Choice of Nebulizer for Inhaled Tobramycin Treatment in Cystic Fibrosis
|
|
- Ami Little
- 6 years ago
- Views:
Transcription
1 Respiratory Drug Delivery 2010 Müllinger et al. Choice of Nebulizer for Inhaled Tobramycin Treatment in Cystic Fibrosis Bernhard Müllinger, 1 Thomas C. Topini, 2 Anna L. Valeri, 2 Juliane Gleske, 1 Philipp Kroneberg, 1 Monika Hartmann, 1 and Gerhard Scheuch 1 1 Activaero GmbH, Gemuenden/Wohra, Germany 2 Chiesi Farmaceutici S.p.a, Parma, Italy KEYWORDS: tobramycin, treatment time, antibiotic, drug output, particle size distribution, laser diffraction analysis INTRODUCTION The success of an anti-infective inhalation treatment is strongly dependent on the choice of the inhalation device (1). Generally, nebulizer systems are sold separately from solutions and suspensions containing active substances for nebulization. Therefore, these formulations are often inhaled via any available nebulizer rather than the system used during the development of the medicinal product. Most conventional nebulizers require a large filling amount of the compound, because only a small fraction is deposited in the targeted lung region. In contrast, techniques based on controlled inhalation allow a high and reproducible deposition of the drug in specific lung regions (2-4). The aim of this evaluation was to assess and compare in vitro performance of drugdevice combination of standard jet, vibrating mesh, ultrasonic and intelligent controlled breathing nebulizers with a tobramycin solution for inhalation (Bramitob, Chiesi Farmaceutici S.p.a). A secondary objective was to assess the optimal setting for the controlled-breathing inhalation system to achieve an equivalent lung dose of tobramycin as compared to the reference PARI LC PLUS. METHODS Bramitob was aerosolized by a jet nebulizer with controlled breathing and aerosol pulse technology (AKITA JET with PARI LC SPRINT Sinus nebulizer) as well as by the jet nebulizer (PARI LC PLUS with TurboBoy N compressor) that was used in the phase III trials within EU for inhalation of Bramitob. The data for the vibrating mesh nebulizer (Pari eflow ) and the ultrasonic nebulizer (Optineb-ir) was extracted from a previous aerosol characterization study (5). The AKITA JET nebulizer system guides the patient through the inhalation treatment using a controlled flow rate and inhalation volume (Figure 1). The AKITA uses a jet nebulizer (PARI LC SPRINT Sinus) that is triggered by the AKITA at a pre-selected period of time once 1
2 2 Choice of Nebulizer for Inhaled Tobramycin Treatment in Cystic Fibrosis Müllinger et al. the patient starts to inhale. In order to individualize the breathing pattern as well as assure correct dosage and reproducible drug delivery, a smart card technology is incorporated into the AKITA JET inhalation system. Figure 1. AKITA JET nebulizer system with PARI LC SPRINT sinus nebulizer. The devices were investigated in regards to particle size distribution and device output. All measurements were performed with five different nebulizer handsets of each device. Nebulizers were filled with 4 ml Bramitob inhalation solution containing 75 mg/ml Bramitob. Particle size distribution was determined using a laser diffraction particle sizer (Helos, Sympatec). Delivered dose was assessed by radioactive analysis of filter samples. Bramitob solution was labelled with a radioactive tracer ( 99m Tc), nebulized and collected on a filter. The radiolabelling method and the filter method were validated for Tobramycin solutions at different drug concentrations (7). The amount of radioactivity on the filter was determined by scintigraphy. To determine the delivered dose, filter samples were taken while breathing was simulated (Hans Rudolph, USA). A sinus breathing pattern was used to simulate breathing (0.5 l/breaths, 15 breaths/min) for devices that did not provide active control of breathing pattern (PARI LC PLUS with BOY compressor). For the AKITA JET, an optimized breathing pattern was used during output tests controlled by the AKITA JET with 4.0 sec inhalation time per breaths and a fixed number of breaths to control the delivered dose. This pre-set dose was calculated on the basis of the reference dose of the PARI LC PLUS nebulizer (Figure 2?). The treatment time needed to achieve a lung dose of 38mg compared to the reference nebulizer PARI LC PLUS was calculated by means of the actual measured time. Lung dose was calculated using the deposition model that was developed by the International Commission for Radiation Protection (ICRP). The ICRP deposition model is a semi-empirical model that allows calculation of regional deposition within the respiratory tract based on the input parameters such as particle size distribution, inhalation volume, inhalation flow rate for healthy subjects at different age. (6-8)
3 Respiratory Drug Delivery 2010 Müllinger et al. 3 RESULTS Particle size (MMD) was smallest for AKITA JET (3.6µm) and largest for Optineb-ir (5.5µm). Geometric standard deviation was smallest for the PARI eflow (1.6) (Table 1). Table 1. Particle size (MMD) measured by laser diffraction (n=5). In this aerosol characterization study of Bramitob, no significant differences in the lung dose could be noticed for the AKITA JET (p Wilcoxon = ) and the PARI eflow (p Wilcoxon = ) compared to the PARI LC PLUS. But the Optineb-ir showed a significantly lower lung dose (p Wilcoxon < ). Delivered dose and variability of dose was lowest for AKITA JET (Figure 3). Figure 3. Comparison of delivered dose and lung dose. Calculated treatment time ranged between 5 and 12 min. Shortest treatment times were observed for the eflow and AKITA JET (Figure 4). copyright 2010 VCU
4 4 Choice of Nebulizer for Inhaled Tobramycin Treatment in Cystic Fibrosis Müllinger et al. Figure 4. Calculated treatment time for the delivery of a 38mg to the lungs for the tested nebulizers. DISCUSSION In our study, it could be demonstrated, that compared with conventional inhalation devices, the AKITA JET allows for a reduction of the delivered dose of 44%, while having comparable lung dose of Bramitob. Because of the reduction of the required nebulized dose, there is a reduction of treatment time compared to the LC PLUS and Optineb systems, which may improve the compliance of the patients. The AKITA JET nebulizer system provides a time efficient and highly reproducible drug delivery to the lungs due to its controlled breathing and aerosol pulse technology.
