results, such that the der properties (e.g., poor powder flow, fluidization, and dis micronized drug or drugs adhere strongly to the carrier par persibility). ticles forming stable respirable agglomerates. The carrier 0005 To improve bulk powder properties of dry powder particles are Small and/or porous. aerosols, micronized drug particles are often blended with 0011 Embodiments of the invention comprise a plurality coarse lactose monohydrate carrier particles with a geometric of Small porous carrier particles, together with a plurality of diameter between 50 and 200 um. The blend forms a mixture one or more Small active drug particles which together form with the fine particles adhering to the carrier, and the mixture an ordered mixture of aerodynamically sized, pulmonarily taking on the bulk powder characteristics of the coarse carrier deliverable respirable agglomerates. particles. 0012 Embodiments of the present invention obviate the 0006 Engineered particle blends require a delicate bal need for dispersion of the drug from the carrier during a ance of surface forces. The adhesive force between the drug patients inhalation, and the patient instead inhales the respi and carrier must be strong enough to create an ordered mix rable agglomerates of micronized drug and Small porous car ture that maintains its structure during filling and on storage, rier particles into their lungs. As such, the physicochemical yet weak enough to allow the drug and carrier to separate properties of the drug Substance and its content in the powder during aerosol administration. The adhesive force between become largely irrelevant. This is in contrast to the conven the fine particles and the carrier particles in current marketed tional mixtures of coarse lactose and micronized drug, where products remains high, however, leading to mean lung deliv both the adhesive forces between the drug and carrier, and the ery efficiencies of just 10-30% of the nominal dose, and mean cohesive forces between the micronized drug particles are interpatient variability in lung delivery of approximately critical in the resulting bulk powder properties. Thus, the 30-50%. aerosol performance of the respirable agglomerates of 0007. In practice, the engineered blends of micronized embodiments of the present invention do not depend on a drug adhered to lactose carrier particles do not exist as simple balance of adhesive and cohesive forces between carrier and ordered mixtures. Drug may be stuck to coarse lactose, to fine drug particles, but instead depend only on the cohesive forces lactose, or to itself in large agglomerates. This led some to between the respirable agglomerates. refer to these complex formulations as “multi-particulate 0013 The cohesive forces between small porous carrier nightmares'. The interactions become even more complex for particles are significantly reduced relative to standard fixed dose combinations of two or more drugs. Each drug in micronized drug particles, due to the decreased area of con the combination exhibits a different force of adhesion with tact between particles afforded by the porous particle mor the carrier, and a different dependence of drug dispersion phology, and the hydrophobic nature of the excipients from the carrier with flow rate. In addition, there are addi enriched at the particle Surface. As a result, Small porous tional adhesive forces between the two drugs and between carrier
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