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2
 Background & historical perspective
 Physicochemical factors governing
lung deposition
 Physiological and anatomical features
governing lung deposition
 Mechanism of drug clearance and
pharmacokinetics of disposition
3
 Inhaled therapies have existed for at
least 5000 year
 Modern drug therapy can be traced to
the propellant driven metered dose
inhaler (pMDI) of the 1950
 1990 actively alternative methods of
delivering macromolecular drug
 Which were difficult to deliver in
therapeutic doses by the oral or parental
route
4
 The physicochemical properties of the droplet
or particles being delivered the mechanical
aspect of aerosol dispersion
 Aerosol are aerodynamic properties
 Size of particle
 Visual examination
 Surface area measurement
 Equivalent volume diameter
 Shape and density is the important role
5
 Thermal settling velocity measure this
formula
 Pharmaceutical aerosol high level of
rotational symmetry and spherical behavior
 Aerosol are hydroscopic nature
 Rise to a kinetic reaction change in particle
size so transit though the high humidity
environment of the lungs ( 99.5% RF at 370C )
6
7
8
Estimate of the length, cross sectional, linear velocity of airway
indicating the lungs
9
Respiratory rates volumes in laboratory animals
10
Respiratory rates volumes for healthy young men
11
 The mechanism of drug clearance from the
airway must be considered
 Mainly involved mucociliary transport ,
absorption and cell mediated translocation
 The nature of the mechanism involved and
the interaction with the aerosol particle
complicate the pharmacokinetic of drug
clearance from the lungs
 The site of deposition in the lungs the nasal,
oropharyngeal, tracheobronchial and
pulmonary region
12
13
 In this topic discussed about droplet
formation may be characterized in term of
the nature of the propulsive force and liquid
being dispersed
 Different type of inhalers
A. Propellant driven metered dose inhalers
B. Dry powder
C. Nebulizers
14
 Several key components
a) Propellants
b) Drugs
c) Co solvents
d) Surfactants
 Propellants are CFCs (chlorofluorocarbons),
hydrofluoroalkanes and alkenes
 The vapor pressure and density of
propellants mainly involved in formulation
15
 The vapor pressure is the force of emission of
the droplet from the metering valve of the
inhaler
 A co solvent - ethanol
 surfactants are sorbitan , trioleate , oleic acid
16
 Valve and actuator
 Majority of product marketed by plastic
coated glass or aluminum container
 The performance should be evaluated in
terms of drug and component physical and
chemical compatibilities
 Temperature , humidity and stability of the
product should be considered
17
18
19
 The forces of interaction between particles
present barrier to their flow and dispersion
 The major forces of interaction are
1. Vander waals force
2. Electrostatic
3. Capillary force
 The dry powder is delivered for local and
systemic effect via to the pulmonary route
 The dry powder for inhaler are formulated
loose agglomerates
 Size range less than 5μg
20
 Dry powder inhaler are rapid action
 Portable ( essay to handle)
 Good bioavailability
21
 Dry powder inhaler available in
1. tablet
2. Capsule
3. Reservoir system
22
23
 Nebulizer formation conforms to sterile
product preparation
 Sufficient used antimicrobial agent in the
formulation , notably benzalkonium chloride
 The solubility of the drug important the
performance of the solution a selected
nebulizer
 Component include an energy source (gas ,
electrical ) a site of energy input to
solution(capillary tubes )
24
 Mechanism of delivery device is
1. air blast
2. Air jet
3. Ultra sonic system
25
26
27
Emitted dose
 The therapeutic effect of aerosol is
dependent upon their delivery to lungs
 Two unit dose
sampler are
popular
 These airborne
particulate are
sample at a fixed
flow rate of
60 L/ min
28
 In vitro characterization
 General sizing methods
 In vivo characterization
 Impaction is the method of choice for
evaluating particle or droplet size delivery
from pharmaceutical aerosol system
 Stoke volume determine aerodynamic
diameter of particles being evaluated
In vitro characterization
29
 Reynold’s number for flow greater than 500
but less than 3000
 The linear velocity can be derived from the
ratio of the volumetric flow
Method is used to prepare of mono disperse
aerosols
30
 It highly accurate sources of monodisperse
particle range from 1-200µm
 Produces solid or liquid check the
droplet uniformity by using a
gentle flow of air. Measure size ,
shape , density and surface area
31
 Measure uniformity
 To measure particle size of aerosol
 This method are suggested to for preparing
insoluble particle in 2- 10µm
 This instrument has proven useful in studies
involving the transport
and deposition of
particle
 (Ex) the measure the
particle deposition
In elbow formed in
Aluminium tube
32
 It is a 8- stage , 8- orifice sampler used in
environment working areas to measure the size
distribution and mass concentration levels of solid
particles and liquid aerosols
33
 Which can be used for determine the particle
size (aerodynamic size distribution )
34
 Number of alterative sizing methods are
available
General sizing method
35
36
 The Dry Powder Insufflator™ – Model DP-
4M is the world’s only commercially available
device that is pulmonary administration of
dry powders to mice.