5 Respiratory Drug Delivery 2010 Müllinger et al. 5 REFERENCES 1. Standaert, T.A., Vandevanter, D., Ramsey, B.W., Vasiljev, M., Nardella, P., Gmur, D., Bredl, C., Murphy, A., and Montgomery, A.B. (2000), The choice of compressor effects the aerosol parameters and the delivery of tobramycin from a single model nebulizer, J Aerosol Med, 13(2), pp Brand, P., Schulte, M., Wencker, M., Heripch, C.H., Klein, G., Hanna, K., and Meyer, T. (2009), Lung deposition of inhaled alpha1-proteinase inhibitor in cystic fibrosis and alpha1- antitrypsin deficiency, Eur Respir J, 34, pp Brand, P., Friemel, I., Meyer, T., Schulz, H., Heyder, J., and Häußinger, K. (2000), Total deposition of therapeutic particles during spontaneous and controlled inhalations, J Pharmaceut Sci, 89, pp Bennett, W.D. (2005), Controlled inhalation of aerosolised therapeutics, Expert Opin Drug Deliv, 2(4), pp Topini, T.C.M., Pechtold, O., Sommerer, K., and Garzia, R. (2008), In vitro characterization of BRAMITOB (inhaled tobramycin 300mg/4ml) with next generation nebulizers, J Cystic Fibrosis, 7 (Suppl 2), p International Commission on Radiological Protection (1994), Human respiratory model for radiological protection, ICRP Publication 6, Ann ICRP, 24, pp Köbrich, R., Rudolf, G., and Stahlhofen, W. (1994), A mathematical model of mass deposition in man, Ann Occup Hyg, 38, pp Fleming, J.S., Epps, B.P., Conway, J.H., and Martonen, T.B. (2006), Comparison of SPECT aerosol deposition data with a human respiratory tract model, J Aerosol Med, 19(3), pp copyright 2010 VCU
6 Notes 6
FRI aerosol. deposition. A unique way to look at regional inhaled drug deposition.
FRI aerosol deposition A unique way to look at regional inhaled drug deposition www.fluidda.com EXECUTIVE SUMMARY FRI - AN UPDATE OF SCINTIGRAPHY FRI deposition technology is based on CT imaging, and uses
More informationFRI aerosol. deposition. A unique way to look at regional inhaled drug deposition.
FRI aerosol deposition A unique way to look at regional inhaled drug deposition www.fluidda.com EXECUTIVE SUMMARY Since 2005, Functional Respiratory Imaging (FRI) has been used many times to evaluate the
More informationParticle Clearance in Human Bronchial Airways: Comparison of Stochastic Model Predictions with Experimental Data
Ann. occup. Hyg., Vol. 46, Supplement 1, pp. 329 333, 2002 2002 British Occupational Hygiene Society Published by Oxford University Press DOI: 10.1093/annhyg/mef659 Particle Clearance in Human Bronchial
More informationCitation for published version (APA): Westerman, E. M. (2009). Studies on antibiotic aerosols for inhalation in cystic fibrosis s.n.
