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• W3041292599 abstract "Journal of Aerosol Medicine and Pulmonary Drug DeliveryVol. 33, No. 2 AbstractsFree AccessAbstracts from The Aerosol Society Drug Delivery to the Lungs 30 Edinburgh International Conference Centre Edinburgh, Scotland, UK December 11–13, 2019Published Online:2 Apr 2020https://doi.org/10.1089/jamp.2020.ab01.abstractsAboutSectionsPDF/EPUB Permissions & CitationsPermissionsDownload CitationsTrack CitationsAdd to favorites Back To Publication ShareShare onFacebookTwitterLinked InRedditEmail Abstracts: Drug Delivery to the Lungs 3001.Optimisation of an isoniazid dry powder formulation for pulmonary administrationI. Sibum, F. Grasmeijer, P. Hagedoorn and H.W. FrijlinkDepartment of Pharmaceutical Technology and Biopharmacy, Ant. Deusinglaan 1, Groningen, 9713 AV, the NetherlandsThe aim of this study was to improve the storage stability by optimizing the L‐leucine coating of our previously described isoniazid formulation for pulmonary administration with the Twincer® or Cyclops® DPI. Time‐of‐Flight secondary ion mass spectrometry (TOF‐SIMS) showed that trileucine results in higher leucine:isoniazid ratios of 29 and 38 at the surface of the particles, compared to the previously described L‐leucine formulation, which has surface ratios of 11 and 28. The trileucine coating improves the stability considerably. All L‐leucine formulations are stable for less than a day with the exception for the 3% and 5% formulations spray dried at 120 °C and stored at 0% relative humidity (RH), which are stable for at least a month. The trileucine formulations are stable longer. The optimum formulation contains 3% trileucine and is spray dried at 40 °C. It is stable for at least three months, even when exposed to 75% RH. This formulation is best dispersed with the Cyclops®. While the Twincer® results in a higher fine particle fraction (FPF), retention is considerably higher. As a result, the Cyclops® results in a higher fine particle dose. The Cyclops® can disperse 100 mg, which results in a fine particle dose of 61.9 ± 1.8 mg. However, 100 mg was the maximum that fit in the inhaler. Further research is needed to study whether a higher dose can be dispersed by increasing the size of the dose compartment, and if this increases the fine particle dose further.02.Modifications to an inhaler device to aid the interpretation of clinical trial dataGeorge Bostock1, Tom Lawrie‐Fussey1, Alison Hart1, Neil McCarragher1, David Harris1, James Baker1, Mark Parry2 and Ben Crundwell11Cambridge Design Partnership, Church Road, Toft, Cambridge, CB23 2RF, UK2Intertek Melbourn, Saxon Way, Melbourn, Royston, SG8 6DN, UKSummaryOf the 200+ respiratory new chemical entities (NCE)s currently in clinical studies, a significant proportion are evaluated in clinical studies using the RPC Plastiape RS01 capsule dry powder inhaler (cDPI). As with any drug delivery device, it is prone to use error and variability of dose. This study demonstrates the benefits that can be obtained by instrumenting this type of device within the clinical setting. By equipping the cDPI with a variety of commercial off‐the‐shelf (COTS) sensors, we are able to identify several critical patient behaviours within our laboratory test data, including failure to pierce the capsule, inhalation flowrate profile, orientation of inhaler throughout and confirmation of successful capsule emptying. This enhanced‐fidelity approach to inhaler instrumentation, where the device is designed for long‐term in‐home clinical studies (without needing any additional training or charging by the patient), represents a significant improvement in the level of usage data captured. It is already clear that this quantified data could provide invaluable clarity on actual usage, potentially informing which data outliers could be discarded from drug efficacy studies, therefore improving the statistical power of the results.03.The environmental impact of MDI propellants – what now ?John N PritchardInspiring Strategies, 109 Main Street, Newtown Linford, LE6 0AF, UKSummaryThe phase‐out of chlorofluorocarbons for use in propellant‐based metered dose inhalers (pMDIs) has completed. This has not only had positive impacts on stratospheric ozone levels, but has reduced the emission of gases with global