 It can be used to administer a wide range of
pharmaceutical, biologic, radio-opaque and
toxicological powder formulations – from
nanoparticles to macro porous particles
37
Dry Powder Insufflator™ – Model DP-4M
 pMDI asthma therapy was introduced a new
product have been developed
 The major therapeutic categories are β2
adrenergic agonist , anticholinergics ,
glucocorticosteroids, and anti inflammatory
agents used
 Parasympathetic and sympathetic nervous
system induced brochodilatation
38
 Drug delivery to the respiratory tract has
been characterized by a increase in
knowledge of drug droplet or particle
manufacturing , behavior ,aerosol dispersion ,
lung deposition , clearance
 The number of disease for which aerosol
therapy may be applicable has increase
dramatically
39
 Modern pharmaceutics fourth edition ,
revised and expanded , edited by Gilbert S.
Banker , Christopher T. Rhodes
printed and bound by Replika press pvt. Ltd.
india (pg no) 479-496
40
41

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Aerosol

  • 2. 2
  • 3.  Background & historical perspective  Physicochemical factors governing lung deposition  Physiological and anatomical features governing lung deposition  Mechanism of drug clearance and pharmacokinetics of disposition 3
  • 4.  Inhaled therapies have existed for at least 5000 year  Modern drug therapy can be traced to the propellant driven metered dose inhaler (pMDI) of the 1950  1990 actively alternative methods of delivering macromolecular drug  Which were difficult to deliver in therapeutic doses by the oral or parental route 4
  • 5.  The physicochemical properties of the droplet or particles being delivered the mechanical aspect of aerosol dispersion  Aerosol are aerodynamic properties  Size of particle  Visual examination  Surface area measurement  Equivalent volume diameter  Shape and density is the important role 5
  • 6.  Thermal settling velocity measure this formula  Pharmaceutical aerosol high level of rotational symmetry and spherical behavior  Aerosol are hydroscopic nature  Rise to a kinetic reaction change in particle size so transit though the high humidity environment of the lungs ( 99.5% RF at 370C ) 6
  • 7. 7
  • 8. 8
  • 9. Estimate of the length, cross sectional, linear velocity of airway indicating the lungs 9
  • 10. Respiratory rates volumes in laboratory animals 10
  • 11. Respiratory rates volumes for healthy young men 11
  • 12.  The mechanism of drug clearance from the airway must be considered  Mainly involved mucociliary transport , absorption and cell mediated translocation  The nature of the mechanism involved and the interaction with the aerosol particle complicate the pharmacokinetic of drug clearance from the lungs  The site of deposition in the lungs the nasal, oropharyngeal, tracheobronchial and pulmonary region 12
  • 13. 13
  • 14.  In this topic discussed about droplet formation may be characterized in term of the nature of the propulsive force and liquid being dispersed  Different type of inhalers A. Propellant driven metered dose inhalers B. Dry powder C. Nebulizers 14
  • 15.  Several key components a) Propellants b) Drugs c) Co solvents d) Surfactants  Propellants are CFCs (chlorofluorocarbons), hydrofluoroalkanes and alkenes  The vapor pressure and density of propellants mainly involved in formulation 15
  • 16.  The vapor pressure is the force of emission of the droplet from the metering valve of the inhaler  A co solvent - ethanol  surfactants are sorbitan , trioleate , oleic acid 16
  • 17.  Valve and actuator  Majority of product marketed by plastic coated glass or aluminum container  The performance should be evaluated in terms of drug and component physical and chemical compatibilities  Temperature , humidity and stability of the product should be considered 17
  • 18. 18
