Aerosols Ppt

AEROSOLS

(Pressurized package system)

Types of aerosol systems

• Liquefied gas system

• Compressed gas system

• Barrier packs

Component of aerosol systems

1. Propellant

2. Container

3. Valve and actuator

4. Product Concentrate

Types of propellant

• Hydrocarbon

(Propane, Butane, Isobutane)

• Chlorofluorocarbon (EPA Banned )

(Trichloromonofluromethane,Dichlorodifluromethane)

• Compressed gases: (Nitrogen, Nitrous oxide,Carbondioxide)

Types of containersThey must be stand at pressure as high as 140 to 180 psig(pounds per sq. inch

gauge) at 1300 F1)Tinplated containers

– Available in sheets– 3 piece body– Coating is done after fabrication

2) Aluminum containers– Seamless – Great resistance to corrosion– Incompatible with pure water and ethanol

3) Stainless steel containers– Production hurdles– Costly– Use in inhalation aerosols– No internal coating

4) Glass containers– 15-30ml Volume– Available without plastic coating– Good corrosion resistance– Freedom for design of containers– Not recommended for suspension

An aerosol is made up of several basic components: • An aerosol can •The product •The propellant •A valve with dip tube •An actuator

The product, usually in the form of a liquid, is added.This contains active ingredients, except propellant.

The propellant is injected under pressure, through the valve.The propellant may be in the form of a liquified gas, or a compressed gas.

Valve and actuators• FDA approved valve• Valve made-up of Actuator,Stem,Gasket,Spring,Mounting cup,

Housing, Dip-tube• Metering Valve Actuator : • Integral part of aerosol• Spray actuator• Foam actuator• Solid stem actuator• Special actuator

Dispensing System: Actuators Foam Actuator Metered aerosol

Special actuator

Product concentrate

1. Active ingredient2. Solvent 3. Antioxidant4. Surfactant (Isopropyl myristate)5. Sweetener (Aspartame)6. Flavors (Strawberry )

Objective of Aerosol dosage form

• Dose removed without contamination• Stability is enhanced for oxygen and moisture

sensitive drugs• Irritation by local administration is reduced• Ease and self administration• Uniform application of drugs• Ideal for the drug entity exhibits erratic

pharmacokinetic• Quick effect of drug

Aerosol solution

• Preferred dosage form• Two phase system• Generally single propellant is used• Lowering of vapor pressure produced by

ethyl alcohol, propylene glycol, glycerine and acetone

• Amount of propellant 5% - 95%

Aerosol suspension

• To avoid co-solvency

• Dispersion of active ingredient

• Used for oral administration

• Surfactant is used ?

Physical stability of aerosols:

• Reduction of particle size (2-5 Micron)

• Adjustment of density

• Use of dispersing agent

Aerosol EmulsionComponent

1. Active ingredient2. Aqueous and nonaqueous vehicle3. Surfactant4. Propellant

• Approx 7-10% Propellant• Stable foam • Quick breaking foam

• Emulsion are available in foam forms, Edible foams, Cough remedies , Antacids, vitamins

Drug deposition

• System affected by- Particle size,

Aerosols velocity, Hygroscopicity

• Device characteristic

• Breathing pattern

• Morphology of upper and lower airways

Intranasal application

• Steroids, insulin, peptide and proteins are administered

• Excellent depth of penetration

• Lower doses compared to oral dose

• Maintenance of sterility of dose

• Aerosols suspension are preferred formulation for nasal

administration

• Bypass Blood Brain Barrier

• Nose to brain drug delivery system

Intra Nasal DDs

The FDA has cleared the NasalNeb™ for the delivery of aerosol to the upper airway! And, in an unprecedented move, Healthline Medical has incorporated its integrated filter, thereby protecting both caregiver and the environment!

Metered dose containers

• Use in the treatment of asthma

• Popular than nebulizer and DPI

• 60-90% of drug deposited in pharyngeal

area

• Spacers are use

Drug substances for intranasal DDS

• Local effect of drug

• Less bioavailability

• Quick effect of drug

• Airway obstruction

• Antispasmodic

• Corticosteroids

• Antidiabetic

Manufacturing of aerosols

• Pressure filling apparatus

• Cold filling apparatus

• Compressed gas filling apparatus

• Consist of pressure burette• Desired amount of propellant is allowed to

flow• Additional propellant is added through the

hose or piston• Metered dose intranasal preparation are

not filled by this method

Pressure filling apparatus

Cold filling apparatus

• Insulated box fitted with copper tubing

• Filled with dry ice/acetone prior to use

• Use with meter as well as non metered

valve

• Unsuitable for hydrocarbon aerosol

Compressed gas filling apparatus

• Concentrate is filled in the container• The valve is crimped in the place• Air is evacuated by means of vacuum pump• Filling head is inserted into the valve opening• Gas is allow to flow in the container• The container is shaken manually during and

after filling

Evaluation of aerosols

1. Flammability and combustibility– Flash point (-25°F,Tag open cup Apparatus)– Flame extension (Flame)

2.Physicochemical characteristic– Vapor pressure – Density (Hydrometer or Pycnometer)– Moisture content (Karl Fischer & GC )– Identification of propellant (GC&IR)– Concentrate propellant ratio

3. Performance

– Aerosols valve discharge (gm/sec)

– Spray pattern (Dye-talc power)

– Dosage with metered dose (Assay technique)

– Net content (Destructive method) (Eye drops)

– Foam stability (Visual,Mass,Line)

– Particle size determination (Light scattering viscometer)

– Leakage (Heating at 130ºF)4. Biologic characteristic 5. Therapeutic testing6. Toxicity studies

Evaluation of Aerosols

Recent advances

• Metered dose inhalers

• Sublingual aerosols

• Anti diabetic aerosols (Insulin liposome for

controlled drug delivery system)

• Pressurized metered dose inhalers

• Administration of proteins and peptides