University of Groningen Studies on antibiotic aerosols for inhalation in cystic fibrosis Westerman, Elisabeth Mechteld IMPORTANT NOTE: You are advised to consult the publisher's version (publisher's PDF)
More informationOPTIMISING ANALYTICAL STRATEGIES FOR THE DEMONSTRATION OF BIOEQUIVALENCE IN A GENERIC NEBULISER
OPTIMISING ANALYTICAL STRATEGIES FOR THE DEMONSTRATION OF BIOEQUIVALENCE IN A GENERIC NEBULISER US FDA guidance for the in vitro demonstration of bioequivalence in a generic nebuliser directly references
More informationUse of Math Modelling to Understand Delivery of Biopharmaceutical Molecules to the Lung
Use of Math Modelling to Understand Delivery of Biopharmaceutical Molecules to the Lung Nia Stevens 9 th November 2016 Thanks to Richard Kaye, James Mitchell, Dave Prime at GSK Bahman Asgharian and Owen
More informationNIV and Aerosoltherapy
NIV and Aerosoltherapy Workshop Jean-Bernard Michotte (Lausanne-CH) Simone Gambazza (Milano-IT) Jean-Bernard Michotte Haute Ecole de Santé Vaud, 1011 Lausanne - Suisse Cliniques Universitaires Saint-Luc,
More informationDolci U 1, Sidler-Moix AL 1, Di Paolo ER 1,Berger- Gryllaki 1 M, Pannatier A 1, Cotting J 2
SALBUTAMOL DELIVERY IN AN IN VITRO PAEDIATRIC VENTILATOR-LUNG MODEL: COMPARISON OF JET, ULTRASONIC AND MESH NEBULISERS Dolci U 1, Sidler-Moix AL 1, Di Paolo ER 1,Berger- Gryllaki 1 M, Pannatier A 1, Cotting
More informationNOVEL DEVICES FOR INDIVIDUALIZED CONTROLLED INHALATION CAN OPTIMIZE AEROSOL THERAPY IN EFFICACY, PATIENT CARE AND POWER
71 Eur J Med Res (2009) 14(Suppl. IV): 71-77 I. Holzapfel Publishers 2009 NOVEL DEVICES FOR INDIVIDUALIZED CONTROLLED INHALATION CAN OPTIMIZE AEROSOL THERAPY IN EFFICACY, PATIENT CARE AND POWER OF CLINICAL
More informationPulsating Aerosols Prove Highly Effective in Delivering Medications to the Sinuses
PARI Respiratory Equipment, Inc. White Paper 2943 Oak Lake Blvd. Midlothian, VA. 23112 800 327 8632 www.pari.com Pulsating Aerosols Prove Highly Effective in Delivering Medications to the Sinuses Bob Bruno,
More informationISO INTERNATIONAL STANDARD. Anaesthetic and respiratory equipment Nebulizing systems and components
INTERNATIONAL STANDARD ISO 27427 First edition 2009-05-01 Anaesthetic and respiratory equipment Nebulizing systems and components Matériel d'anesthésie et de réanimation respiratoire Systèmes de nébulisation
More informationPredictive modeling of deposition, dissolution, absorption and systemic exposure
Predictive modeling of deposition, dissolution, absorption and systemic exposure IPAC-RS/UF Orlando Inhalation Conference March 20, 2014 Per Bäckman and Bo Olsson, AstraZeneca R&D, Mölndal Sweden The views
More informationAEROSOL THERAPY: THE PRACTICALITIES
AEROSOL THERAPY: THE PRACTICALITIES Lester I. Harrison, PhD Section Head, Clinical Pharmacokinetics, 3M Pharmaceuticals, 3M Center 270-3S-05, St. Paul, MN, USA 55144 liharrison@mmm.com Introduction: Horses,
More informationLatex Free. An affordable, easy to use, high density, small volume nebulizer with a breath enhanced design! Breath Enhanced High Density Jet Nebulizer
Latex Free Breath Enhanced High Density Jet Nebulizer The NebuTech HDN nebulizer, a breath enhanced design, by Salter Labs is quickly becoming the product of choice for caregivers and patients alike. This
More informationThis letter is to notify you of recent changes to the PULMOZYME product monograph. Please note, additions/changes have been highlighted in yellow.
April 9, 2015 Subject: Revised Product Monograph - PULMOZYME (dornase alfa) Dear Drug Information / Poison Control Centres, This letter is to notify you of recent changes to the PULMOZYME product monograph.
More informationRespiratory Drug Delivery. Be inspired. Nebulizer and compressor catalog
Respiratory Drug Delivery Be inspired Nebulizer and compressor catalog Introduction Inspiring innovation Philips is committed to enhancing patients lives by delivering cost-effective solutions that drive
More informationAerosol Delivery of Recombinant Human DNase I: In Vitro Comparison of a Vibrating-Mesh Nebulizer With a Jet Nebulizer
Aerosol Delivery of Recombinant Human DNase I: In Vitro Comparison of a Vibrating-Mesh Nebulizer With a Jet Nebulizer Jeremy C Johnson DO, J Clifford Waldrep PhD, Jennifer Guo MD, and Rajiv Dhand MD FAARC
More information21/03/2011 AEROSOL DEPOSITION AND THE ASSESSMENT OF PULMONARY DRUG DELIVERY. Fundamentals of aerosols
AEROSOL DEPOSITION AND THE ASSESSMENT OF PULMONARY DRUG DELIVERY AEROSOL DEPOSITION AND THE ASSESSMENT OF PULMONARY DRUG DELIVERY Steve Newman Scientific Consultant Norfolk, UK steve.newman@physics.org
More informationwithout the permission of the author Not to be copied and distributed to others
Emperor s Castle interior-prato What is the Role of Inhaled Polymyxins for Treatment of Respiratory Tract Infections? Helen Giamarellou CONCLUSIONS: Patients with Pseudomonas and Acinetobacter VAP may
More informationRespiratory Therapy. Medical/Scientific/General Background
Respiratory Therapy Medical/Scientific/General Background Marketing Europe Dr. Rainer Jakobs PMM Europe 1 Dr. Rainer Jakobs, PMM Europe RT Medical/Scientific/General Background 2 Dr. Rainer Jakobs, PMM
More informationAnaesthetic and respiratory equipment Nebulizing systems and components
Provläsningsexemplar / Preview INTERNATIONAL STANDARD ISO 27427 Third edition 2013-12-15 Anaesthetic and respiratory equipment Nebulizing systems and components Matériel d anesthésie et de réanimation
More informationLatex Free. An affordable, easy to use, high density, small volume nebulizer with a revolutionary breath enhanced design!
