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Pharmaceutical Technology
& Engineering
PRESENTATION ON
AEROSOLAND SPRAY
PRODUCTS
Submitted To
PROF. MUZIB KHAN
DEPT. OF PHARMACY
UODA
Submitted By
GROUP -MARS
M- MAKSUDA MUSTARI-031153001
A- AIRIN AKTER-031153012
R- MD. FORHAD REZA- 031143005
S- SILVIA SHOMBA-031153004
GUIDED BY:
ISHITA MALEK
Sr. Lecturer Of UODA
Abstract
The Pharmaceutical Industry is a major global economic force, that
increasingly relies on the safe and efficient production of
technically advanced products.
Aerosol are the products that depend on the power of a compressed or
liquefied gas to expel the contents from the container. Aerosols are
termed also pressurized package.
Aerosol dosage form is a dosage form with an easy administration. It’s
main advantage is it requires lesser amount of active ingredients or
medicaments. It has rapid onset of action. It will act on targeted
area without any contamination.
CONTENTS
 DOSAGE FORM WITH TYPES
 AEROSOL
 WORKING PROCESSOF AEROSOL
 COMPONENTS
 TYPES OF AEROSOL SYSTEM
 MANUFACTURING OF AEROSOL
 ADVANTAGES & DISADAVNTAGES
 CONCLUSION
 REFERENCES
Dosage forms
Dosage forms are the means by which drug molecules are delivered to
sites of action within the body.
The need for dosage forms:
• Accurate dose.
• Protection e.g. coated tablets, sealed ampoules.
• Protection from gastric juice.
• Masking taste and odor.
• Placement of drugs within body tissues.
• Sustained release medication.
• Controlled release medication.
• Optimal drug action.
• Insertion of drugs into body cavities (rectal, vaginal)
• Use of desired vehicle for insoluble drugs.
Aerosol
“The aerosol container is considered as 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 compressed gas.
It is also know as canister/ pressure package/ pressurized package.
 In mid 1950 therapeutic aerosol was introduced in market.
 pharmaceutical therapeutic aerosol represent the complex dosage form
which will allow delivery of therapeutically active medicament to the
respiratory tract.
 It provide high drug concentration in broncho-alveolar fluid and other lung
parts.
Working process of Aerosol
 In aerosol the liquefied gas propellant /propellant mixture and product
concentrate is sealed within an aerosol container. Equilibrium is quickly
established between the propellant that remain liquefied and the propellant
which vaporize and occupies the upper portion of the container .
 The equilibrium which is developed, develops pressure against the wall of the
container.
 This pressure is responsible for the actuation of aerosol valve. It forces the
liquid phase upto the dip tube through the orifice of the valve and the
contents will release into the atmosphere.
 As the propellant release in the air it expands and evaporates because of the
drop down in the pressure which leaves the product concentrate as the airborne
liquid droplet or dry particle depending upon the formulation type.
fig. Working process of Aerosol
 Many studies have demonstrated that drug distribution and deposition
along the respiratory tract depends on several factors:
(1) characteristics of the inhaled formulation (particle diameter, size
distribution, shape, electrical charge, density, and hygroscopicity)
(2) anatomy of the respiratory tract, and
(3) breathing patterns, such as frequency, tidal volume, and flow.
 The ideal site of deposition along the airways for drugs intended for local
delivery is not well understood.
 Because the location of autonomic receptors varies within the respiratory
tract, successful therapy may depend on targeting specific receptor sites in
the lung with different types of drugs.
Components of Aerosol
 The delivery of components of aerosols depends on its valve assembly,
containers and actuators as well as on the propellant. The two components
of aerosols are product concentrate and propellant.
 The product concentrate contains the the therapeutically active ingredients.
 The propellant having vapour pressure greater than atmospheric pressure at
40 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. Thus aerosol components are classified as,
 Propellant:
The development of pressure within the container by the propellant
causes the opening of the valve which expels the product by atomization or foam
formation.
