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Aerosol inhalers
Ms. Punam Dilip Bagad
Assistant Professor, Dept. of Pharmaceutics
GES’s Sir Dr. M. S. Gosavi College of Pharm. Edu. & Research,
Nashik-422005, INDIA
1
Aerosols
 The aerosol container is referred to as a pressurized package in which
the therapeutically active drug is dissolved or suspended in
compressed or liquefied gas.
 The delivery of therapeutically active drug in the form of spray or foam
or solid stream is dependent on the ability of the liquefied or
compressed gas.
 It is also known as Pressurized packages, Pressure package or
Pressurized dosage forms.
2
Aerosols
 Aerosol technology is basis of pharmaceutical
product like pulmonary sprays and topical
muscle relaxant sprays etc.
 It is also basis of cosmetic products such as
deo’s
 Non-pharma products which are based on
Aerosol technology – insectisides sprays, fire
extinguisher, room freshner, color sprays
3
Advantages of Aerosols
 The drug sensitivity to the effect of oxygen or moisture is protected and
stability is enhanced.
 The drug can be directly applied to the affected areas.
 Administration of drug by aerosol is a rapid process.
 It protects the drug from gastrointestinal tract degradation.
 Hepatic first pass metabolism is avoided.
 Aerosols are used for both systemic and local application.
 Easy to apply.
 A sterile dose of drug is dispensed and also the contamination of drug is
prevented.
4
disadvantages of Aerosols
 Costly
 Difficult disposal of empty aerosol containers
 Allergic in some cases
 Aerosol packs must away from temperature and fire, because it may develop
high pressure inside the container leads to explosion.
 Due to volatility of the propellant/s can irritate the injured skin.
5
Aerosols
 The delivery of contents of
aerosol depends on its valve
assembly, containers, and
actuators as well as on the
propellant.
 The two components of
aerosol are product
concentrate and propellant.
6
Component
s of aerosol
Product
concentrat
e
Container
Actuator
Valves
Propellant
Components of Aerosols
7
product concentrate
 The product concentrate contains the therapeutically active
ingredients.
 The propellant having vapour pressure greater than atmospheric
pressure at 40°C (105°F) is responsible for the development of proper
pressure in the container to expel the product concentrate in the
desired form like spray, mist, solid, foam, stream etc.
 Propellant can also act as the solvent or vehicle for the product
concentrate.
8
propellant
 The development of pressure within the container by the propellant
causes the opening of valve which expels the product by atomisation or
foam formation.
9
Application Name of propellant
For oral and inhalation Fluorinated hydrocarbons
Di-chloro di-fluro methane (propellant 12)
Trichloromonoflouromethane (propellant 11)
Di-chloro tetra-fluro ethane (propellant 114)
Topical preparation Propane, Butane, Isobutane
Compound gases Nitrogen,Carbon dioxide, Nitrous oxide
propellant
 The basic characteristics of propellants are:
• chemical inertness
• lack of toxicity
• lack of flammability
• explosiveness
 Due to the presence of these characteristics, the chlorofluorocarbon
(CFC) propellants P-11, P-12, and P- 114 were used in aerosol products
for several years.
10
containers
 Aerosol containers are generally made of:
 Glass
 Metals: e.g. tin plated steel, aluminium, and stainless steel
 Plastics
 The materials of aerosol container to be selected should be able to
withstand high pressure.
 Thus the aerosol containers must withstand pressure as high as 140
to 180 psig (pounds per sq. inch gauge) at 130°F.
11
Valves
 A valve delivers the drug in desired form and regulates the flow of
product concentrate from the container.
 The valve should be able to withstand the pressure encountered by
product concentrate and the container, should be corrosion resistant.
 The two types of valves available are continuous spray valve and
metering valve
12
Aerosol Valve Components
 Actuator
 Stem
 Gasket
 Spring
 Mounting Cup or Ferrule
 Housing or Valve body
 Dip Tube
13
Aerosol Valve Components
Actuator:
 It is the button which the users press to activate the valve assembly
and controls the easy opening and closing of valve; also directs the
spray to the desired area.
 The actuator contains orifices of varying size and shapes as well as
the expansion chamber which determines the type and quantity of
propellant used, actuator design
14
Aerosol Valve Components
15
Types of
aerosols
Foam
actuator
Solid
stream
actuator
Mist
actuator
Spray
actuator
Types of inhalers
 Depending on the physical state of the dispersed phase and continuous
medium, inhaled drug delivery system is classified into three principle
categories:
1. Pressurised metered dose inhalers (pMDIs)
2. Dry powder inhalers (DPIs)
3. Nebulisers.
16
Metered dose inhaler
 The pressurised metered dose inhalers
(pMDIs) are composed of a canister, and
actuator, and sometimes a spacer.
 The canister is composed of a metering dose
valve with an actuating stem.