Latex Free Breath Enhanced High Density Jet Nebulizer The NebuTech HDN nebulizer, a revolutionary breath enhanced design, by Salter Labs is quickly becoming the product of choice for caregivers and patients
More informationMisty Max 10 nebulizer
AirLife brand Misty Max 10 nebulizer Purpose Introduction Delivery of nebulized medication to the lungs is a complex process dependant upon a variety of clinical and device-related variables. Patient breathing
More informationNebulised tobramycin for cystic fibrosis. Information for patients Pharmacy
Nebulised tobramycin for cystic fibrosis Information for patients Pharmacy This leaflet has been made to give you some more information to help you with your treatment. Please also read the manufacturers
More informationSELECTING A DOSAGE FORM FOR DRUG DELIVERY TO THE LUNGS
SELECTING A DOSAGE FORM FOR DRUG DELIVERY TO THE LUNGS Poonam Sheth, PharmD, PhD, Research Scientist, Inhalation Matthew T. Marmura, Research Scientist, Inhalation Recipharm is frequently asked to help
More informationComputational toxicology: an in silico dosimetry model for risk assessment of air pollutants
Computational toxicology: an in silico dosimetry model for risk assessment of air pollutants T. Martonen 1,2 & K. K. Isaacs 1,3 1 Experimental Toxicology Division, National Health and Environmental Effects
More informationRedefining Continuous Aerosol Drug Delivery 2015 PM223
Redefining Continuous Aerosol Drug Delivery 2015 PM223 Explanation of Continuous via Traditional Small Volume (Jet) Nebulizer Traditional small volume (jet) nebulizers require compressed gas to aerosolize
More informationDeposition of Inhaled Particle in the Human Lung for Different Age Groups
Deposition of Inhaled Particle in the Human Lung for Different Age Groups Xilong Guo 1, Qihong Deng 1* 1 Central South University (CSU), Changsha, China * Corresponding email: qhdeng@csu.edu.cn, qhdeng@gmail.com.
More informationLONGITUDINAL EVALUATION OF COMPRESSOR/NEBULIZER PERFORMANCE
LONGITUDINAL EVALUATION OF COMPRESSOR/NEBULIZER PERFORMANCE Samah Awad, MBBS 1,4, David K Williams, PhD, MPH 2 and Ariel Berlinski, MD 1,3 1 University of Arkansas for Medical Sciences, College of Medicine,
More informationInhalation Aerosols. jnforma healthcare. Physical and Biological Basis for Therapy. Second Edition. Edited by. Anthony J. Hickey
Inhalation Aerosols Physical and Biological Basis for Therapy Second Edition Edited by Anthony J. Hickey University of North Carolina Chapel Hill, North Carolina, U.S.A. jnforma healthcare New York London
More informationRush University, College of Health Sciences
Rush University, College of Health Sciences An Evaluation of the Prototype OxyMulti Mask Prototype Compared to the Oxymask Aerosol, OxyMulti Mask and Airlife Aerosol Mask for Aerosol Delivery in Adults
More informationNew Aerosol Delivery Devices for Cystic Fibrosis
New Aerosol Delivery Devices for Cystic Fibrosis Kenneth C Kesser RRT and David E Geller MD Introduction Why Do We Need New Aerosol Devices? Time Burden Dealing With Aerosol and Host Factors in Cystic
More informationChallenges in Nonclinical Development of Inhalation Drug Products
Challenges in Nonclinical Development of Inhalation Drug Products Luqi Pei, Ph.D. Senior Pharmacologist DPARP, CDER August 6, 2015 Rockville, MD Disclaimer This speech reflects the views of the speaker
More informationRedefining Continuous Aerosol Drug Delivery PM223
Redefining Continuous Aerosol Drug Delivery PM223 Explanation of Continuous via Traditional Small Volume (Jet) Nebulizer Traditional small volume (jet) nebulizers require compressed gas to aerosolize medication
More informationDelivery of Iloprost Inhalation Solution With the HaloLite, Prodose, and I-neb Adaptive Aerosol Delivery Systems: An In Vitro Study
Delivery of Iloprost Inhalation Solution With the HaloLite, Prodose, and I-neb Adaptive Aerosol Delivery Systems: An In Vitro Study Robert E Van Dyke MSc and Kurt Nikander BACKGROUND: Iloprost (Ventavis)
More informationCOMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) GUIDELINE ON THE PHARMACEUTICAL QUALITY OF INHALATION AND NASAL PRODUCTS
European Medicines Agency Inspections London, 16 February 2005 Doc Ref.: EMEA/CHMP/QWP/49313/2005 corr. COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) GUIDELINE ON THE PHARMACEUTICAL QUALITY OF
More informationAchieving Optimal Particle Size Distribution in Inhalation Therapy
Achieving Optimal Particle Size Distribution in Inhalation Therapy By Bob Bruno Inhalation therapy has proven to be an effective method of administering a number of pharmaceuticals for more than a century.
