Combo in vitro performance (ACI)
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The document summarizes several in vitro studies comparing the lung deposition characteristics of formoterol and fluticasone delivered by different inhalation systems including nebulizers, dry powder inhalers, and metered dose inhalers. The studies found that the respirable dose of both drugs delivered by nebulized solutions was comparable to other delivery systems and higher than suspensions delivered by nebulization. MDI systems showed greater oropharyngeal deposition compared to nebulizers.
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![IN VITRO PERFORMANCE OF FORMOTEROL AND FLUTICASONE FROM AN INHALATION SOLUTION BY NEBULIZATION AND OTHER INHALATION DELIVERY SYSTEMS Tang Nguyen, Melisa Barron 1 , John Miyawa, and Partha S. Banerjee Dey L.P., Napa, CA, USA 1 current address: Theravance Inc., South San Francisco, CA, USA ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],The ACI method was adopted from USP <601> using apparatus 1 (Graseby Andersen, GA). The ACI was assembled (Fig. 1) with eight stages, induction port and cone. Filter support base was connected to the vacuum line with gauges and digital airflow meter. The airflow was adjusted to within 0.5 L/min of the nominal desired rate by opening or closing the toggle valve located between the two vacuum gauges. A nebulizer mouthpiece adapter was used to couple the nebulizer mouthpiece to the induction port inlet and create an airtight seal. The nebulizer/compressor was assembled according to manufacturer’s instructions. Prototype formoterol inhalation solution, 125 g/2 ml, was compared to 10 doses of the DPI product, Foradil Aerolizer , 12 g/dose (Novartis, NJ). Prototype fluticasone inhalation solution, 400 g/3 ml, was compared to Flixotide suspension for inhalation, 0.5 mg/2 ml and 2 mg/2 ml (Allen & Hanburys, UK) and the MDI product, Flovent 110 g (GlaxoSmithKline, NC). The nebulizer systems used were Pari LC Star / Proneb (Pari, VA) jet nebulizer, and Omron MicroAir (Omron, IL) ultrasonic nebulizer for formoterol inhalation solution and Pari LC Plus /Proneb for fluticasone inhalation solution and Flixotide suspension. Effect of temperature on aerodynamic size profile was studied by nebulizing formoterol inhalation solution, stored at 5 C and 25 C, using Pari LC Star / Proneb system immediately after the solution was pulled from the chamber. After nebulization to complete aerosolization, the ACI stages and plates and nebulizer were carefully rinsed with defined volume (5 to 20 ml) of solvent and analyzed by validated, stability indicating HPLC method (Table 1). The wash solvents were water for formoterol, and acetonitrile:water (1:1) for fluticasone. ACI vacuum flow rate was set at 28.3 L/min for all except the DPI product, Foradil , in which case 60 L/min flow rate was used. The particle size of the Flixotide suspensions was determined by laser diffraction spectrophotometry (Sympatec, NJ). The surface tension of the fluticasone inhalation solution and Flixotide were measured at 25 C by a tensiometer (KSV instruments, Finland) using the Wilhelmy Plate method. Fig. 1 ACI set up Table 1. HPLC parameters of formoterol and fluticasone ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],ACKNOWLEDGEMENTS: The authors wish to acknowledge and thank Renee Yang, Lan Tran, Rahel Kahsey and Douglas Johnson for their technical support. REFERENCES: 1. Task Group on Lung Dynamics. Deposition and retention models for internal dosimetry of the human respiratory tract. Health Physics 1966; 12:173-208. 2. JG Hardy, SP Newman and M. Knoch. Lung deposition from four nebulizers. Respiratory Medicine 1993: 87; 461-465. 3. AR Clark. The use of laser diffraction for the evaluation of the aerosol clouds generated by medical nebulizers. Int J Pharm 1995; 115: 69-78. 4. T Fok, M Al-essa, S Monkman, et al. Pulmonary deposition of salbutamol aerosol delivered by metered dose inhaler, jet nebulizer and ultrasonic nebulizer in mechanically ventilated rabbits. Pediatr Res 1997; 42: 7210727. 5. U.S. Department of Health and Human Services. Guidance for Industry: Nasal spray and inhalation solution, suspension, and spray drug products – chemistry, manufacturing, and controls documentation. July 2002. Available from URL: http://www. fda . gov / cder /guidance/index. htm 6. WH Finlay and KW Stapleton. Undersizing of droplets from a vented nebulizer caused by aerosol heating during transit through an anderson impactor. J Aerosol Sci 1999; 30: 105-109. 