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1 Inhaler Devices Dr. Dane EDIGER Uludağ University School of Medicine Departement of Allergy.

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Presentation on theme: "1 Inhaler Devices Dr. Dane EDIGER Uludağ University School of Medicine Departement of Allergy."— Presentation transcript:

1 1 Inhaler Devices Dr. Dane EDIGER Uludağ University School of Medicine Departement of Allergy

2 2 Inhalation Devices Aim To make aerosol from the drugs solution or solid particles 1-Metered dose inhaler 2-Dry powder inhaler 3-Nebulizer

3 3 Definition of an aerosol Aero air Sol solution Liquid or solid suspensions into gas medium Particles which are sufficiently small so as to remain airborne for a considerable period of time

4 4 Lower aerosol size Upper aerosol size. 0,001 µm 0,01 µm0,1 µm1 µm10 µm100 µm =0,1 mm

5 5 History of Inhaled Therapy China, India, Middle-east Hippokrattes Galenos 4000 years ago: the smoke of ephedra sinica was used to asthma therpy Smoke of Atropa belladona, Datura stramonium Sulphur, arsenic, menthol, timol, eucaliptus

6 6 Modern age Metered dose inhaler 1956 Medihaler Dry powder inhaler1960 Multidose dry powder inhaler million boxes aerosols per year are manufactured in the world

7 7 Why Inhalation Therapy? Targeted delivery of medication to the lungs Rapid onset of action Smaller doses Less systemic and GI adverse effects Relatively comfortable

8 8 Oropharynx absorbtion Lung absorbtion Vena porta Hepatic inactivation Gastrointestinal absorbtion SYSTEMIC CIRCULATION Urine elimination first pass effect PHARMACOKINETICS OF INHALED DRUGS

9 9 Adverse Effects LOCALSYSTEMIC INH KS Candidiasis Dysphonia Adrenal suppression Growth retardation (large doses) INH B2 AGONIST Sympathetic stimulation- tremor Tachicardia Hypokalemia

10 10 Deposition of particles > 5 µ impaction 1-5 µ sedimentation < 1 µ like gas

11 11 Hypothesis from available data 1 – 5 Upper / central airways Clinical effect Subsequent absorption from lung < 1 Peripheral airways / alveoli Some local clinical effect High systemic absorption > 5 Particle size (microns) Regional deposition EfficacySafety Mouth / oesophageal region No clinical effect Absorption from GI tract if swallowed > 5 Particle size (microns) Regional deposition EfficacySafety Mouth / oesophageal region No clinical effect Absorption from GI tract if swallowed

12 12 Lung deposition of drug Particle –size –shape –particle density –solid or liquid phase Type of inhalation device Tecknique Airway obstruction Drug molecule

13 13 4 Types of Inhaler Devices MDI/ DPI Small volumes Ready for use Stable obstructive disease Jet /Ultrasound nebulizer High fill volume > 1 ml Preparation required Severe respiratory insufficiency (asthma attack, COPD exac., CF)

14 14 Pressured Metered Dose Inhalers (pMDI) Canister Small reservoir Metering reservoir After pressure valve drug sprays Aerosol

15 15 Metered Dose Inhalers (pMDI) Canister –Propellent gas (liquid under pressure) Drug –Dissolved or solid microparticules into the gas Surfaktant –Physical stabilisation –Prevent clustering –Decreas valv friction Drug layer is surface of liquid propellent because more lightweight, it must be rinced before use

16 16 Propellant Chloro fluoro carbon (CFC) –CFC (freon gas) –CFC not flammable –Vapouring after spray –Particules continue movement

17 17 Propellant Hydro fluoro alcan (HFA) –Not include chloride –Not disturbe Ozone layer –İt influence on global heating

18 18 Rapid application Handling Multidose MDI advantages

19 19 Hand-breathe coordinations İneffective use in poor ventilated patiens Oropharyngeal deposition and local side effects Not include dosimeter MDI Disadvantages

20 20 Hand-breathe coordinations Autohaler

21 21 MDI spacer Decrease of oropharyngeal deposition Proposing inhaled CS

22 22 MDI spacer

23 23 Not include dosimeter

24 24 Chest. 2002;121: The SmartMist was 100% accurate, The Doser CT was 94.3% and MDILog was 90.1% All three devices are sufficiently accurate to monitor adherence in most clinical settings

25 25 Cold freon effect Oropharyngeal irritation, cough and bronchospasm Harmfull for ozone layer Cardiac arrhytmia Less effective in cold climate Freon (CFC)