More informationImportant Principles of Aerosol Therapy for Your Patients
Important Principles of Aerosol Therapy for Your Patients Disclaimer Appendix 3 Declaration of Vested Interest Form Name of presenter: David Henry RRT Name of employer: DeVilbiss Healthcare Inc. Definition:
More informationOnline data supplement. Matthias Griese, Jan Ramakers, Angela Krasselt, Vitaliy Starosta, Silke van
Online data supplement Improvement of Alveolar Glutathione and Lung Function but Not Oxidative State in Cystic Fibrosis Matthias Griese, Jan Ramakers, Angela Krasselt, Vitaliy Starosta, Silke van Koningsbruggen,
More informationate, little or no aerosol may be deposited in the lung and consequently there may be an inadequate effect.
Thorax 1983;38:755-759 Factors influencing the size distribution of aerosols from jet nebulisers MICHLL M CLAY, DMTRI PAVIA, STPHN P NWMAN, STWART W CLARK From the Department of Thoracic Medicine, Royal
More informationPediatrics in mechanical ventilation
Pediatrics Optimization Intitulé du cours of aerosol therapy in mechanical ventilation Thèmes donnés Ermindo Di Paolo, PhD Departments of Pharmacy and Pediatrics Lausanne University Hospital Switzerland
More informationNext Generation Nebuliser Formulations Background
Precious Akhuemokhan PhD Candidate 1 st Supervisor: Professor Ben Forbes 2 nd Supervisor: Dr Richard Harvey Next Generation Nebuliser Formulations Background The use of aerosols in inhaled delivery remains
More informationInhalation Product Research at FDA
Inhalation Product Research at FDA Changning Guo Ph. D., Chemist Division of Pharmaceutical Analysis FDA/CDER/OPS/OTR 2016 GPhA CMC workshop, May 17, 2016 Disclaimer: This presentation reflects the views
More informationPIPELINE TRENDS AND CHALLENGES IN PULMONARY DELIVERY
PIPELINE TRENDS AND CHALLENGES IN PULMONARY DELIVERY Here, Gunilla Petersson, PhD, Science & Innovation Director, Inhaled Drug Delivery, AstraZeneca, provides an overview of the inhalables sector from
More informationModelling Jet Nebulizers to Estimate Pulmonary Drug Deposition
Modelling Jet Nebulizers to Estimate Pulmonary Drug Deposition by Wallace Bo-Neng Wee A thesis submitted in conformity with the requirements for the degree of Masters of Health Science Clinical Engineering,
More informationAppendix D Clinical specialist statement template
Appendix D Colistimethate sodium powder and tobramycin powder for inhalation for the treatment of pseudomonas lung infection in cystic fibrosis Thank you for agreeing to give us a statement on your organisation
More informationChanges in International Standards (ICRP) and Potential Implications
Changes in International Standards (ICRP) and Potential Implications Overview Who is the ICRP? Brief Sojourn Epidemiology Studies vs. Dosimetric Modelling What does the ICRP say about radon? What is the
More informationPARI Product Catalog
Page 1 PARI Product Catalog PARI VORTEX Non Electrostatic Holding Chamber Configurations PARI LC Reusable Nebulizers PARI Trek S Compact Compressor System PARI LC Nebulizer Masks and Conversion Kits Vios
More informationFREQUENTLY ASKED QUESTIONS AND REFERENCE GUIDE
FREQUENTLY ASKED QUESTIONS AND REFERENCE GUIDE www.pari.com/erapid erapid Nebulizer System: FAQ s for the CF Care Team Important: Please refer to the erapid Nebulizer System Instructions For Use for complete
More informationNEBULIZERS, METERED DOSE INHALERS, AND DRY POWDER INHALERS
NEBULIZERS, METERED DOSE INHALERS, AND DRY POWDER INHALERS Douglas S. Gardenhire, Ed.D, RRT-NPS MODULE 1 Manipulate Small Volume Nebulizers by Order or Protocol 1 Objectives for Module 1 At the end of
More informationH.L. Chua*, G.G. Collis*, A.M. Newbury**, K. Chan, G.D. Bower**, P.D. Sly, P.N. Le Souef*
Eur Respir J, 1994, 7, 2185 2191 DOI: 10.1183/09031936.94.07122185 Printed in UK - all rights reserved Copyright ERS Journals Ltd 1994 European Respiratory Journal ISSN 0903-1936 The influence of age on
More informationIntracheal antibiotics administration
Intracheal antibiotics administration Jean Chastre, M.D. www.reamedpitie.com Disclosure Conflicts of interest: Consulting or Lecture fees: Bayer, Pfizer, Cubist/Merck, Basilea, Kenta/Aridis, Roche, AstraZeneca/Medimmune
More informationUnderstanding Regulatory Global Requirements for Nasal Drug Products. Julie D. Suman, Ph.D. April 8, 2016
Understanding Regulatory Global Requirements for Nasal Drug Products Julie D. Suman, Ph.D. April 8, 2016 AGENDA NDA vs ANDA Regulatory Approaches for Bioequivalence (BE) FDA Drug Specific Guidances FDA,
More informationSELECTING A DOSAGE FORM FOR DRUG DELIVERY TO THE LUNGS. Dr. Jay T. Holt, Ph.D., Sr. Director, Inhalation & Analytical
SELECTING A DOSAGE FORM FOR DRUG DELIVERY TO THE LUNGS Dr. Jay T. Holt, Ph.D., Sr. Director, Inhalation & Analytical www.cirruspharm.com February 2014 INTRODUCTION Cirrus, a Kemwell company, is frequently