 The formulation (containing the active
ingredient i.e. drug, a liquefied gas propellant,
and a stabilizer) is present in the canister.
 The drug may be suspended or dissolved in the
liquefied gas propellant.
17
Metered dose inhaler
 Upon actuation, the metering dose valve is opened which releases a
single metered dose of medication alongwith the liquified gas
propellant to spray out of a carnister. This process is called
cavitation.
 The liquefied gas propellant is volatile in nature; breaks down into
liquid droplets which evaporates rapidly, and the dried micronized
drug are inhaled to the lung.
18
Metered dose inhaler
Advantages:
1. It delivers a specified amount of dose
2. Portable and compact
3. No product contamination and easy to use
4. Dose to dose reproducibility
Disadvantages:
1. A careful coordination of actuation and inhalation are required.
2. High chances of pharyngeal depositions.
3. As pMDIs is pressurised, it emits the dose at high velocity and gets deposited
in the oropharynx.
4. The propellant and the cosolvent may extract some of the organic compounds
from the device components and leads to chemical degradation.
19
https://www.webmd.com/asthma/video/video-asthma-medication
20
21
Dry powder inhaler
 It consist of only dry powder and does not
require a propulsion system.
 So it is a manual device wherein the powder is
loaded and the patient is required to manually
suck the powder using the device called as
rotahaler.
 The DPIs are classified into two types:
I. Unit dose devices
II. Multi dose devices
22
Dry powder inhaler
 It consist of only dry powder and does not require a propulsion system.
 So it is a manual device wherein the powder is loaded and the patient is
required to manually suck the powder using the device called as
rotahaler.
 The DPIs are classified into two types:
I. Unit dose devices
II. Multi dose devices
23
Dry powder inhaler
Unit-dose devices:
 Unit dose devices are being developed as re-useable or disposable single-
dose dry powder inhalers.
 They are designed to be easy to use and inexpensive to manufacture and
may be suitable for a wide range of conditions that require a rapid onset of
effect or that are for occasional use.
 One such unit dose device is the filled capsule placed in the device.
24
Dry powder inhaler
 The capsule shell is opened in the device and the powder is inhaled by the
user.
 The capsule shell remaining in the device is to be discarded after use, so
that the device can be reused with a new filled capsule.
 It cannot provide large dose as in the case of Asthma attack
 A wide range of unit dose dry powder inhalers are in use such as-
 The Innova TM
 The Solo TM
25
Dry powder inhaler
Multiple-dose devices:
 Turbuhaler
 Diskhaler
 Diskuse
 Clickhaler
 Duohaler
 PowderHale
26
Dry powder inhaler
Advantages:
1. It is compact and portable
2. Does not require propellant system
3. More appropriate lung deposition than pMDI
Disadvantages:
1. Works improperly if inhalation is not forceful
2. Most types are moisture sensitivec
3. Complex/expensive development and manufacturing process
4. It may lead to pharyngeal deposition of the drug
5. DPIs suffer from dose uniformity problems
27
nebulisers
 Nebulizer is a device used to administer
aerosolised medication in the form of a
mist inhaled into the lungs.
 Nebulizers use oxygen, compressed air
or ultrasonic power to break up medical
solutions and suspensions into small
aerosol droplets called mists that can be
directly inhaled from the mouthpiece of
the device.
28
nebulisers
 Nebuliser produce a mist of drug containing water droplets for inhalation.
 The drug is present either in solution form or suspension form in the
nebulizer.
 It is usually of two types:
1. Electronic nebulizer
2. Jet or ultrasonic nebulizer
 The nebulisers are generally used for the treatment of acute conditions
(e.g. acute asthma, respiratory infection) or in those patients who have
difficulties using other respiratory dosage forms.
29
nebulisers
 Some of the marketed products of nebulizers are as follow:
 Omron Microair Nebulizer
 DeVilbiss DeVilbiss PulmoMate Compressor / Nebulizer
 Pari Trek S
30
nebuliser
Advantages:
1. Provide therapy for patients who cannot use any other modalities such as MDI
or DPI
2. Allows administration of large dose of medicine
3. Patient coordination is not required
4. Dose modification is possible
5. Can be used with supplemental oxygen
Disadvantages:
1. Decreased portability
2. Electric supply required
3. Longer setup and administration time
4. Higher cost
31
Types of Aerosol system
Solution system or two phase system
 It is also called two-phase system as it contains both the vapour and the
liquid. Based on the desired spray, the propellant can be used single or
a mixture of propellants can be used.
Water based system or three phase system
 In the water based or three phase system, large quantity of water is
present to solubilise the contents. The water is immiscible with the
propellant.
 Generally water based system is a three phase system consisting of a
water phase, vapour phase and the propellant.