7. MB Dolovich. Assessing nebulizer performance. Respiratory Care 2002; 47: 1290-1301. 8. RA Lewis and JS Fleming. Fractional deposition from a jet nebulizer: how it differs from a metered dose inhaler. Br J Dis Chest 1985; 79: 361-367. 9. BMZ Zainudin, M Biddiscombe et al. Comparison of bronchodilator responses and deposition patterns of salbutamol inhaled from a pressurized metered dose inhaler, as a dry powder, and as a nebulized solution. Thorax 1990; 45: 469-473. 10. TG O’Riordan. Formulations and nebulizer performance. Respiratory Care 2002; 47: 1305-1312. 11. PW Barry, and C O’Callaghan. An in vitro analysis of the output of budesonide from different nebulizers. J Allergy Clin Immunol 1999:104: 1168-1173. Correspondence : partha .banerjee@ dey .com Ultrasonic Nebulization System ACI House Vacuum Hose INTRODUCTION METHODS RESULTS Fig. 2..In vitro deposition profile (Anderson Cascade Impaction) of formoterol using PARI LC Star Jet Nebulizer Fig. 3. In vitro deposition (Anderson Cascade Impaction) profile of formoterol at 25C Fig. 5. In vitro deposition (Andersen Cascade Impaction) profile of Fluticasone by nebulization and MDI (@28.3 LPM) [First Study] [n = 3] Fig. 4. In vitro deposition profile of formoterol by nebulization (@ 28.3 LPM) vs DPI (@ 60 LPM) Table 2. Effect of temperature and type of nebulizer on comparative in vitro deposition (Andersen Cascade Impaction) profile of formoterol. Table 3. Comparative in vitro deposition (Andersen Cascade Impaction) data on formoterol by nebulization vs. DPI. Table 4. Comparative in vitro deposition (Andersen Cascade Impaction) data on fluticasone by nebulization (solution vs. suspension) and MDI product. Fig. 6. In vitro deposition (Andersen Cascade Impaction) profile of fluticasone by nebulization vs. MDI (@ 28.3 LPM) [Second Study] [n = 3] DISCUSSION DISCUSSION The total percent recovery for samples was within the range recommended in recent FDA guidance. 5 . The critical parameter of the comparative analysis was the amount of the respirable dose/fraction recovered from stages 2 to 5 of the ACI, which corresponded to particle sizes ranging from 1.1 µm to 5.8 µm at 28.3 L/min, and stages 1 to 4 corresponding to 1.1 µm to 6.5 m at 60 L/min flow rate. The mass median aerodynamic diameter (MMAD) and geometric standard deviation (GSD) were determined for all based on log probability of cumulative percentile distribution. Effect of temperature During jet nebulizer operation, solvent evaporation decreases the solution temperature and this has been suggested to cause undersizing of the particle size. 6,7 The nebulizer performance can also change due to the temperature dependency of the solution properties. The in vitro impactor deposition data (Fig. 2, Table 2), however, shows that respirable doses at 5 C and 25 C were not significantly different although higher temperature tends to increase the respirable dose. The increasing trend in respirable dose at higher temperature is not consistent with the temperature related undersizing theory. Fig. 7. In vitro deposition (Andersen Cascade Impaction @ 28.3 LPM) profile of fluticasone by nebulization: solution vs. suspension [Second Study] [n = 3] CONCLUSIONS ------- Vacuum Gauge 2 Vacuum Gauge 1 Air Jet Nebulization System Nebulizer Mouthpiece Adapter Toggle Valve](https://image.slidesharecdn.com/PosterW4099-123274296307-phpapp03/85/Combo-in-vitro-performance-ACI-1-320.jpg)
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3. The formulations were evaluated for morphology, vesicle size, entrapment efficiency and in vitro drug release. Optimum formulations with smaller vesicle size and higher entrapment efficiency were selected for further stability studies.
Pulmonary drug delivery system by mali vidhya v
The document discusses pulmonary drug delivery systems (PDDS). It begins by describing the anatomy and physiology of the respiratory tract, then outlines some key advantages and disadvantages of PDDS. It discusses different approaches to PDDS including aerosols, metered dose inhalers, dry powder inhalers, and nebulizers. Factors affecting pulmonary drug delivery are enumerated. Applications include treatment of asthma, COPD, infections, and cancers of the lungs. In summary, PDDS provide targeted delivery to the lungs while avoiding first-pass metabolism.