More informationPublished online 8 June 2010 in Wiley Online Library (wileyonlinelibrary.com). DOI /jps.22231
BIOTECHNOLOGY A Technical Feasibility Study of Dornase Alfa Delivery with eflow 1 Vibrating Membrane Nebulizers: Aerosol Characteristics and Physicochemical Stability THOMAS SCHERER, 1 DAVID E. GELLER,
More informationRegional deposition and retention of particles in shallow, inhaled boluses: effect of lung volume
Regional deposition and retention of particles in shallow, inhaled boluses: effect of lung volume WILLIAM D. BENNETT, 1 GERHARD SCHEUCH, 2 KIRBY L. ZEMAN, 1 JAMES S. BROWN, 1 CHONG KIM, 3 JOACHIM HEYDER,
More informationSupplementary Online Content 2
Supplementary Online Content 2 van Meenen DMP, van der Hoeven SM, Binnekade JM, et al. Effect of on demand vs routine nebulization of acetylcysteine with salbutamol on ventilator-free days in intensive
More informationMONITORING NEBULISER USAGE & LUNG FUNCTION IN CLINICAL TRIALS
MONITORING NEBULISER USAGE & LUNG FUNCTION IN CLINICAL TRIALS Adherence levels to inhalation treatments are known to be generally low. This issue is particularly important when testing nebulised drugs
More informationPatient. Device Clinician. Safety & efficacy
Patient Device Clinician Formulation Safety & efficacy 1. Modified from Daley-Yates et al., Expert Opin. Drug Deliv. 2011: 8(10):1297-1308 2. Modified from Laube et al., Eur Respir J 2011; 37: 1308 1331
More informationIntroduc)on & Background
Doug Gardenhire, EdD RRT- NPS FAARC Georgia State University Atlanta, GA January 2013 Introduc)on & Background The standard Circulaire II high- efficiency aerosol drug delivery system has been shown to
More informationTransactions on Biomedicine and Health vol 2, 1995 WIT Press, ISSN
Biomedical application of the supercomputer: targeted delivery of inhaled Pharmaceuticals in diseased lungs T.B. Martonen,* I. Katz,* D. Hwang,' Y.Yang* "Health Effects Research Laboratory, U.S.Environmental
More informationIn Vitro Evaluation of Positive Expiratory Pressure Devices Attached to Nebulizers
In Vitro Evaluation of Positive Expiratory Pressure Devices Attached to Nebulizers Ariel Berlinski MD BACKGROUND: Patients with cystic fibrosis perform airway clearance techniques and receive nebulized
More informationSmall Volume Nebulizer Treatment (Hand-Held)
Small Volume Aerosol Treatment Page 1 of 6 Purpose Policy Physician's Order Small Volume Nebulizer Treatment To standardize the delivery of inhalation aerosol drug therapy via small volume (hand-held)
More information...Porta-neb matched systems from Respironics (UK)
...Porta-neb matched systems from Respironics (UK) It is important that the system you choose consists of a compressor and nebulizer designed to work together. The matching of a nebulizer and compressor
More informationCigarette Smoke Generator
Sophisticated Life Science Research Instrumentation Cigarette Smoke Generator For Inhalation and Analytic Studies Info@TSE-Systems.com Contents Cigarette Smoke Generator Fully Automatic 3 Sensors 3 Cigarette
More informationRecommendations for Aerosol Applications of Silicone-Based Materials
Recommendations for Aerosol Applications of Silicone-Based Materials September 2001 Revised March 2018 This document provides information and recommendations relevant to formulating aerosol products containing
More informationA PRACTICAL GUIDE TO nebulization
A PRACTICAL GUIDE TO nebulization therapy a initiative This book is based on sources believed to be reliable in providing information that is complete and generally in accordance with the standards accepted
More informationPulmo Waves Device for respiratory physiotherapy
MADE IN ITALY Pulmo Waves Device for respiratory physiotherapy Respiratory physiotherapy Accumulation of secretions in certain parts of the human respiratory system can take place for different reasons.
More informationAerosolized Antibiotics in Mechanically Ventilated Patients
Aerosolized Antibiotics in Mechanically Ventilated Patients Gerald C Smaldone MD PhD Introduction Topical Delivery of Antibiotics to the Lung Tracheobronchitis Aerosolized Antibiotic Delivery in the Medical
More informationGuidelines for Use of Nebuliser Systems in the Home Environment
Guidelines for Use of Nebuliser Systems in the Home Environment Table of Contents Sections Contents Page Number Acknowledgements 2 1.0 Introduction 2 2.0 Methodology 2 3.0 Nebuliser Therapy 3 4.0 Definitions
More informationIVIVC in Pediatric OIPs
IPAC-RS/UF Orlando Conference 2014 March 20, 2014 IVIVC in Pediatric OIPs Herbert Wachtel Declaration of Conflicts of Interest H. Wachtel is employee of Boehringer Ingelheim Pharma GmbH & Co. KG, Germany.