32
Types of Aerosol system
33
Solution system or two
phase system Foam system
Water based system or
three phase system
Suspension and
dispersion system
THANK YOU
34

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Aerosol Inhalers.pptx

  • 1. Aerosol inhalers Ms. Punam Dilip Bagad Assistant Professor, Dept. of Pharmaceutics GES’s Sir Dr. M. S. Gosavi College of Pharm. Edu. & Research, Nashik-422005, INDIA 1
  • 2. Aerosols  The aerosol container is referred to as a pressurized package in which the therapeutically active drug is dissolved or suspended in compressed or liquefied gas.  The delivery of therapeutically active drug in the form of spray or foam or solid stream is dependent on the ability of the liquefied or compressed gas.  It is also known as Pressurized packages, Pressure package or Pressurized dosage forms. 2
  • 3. Aerosols  Aerosol technology is basis of pharmaceutical product like pulmonary sprays and topical muscle relaxant sprays etc.  It is also basis of cosmetic products such as deo’s  Non-pharma products which are based on Aerosol technology – insectisides sprays, fire extinguisher, room freshner, color sprays 3
  • 4. Advantages of Aerosols  The drug sensitivity to the effect of oxygen or moisture is protected and stability is enhanced.  The drug can be directly applied to the affected areas.  Administration of drug by aerosol is a rapid process.  It protects the drug from gastrointestinal tract degradation.  Hepatic first pass metabolism is avoided.  Aerosols are used for both systemic and local application.  Easy to apply.  A sterile dose of drug is dispensed and also the contamination of drug is prevented. 4
  • 5. disadvantages of Aerosols  Costly  Difficult disposal of empty aerosol containers  Allergic in some cases  Aerosol packs must away from temperature and fire, because it may develop high pressure inside the container leads to explosion.  Due to volatility of the propellant/s can irritate the injured skin. 5
  • 6. Aerosols  The delivery of contents of aerosol depends on its valve assembly, containers, and actuators as well as on the propellant.  The two components of aerosol are product concentrate and propellant. 6 Component s of aerosol Product concentrat e Container Actuator Valves Propellant
  • 8. product concentrate  The product concentrate contains the therapeutically active ingredients.  The propellant having vapour pressure greater than atmospheric pressure at 40°C (105°F) is responsible for the development of proper pressure in the container to expel the product concentrate in the desired form like spray, mist, solid, foam, stream etc.  Propellant can also act as the solvent or vehicle for the product concentrate. 8
  • 9. propellant  The development of pressure within the container by the propellant causes the opening of valve which expels the product by atomisation or foam formation. 9 Application Name of propellant For oral and inhalation Fluorinated hydrocarbons Di-chloro di-fluro methane (propellant 12) Trichloromonoflouromethane (propellant 11) Di-chloro tetra-fluro ethane (propellant 114) Topical preparation Propane, Butane, Isobutane Compound gases Nitrogen,Carbon dioxide, Nitrous oxide
  • 10. propellant  The basic characteristics of propellants are: • chemical inertness • lack of toxicity • lack of flammability • explosiveness  Due to the presence of these characteristics, the chlorofluorocarbon (CFC) propellants P-11, P-12, and P- 114 were used in aerosol products for several years. 10
  • 11. containers  Aerosol containers are generally made of:  Glass  Metals: e.g. tin plated steel, aluminium, and stainless steel  Plastics  The materials of aerosol container to be selected should be able to withstand high pressure.  Thus the aerosol containers must withstand pressure as high as 140 to 180 psig (pounds per sq. inch gauge) at 130°F. 11
  • 12. Valves  A valve delivers the drug in desired form and regulates the flow of product concentrate from the container.  The valve should be able to withstand the pressure encountered by product concentrate and the container, should be corrosion resistant.  The two types of valves available are continuous spray valve and metering valve 12
  • 13. Aerosol Valve Components  Actuator  Stem  Gasket  Spring  Mounting Cup or Ferrule  Housing or Valve body  Dip Tube 13
  • 14. Aerosol Valve Components Actuator:  It is the button which the users press to activate the valve assembly and controls the easy opening and closing of valve; also directs the spray to the desired area.  The actuator contains orifices of varying size and shapes as well as the expansion chamber which determines the type and quantity of propellant used, actuator design 14
  • 15. Aerosol Valve Components 15 Types of aerosols Foam actuator Solid stream actuator Mist actuator Spray actuator
  • 16. Types of inhalers  Depending on the physical state of the dispersed phase and continuous medium, inhaled drug delivery system is classified into three principle categories: 1. Pressurised metered dose inhalers (pMDIs) 2. Dry powder inhalers (DPIs) 3. Nebulisers. 16
