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Slide 1:

AEROSOLS Presented by T. Rajaram, K. Sreekanth M. Pharmacy I Year Rao’s college of pharmacy, nellore

Definition :

Definition These are pressurized dosage form of medicaments in which solid or liquid drugs are dissolved or suspended in a propellant. When pressure is applied to the valve the contents are expelled out in the form of mist, spray, stream or a foam.

Advantages :

Advantages A dose can be removed with out contamination of materials. The medication can be delivered directly to the affected area in a desired form, such as spray, steam, quick breaking foam or stable foam. Irritation produced by the mechanical application of topical medication is reduced or eliminated. Ease of convenience of application. Application of medication in thin layer


Disadvantages Expensive Catalytic oxidation of drugs. e.g. Ascorbic acid and Epinephrine Discomfort on injured skin Limited safety hazard Inflammable Pressurized

Slide 5:

Container Valve Actuator Components of aerosols Propellant Container Valve and actuator Product concentrate


Propellant It is responsible for developing the power pressure with in the container and also expel the product when the valve is opened and in the atomization or foam production of the product. For oral and inhalation eg. Fluorinated hydrocarbons Dichlorodifluoromethane (propellant 12) Dichlorotetrafluromethane (propellant 114) Topical preparation eg. Propane, Butane, Isobutane Compound gases eg. Nitrogen, Carbon dioxide, Nitrous oxide


containers They must be stand at pressure as high as 140 to 180 psig. TYPES OF CONTAINERS: 1. Tin plate containers Consists of sheet of steel plate that has been electroplated on both sides with tin. 2. Aluminium containers Greater resistance to corrosion. Light weight. Good for light sensitive drugs.


Contin … 3.Stainless steel container Limited for smaller size Extremely strong and resistant to most materials Pressure stand 4. Glass containers Available with plastic or without plastic coating Compatible with many additives No corrosion problems Can have various shape because of molding Not for light sensitive drugs

Valve components:

Valve components Actuator Ferrule or mount cap Valve body or housing Stem Gasket Spring Dip tube

Actuators :

Actuators To ensure that aerosol product is delivered in the proper and desired form. Different types of actuators Spray actuators Foam actuators Solid steam actuators Mist actuators

Spray actuator:

Spray actuator

Foam actuators:

Foam actuators

Solid steam actuator:

Solid steam actuator

Mist actuator:

Mist actuator

Metered dose inhalers (MDIs):

Metered dose inhalers (MDIs) Metered dose inhalers (MDIs) are pharmaceutical delivery systems designed for oral or nasal use, which deliver discrete doses of aerosolized medicament to the respiratory tract. e.g. salbutamol 100-200µg, terbutaline sulphate 250-500µg, sodium chromoglycate 5mg


contin …. The metering valve is place in inverted position. Depression of the valve stem allows the content of the metering chamber refill with liquid from the bulk is ready to dispense next dose



Dry powder inhalers:

Dry powder inhalers Delivers medication to the lungs in the form of a dry powder e.g. salbutamol sulphate 200-400µg, ipratropium bromide 20-40µg,

Advantages of DPIs:

Advantages of DPIs In DPI the drug is inhaled as a cloud of fine particle . The drug is either preloaded in the inhaled device or filled in hard gelatin capsule . DPI are propellant free. No additive except carrier like lactose . It can deliver large dose than MDI DISADVANTAGES It chances for spilling of powder from device.


TYPES OF AEROSOL SYSTEM There are four types of aerosol system: Solution system / Two phase system Water based system / Three phase system Suspension or Dispersion system Foam system Aqueous stable foam Non-Aqueous stable foam Quick Breaking Foam Thermal foam


SOLUTION SYSTEM which consists of two phases: a vapor phase and a liquid phase Propellant has high pressure hence propellant 114 is added to reduce its vapour pressure .


WATER BASED SYSTEM It is three phase system containing vapor phase, propellant , water. Ethanol used as a co solvent to solubilize the propellant in water. Propellant content varies from 25 -60%


SUSPENSION SYSTEM It is prepared by dispersion active ingredients in mixture propellant and by using suspending agent The physical stability of suspension can be increased by use minimum solubility of API. Eg. Ephedrine bitartarate is less soluble than Hcl By Use of surfactant to reduce the agglomeration Eg. Sorbitan monolaurate ,sorbitan monooleate, sorbitan trioleate, isopropyl myristae.