More informationUnderstanding the mode of action of a drug using Functional Respiratory Imaging (FRI) Roflumilast Study. Jan De Backer, MSc, PhD, MBA CEO
Understanding the mode of action of a drug using Functional Respiratory Imaging (FRI) Roflumilast Study Jan De Backer, MSc, PhD, MBA CEO IPAC RS/UF Orlando Inhalation Conference March 20, 2014 OVERVIEW
More informationReliability of Vibrating Mesh Technology
Reliability of Vibrating Mesh Technology Ashwin A Gowda DO, Ann D Cuccia MPH RRT-NPS RPFT, and Gerald C Smaldone MD PhD BACKGROUND: For delivery of inhaled aerosols, vibrating mesh systems are more efficient
More informationMEET THE DRIVING FORCE IN NEBULIZER THERAPY... Matched Nebulizer Compressor System
MEET THE DRIVING FORCE IN NEBULIZER THERAPY... Matched Nebulizer Compressor System Matched Nebulizer Compressor System 4 1 Air is passed through an inlet filter. 2 Clean air is then driven through the
More informationLong-term Excretion of Thorium with Faeces and Urine from TIG Welders after Continuos Occupational Handling of Thoriated Electrodes
Long-term Excretion of Thorium with Faeces and Urine from TIG Welders after Continuos Occupational Handling of Thoriated Electrodes P. Ostapczuk 1, R. Hille 1, A Titze 2, N. Witkowski 1 1 Division of Safety
More informationCompressor/nebulizers differences in the nebulization of corticosteroids. The CODE study (Corticosteroids and Devices Efficiency)
European Review for Medical and Pharmacological Sciences 2007; 11: 225-237 Compressor/nebulizers differences in the nebulization of corticosteroids. The CODE study (Corticosteroids and Devices Efficiency)
More informationPaediatric pulmonary drug delivery: considerations in asthma treatment
Review Paediatric pulmonary drug delivery: considerations in asthma treatment 1. Introduction 2. Guideline recommendations 3. Factors affecting drug delivery to the lung 4. Nebulisers 5. Metered-dose inhalers
More informationDrug/Device Combination Products: Bioequivalence
Drug/Device Combination Products: Bioequivalence Three stories:. The story of Nasal and Inhalation Product BE 2. The story of the Generic Auto-Injector 3. The story of User Interface Considerations Bioequivalence
More informationPerforming a Methacholine Challenge Test
powder for solution, for inhalation Performing a Methacholine Challenge Test Provocholine is a registered trademark of Methapharm Inc. Copyright Methapharm Inc. 2016. All rights reserved. Healthcare professionals
More informationAerosol recovery from large-volume reservoir delivery systems is highly dependent on the static properties of the reservoir
Eur Respir J 1999; 13: 668±672 Printed in UK ± all rights reserved Copyright #ERS Journals Ltd 1999 European Respiratory Journal ISSN 0903-1936 Aerosol recovery from large-volume reservoir delivery systems
More informationEffect of particle size of bronchodilator aerosols on lung distribution and pulmonary function in patients
Thorax 1987;42:457-461 Effect of particle size of bronchodilator aerosols on lung distribution and pulmonary function in patients with chronic asthma D M MITCHELL, M A SOLOMON, S E J TOLFREE, M SHORT,
More informationTargeting Aerosolized Drugs to the Conducting Airways Using Very Large Particles and Extremely Slow Inhalations
JOURNAL OF AEROSOL MEDICINE AND PULMONARY DRUG DELIVERY Volume 23, Number &, 2010 ª Mary Ann Liebert, Inc. Pp. 1 7 DOI: 10.1089=jamp.2008.0711 Original Research Targeting Aerosolized Drugs to the Conducting
More informationBreakout Session # A 12:45 1:25. New Methods of Medication Delivery to the Lungs: Say Goodbye to the MDI as we know it
Breakout Session # A 12:45 1:25 New Methods of Medication Delivery to the Lungs: Say Goodbye to the MDI as we know it Michael J. Welch MD, FAAP, FAAAAI, CPI Co-director, Allergy & Asthma Medical Group
More informationIn-Vitro Comparison of Aerosol Drug Delivery in Pediatrics Using Pressurized Metered Dose Inhaler, Jet Nebulizer, and Vibrating Mesh Nebulizers
Georgia State University ScholarWorks @ Georgia State University Respiratory Therapy Theses Department of Respiratory Therapy 7-31-2012 In-Vitro Comparison of Aerosol Drug Delivery in Pediatrics Using
More informationThe promise of nebulized antibiotic therapy
1 st ATHENA International Conference Athens, 19-20 November 2015 Let s Talk About Inhaled Antibiotics Inhaled Antibiotics: The Story Stijn BLOT Dept. of Internal Medicine Faculty of Medicine & Health Science
More informationVariation in nebulizer aerosol output and weight output from the Mefar dosimeter: implications for multicentre studies
Eur Respir J 1997; 10: 452 456 DOI: 10.1183/09031936.97.10020452 Printed in UK - all rights reserved Copyright ERS Journals Ltd 1997 European Respiratory Journal ISSN 0903-1936 Variation in nebulizer aerosol
More informationDRUG: Introduction. `Shared Care Guidelines. They can also be used long term for chronic pulmonary Pseudomonas aeruginosa infection.