warming potential (GWP) by an amount similar to the annual emission of carbon dioxide produced by burning fossil fuels at the start of this decade to generate heat and electricity. However, the replacement propellants are hydrofluorocarbons (HFCs) still with significant GWP. As such, they are now considered within the basket of gases (F‐gases) whose phase‐down will be managed under the 2016 Kigali Amendment to the Montreal Protocol, which came into effect on 1st January 2019.The emissive use of pMDIs contributes only a small percentage of F‐gas emissions today but this will change as other uses are eliminated. There are now pressures from many different sources, including NICEiiNational Institute for Health and Care Excellence (2019). Patient Decision Aid. Inhalers for Asthma. to move to inhalers with lower carbon footprint. At the same time, the cost of HFCs will increase and availability of pharmaceutical grade propellant will decrease with a reduction in other applications. Without an affordable alternative to deliver rescue medication, pMDIs will remain essential. Whilst not‐in‐kind alternatives appear to be too expensive, alternative propellants with low GWP are required. One candidate, HFC 152a is in active development with encouraging results.04.Comparison of commercially available HPMC inhalation‐grade capsules and effect on aerosol performance within model DPI formulationsLi Ding1, Ashlee D. Brunaugh1, Christian Lee1, Qingyan (Jenny) Zhao1, Justin Kalafat2, Sanjay Powale3, Jnanadeva Bhat3, Dorene Almeida3, Anita Solanki3, Hugh DC Smyth‡11Division of Molecular Pharmaceutics and Drug Delivery, College of Pharmacy, The University of Texas at Austin, Austin, Texas, 78712, USA2ACG North America, LLC. 262 Old New Brunswick Road, Suite A, Piscataway, NJ 08854, USA3ACG Scitech Centre, 7 Prabhat Nagar Patel Estate, Jogeshwari (West), Mumbai, 400102, IndiaSummaryDespite the major role capsules have in many dry powder inhalation (DPI) systems, few studies have been performed to examine the interaction of the capsules with respirable powders. This study of four commercially available HPMC inhalation grade capsule types investigated their effect on aerosol performance of two model DPI formulations (lactose carrier and a carrier free formulation) at two different pressure drops. No statistically significant performance differences were found in carrier‐based formulation. Using carrier‐free rifampin formulation, Embocaps® VG capsules exhibited higher mean emitted fraction (EF) (89.86%) and lower mean mass median aerodynamic diameter (MMAD) (4.19) than Vcaps® (Capsugel) (85.54%, 5.10) and Quali‐V® I (Qualicaps) (85.01, 5.09) at 2 kPa pressure drop conditions (p < 0.05), but no significant performance differences between ACGcaps™ HI and Embocaps® VG in this study. At 4 kPa pressure drop condition, Embocaps® VG demonstrated a higher mean respirable fraction (RF)/fine particle fraction (FPF) with a 5 μm size cut‐off (RF/FPF <5 μm) (49.15% / 52.57%) versus ACGcaps™ HI (38.88 / 41.99%) (p < 0.01), and a higher mean RF/FPF with a 3 μm size cut‐off (RF/FPF <3 μm) (33.05% / 35.36%) versus Quali‐V® I (28.16% / 31.75%) (p < 0.05). Therefore, optimal capsule type varies depending on the DPI formulation and the desired performance outcomes. For the carrier‐based formulation, aerosol performance variability as well as the pierced‐flap detachment may also drive selection of capsule type. For the carrier free formulation, capsule type influenced EF, RF, FPF, and MMAD.05.Investigating the effect of nasal suspension rheology on API particle size and dissolution propertiesGonçalo Farias, Abel Garcia Penas, William Ganley, Robert Price, Benedicte Grosjean and Jagdeep ShurNanopharm Ltd, an Aptar Pharma Company, Cavendish House, Hazell Drive, Newport, NP10 8FYSummaryDemonstrating bioequivalence of nasal suspension sprays is a challenging task. The application of analytical tools are required to determine particle size of the active pharmaceutical ingredient (API) and formulation structure. This study investigated, the utility of the Morpologi‐M4‐ID to investigate the particle size distribution (PSD) of API formulated nasal sprays. Rotational rheometry was used to investigate formulation structure. A systematic approach was utilised to develop a robust method for the analysis of the PSD of