26 26 MDI with HFA (CFC-free) Evohaler Salbutamol Flutikazon BDP Levalbuterol Budesonide Formoterol

27 27 Therapeutic Ratio of Hydrofluoroalkane and Chlorofluorocarbon Formulations of Fluticasone Propionate Fowler SJ., Chest, 2002

28 28 Dry powder inhaler (DPI)

29 29 Classification of Dry Powder Inhalers, Based on Design and Function Single-Dose Devices Aerolizer formoterol capsulesingle HandiHaler tiotropium capsulesingle Multiple Unit-Dose Devices Diskhaler fluticasone blistercassette zanamivir blistercassette Multiple-Dose Devices Turbuhaler budesonidereservoir 200 Turbuhaler budesonide/formoterol reservoir 120 Diskus salmeterol blister strip 60 Diskus salmeterol/fluticasone blister strip 60

30 30 Dry powder inhaler (DPI) Multi doses

31 31 Lung depostion form a budesonide Turbohaler measured by gamma scintigraphy Borgstrom et al Eur Respir J 1994;7: L/min 60L/min Inspiration Rate Total lung deposition (% of inhaled dose)

32 32 FAST vs SLOW INHALATION USING 500mcg TERBUTALINE via A TURBOHALER Newman et al Int J Pharm L/min 30L/min LUNG DEPOSITION (% OF THE DOSE) FEV 1, MMFR & PEFR FOR FAST > SLOW BUT N.S. (n=10 ASTHMATICS)

33 33 Dry powder inhaler (DPI) single dose

34 34 Device dependent factors Device pMDI: Portability, Treatment time, Drug preparation, Reproducibility, Coordination, Actuation, Drug availability, Holding chamber, Propellant DPI: Breath-actuation, Coordination, Portability, Treatment time, Dose counters, Flow requirement, Drug availability, Resistance, Costs. Aerosol Particle size, Velocity, Physico-chemical characteristics

35 35 Patient dependent factors Age co-operation compliance airway anatomy breathing patterns Disease

36 36 Dose to the lungs MDIs Ciclesonide 52% Fluticasone 16% Budesonide 5-12% BDP HFA MDI51% DPIs Different flow rates Budesonide Turbuhaler17-39% Budesonide Novolizer19-32% Budesonide Airmax28-30% One flow rate Budesonide Clickhaler27% Fluticasone Diskus13% Lung Deposition of ICS

37 37 TOTAL LUNG DEPOSITION AND DISTRIBUTION OF TERBUTALINE IN THE LUNG FOLLOWING INHALATION USING A TURBOHALER AND MDI TOTAL LUNG CENTRAL ZONE INTERMEDIATE ZONE PERIPHERAL ZONE % DEPOSITION Borgstrom & Newman Int J Pharm 1993;97:47-53 MDI TURBOHALER

38 38 Mean intra-subject variability % coefficient of variability Volumatic 31.8% Aswania O et al. J Aerosol Med 2004; 17(3): Easi-BreatheAccuhalerTurbohalerEvohaler pMDI Device % 40.4% 42.4% 52.0%

39 39 a review looking systematically at the clinical effectiveness and cost-effectiveness of inhaler devices in asthma and COPD

40 40 Only randomized controlled trials (RCT) (394 trials- years 1982 to 2001) assessing –inhaled corticosteroid, –B 2- agonist –anticholinergic agents delivered by MDI, MDI with a spacer/holding chamber, nebulizer, DPI Only 59 (primarily those that tested B2- agonists) proved to have usable data

41 41 Type 1 Trials: Device Performance Under Conditions of Actual Clinical Use example 1-To compare the effect of a B2-agonist agent delivered by nebulizer, DPI, and/or MDI in patients presenting to the emergency dept. with acute asthma –improvement in lung function –oxygenation –hospital admission rate To compare the effect of inhaled corticosteroids delivered by different devices over a period of weeks –daily asthma symptoms, –B2-agonist use –daily peak flow measurement

42 42 Type 2 Trials: Device Performance in the Clinical Laboratory Setting To compare drug delivery to the lungs and the clinical response to drugs administered by different devices under carefully controlled clinical laboratory conditions To establish dose-response curves for each of the devices To estimate differences in the clinical potency of the devices (relative potency or potency ratio) and a confidence interval The results; 1 actuation (or µg of drug) delivered from device A is equivalent to X number of actuations (or µg) delivered from device B.