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L'Docile - Respiratory diseases & nebulization Report
This document discusses respiratory diseases and the importance of proper nebulization. It outlines four main respiratory diseases: asthma, chronic obstructive pulmonary disease (COPD), respiratory allergies, and occupational lung diseases/pulmonary hypertension. For each disease, it describes symptoms and risk factors. It emphasizes that medication and avoiding triggers can help manage asthma and COPD. Nebulizers are used to effectively deliver medications to control and treat respiratory diseases. The document promotes two L'Docile nebulizer models and their silent, efficient, and portable designs well-suited for family use.
VG-ICP-MS
VG-ICP-MS combines a vapour generator, inductively coupled plasma, and mass spectrometer to analyze samples. The vapour generator converts analytes like hydrides into gas that is then ionized by the inductively coupled plasma. These ions are then separated and detected by the quadrupole mass filter. VG-ICP-MS offers advantages like measuring all samples simultaneously, achieving higher sensitivity through 100% transport efficiency to the plasma, and removing potentially interfering sample matrix components. While it provides better sensitivity and separation of interferences, it requires hydride reagents and has limitations processing samples with high salt content.
Nebulized antibiotics for treating Ventilator-Associated Pneumonia
Nebulized antibiotics for treating Ventilator-Associated PneumoniaVall d'Hebron Institute of Research (VHIR)
VHIR Seminar led by prof. Jean-Jacques Rouby, from the Réanimation Polyvalente Département d'Anesthésie-Réanimation Faculté de Médecine Pierre et Marie Curie UPMC Hôpital Pitié-Salpêtrière Assistance Publique Hôpitaux de Paris.
Abstract:
1 - What we have learnt from experimental studies: relevant animal models,
optimization of aerosol delivery during mechanical ventilation,
penetration of aerosolized antibiotics within the infected parenchyma,
toxicity and pharmacokinetics
2 - the existing human litterature concerning nebulization of antibiotics
in critically ill patients with Ventilator-Associated Pneumonia
3 - The promising place of nebulized colistin and vancomycin for treating
multi-drug resistant Ventilator-Associated Pneumonia
Recent recommendation for nasal nebulization
1) Nebulization is a common method to deliver drugs to the lungs using a nebulizer device that converts liquid medications into a mist. It is often used to treat asthma and respiratory infections.
2) There are different types of nebulizers including jet, ultrasonic, and vibrating mesh nebulizers. Newer models are smaller, quieter, and more portable.
3) An in vitro study compared three nebulizer types (jet, ultrasonic, vibrating mesh) and found ultrasonic and vibrating mesh nebulizers delivered higher amounts of albuterol to the lungs more quickly and with fewer side effects than the jet nebulizer.
Aerosol therapy
This document discusses aerosol therapy and factors that influence aerosol deposition. It describes three main mechanisms of aerosol deposition - inertial impaction, sedimentation, and diffusion - and how particle size affects each. It also discusses different aerosol delivery devices (pMDIs, DPIs, nebulizers), how they work, advantages and disadvantages. Patient-related factors like age, breathing pattern and airway geometry are also reviewed as important considerations for effective aerosol therapy.
Inhalers. dry powder. wet inhalers
this topic is based on various inhalations like steam inhalation, metered dose inhalers and dry powder inhalers & nebulization
Nebulization therapy
In medicine, a nebuliser or nebulizer (see spelling differences) is a drug delivery device used to administer medication in the form of a mist inhaled into the lungs. Nebulizers are commonly used for the treatment of cystic fibrosis, asthma, COPD and other respiratory diseases.
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Computer hardware devices include webcams, scanners, mice, speakers, trackballs, and light pens. Webcams connect via USB or network and are used for video calls and conferencing. Scanners optically scan images and documents into digital formats. Mice are pointing devices that detect motion to move a cursor. Speakers have internal amplifiers and audio jacks. Trackballs contain ball and sensors to detect rotation for cursor movement. Light pens allow pointing directly on CRT displays.
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Pulmonary review
1) Pulmonary drug delivery provides a non-invasive route for systemic delivery of therapeutic agents like peptides and proteins due to the large absorptive surface area of the lungs. However, the complexity of the respiratory system and disposition during respiration complicates delivery.
2) The respiratory system consists of conducting airways and respiratory regions. Drugs can be administered via aerosol inhalation or intratracheal instillation, with aerosols allowing more uniform distribution but being more difficult to measure doses.
3) Recent developments include formulations using permeation enhancers to improve bioavailability of macromolecules, controlled release approaches like liposomes, and technologies from companies like Aradigm and Alkermes to
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Respiratory studies right approach in designs dia 11 april 2019 r
This presentation guides ANDA preparation for Orally Inhaled and Nasal Drug Products. It gives a few in vitro models mimicking inhalation.