Mometasone fuorate in five test formulations containing different concentrations of Avicel. Rheometric measurements were sensitive to variations in the Avicel content and at lower concentration than Nasonex exhibited different gel‐like and shear thinning properties. Together, these analytical methods may facilitate the determination of critical material and process attributes that may affect drug product quality.06.Assessment of Naïve Inhaler User Inhalation Profiles and the Impact on Subsequent Aerosol Performance : Comparison of a Dry Powder Inhaler (DPI) and a Pressurized Metered Dose Inhaler (pMDI) with Valved Holding Chamber (VHC) using the Same Active Pharmaceutical Ingredients (APIs)Jason A Suggett1, Mark W Nagel1 and Jolyon P Mitchell21Trudell Medical International, 725 Third Street, London, Ontario, NV5 5G4, Canada2Jolyon Mitchell Inhaler Consulting Services Inc., 1154 St. Anthony Road, London, N6H 2R1, CanadaSummaryThe present scoping study was designed to determine the potential impact of variable inhalation technique on fine particle mass (FPM) emitted from the widely prescribed Diskus* passive DPI (GSK) compared with inhalation of the same active pharmaceutical ingredients (APIs) via a pMDI with antistatic AeroChamber Plus* Flow Vu* VHC either tidally breathing or taking a slow inhalation followed by a breath‐hold. Inspiratory flow rate‐elapsed time profiles were initially acquired with three volunteer adult participants, trained in the use of both inhalers, using a pneumotachometer with its own mouthpiece attached to the mouthpiece of the inhaler, which was rendered incapable of delivering medication. Subsequently, each inhalation waveform was re‐played via an ASL5000 breathing simulator in order to actuate either an Advair* Diskus* DPI (250 μg/actuation fluticasone propionate (FP) +50 μg/actuation salmeterol xinafoate (SX)) or an Advair* Evohaler* pMDI (250 μg/actuation FP +25 μg/actuation SX with VHC. In each case, the emitted aerosol was sampled via a Next Generation Impactor (NGI) operated at either 60 L/min, or at 30 L/min alone for pMDI + VHC evaluations. Variation in breathing profile parameters was observed in both delivery platforms, however, FPM<5.0μm for either API delivered by pMDI with VHC was higher and more consistent across all breathing patterns from the three volunteers.07.Extending the capability of high dose DPI formulation using a new blending technologyJasdip S Koner1, David Wyatt1,2, Shital Lungare1, Rhys Jones1 and Afzal R Mohammed1,21Aston Particle Technologies Ltd., Aston University, Birmingham, B4 7ET, United Kingdom2Aston University, School of Life & Health Sciences, Birmingham, B4 7ET, United KingdomSummaryIndustry standard blending technologies, such as high shear mixers, do not adequately deagglomerate and disperse active pharmaceutical ingredient (API) particles at concentrations greater than 5%w/w so traditional carrier‐based DPI systems are dose limited. It is thought that the challenge of developing a ‘high dose’ dry powder inhaler (DPI) formulation routinely requires the application of advanced manufacturing techniques such as spray drying to formulate powder blends. Unfortunately, such technologies often require that the API be subjected to less than ideal processing conditions and are disproportionately expensive to implement. A relatively new and benign dry powder blending technology has been employed in this work to attempt to extend the dosing range of traditional DPIs more simply. At the heart of this technology, individual particles are dispersed by centrifugal force and fluidised by an air‐blade which does not damage the input materials. A model API, micronised fluticasone propionate (FP), was processed with inhalation grade lactose at concentrations of up to 25%w/w. At all concentrations studied, the new technique fully removed all agglomerates of the API. At FP concentrations above 5%w/w, multilayers of fine particles were formed at the surface of the carrier particles. At all concentrations the formulations were found to produce homogeneous powder blends with excellent content uniformity, more than adequate for requirements of a high dose DPI formulation. Furthermore, the aerodynamic particle size distributions determined from each of the blends became increasingly fine as the FP concentration was