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6. Pharmaceutical Aerosols:

6. Pharmaceutical Aerosols Berhanemeskel W.G, Asst. Prof. Department of Pharmaceutics School of Pharmacy College of Medicine and Health Sciences University of Gondar 1 Tuesday, February 28, 2012

Presentation Outline :

Presentation Outline Introduction Components of aerosol Package Stability testing Equipment used Quality control 2


Introduction Definition: A suspension of small solid particles or droplets suspended in a gas or vapor. Aerosol or pressurized package is a system that depends on the power of a compressed or liquefied gas to expel the contents from the container Pressurized packages existed during the early 1900s Aerosol industry begin in 1942 , aerosol insecticide developed by Good hue and Sullivan of the US Department of Agriculture. 3

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The principle of aerosol technology were applied to the development of pharmaceutical aerosols in the early 1950s In 1950s - intended for topical administration In 1955 - intended for local activity in the respiratory tract Introduction (2) 4

Advantages of Pharmaceutical Aerosols:

Advantages of Pharmaceutical Aerosols Dose can be removed without contamination of remaining material Medication can be delivered directly to the affected area in a desired form Irritation produced by the mechanical application of topical medication is reduced or eliminated Ease and convenience of application and application of medication in thin layer 5


Limitations Expensive Performance of package can deteriorate during life of product Limited safety hazard Flammable Pressurized Inadvertent inhalation 6

Types of drug delivery systems:

Types of drug delivery systems Nebulizers used to administer medication to people in the form of a mist inhaled into the lungs. Meter dose Inhaler (MDI) are pressurized, hand-held devices that use propellants to deliver doses of medication to the lungs of a patient Propellant driven Aqueous pump sprays Dry powder inhaler (DPI) delivers medication to the lungs in the form of a dry powder. 7

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Components of Aerosol Package:

Components of Aerosol Package An aerosol product consists of the following component parts: Propellant Container Valve and actuator (Button) Product concentrate 9

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Propellant :

Propellant It is responsible for developing the proper pressure within the container It expels the product when the valve is opened and aids in the atomization or foam production of the product Types of Propellant 1. Fluorinated hydrocarbons e.g. Trichloromonfluoromethane (Prop 11) Dichlorodifluoromethane (Prop 12) Dichlorotetrafluoroethane (Prop 114) 2. Hydrocarbons e.g. Propane, Butane, and Isobutane 3. Compressed gases e.g. Nitrogen, Carbon dioxide, and Nitrous oxide 4. Hydrofluoroalkanes In practice blends are used to provide various vapor pressure. The ultimate interest is to have vapor pressure 11

Hydrocarbon Propellants:

Hydrocarbon Propellants Advantages Inexpensive Minimal ozone depletion Negligible “greenhouse effect” Excellent solvents Disadvantages Flammable Aftertaste Unknown toxicity following inhalation Low liquid density 12

Chlorofluorcarbons (Used only in inhalation aerosols):

Chlorofluorcarbons (Used only in inhalation aerosols) Advantages Low inhalation toxicity High chemical stability High purity CFC-11 is a good solvent Disadvantages Destructive to atmospheric Ozone Contribute to “greenhouse effect” High cost 13

Hydrofluoroalkanes (aka Hydrofluorocarbons):

Hydrofluoroalkanes (aka Hydrofluorocarbons) Advantages Low inhalation toxicity High chemical stability High purity Not ozone depleting Disadvantages Poor solvents Minor “greenhouse effect” High cost e.g. 1,1,1,2,3,3,3 – Heptafluoropropane (HFA-227), 1,1,1,2 – Tetrafluoroethane (HFA-134a) 14

Compressed gas propellants:

Compressed gas propellants Advantages Low inhalation toxicity High chemical stability High purity Inexpensive No environmental problems Disadvantages Require use of a nonvolatile co-solvent Produce course droplet sprays Pressure falls during use 15


Containers Containers must withstand 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. Aluminum containers greater resistance to corrosion Light weight, not fragile Good for light sensitive drugs 16

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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 Fragile Not for light sensitive drugs 17


Valves Deliver the content in the desired form Generally designed to work in inverted position Primary function – reproducibly delivery an aliquot of liquid phase in which drug is dissolved or suspended There are mainly two types of valves Continuous spray valve Metering valves Has various components: Mount cap, Valve housing, Stem, Gasket (rubber), Spring, Deep tube 18

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Are specially designed buttons Ensure proper delivery of the aerosols by allowing the opening and closing of the valve When actuators depressed valve open They produce different forms of final product Actuators 20


Formulations Pharmaceutical aerosol Product concentrate + Propellant Filling first product concentrate to the container and then fill propellant during package = two steps Product concentrate is composed of Active ingredients Solvent Additives 21

Types of systems:

Types of systems 1. Solution system Consist of two phases liquid and vapor If the active ingredient is soluble in propellant it has one system The ratio of propellant and solvent could range from 5% (foaming) to 95% (inhalation). To lower vapor pressure we can add solvents of non volatile e.g. Propylene glycol, acetone, alcohol 22

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2. Water based systems Are increasing in use nowadays Have relatively large amount of water There is three phase system: water, propellant and vapor In aquasol system it has two phases i.e. water and vapor 3. Dispersed systems (suspension) It needs surfactants Particle size is important 4. Foam systems Have foaming agent Aqueous or non aqueous 23

Stability testing:

Stability testing Stability is tested during the product development Parameters for product concentrate and propellant are: Vapor pressure - Spray rate (pattern valve) pH - Specific gravity Viscosity - Total weight with time Purity of propellant Total weight of active ingredient with time Color and odor Containers stability Pressure withstand Corrosion Stability of valves and actuators functions 24

Equipments used:

Equipments used Those fill at pressurized and low temperature Pressure filling (gauge-burette) Cold filling (low temp.) Compressed gas filling (after concentrate has been filled) 25

Quality control (QC):

Quality control (QC) Leak test Passing the filled container to hot water. If there is bubble it has leak Q.C on propellant Q.C on concentrate and their stability 26

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