Inhalation 2015
This document provides an overview of pharmaceutical inhalation technology. It discusses why inhalation is an effective drug delivery method, focusing on the lungs' ability to absorb molecules. Different dosage forms for inhalers are described, including metered dose inhalers, dry powder inhalers, and nebulizers. Key parameters for successful inhalers include reproducibility, purity, efficiency, and cost-effectiveness. Characterization techniques are outlined, such as measuring aerodynamic particle size distribution using cascade impactors to determine particle deposition in the lungs. Overall, the document covers the fundamentals of inhalation technology and characterization methods for developing effective inhaled pharmaceutical products.
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Foammanuscript
Polidocanol endovenous microfoam (PEM) and physician-compounded foams (PCFs) were tested to compare their bubble size distributions, stability, and degradation rates. PEM was found to have a narrower bubble size distribution with no large bubbles compared to PCFs. PEM also had a lower degradation rate and longer dwell time in a model vein than PCFs, indicating greater stability. Testing showed PEM provides more consistent properties than PCFs for treating varicose veins.
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This document discusses various types of asthma inhalers and proper inhaler techniques. It covers the basics of metered dose inhalers (MDIs) including their components, how they work, and factors affecting lung deposition. Key points include that MDIs were traditionally propelled by CFCs but now use HFA propellants, and that inhaler technique and ensuring the correct fine particle dose reaches the lungs is important for therapeutic effectiveness. Proper use, maintenance, and determining when an inhaler is empty are also addressed.
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This document describes a study that used artificial neural networks and genetic algorithms to develop performance models for a vibrating mesh nebulizer and a jet nebulizer. The models examined how different fill volumes (1, 2, and 4 mL) and nebulizer types affected drug delivery in non-invasive ventilation. In vitro, ex vivo, and in vivo experiments were conducted. The results showed that the vibrating mesh nebulizer had higher nebulization efficacy and was less affected by changes in fill volume compared to the jet nebulizer. Optimization of the in vivo model suggested increased pulmonary bioavailability and systemic absorption with the vibrating mesh nebulizer using a 2 mL fill volume.
Jairam
This document summarizes the development and evaluation of a dry powder inhaler formulation. It first defines asthma and common asthma therapies. It then discusses various dry powder inhaler device types and their advantages. The document outlines the characterization of active pharmaceutical ingredients and lactose carrier particles. It details the formulation of different batches varying lactose carrier grade. The batches were evaluated for various properties and fine particle fraction. The optimized batch with highest fine particle fraction was subjected to 3-month stability studies under specified conditions.
Aerosol
This document discusses lung deposition and clearance of inhaled drugs. It begins by providing historical context on inhaled therapies dating back 5000 years and the development of modern inhalers like metered dose inhalers in the 1950s. The document then covers various physicochemical and physiological factors that govern lung deposition, such as aerosol size, shape, density and the humid environment of the lungs. It also addresses mechanisms of drug clearance from the lungs and pharmacokinetics. Various inhaler devices including metered dose inhalers, dry powder inhalers and nebulizers are described. In vitro and in vivo characterization techniques for evaluating aerosol deposition in the lungs are also summarized.
Airborne transmission of virus laden aerosols
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Surfactante tratamiento prevencion y tratamiento
The document summarizes clinical trials comparing animal-derived surfactants for treating neonatal respiratory distress syndrome. It finds:
1) Calfactant provides short-term benefits like faster weaning from ventilation compared to beractant, likely due to its higher surfactant protein B content, though it does not reduce mortality or oxygen need at 36 weeks.
2) Studies found no clear advantage of alveofact over beractant, as alveofact's higher surfactant protein B is balanced by beractant's higher phospholipid dose.
3) Poractant may have advantages over beractant for some secondary outcomes when a higher initial dose is used, strengthening the case for poract
Solubility enhancement technique of BCS Class II drug by Solvent Evaporatiom
I am very happy to share with you my B.Pharm Final semester Presentation. The topic of the presentation was “SOLUBILITY ENHANCEMENT TECHNIQUE OF BCS CLASS II DRUG BY SOLVENT EVAPORATION TECHNIQUE – FORMULATION & EVALUATION" which i have done under the esteemed guidance of Dr. Goutam Kumar Jena. It was a great experience to deliver this topic infront of the expert jury. I would also like thank all my teammates especially Agniv Masanta for his efforts. I hope everyone of you will like presentation and the research and efforts behind it.Thank you for giving your precious time. #research #science #thankyou #experience #share
Pulmonary Drug delivery system.pdf
Anatomy and physiology of lungs
Targeting drug delivery
pulmonary drug delivery
Pulmonary drug delivery is primarily used to treat conditions of the airways, delivering locally acting drugs directly to their site of action.