`Shared Care Guidelines DRUG: Introduction Inhaled antibiotics (Adults and Paediatrics) in Cystic Fibrosis. EXISTING ESTABLISHED PATIENTS ONLY Colistimethate (Colomycin, Promixin ) Tobramycin (Tobi Bramitob
More informationDelivering Aerosol Medication in ICU
Delivering Aerosol Medication in ICU 18th Aug 2017 Lau Chee Lan Pharmacist HCTM PPUKM ASMIC 2017 Aerosol Therapy Part of the treatment for a variety of respiratory disease * asthma and chronic obstructive
More informationPharmacokinetics and Safety of MP-376 (Levofloxacin Inhalation. Solution) in Cystic Fibrosis Subjects
4 1 2 3 5 6 7 8 9 AAC Accepts, published online ahead of print on 28 March 2011 Antimicrob. Agents Chemother. doi:10.1128/aac.01744-10 Copyright 2011, American Society for Microbiology and/or the Listed
More informationARTICLE IN PRESS. Experimental Measurements of Regional Lung Deposition in Taiwanese
Aerosol and Air Quality Research, x: 1 8, xxxx Copyright Taiwan Association for Aerosol Research ISSN: 1680-8584 print / 2071-1409 online doi: 10.4209/aaqr.2018.06.0213 Experimental Measurements of Regional
More informationNebuTech nebulizer from Salter. Striving to be #1 IN PATIENT SATISFACTION. To help you and your patients. easy. breathe
nebulizer from Salter To help you and your patients breathe easy Striving to be #1 IN PATIENT SATISFACTION nebulizer from Salter Let go to work for you and your patients today. Performance Versatility
More informationRespiratory Care in PICU Aerosol Therapy ส พ ชชา ชา แสงโขต โรงพยาบาลสมเด จพระป นเกล า
Respiratory Care in PICU Aerosol Therapy น.อ.หญ ง ส พ ชชา ชา แสงโขต โรงพยาบาลสมเด จพระป นเกล า Aerosol liquid droplets or solid particles suspended in a gas(air) visible like fog Aerosol vs Humidity Humidity
More informationMICRODOSIMETRY CALCULATION OF THE DOSE CONVERSION COEFFICIENT FOR RADON PROGENY. B.M.F. Lau, D. Nikezic, K.N. Yu
MICRODOSIMETRY CALCULATION OF THE DOSE CONVERSION COEFFICIENT FOR RADON PROGENY B.M.F. Lau, D. Nikezic, K.N. Yu Department of Physics and Materials Science, City University of Hong Kong, Tat Chee Avenue,
More informationL. Borgström*, E. Bondesson*, F. Morén**, E. Trofast*, S.P. Newman +
Eur Respir J, 1994, 7, 69 73 DOI: 10.1183/09031936.94.07010069 Printed in UK - all rights reserved Copyright ERS Journals Ltd 1994 European Respiratory Journal ISSN 0903-1936 Lung deposition of budesonide
More informationUS FDA approved ARIKAYCE (amikacin liposome inhalation suspension) antibacterial drug to treat a serious lung disease approved on 28 th Sept 2018
US FDA approved ARIKAYCE (amikacin liposome inhalation suspension) antibacterial drug to treat a serious lung disease approved on 28 th Sept 2018 Lung Infection due to MAC Burden Lung Infection Signs &
More informationThe Use of Physics-Based Modeling to Better Design Drug- Device Interface. Yoen-Ju Son, PhD Merck Research Laboratory, Summit, NJ
The Use of Physics-Based Modeling to Better Design Drug- Device Interface Yoen-Ju Son, PhD Merck Research Laboratory, Summit, NJ Presentation Outline Physics-based modeling in pharmaceutical industry Pulmonary
More informationEffect of mask dead space and occlusion of mask holes on delivery of nebulized albuterol. Ariel Berlinski, MD 1,2. Little Rock, Arkansas.
Effect of mask dead space and occlusion of mask holes on delivery of nebulized albuterol Ariel Berlinski, MD 1,2 1 University of Arkansas for Medical Sciences, Department of Pediatrics, Pulmonology Section
More informationNovel Therapies for NTM
NTM Lecture Series for Providers Novel Therapies for NTM Kenneth N Olivier, MD, MPH Laboratory of Chronic Airway Infection Chief, Pulmonary Branch/DIR October 20, 2017 Disclosures Past: Cooperative Research
More informationLung deposition of inhaled tobramycin with eflow rapid/lc Plus jet nebuliser in healthy and cystic fibrosis subjects
Journal of Cystic Fibrosis 10 (2011) 9 14 www.elsevier.com/locate/jcf Original Article Lung deposition of inhaled tobramycin with eflow rapid/lc Plus jet nebuliser in healthy and cystic fibrosis subjects
More informationA Primer on Acute Inhalation Toxicity Testing
A Primer on Acute Inhalation Toxicity Testing Where do Alternative Methods Fit? Jon A. Hotchkiss, PhD Toxicology and Environmental Research and Consulting The Dow Chemical Company 1 Outline Why do we test?
More information