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PHARMACEUTICAL AEROSOLs

ByDr.Usama khan

Hamdard university Islmabad Pakistan 20/2/2015

Definition Packaging of therapeutic active ingredients in a pressurized system. Aerosols depends on the power of compressed or liquefied gas to expel the contents from containers.

Pharmaceutical aerosols: Aerosol products containing therapeutically active

ingredients dissolved, suspended or emulsified in a propellant or a mixture of solvent and propellant and intended for topical application, for administration into one of the body cavities (ear, rectum and vagina) or intended for administration orally or nasally as fine solid particles or liquid mists through the pulmonary airways, nasal passages or oral cavity.

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CLASSIFICATION OF AEROSOLS

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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.

• Controlled and uniform dose is released

• Ease of convenience of application.

• The onset of action is faster because the medicament

is directly administered to the affected part.

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Components of aerosols

Propellant

Container

Valve and actuator

Product concentratecontainer

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Propellant:A propellant is a chemical with a vapor pressure

greater than atmospheric pressure at 40°C (105°F.

Function:1) It is responsible for developing the vapor

pressure within the container 2)Expel the product when the valve is opened

and in the atomization or foam production of the product.

3)When the propellant is a liquefied gas or compressed gases, it can also serve as the solvent or vehicle for the product concentrate.

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Compressed Gas Propellants Inert Gases

Carbon DioxideNitrous OxideNitrogen

Liquefied Gas Propellants

Hydrocarbons

Liquefied Petroleum Gases(Propane, Isobutane, n-Butane) Isopentane, n-Pentane

Fluorocarbons1,1 Difluoroethane (152a)1,1,1,2 Tetrafluoroethane (134a)

Ethers Dimethyl Ether

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ContainersThey must be stand at pressure as high as 140 to 180 psig (pounds per sq. inch gauge) at 1300 F.

1.Tinplated steel: Consist of sheet of that has been electroplated on both sides with tin.

2. Aluminium :Greater resistance to corrosionLight weightGood for light sensitive drugs.

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3. Glass Container: 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 drug

4, Stainless steel:Limited for smaller sizeExtremely strong and resistant to moist materialsPressure stand

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Valves To delivered the drug in desired form. To give proper amount of medication. Not differ from valve to valve of medication in pharmaceutical preparation.

Types: Continuous spray valve: usually used for topical Metering valvesDispersing of potent medication at proper dispersion/ spray approximately 50 to 150 mg ±10 % of liquid materials at one time use of same valve. (minimize wastage and errors of overdosing)

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Actuator: These are specially designed buttons which helps in delivering the drug in desired form i.e., spray, wet stream, foam or solid stream. To ensure that aerosol product is delivered in the proper and desired form.

Different types of actuators

Spray actuators Foam actuators Solid steam actuators Special actuators

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Formulation of pharmaceutical aerosolsContains two essential components

Product concentrateProduct concentrate contains ingredients or mixture of active ingredients and other such as solvents, antioxidants and surfactants.

Propellant

May be single or blend of various propellants Blends of propellant used in a p’ceutical formulation to achieve desired solubility characteristics or various surfactants are mixed to give the proper HLB value for emulsion system. To give the desired vapor pressure, solubility & particle size.

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Manufacturing of Pharmaceutical Aerosols

Pressure filling method

Cold filling method

Compressed gas filling method

Manufacturing of AEROLOS

• AAddition of propellant

Manufacturing of concentrate

In general Manufacturing of aerosols takes place in two stages

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METHODS

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COLD FILLING PROCESSCOLD FILLING PROCESS

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