increased. Scanning electron micrographs showed that multilayer structures formed at high concentration on the lactose surface have an open porous nature. It is reasonable to hypothesise that it is the nature of the structure of the surface coating that determines the respirable dose performance of the blend.08.Monitoring k‐valve Latching Performance using High‐Speed X‐Ray ImagingA.P. McKiernan1, J. Tuohy1, T. Nicholls2, H Danagher2, C. Duignan11Prior PLM Medical, IDA Business & Technology Park, Carrick‐on‐Shannon, N41 WK46, Ireland2Mundipharma International Technical Operations Limited Cambridge Science Park, Milton Road, Cambridge, CB4 0GW, UKSummaryIt is well known that drug delivery into the lungs is highly dependent on a patient's inhaler technique. Failure to co‐ordinate actuation with dose inhalation from pressurised Metered Dose Inhalers (pMDIs) is often a barrier to correct dose administration. Dry Powder Inhalers (DPI's) do not need such coordination of actuation and inhalation but require forceful inhalation which many patients fail to achieve [1].Breath triggered inhalers (BTI) have been developed to help these problems. The k‐haler® is a breath triggered inhaler with a unique mechanism of dose delivery based on a kinked valve design, dosing being initiated by patient breath inhalation. The device is easy to use, activated with a low inspiratory force and emits a gentle plume making it suitable for patients who have difficulty with producing high inspiratory force needed for DPIs [2, 3].The k‐haler has evolved since the initial concept design and now incorporates a dose counter and bespoke mechanism to accommodate canister height variability resulting from the canister crimping process. The k‐valve® mechanism is a kinked tube acting as a holding chamber. Latching of the kinked k‐valve component occurs as the mouthpiece is opened and is important for placing the holding chamber into a closed state so that the dose is retained. The mechanism unlatches the k‐valve under a low inspiratory flow rate, the tube unkinks, and the dose is delivered into the lungs.A high‐speed phase‐contrast X‐Ray imaging technique was employed at a synchrotron facility to monitor, diagnose and resolve latching performance and the results have enabled comparison of real internal device motion to theoretical expectation. The technique is significantly faster and more sensitive than industrial CT scanning. This work has led to design enhancement to increase latching margin and further improve overall performance.Key MessageHigh‐speed phase contrast X‐Ray imaging enables quantification of dynamic angles and displacements and has been used as part of k‐haler development programme to optimise latching performance and to enable comparison of real internal device motion to theoretical calculation.09.Clogging Challenge Test on Mesh Vibrating Nebuliser Using Budesonide SuspensionEdgar Hernan Cuevas Brun, Yi‐Ying Chen, Ke‐Ting Chen, and Huei‐An TsaiHCmed Innovations Co. Ltd., Rm. B, 10F., No.319, Sec.2, Dunhua S. Rd., Taipei City, 106, TaiwanSummaryIn the past few decades, inhalation therapy has undergone a series of changes due to the introduction of new technologies and treatments; among them, vibrating mesh nebulisers have made their way into the field supported by their features that highlight portability and efficiency to deliver respiratory drugs. Although these devices have been proven to produce desired outcomes, there are still limitations to their use. Mesh clogging is one of the top concerning issues caused by device handling and cleaning habits. It can influence aerosol particle size and nebulisation time, the former being particularly relevant to central and peripheral lung deposition. This study investigated potential mesh clogging on a nebuliser and the effects it could cause on the aerosol characteristics. Deepro™ Vibrating Mesh Nebuliser was used to aerosolize budesonide inhalation suspension during several days without washing the device. The results showed that aerosol particle size stayed below 5 μm and fine particle fraction held above 45% even when the device was not washed for up to five days. Some minimal variations in the results were normalized once the device was washed under standard cleaning procedure in both challenge tests. The results supported the