aerosols powerpoint

7/29/2019 Aerosols powerpoint

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Definition:products that depend on the power of acompressed or liquefied gas to expel the contentsfrom the container.

Aerosolsare termed also pressurized package.

Pharmaceutical aerosols: aerosol productscontaining therapeutically active ingredientsdissolved, suspended or emulsified in a propellantor a mixture of solvent and propellant and intended

for topical administration, for administration intoone of the body cavities (ear, rectum and vagina) orintended for administration orally or nasally as finesolid particles or liquid mists through thepulmonary airways, nasal passages or oral cavity.
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The product is administered easily and quickly.

A dose can be removed with out contamination of materials.

Stability is enhanced for these substances adversely affected byoxygen and or moisture.

When sterility is an important factor, it can be maintained while adose is being dispensed.

Rapid onset of action, avoidance of degradation of the drug in theGIT and first pass effect.

Lower dose of drug can be used and hence minimize adverse andside effects.


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The medication can be delivered directly to theaffected area in a desired form, such as spray,steam, quick breaking foam or stable foam.

Irritation produced by the mechanicalapplication of topical medication is reduced oreliminated.

Application of medication in thin layer
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Components of aerosols: Propellant

Container

Valve and actuator Product concentrate


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Propellant: It is responsible for developing thepower pressure within the container and alsoexpel the product when the valve is openedand in the atomization or foam production ofthe product.

For oral and inhalation:eg. Fluorinated hydrocarbons

Dichlorodifluromethane (propellent 12)Dichlorotetrafluromethane (propellent 114)

For Topical preparation:PropaneButaneIsobutane


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A- Liquefied gas- these are materials that at room temperatureand atmospheric pressure exist in the gaseous or

vapor state and are capable of being liquefied at

relatively low pressures or temperatures.

- E.g. Chloroflurocarbon (CFCs)Hydrocarbons- Because the aerosol is under pressure the propellant exists mainly

as a liquid, but it will also be in the head space as a vapour.

- As the product is used up as the valve is opened, some of the liquidpropellant turns to vapour and keeps the head space full of vapour

- In this way the pressure in the can remains constant and the sprayperformance is maintained throughout the life of the aerosol.

-


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B- Compressed Gas Propellants Compressed gas propellants onlyoccupy the head space above the liquidin the can.

When the aerosol valve is opened the gas 'pushes' theliquid out of the can.

The amount of gas in the headspace remains the samebut it has more space, and as a result the pressure will

drop during the life of the can.

E.g. nitrogen, nitrous oxide, carbon dioxide


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

A. Metals

1. Tinplated steel

2. Tin free steel3. Aluminium

4. Stainless steel

B. Glass1. Uncoated glass

2. Plastic coated glass
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Tinplated steel :- Used in topical pharmaceutical aerosols

- Coating decreases the compatibility problems

- Light

- InexpensiveAluminum:

- Used in oral aerosols

** Metal containers may be further coated withorganic coating, e.g. oleoresin, phenolic, vinylor epoxy coating for additional protection.
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Glass- Advantage: Absence of incompatibility

- Its use is limited for products having lowerpressure and lower percentage of propellant

- There are two types of glass containers:Uncoated glass:

- Low cost - High clarity

Plastic coated glass:

- Prevent the glass from shattering in the eventof breakage

- Used for some topical and MDI aerosols


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Why a Curved Bottom?In most aerosol cans, the bottom curves inward.

This serves two functions:

1-The shape strengthens the structure of thecan. If the can had a flat bottom, the force ofthe pressurized gas might push the metaloutward. A curved bottom has greater

structural integrity.2-The shape makes it easier to use up all theproduct.
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To deliver the drug in desired form. To give proper amount of medication.

Types:

1- Continuous spray valve- High speed production technique.2- Metering valves- Dispersing of potent medication at proper

dispersion

- spray approximately 50 to 150 mg 10 % ofliquid materials at one time use of same valve.


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Valve Cup :- typically constructed from tinplated steel, or aluminium. Outer Gasket :- this is the seal between the valve cup and the aerosol can. Valve Housing :- contains the valve stem, spring and inner gasket. Valve Stem :- in effect, the tap through which the product flows. Inner Gasket :- covers the hole in the valve stem. Valve Spring :- usually stainless steel. Dip Tube :- allows the liquid to enter the valve. Actuator (not shown) :- fits onto the valve stem.
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To ensure that aerosol product is delivered inthe proper and desired form.