Types of propellant used:
depending on the route of administration and the use ,the propellant can be
classified
Table no: 1 types of propellant
Application Name of propellant
For oral inhalation Fluorinated hydrocarbons
Di-chloro di-fluro methane
Topical preparation Propane , butane,
isobutane
Compound gases Nitrogen , carbondioxide
Container
 Withstand a pressure as high as 140 to 180 psig (pounds per sq. inch gauge) at 1300 F
A. Metal
1. Tinplated steel
(a) Side-seam (three piece)
(b) Two-piece or drawn
(c) Tin free steel
2. Aluminum
(a) Two-piece
(b) One-piece (extruded or drawn)
 3. Stainless steel
B. Glass
1. Uncoated glass
2. Plastic coated glass
 VALVE
1. Actuator
2. Ferrule or mount cap
3. Valve body or housing
4. Stem
5. Gasket
6. Spring
7. Dip tube
TYPES OF AEROSOL SYSTEM
Types of Aerosol
system
Solution system
or two phase
system
Water system or
based three phased
system
Suspension or
dispersion
system
Foam system
Two phase system
 Contains both vapor & liquid.
 Drug soluble in propellant – no co-solvent.
 Propellant 12 – single or mixture.
 In mixture – propellant with vapor pressure less than propellant 12 , vapor
pressure reduction, bigger sized aerosol particles.
 E.g. propellant 12/11(30:70), propellant 12/114(45:55)
Three phase system
 Contains water phase, vapor phase and the propellant.
 Water immiscible with propellant – solubility increased by
adding,
- Co – solvent (ethanol)
- Surfactants (0.5% - 2.0%) – non polar (
esters of oleic acid, palmitic acid, stearic
acid)
Suspension system
 Using suspending agent.
 Oral inhalation aerosols.
 Active ingredients dispersed in propellant or mixture
 Physical stability by,
- Control of moisture content
- Active ingredients with minimum solubility.
- Initial particle size < 5 microns
- Propellant density
Foam system
 Consists of aq. or non aq. vehicles, propellant & surfactants.
 Four types -
 Aqueous stable foams
 Non aqueous stable forms
 Quick breaking forms
 Thermal forms
 Aqueous stable foams
- Propellant 3-4%
- Dry spray is produced
- Propellant – internal phase
- Steroidal antibiotics
 Non aqueous stable foams
- Emulsifying agent - glycol
 Quick breaking foams
- Propellant – external phase
- Topical application
- Cationic, anionic, non ionic surfactants
 Thermal foams
- Delivered as foam on application of heat
- Shaving creams
MANUFACTURING OF THERAPEUTICAL
AEROSOLS
Cold filling Apparatus
Pressure filling Apparatus
Compressed gas filling Apparatus
Rotary filling machine
ADVANTAGES
 Convinience, speed and ease of
administration.
 Avoidance of personal contact with
medicament.
 Useful for both systemic and local effect.
 Hepatic first pass avoided.
 Controlled and uniform dose delivered by
metered valve.
 Absence of air in the container prevent
oxidation of the drug.
 Dose can be removed without
contamination of remaining material.
 Directly delivered to the affected area in a
desired form.
DISADVANTAGES
 Costly.
 Difficulty in disposal.
 Difficulty in formulation.
 Q.C testing is complicated.
 Cannot be subjected to heat.
 There may be propellant toxicity when
inhalation therapy last for a long period
 Some propellant (CFC) cause
environment problem.
Marketed therapeutic aerosol products
BRAND NAME DRUG USE
Flovent Diskus fluticasone Asthama
Advair Fluticasone and
Salmeterol
Asthma
Aerobid Flunisolide Asthma
Qvar Beclomethasone Asthma
Proventil Albuterol Bronchospasm
Flovent Diskus
Advair
Conclusion
 Pharmaceutical Aerosol is a noninvasive pulmonary drug delivery system which is
considered to be the one of the best method as compared to other route of
administration.
 Its advantages over other route enhances its wide range of application in treatment of
illness like Asthma and Chronic obstructive pulmonary disease(COPD) etc.
 Some of its advantages include directly targeting the drug at the site of action ,
avoidance of first pass metabolism, rapid action
References
 Remington’s “The Theory and Practice Of Pharmacy”, 21st edition.
 Sandra Suarez and Anthony J Hickey, “Drug Properties Affecting
Aerosol Behavior”,IRJP JUNE 2000.