FOAM SYSTEM They contain Dispersion of AI, A.Vehicle, surfactant and propellant. Liquified propellant used as internal phase Aqueous stable foam : A. Ingredients( antiseptic ) oil waxes O/W surfactant Water Hydrocarbon propellant Non aqueous stable foam : These are prepared by using Glycols Emulsifying agent used this type PEG Esters

Slide 30:

Quick breaking foam : The product is dispensed as a foam which then collapsed into liquid. Useful for topical medication. Thermal foams: Used for shaving


MANUFACTURING OF PHARMACEUTICAL AEROSOL Apparatus Cold filling process Pressure filling process Compressed gas filling process

Pressure filling:

Pressure filling Product concentrate is placed in aerosol container. Valve assembly is inserted. Liquified gas(propellant) is metered under pressure by means of pressure burette into the container. The desired amount of propellant is allowed to flow through the aerosol valve into the container under its own vapor pressure. When the pressure is equalized between the burette and the container , the propellant stops flowing. Additional propellant is added with compressed air(N2, CO2, NO) to increase pressure of the propellant in the container. Trapped air inside the container was evacuated.

Pressure filling apparatus:

Pressure filling apparatus


ADVANTAGES It is the preferred method for solutions, emulsions and suspension. Less chances for contamination of product with the moisture Less propellant is lost No refrigeration is required, can be carried out at RT

Cold filling:

Cold filling The principle of cold filling method requires the chilling of all components including concentrate and propellant to a temperature of -30 to -40 º F. This temprature is necessary to liquify the propellant gas . The cooling system may be a mixture of dry ice and acetone or refergiration system. First, the product concentrate is chilled and filled into already chilled container followed by the chilled liquefied propellant. The heavy vapour of the cold liquid propellant generally displace the air in the container

Advantages :

Advantages Easy process.

Disadvantages :

Disadvantages Aqueous products, emulsions and those products adversely affected by cold temperature cannot be filled by this method.

Compressed gas filling:

Compressed gas filling Product concentrate is placed in the container. Valve assembly is inserted. Air is evacuated from the container by a vacuum pump. Compressed gas is passed into the container. When pressure is equal to the pre-determined & regulated pressure, the gas flow stops.

Compressed filling apparatus:

Compressed filling apparatus

Quality Control of Pharmaceutical Aerosols:

Quality Control of Pharmaceutical Aerosols

Evaluation of aerosols:

Evaluation of aerosols A. Flammability and combustibility Flame extension Flash point B. Physiochemical characteristics Vapor pressure Density Moisture content Identification of propellant(s) C. Performance Spray pattern Dosage with metered valves Net contents Foam stability Particle size determination Leakage


FLAME EXTENSION TEST This test indicates the effect of an aerosol formulation on the extension of an open flame. Product is sprayed for 4 sec. into flame. Depending on the nature of formulation, the flame is extended, and exact length was measured with ruler.


FLASH POINT Determined by using standard Tag Open Cap apparatus. PROCEDURE: Aerosol product is chilled to temperature of - 25 0 F and transferred to the test apparatus. Temperature of test liquid increased slowly, and the temperature at which the vapors ignite is taken a flash point. Calculated for flammable component, which in case of topical hydrocarbons.


MEASUREMENT OF VAPOR PRESSURE Determined by pressure gauge. Variation in pressure indicates the presence of air in headspace.


MEASUREMENT OF DENSITY Determined by Hydrometer or a Pycnometer. Procedure: A pressure tube is fitted with metal fingers and hoke valve, which allow for the introduction of liquids under pressure. The hydrometer is placed in to the glass pressure tube. Sufficient sample is introduced through the valve to cause the hydrometer to rise half way up the length of the tube. The density can be read directly.


MOISTURE CONTENT Method used — Karl Fischer method



Spray pattern:

Spray pattern Spray the product on the coated (dye +talc ) Paper. Depending upon the nature of aerosol water /oil soluble dye is used.

Dosage with Metered valves:

Dosage with Metered valves Weigh accurately the filled container. Dispense no. of doses. Reweigh the container & calculate the weight difference. Weight diff/ No. of times dose dispensed gives avg. dose. We should note the time of the each dose dispensed also. Dose is measured in gms/sec.

Net content:

Net content The difference in the weight of the full container and tarred container gives the content in the container. Net wt = gross wt. – Tare wt.

Foam stability:

Foam stability It can be determined by visual examination Time for given mass to penetrate the foam Time for given rod that is inserted in the foam to fall. Use of rational viscometers.

Particle size determination:

Particle size determination It is done by cascade impactor & light scatter decay methods.

Leakage test:

Leakage test Aerosol containers are completely immersed in hot water bath until temp. reaches 54.4ºc and is tested for leakage.

Slide 54:

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