hypothesis that the nebuliser did not exhibit significant mesh clogging given that aerosol characteristics remained stable. The assumption that Deepro™ did not exhibit major mesh clogging characteristics highlighted the advantages of its performance. Further research is required to examine data during longer challenge test periods and to compare its performance with other devices.Key MessageDeepro™ was found not to exhibit substantial mesh clogging during two challenge tests, considering the expected effects of clogging. The performance of the device was described as stable even when it was not washed for up to 5 days. The results contradicted typical concerns about clogging in mesh nebulisers.10.How does the device determine nose‐to‐brain drug delivery to mice?Joana Gonçalves1,2, Soraia Silva1,2, Carla Vitorino3,4, Gilberto Alves5 and Ana Fortuna1,21Faculty of Pharmacy of University of Coimbra, Pólo das Ciências da Saúde, Azinhaga de Santa Comba, Coimbra, 3000‐548, Portugal2CIBIT/ICNAS – Coimbra Institute for Biomedical Imaging and Translational Research of University of Coimbra, Pólo das Ciências da Saúde, Azinhaga de Santa Comba, Coimbra, 3000‐548, Portugal3Centre for Neurosciences and Cell Biology (CNC), University of Coimbra, Faculty of Medicine, Rua Larga, Pólo I, 1st floor, 3004‐504 Coimbra, Portugal4Coimbra Chemistry Centre, Department of Chemistry, University of Coimbra, Rua Larga, 3004‐535 Coimbra, Portugal5CICS‐UBI – Health Sciences Research Centre, University of Beira Interior, Av. Infante D. Henrique, Covilhã, 6201‐506 PortugalSummaryOwing to the unique anatomical connection between nasal cavity and central nervous system, a great deal of interest has been focused on the exploitation of intranasal route for the delivery of therapeutics directly to the brain by circumventing the blood‐brain barrier. Particularly, nose‐to‐brain delivery of the aerosolized levetiracetam was recently demonstrated in mice, emerging as a new hope for the treatment of epilepsy.However, it is not yet clear whether the extent of nose‐to‐brain drug delivery depends (or not) on the device utilized for intranasal administration.Therefore, a thermoreversible gel loaded with levetiracetam was intranasally administered to CD‐1 male mice with a micropipette or a polyurethane tube 1 cm inserted into nasal cavity. At 5 and 15 min post‐administration, concentrations were determined in plasma, brain and lungs and plasma‐tissue ratios calculated.Results showed that when administered with the micropipettor, levetiracetam was not detected in the brain, and its concentrations in plasma and lungs were only 17% and 6% of those observed with the polyurethane tube. Moreover, plasma‐brain ratio observed with the polyurethane tube was lower than that reported for aerosolized levetiracetam, suggesting that a direct delivery into the brain may occur, but at less extent. Moreover, lung concentrations with polyurethane tube were significantly higher at 5 min (151.36 μg/g).This study highlights (i) the importance of selecting the adequate device for intranasal administration, that does not compromise the direct passage into the brain, and (ii) proposes the use of an aerosolizer to attain this objective during pre‐clinical studies, in order to prompt a correct translation to humans.11.Incorporating Chemotherapeutic Drug into a Personalisable Silicone Airway Stent for the Treatment of Lung Cancer and TracheobronchomalaciaJesse Xu1,2, Hui Xin Ong1,2, Michael Byrom3, Jonathan Williamson4, Daniela Traini1,2 and Paul M. Young1,21Respiratory Technology Group & Centre for Lung Cancer Research, Woolcock Institute of Medical Research, 431 Glebe Point Road, Glebe, Sydney, NSW 2037, Australia2Discipline of Pharmacology, Faculty of Medicine and Health, University of Sydney, Camperdown, Sydney, NSW 2006, Australia 3RPA Institute of Academic Surgery, Sydney, NSW 2050, Australia 4MO Respiratory and Sleep, Macquarie University Hospital, Macquarie University, Sydney, NSW 2113, AustraliaSummaryCentral Airway Obstruction (CAO) is a symptom experienced by patients who suffer from obstructed airways between the trachea to secondary bronchus. These may arise from airway strictures, obstructing airway cancers, or tracheobronchomalacia. Such disease states result in loss of airway patency and the potential dynamic collapse