Different types of actuators:Spray actuators,Foam actuators, Solid steam actuators,

Special actuators
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Contains two essential components: Product concentrate

- contains ingredients or mixture of activeingredients and other such as solvents,antioxidants and surfactants

Propellant.

- Propellant May be single or

blend of various propellants
http://en.wikipedia.org/wiki/File:Aerosol_drawing_type.svg


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Solution system- Consist of a solution of active ingredients in pure

propellant or a mixture of propellant and solvents.

- Easy to formulate, provided that the ingredients aresoluble in the propellant


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Suspension or Dispersion systems- Active ingredients are suspended or dispersed

throughout the propellant or propellant and solventphase.

- Problems associated with the formulation:

Agglomeration, caking, particle-size growth and valveclogging (closing).

- To overcome these problems:1-lubricants: isopropyl myristate, oleic acid- Provide slippage between particles- Lubricate components parts of the valve2- Surfactants: to disperse particles


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3- Dispersing agents: oleic acid, lecithin- Keep the suspended particles from agglomeration

4- The particle size of metered-dose inhalant shouldbe between 2 8 um, while those for topicalaerosols should be 50 100 um.


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Metered dose inhalers

Consists of a pressurizedcontainer with metered-dose

valve and placed in an oral

adapter (mouthpiece).

When the unit is dispensed,the exact amount of the drug

is expelled in the proper

particle size to achieve

maximum deposition in the

lungs.

Formulated as solution or

suspension.

ff f i l i d d i i


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Effect of particle size on drug deposition

in the lung
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3- Emulsion:- Suitable for topical aerosols

- Two types of emulsions can be formulated- o/w OR

w/o- If the product concentrate is dispersed throughout

the propellant ..W/O emulsiontheproduct is dispersed as wet stream

- If the propellant is in the internal phase..O/Wemulsionfoam is emitted
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Cold filling apparatus- Lowering the temperature of the concentrate (solution or

suspension) below room temperature (-30C to - 60C)

- The cold concentrate is added to chilled (cooled) container

- The propellant is added

- The valve is crimped in place

- The container is passed into a water path (55C) to ensurethere is no leakage or distortion in the container.


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Pressure filling apparatus- The concentrate may be chilled slightly (15 -20C)

to reduce vaporization of any volatile solvent orpropellant.

- The concentrate is added to an open container- The valve is crimped in place

- The propellant is added under pressure throughthe valve.

- The filled container is passed through the waterpath.


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A. Flammability and combustibility1-Flame ProjectionThis 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, thefame is extended, and exact length wasmeasured with ruler.

-


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2- Flash pointDetermined by using standard Tag Open Cap

Apparatus.- Aerosol product is chilled to temperature of - 25 F

and transferred to the test apparatus.

- Temperature of test liquid increased slowly, and thetemperature at which the vapors ignite is taken aflash point.

- Calculated for flammable component, e.g. topicalhydrocarbons.


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B. Physiochemical characteristics1- Vapor pressureDetermined by pressure gauge

Variation in pressure indicates the presence of air in

headspace.

2-DensityDetermined by hydrometer or a pychnometer.

3-Moisture contentBy Karl Fischer method

4- Identification of propellantsI.R spectrophotometry


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C. Performance1- Aerosol valve discharge rate- Determined by taking an aerosol known weight

and discharging the contents for given time using

standard apparatus.

- By reweighing the container after time limit hasexpired, the change in weight per time dispensedis discharge rate, Expressed as gram per seconds.


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2- Dose uniformity- To determine amount of medication actually

received by the patient.- The method involves accurate weighing of filled

container followed by dispersing of severaldoses.

- Container can reweighed

- Difference in weight divided by No. of dose,gives the average dosage.


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3- Net contents- Weight filled full container

- Dispensing the contents, then reweight thecontainer

- The difference in weight, will be the net weight

4- LeakageUsed to estimate the weight loss over a 1-year

period.


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5- Particle size distribution- By using Cascade Impactor

- Carrying particles in a stream of air through aseries of consecutively smaller jet openings.

- The heavier and larger diameter particles areimpacted on a slide under the larger opening.

- As the openings get smaller, the velocity of the

stream increases and the next larger particlesare deposited on the next slides.

E. Therapeutic activity


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