43 43 Summaries and Results

44 44 Results None of the pooled meta-analyses showed a significant difference between devices in any efficacy outcome in any patient group for each of the clinical settings that was investigated The adverse effects that were reported were minimal and were related to the increased drug dose that was delivered Each of the delivery devices provided similar outcomes in patients using the correct technique for inhalation

45 45 B2 agonist ED /ICU

46 46 Aerosol Delivery of Short-Acting B2-Agonists in the Hospital Emergency dept SABA in the ED: nebulizer = MDIs with spacer –improving pulmonary function –reducing symptoms of acute asthma –in both adult and paediatric patients (quality of evidence: good). SABA in the ED: DPI = nebulizer = MDIs with spacer –in adults –data is inadequate (quality of evidence: low) Heart rate in the ED : nebulizer > MDIs with spacer (quality of evidence: good)

47 47 Recommendations 1. Both the nebulizer and MDI with spacer are appropriate for the SABA in the ED –Quality of evidence: good –net benefit: substantial –strength of recommendation: A 2. Data for DPIs are limited –Quality of evidence: low –net benefit: none –strength of recommendation: I

48 48 The appropriate selection of a particular device in this setting –the patients ability to use the device correctly –the preferences of the patient for the device –the availability of the drug/device combination –the compatibility between the drug and the delivery device –the lack of time or skills to properly instruct the patient in the use of the device or to monitor the appropriate use –the cost of the therapy –the potential of reimbursement –Quality of evidence: low –net benefit: substantial –Strength of recommendation: B

49 49 Aerosol Delivery of SABA in the Inpatient Hospital Setting SABA in the inpatient: nebulizer = MDI with spacer –pulmonary function response (quality of evidence: good) Recommendations: 1. Both nebulizers and MDIs with spacer are appropriate for use in the inpatient setting –Quality of evidence: good –Net benefit: substantial –strength of recommendation: A 2. Data for DPIs are limited –Quality of evidence: low –net benefit: none –strength of recommendation: I

50 50 Aerosol Delivery of SABA for Asthma in the Outpatient Setting SABA in the adult and paediatric outpatient: MDI = DPI –pulmonary function responses –symptom scores –heart rate –(quality of evidence: good) SABA in the outpatient: MDI =MDI with spacer –pulmonary function responses (quality of evidence: low) Data for nebulizers are limited –(quality of evidence: low)

51 51 Recommendations 1. Both the MDI with or without spacer and DPI are appropriate for the SABA in outpatient –Quality of evidence: good –net benefit: substantial –strength of recommendation: A 2. Data for DPIs are limited –Quality of evidence: low –net benefit: none –strength of recommendation: I

52 52 Inhaled Corticosteroids for Asthma Same dose of the same corticosteroid for adult patients with asthma in the outpatient: DPI or MDI with spacer –Pulmonary function response –symptom scores (quality of evidence: good) Patient preference: DPI > MDI with spacer –2 studies (quality of evidence: good). Data for incidence of oral candidiasis ?? –(quality of evidence: low)

53 53 Recommendations 1. Both the MDI with spacer and DPI are appropriate for the inhaled KS in outpatient –Quality of evidence: good –net benefit: substantial –strength of recommendation: A 2. Data for DPIs are limited –Quality of evidence: low –net benefit: none –strength of recommendation: I

54 54 Inhaled B2-Agonists and Anticholinergic Agents for COPD Inhaled B2-Agonists and Anticholinergic in the outpatient of COPD: MDIs with or without spacer = DPI = nebulizer –pulmonary function responses (quality of evidence: good) Heart rate : albuterol by nebulizer > MDI –(quality of evidence: good)

55 55 Recommendations: MDI, with or without spacer, nebulizer, and DPI are all appropriate for the delivery of inhaled B2- agonist and anticholinergic agents for the treatment of COPD in the outpatient –Quality of evidence: good –net benefit: substantial –strength of recommendation: A

56 56 Cihazların göreceli etkinlikleri birini diğerine tercih etmek için yeterli bir üstünlük sağlamamakta Bu durum hastaya özel cihazı belirlemenin bir sorun olmadığı anlamına da gelmemektedir Tüm bu çalışmalar bu cihazları iyi kullanabilen hastalarda yapılmıştır

57 57 IDEAL INHALER

58 58 Respimat Newman SP J Aerosol Med 1999

59 59 VENTAİRA Uniform dispersion of medication delivered by Ventaira Pharmaceuticals device. Non-uniform dispersion of medication delivered by dry powder inhaler (DPI)

60 60 Kuru toz inhaler DirectHaler TM Pulmonary


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