of the airway wall, which could be managed by airway stents. However, current marketed stents are a ‘one shape fits all’ with individual airway geometries overlooked. As a result, issues of granulation tissue growth and stent migration are prevalent. Current research has focused towards improvement in 3D‐imaging and 3D‐printing methods, with silicone moulding used to create custom‐made stents that are personalised to individual airways. In this study, a chemotherapeutic drug, paclitaxel, was investigated for its possibility to be incorporated in to a personalisable silicone airway stent model. This study aims to establish the release profile and cellular toxicity of paclitaxel when incorporated within silicone. It was confirmed that paclitaxel was eluted from the silicone at different rates between raw paclitaxel concentrations of 0.02%, 0.20%, and ethanol diluted concentrations. It was also confirmed that lung epithelial cell lines remained viable after contact with paclitaxel eluting silicone coupons. This study concluded that there is potential in incorporating silicone stents with drugs such as paclitaxel during the manufacturing process, and its possible future in the treatment of CAO.12.Mapping carrier properties for the intended aerodynamic performance space of dry powder inhalers I: a combinational approach using multivariate analysis andin‐vitrocharacterizationJoana T. Pinto1 and Amrit Paudel1,21Research Center Pharmaceutical Engineering GmbH, Inffeldgasse 13, Graz, 8010, Austria2Institute for Process and Particle Engineering, Graz University of Technology, Inffeldgasse 13,Graz, 8010, AustriaSummaryIn dry powder inhaler (DPI) formulations, it is important to understand if newly engineered carrier and drug particles have the necessary characteristics to achieve the desired performance. Therefore, it was the objective of this work to understand how distinct particle characteristics of various lactose grades presenting distinct solid‐states, particle size distribution (PSD) and morphologies could potentially influence powder bulk properties and thereby affect the DPI performance. Low‐dose blends of salbutamol sulphate (SS) with the distinct lactose particles were prepared and their in‐vitro aerodynamic performance investigated using different device types (capsule v/s. reservoir) at increasing airflow rates (28,60 and 100 L/min). To derive insights into the influence of the various particle and bulk properties on the parameters derived in‐vitro a multivariate statistical analysis was carried out. Likewise, it was shown that when different aerosolization mechanisms and airflows are at work dissimilar forces act on the formulations resulting in distinctive particle and bulk properties impacting the in‐vitro aerodynamic performance. Generally, it was apparent that in combination with a capsule‐based device, carriers with smaller particle size (Dv0.5 ≈ 50 μm) and a certain fraction of fines (about 10%) are less susceptible to different airflows. For certain reservoir devices, excipient particles with a larger particle size (Dv0.5 ≥ 130 μm) might be more advantageous.13. Regional Deposition Analysis Of Non‐Radioactive Aerosol In Mouth‐Throat Models And A Realistic 3d Printed Oropharynx ModelTaciano Rocha, Rod Rhem and Myrna DolovichResearch St Joseph's Hamilton and McMaster University, Hamilton, ON, CanadaSummaryAims and Methods: Given the evolving understanding of in vitro/in vivo relationships for aerosol drug delivery and the demand for clinically relevant model tests, we evaluated the drug delivery from orally inhaled aerosol devices using an in vitro model with a pMDI (5x 100 μg salbutamol) and a Vibrating Mesh nebulizer (VM; 500 μg salbutamol) incorporating three distinct mouth‐ throat (M‐T) inlet models (United States Pharmacopeia Inlet – USP, Alberta Idealized Throat ‐ AIT, and McMaster 3D printed Oropharynx – 3DOR). Furthermore, we evaluated the regional drug deposition over the three compartments of the 3DOR (mouth, pharynx, and trachea). All measurements were performed using a fixed Breath Simulator adult breathing pattern.Results and conclusion: The pMDI aerosol presented similar deposition between all three M‐T inlets, and at the inspiratory filter as well. Whereas, when the VM nebulizer was used, a lower inlet deposition was seeing in the