  • 19. 19
  • 20.  The forces of interaction between particles present barrier to their flow and dispersion  The major forces of interaction are 1. Vander waals force 2. Electrostatic 3. Capillary force  The dry powder is delivered for local and systemic effect via to the pulmonary route  The dry powder for inhaler are formulated loose agglomerates  Size range less than 5μg 20
  • 21.  Dry powder inhaler are rapid action  Portable ( essay to handle)  Good bioavailability 21
  • 22.  Dry powder inhaler available in 1. tablet 2. Capsule 3. Reservoir system 22
  • 23. 23
  • 24.  Nebulizer formation conforms to sterile product preparation  Sufficient used antimicrobial agent in the formulation , notably benzalkonium chloride  The solubility of the drug important the performance of the solution a selected nebulizer  Component include an energy source (gas , electrical ) a site of energy input to solution(capillary tubes ) 24
  • 25.  Mechanism of delivery device is 1. air blast 2. Air jet 3. Ultra sonic system 25
  • 26. 26
  • 27. 27
  • 28. Emitted dose  The therapeutic effect of aerosol is dependent upon their delivery to lungs  Two unit dose sampler are popular  These airborne particulate are sample at a fixed flow rate of 60 L/ min 28
  • 29.  In vitro characterization  General sizing methods  In vivo characterization  Impaction is the method of choice for evaluating particle or droplet size delivery from pharmaceutical aerosol system  Stoke volume determine aerodynamic diameter of particles being evaluated In vitro characterization 29
  • 30.  Reynold’s number for flow greater than 500 but less than 3000  The linear velocity can be derived from the ratio of the volumetric flow Method is used to prepare of mono disperse aerosols 30
  • 31.  It highly accurate sources of monodisperse particle range from 1-200µm  Produces solid or liquid check the droplet uniformity by using a gentle flow of air. Measure size , shape , density and surface area 31
  • 32.  Measure uniformity  To measure particle size of aerosol  This method are suggested to for preparing insoluble particle in 2- 10µm  This instrument has proven useful in studies involving the transport and deposition of particle  (Ex) the measure the particle deposition In elbow formed in Aluminium tube 32
  • 33.  It is a 8- stage , 8- orifice sampler used in environment working areas to measure the size distribution and mass concentration levels of solid particles and liquid aerosols 33
  • 34.  Which can be used for determine the particle size (aerodynamic size distribution ) 34
  • 35.  Number of alterative sizing methods are available General sizing method 35
  • 36. 36  The Dry Powder Insufflator™ – Model DP- 4M is the world’s only commercially available device that is pulmonary administration of dry powders to mice.  It can be used to administer a wide range of pharmaceutical, biologic, radio-opaque and toxicological powder formulations – from nanoparticles to macro porous particles
  • 37. 37 Dry Powder Insufflator™ – Model DP-4M
  • 38.  pMDI asthma therapy was introduced a new product have been developed  The major therapeutic categories are β2 adrenergic agonist , anticholinergics , glucocorticosteroids, and anti inflammatory agents used  Parasympathetic and sympathetic nervous system induced brochodilatation 38
  • 39.  Drug delivery to the respiratory tract has been characterized by a increase in knowledge of drug droplet or particle manufacturing , behavior ,aerosol dispersion , lung deposition , clearance  The number of disease for which aerosol therapy may be applicable has increase dramatically 39
  • 40.  Modern pharmaceutics fourth edition , revised and expanded , edited by Gilbert S. Banker , Christopher T. Rhodes printed and bound by Replika press pvt. Ltd. india (pg no) 479-496 40
  • 41. 41