 Lahkar Sunita, A review on: Pharmaceutical Aerosol , IRJP 2012.
Thank You

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Aeroso spray products (Pharmaceutical technology and genetical engineering)

  • 3. Submitted To PROF. MUZIB KHAN DEPT. OF PHARMACY UODA
  • 4. Submitted By GROUP -MARS M- MAKSUDA MUSTARI-031153001 A- AIRIN AKTER-031153012 R- MD. FORHAD REZA- 031143005 S- SILVIA SHOMBA-031153004 GUIDED BY: ISHITA MALEK Sr. Lecturer Of UODA
  • 5. Abstract The Pharmaceutical Industry is a major global economic force, that increasingly relies on the safe and efficient production of technically advanced products. Aerosol are the products that depend on the power of a compressed or liquefied gas to expel the contents from the container. Aerosols are termed also pressurized package. Aerosol dosage form is a dosage form with an easy administration. It’s main advantage is it requires lesser amount of active ingredients or medicaments. It has rapid onset of action. It will act on targeted area without any contamination.
  • 6. CONTENTS  DOSAGE FORM WITH TYPES  AEROSOL  WORKING PROCESSOF AEROSOL  COMPONENTS  TYPES OF AEROSOL SYSTEM  MANUFACTURING OF AEROSOL  ADVANTAGES & DISADAVNTAGES  CONCLUSION  REFERENCES
  • 7. Dosage forms Dosage forms are the means by which drug molecules are delivered to sites of action within the body. The need for dosage forms: • Accurate dose. • Protection e.g. coated tablets, sealed ampoules. • Protection from gastric juice. • Masking taste and odor. • Placement of drugs within body tissues. • Sustained release medication. • Controlled release medication. • Optimal drug action. • Insertion of drugs into body cavities (rectal, vaginal) • Use of desired vehicle for insoluble drugs.
  • 8.
  • 9. Aerosol “The aerosol container is considered as 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 compressed gas. It is also know as canister/ pressure package/ pressurized package.
  • 10.  In mid 1950 therapeutic aerosol was introduced in market.  pharmaceutical therapeutic aerosol represent the complex dosage form which will allow delivery of therapeutically active medicament to the respiratory tract.  It provide high drug concentration in broncho-alveolar fluid and other lung parts.
  • 11. Working process of Aerosol  In aerosol the liquefied gas propellant /propellant mixture and product concentrate is sealed within an aerosol container. Equilibrium is quickly established between the propellant that remain liquefied and the propellant which vaporize and occupies the upper portion of the container .  The equilibrium which is developed, develops pressure against the wall of the container.  This pressure is responsible for the actuation of aerosol valve. It forces the liquid phase upto the dip tube through the orifice of the valve and the contents will release into the atmosphere.
  • 12.  As the propellant release in the air it expands and evaporates because of the drop down in the pressure which leaves the product concentrate as the airborne liquid droplet or dry particle depending upon the formulation type. fig. Working process of Aerosol
  • 13.  Many studies have demonstrated that drug distribution and deposition along the respiratory tract depends on several factors: (1) characteristics of the inhaled formulation (particle diameter, size distribution, shape, electrical charge, density, and hygroscopicity) (2) anatomy of the respiratory tract, and (3) breathing patterns, such as frequency, tidal volume, and flow.  The ideal site of deposition along the airways for drugs intended for local delivery is not well understood.  Because the location of autonomic receptors varies within the respiratory tract, successful therapy may depend on targeting specific receptor sites in the lung with different types of drugs.
  • 14. Components of Aerosol  The delivery of components of aerosols depends on its valve assembly, containers and actuators as well as on the propellant. The two components of aerosols are product concentrate and propellant.  The product concentrate contains the the therapeutically active ingredients.  The propellant having vapour pressure greater than atmospheric pressure at 40 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.