USP, compared to both 3DOR and AIT (μg; p = 0.001, CI95% ‐73.8 to ‐10.6; p = 0.006, CI95% ‐79.9 to ‐16.6, respectively). The amount of drug collected on the inspiratory filter was significantly higher with the USP, compared to AIT (μg, CI95% 2.5 to 65.8, p = 0.03), and to 3DOR (μg, CI95%14.2 to 77.5, p = 0.002). The tri‐compartmental analysis of 3DOR presented a significant difference in distribution of aerosol when the pMDI was used compared to the vibrating MESH nebulizer, with major aerosol deposition (77%) at the mouth, whereas the VM presented a homogenous distribution between the three compartments. The inhalation devices presented distinct partitioning deposition throughout the inlet models, based on their characteristics.Key MessageIn vitro outcomes may vary with the M‐T inlet used to introduce the aerosol from the delivery system to the model components. In this regard, models need to differentiate between those for QC and those that provide information on in vivo drug delivery.14. Investigation of DPI Particle Microstructure by MDRS to Explain Differences Observed in NGI Results Between Equivalent ProductsDaniella Davies1, Mark Copley2, Deborah Huck‐Jones3, Mervin Ramjeeawon1, Chris Vernall1, Anna Sipitanou2, Robert Taylor3, Teresa Iley11Intertek Melbourn, Saxon Way, Melbourn, Royston, SG8 6DN, UK2Copley Scientific Ltd., Colwick Quays Business Park, Private Road No. 2, Nottingham, NG4 2JY, UK3Malvern Panalytical Ltd, Grovewood Rd, Malvern Worcestershire WR14 1XZ, UKSummaryThe use of the Next Generation Impactor (NGI) to measure the aerodynamic particle size distribution of Dry Powder Inhalers (DPI) is a well‐established technique that allows quantification of Active Pharmaceutical Ingredient (API) present in the respirable fraction <10 μm. Quantification is typically performed via chemical assay (e.g. HPLC).Morphologically‐Directed Raman Spectroscopy (MDRS, performed using the Morphologi 4‐ID by Malvern Panalytical) can be used to characterise particles to evaluate morphological differences between API and excipients. As well as providing a different method to the NGI to measure the particle size of individual APIs in dual (or triple) therapy DPI products, qualitative information can also be understood from the Raman chemical identification and will highlight the presence and composition of agglomerates [1].This is something that cannot be inferred solely from impactor data but will provide hugely important information as to the way the product may behave in‐vivo. The number and composition of agglomerates (i.e. whether they are drug‐drug, drug‐excipient or a combination of these) will ultimately influence dissolution behaviour.15. Mapping carrier properties for the intended aerodynamic performance space of dry powder inhalers II: a combinational approach using multivariate analysis andin‐silicocharacterizationJoana T. Pinto1 and Amrit Paudel1,21Research Center Pharmaceutical Engineering GmbH, Inffeldgasse 13, Graz, 8010, Austria2Institute for Process and Particle Engineering, Graz University of Technology, Inffeldgasse 13, Graz, 8010, AustriaSummaryPhysiologically based pharmacokinetic (PBPK) models can provide crucial information about the performance space intended for medicinal products. Data generated in‐vitro during the development of dry powders inhaler (DPI) products can provide valuable inputs for PBPK modelling. Therefore, the in‐vitro performance of salbutamol sulphate (SS) blends with diverse types of lactose particles was investigated using different device types (capsule v/s. reservoir) at distinct airflows and the generated data input into a PBPK model developed for SS. Likewise, the influence of various carrier particle and bulk properties in combination with different device types and airflows could be investigated in‐silico. Mechanistic insights into the potential impact of carrier characteristics on the in‐vivo performance of a DPI were statistically derived by correlating the distinct carrier characteristics with the performance predicted" @default.
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• W3041292599 title "Abstracts from The Aerosol Society Drug Delivery to the Lungs 30 Edinburgh International Conference Centre Edinburgh, Scotland, UK December 11–13, 2019" @default.
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