Delivery of anti-asthmatic and other locally acting drugs directly to their site of action reduces the dose needed to produce a pharmacological effect, while the low concentrations in the systemic circulation may also reduce side-effects.
The drugs which are administered by pulmonary route are not only for lungs delivery but it goes to systemic circulation and produce the effect where it is desired through out the body. For Eg. A product containing ergotamine tartrate is available as an aerosolized dosage inhaler for the treatment of migraine & Volatile anesthetics, including, halothane, are also given via the pulmonary route.
propellant
aerosol
container
A nebuliser is a small portable device that runs electronically, turning liquid medication into a mist.
The patient then needs to breathe in the aerosol thus created through a mouthpiece.
The mist, when inhaled, travels directly to the lungs, ensuring better absorption of the medication and a more
effective outcome of your ongoing treatment.
Metered Dose Inhaler (MDI)
Used for the treatment of respiratory diseases such as as :-
asthma, chronic obstructive pulmonary disease (COPD)
and other respiratory diseases.
Computational Model for Deposition, Clearance and Dosimetry of Inhaled Aeroso...
This presentation summarizes research on modeling deposition, clearance, and dosimetry of inhaled particles in the human lung. It describes a stochastic computational model called IDEAL that calculates particle deposition based on size, morphology of the lung airways, and breathing parameters. It also models particle clearance mechanisms and calculates radiation doses to different lung regions from deposited radionuclides. The model shows intersubject variability in deposition and dosimetry due to differences in breathing patterns, airway dimensions, and other anatomical factors.
Therapeutic aerosol(sem 2)
The document discusses pulmonary drug delivery systems and aerosol therapy. It provides information on the anatomy of the respiratory tract, defines what an aerosol is, and describes the working and components of aerosol systems. It discusses the types of aerosol systems including two phase, three phase, suspension, and foam systems. It also outlines various drug delivery devices like metered dose inhalers, dry powder inhalers, and nebulizers. In addition, it covers the mechanisms of drug deposition and manufacturing of aerosols.
Effect of intersubject variability of extrathoracic airways on particle depos...
This document discusses how intersubject variability in extrathoracic airway geometry affects particle deposition. It finds that larger values of the shape factor and smaller minimum cross-sectional areas in the nasal airways lead to higher deposition there, due to increased turbulence. Similarly in the oral airways, smaller equivalent diameters cause higher deposition. The results show deposition efficiency approaches 100% at very low and high flow rates in both nasal and oral airways. Intersubject variability most affects penetration efficiency and downstream deposition of ultrafine particles.
Aeroso spray products (Pharmaceutical technology and genetical engineering)
well I don't like to make this type of presentation and i kinda felt super boring... It is described elaborately every single things... during presentation I felt lyk I was just reading not presenting anything... but it would be helpful for students like us to know this topic properly... and this presentation I made according to my course teachers' requirement.. so u guys can give it a shot and don't hesitate to tell me abt my lacking... thank u
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GraphSummit Singapore | The Art of the Possible with Graph - Q2 2024
GraphSummit Singapore | The Art of the Possible with Graph - Q2 2024
Building RAG with self-deployed Milvus vector database and Snowpark Container...
Building RAG with self-deployed Milvus vector database and Snowpark Container...
Alt. GDG Cloud Southlake #33: Boule & Rebala: Effective AppSec in SDLC using ...
Alt. GDG Cloud Southlake #33: Boule & Rebala: Effective AppSec in SDLC using ...
Let's Integrate MuleSoft RPA, COMPOSER, APM with AWS IDP along with Slack
Let's Integrate MuleSoft RPA, COMPOSER, APM with AWS IDP along with Slack
Securing your Kubernetes cluster_ a step-by-step guide to success !
Securing your Kubernetes cluster_ a step-by-step guide to success !
GraphSummit Singapore | The Future of Agility: Supercharging Digital Transfor...
GraphSummit Singapore | The Future of Agility: Supercharging Digital Transfor...
Introducing Milvus Lite: Easy-to-Install, Easy-to-Use vector database for you...
Introducing Milvus Lite: Easy-to-Install, Easy-to-Use vector database for you...
National Security Agency - NSA mobile device best practices
National Security Agency - NSA mobile device best practices