  • 15. Propellant can also act as the solvent or vehicle for the product concentrate. Thus aerosol components are classified as,
  • 16.  Propellant: The development of pressure within the container by the propellant causes the opening of the valve which expels the product by atomization or foam formation. Types of propellant used: depending on the route of administration and the use ,the propellant can be classified Table no: 1 types of propellant Application Name of propellant For oral inhalation Fluorinated hydrocarbons Di-chloro di-fluro methane Topical preparation Propane , butane, isobutane Compound gases Nitrogen , carbondioxide
  • 17. Container  Withstand a pressure as high as 140 to 180 psig (pounds per sq. inch gauge) at 1300 F A. Metal 1. Tinplated steel (a) Side-seam (three piece) (b) Two-piece or drawn (c) Tin free steel 2. Aluminum (a) Two-piece (b) One-piece (extruded or drawn)
  • 18.  3. Stainless steel B. Glass 1. Uncoated glass 2. Plastic coated glass  VALVE 1. Actuator 2. Ferrule or mount cap 3. Valve body or housing 4. Stem 5. Gasket 6. Spring 7. Dip tube
  • 19. TYPES OF AEROSOL SYSTEM Types of Aerosol system Solution system or two phase system Water system or based three phased system Suspension or dispersion system Foam system
  • 20. Two phase system  Contains both vapor & liquid.  Drug soluble in propellant – no co-solvent.  Propellant 12 – single or mixture.  In mixture – propellant with vapor pressure less than propellant 12 , vapor pressure reduction, bigger sized aerosol particles.  E.g. propellant 12/11(30:70), propellant 12/114(45:55)
  • 21. Three phase system  Contains water phase, vapor phase and the propellant.  Water immiscible with propellant – solubility increased by adding, - Co – solvent (ethanol) - Surfactants (0.5% - 2.0%) – non polar ( esters of oleic acid, palmitic acid, stearic acid)
  • 22. Suspension system  Using suspending agent.  Oral inhalation aerosols.  Active ingredients dispersed in propellant or mixture  Physical stability by, - Control of moisture content - Active ingredients with minimum solubility. - Initial particle size < 5 microns - Propellant density
  • 23. Foam system  Consists of aq. or non aq. vehicles, propellant & surfactants.  Four types -  Aqueous stable foams  Non aqueous stable forms  Quick breaking forms  Thermal forms
  • 24.  Aqueous stable foams - Propellant 3-4% - Dry spray is produced - Propellant – internal phase - Steroidal antibiotics  Non aqueous stable foams - Emulsifying agent - glycol  Quick breaking foams - Propellant – external phase - Topical application - Cationic, anionic, non ionic surfactants  Thermal foams - Delivered as foam on application of heat - Shaving creams
  • 25. MANUFACTURING OF THERAPEUTICAL AEROSOLS Cold filling Apparatus Pressure filling Apparatus Compressed gas filling Apparatus Rotary filling machine
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  • 29. ADVANTAGES  Convinience, speed and ease of administration.  Avoidance of personal contact with medicament.  Useful for both systemic and local effect.  Hepatic first pass avoided.  Controlled and uniform dose delivered by metered valve.  Absence of air in the container prevent oxidation of the drug.  Dose can be removed without contamination of remaining material.  Directly delivered to the affected area in a desired form. DISADVANTAGES  Costly.  Difficulty in disposal.  Difficulty in formulation.  Q.C testing is complicated.  Cannot be subjected to heat.  There may be propellant toxicity when inhalation therapy last for a long period  Some propellant (CFC) cause environment problem.
  • 30. Marketed therapeutic aerosol products BRAND NAME DRUG USE Flovent Diskus fluticasone Asthama Advair Fluticasone and Salmeterol Asthma Aerobid Flunisolide Asthma Qvar Beclomethasone Asthma Proventil Albuterol Bronchospasm Flovent Diskus Advair
  • 31. Conclusion  Pharmaceutical Aerosol is a noninvasive pulmonary drug delivery system which is considered to be the one of the best method as compared to other route of administration.  Its advantages over other route enhances its wide range of application in treatment of illness like Asthma and Chronic obstructive pulmonary disease(COPD) etc.  Some of its advantages include directly targeting the drug at the site of action , avoidance of first pass metabolism, rapid action
  • 32. References  Remington’s “The Theory and Practice Of Pharmacy”, 21st edition.  Sandra Suarez and Anthony J Hickey, “Drug Properties Affecting Aerosol Behavior”,IRJP JUNE 2000.  Lahkar Sunita, A review on: Pharmaceutical Aerosol , IRJP 2012.