  • 17. Metered dose inhaler  The pressurised metered dose inhalers (pMDIs) are composed of a canister, and actuator, and sometimes a spacer.  The canister is composed of a metering dose valve with an actuating stem.  The formulation (containing the active ingredient i.e. drug, a liquefied gas propellant, and a stabilizer) is present in the canister.  The drug may be suspended or dissolved in the liquefied gas propellant. 17
  • 18. Metered dose inhaler  Upon actuation, the metering dose valve is opened which releases a single metered dose of medication alongwith the liquified gas propellant to spray out of a carnister. This process is called cavitation.  The liquefied gas propellant is volatile in nature; breaks down into liquid droplets which evaporates rapidly, and the dried micronized drug are inhaled to the lung. 18
  • 19. Metered dose inhaler Advantages: 1. It delivers a specified amount of dose 2. Portable and compact 3. No product contamination and easy to use 4. Dose to dose reproducibility Disadvantages: 1. A careful coordination of actuation and inhalation are required. 2. High chances of pharyngeal depositions. 3. As pMDIs is pressurised, it emits the dose at high velocity and gets deposited in the oropharynx. 4. The propellant and the cosolvent may extract some of the organic compounds from the device components and leads to chemical degradation. 19
  • 21. 21
  • 22. Dry powder inhaler  It consist of only dry powder and does not require a propulsion system.  So it is a manual device wherein the powder is loaded and the patient is required to manually suck the powder using the device called as rotahaler.  The DPIs are classified into two types: I. Unit dose devices II. Multi dose devices 22
  • 23. Dry powder inhaler  It consist of only dry powder and does not require a propulsion system.  So it is a manual device wherein the powder is loaded and the patient is required to manually suck the powder using the device called as rotahaler.  The DPIs are classified into two types: I. Unit dose devices II. Multi dose devices 23
  • 24. Dry powder inhaler Unit-dose devices:  Unit dose devices are being developed as re-useable or disposable single- dose dry powder inhalers.  They are designed to be easy to use and inexpensive to manufacture and may be suitable for a wide range of conditions that require a rapid onset of effect or that are for occasional use.  One such unit dose device is the filled capsule placed in the device. 24
  • 25. Dry powder inhaler  The capsule shell is opened in the device and the powder is inhaled by the user.  The capsule shell remaining in the device is to be discarded after use, so that the device can be reused with a new filled capsule.  It cannot provide large dose as in the case of Asthma attack  A wide range of unit dose dry powder inhalers are in use such as-  The Innova TM  The Solo TM 25
  • 26. Dry powder inhaler Multiple-dose devices:  Turbuhaler  Diskhaler  Diskuse  Clickhaler  Duohaler  PowderHale 26
  • 27. Dry powder inhaler Advantages: 1. It is compact and portable 2. Does not require propellant system 3. More appropriate lung deposition than pMDI Disadvantages: 1. Works improperly if inhalation is not forceful 2. Most types are moisture sensitivec 3. Complex/expensive development and manufacturing process 4. It may lead to pharyngeal deposition of the drug 5. DPIs suffer from dose uniformity problems 27
  • 28. nebulisers  Nebulizer is a device used to administer aerosolised medication in the form of a mist inhaled into the lungs.  Nebulizers use oxygen, compressed air or ultrasonic power to break up medical solutions and suspensions into small aerosol droplets called mists that can be directly inhaled from the mouthpiece of the device. 28
  • 29. nebulisers  Nebuliser produce a mist of drug containing water droplets for inhalation.  The drug is present either in solution form or suspension form in the nebulizer.  It is usually of two types: 1. Electronic nebulizer 2. Jet or ultrasonic nebulizer  The nebulisers are generally used for the treatment of acute conditions (e.g. acute asthma, respiratory infection) or in those patients who have difficulties using other respiratory dosage forms. 29
  • 30. nebulisers  Some of the marketed products of nebulizers are as follow:  Omron Microair Nebulizer  DeVilbiss DeVilbiss PulmoMate Compressor / Nebulizer  Pari Trek S 30
  • 31. nebuliser Advantages: 1. Provide therapy for patients who cannot use any other modalities such as MDI or DPI 2. Allows administration of large dose of medicine 3. Patient coordination is not required 4. Dose modification is possible 5. Can be used with supplemental oxygen Disadvantages: 1. Decreased portability 2. Electric supply required 3. Longer setup and administration time 4. Higher cost 31
  • 32. Types of Aerosol system Solution system or two phase system  It is also called two-phase system as it contains both the vapour and the liquid. Based on the desired spray, the propellant can be used single or a mixture of propellants can be used. Water based system or three phase system  In the water based or three phase system, large quantity of water is present to solubilise the contents. The water is immiscible with the propellant.  Generally water based system is a three phase system consisting of a water phase, vapour phase and the propellant. 32
  • 33. Types of Aerosol system 33 Solution system or two phase system Foam system Water based system or three phase system Suspension and dispersion system