Slide 1: BY
B.PHARMACY Slide 2: DEFINITION
COMPONENTS OF AEROSOL SYSTEMS
FORMULATION OF AEROSOLS
MANUFACTURE OF AEROSOLS
METERED DOSE INHALER DESIGNS
DRY POWDER INHALERS
EVALUATION OF AEROSOLS
QUALITY CONTROL TESTS FOR AEROSOLS Slide 3: Pharmaceutical aerosols are pressurised dosage forms that upon actuation emit a fine dispersion of liquid or solid materials containing one or more active ingredients in a gaseous or liquid medium. These are also to be called as pressurised packages.
It is easy and convenient to use.
It is used in the treatment of asthma or COPD.
It provides minimum contamination.
It provides maximum stability.
Systemic side effects are reduced. Slide 4: Cost is high.
Irritation may occur upon topical administration of aerosols.
It leads to inhalation toxicity. Slide 6: Propellants:
These are the materials which expel the contents of the container through the valves by applying force.
1. Halogenated hydrocarbons
Ex: Fluorinated chlorinated
Trichloro monofluoro methane
Dichloro difluoro methane Slide 7: 2. Hydrocarbon :
1. Soluble gases:
Ex: Carbon dioxide
2. Insoluble gases:
Ex: Nitrogen Slide 8: various types of materials are used in the manufacture of aerosol
containers. The containers used in the formulation of aerosols should
With stand high pressure i.e.,140 to 180 psig and temperature of about 54.44 c.
Types of materials used:
Metal: Two types of metal containers are tin plated steel and aluminium
Glass: Two types of glass containers are plastic coated glass and uncoated glass. Slide 9: 3.Valves : They help in expelling the contents from the container.
Parts of valves :
Mounting cup or Ferrule
4.Actuators : These are specially designed buttons placed on the valve stem.
Types of actuators:
Solid stream actuators Slide 10: Formulation of aerosols:
2.Propellants. Slide 11: Manufacture of aerosols:
Procedure for the manufacturing of aerosols is carried
out in 2 stages
1.The concentrate is manufactured.
2.Then the propellants are added in the formulation. Slide 12: Different apparatus used in manufaturing are
1.The pressure filling apparatus.
2.The cold filling apparatus.
3.The compressed gas filling apparatus. Slide 13: Metered dose inhaler designs:
In this drug is dissolved or suspended in a liquid propellant mixture presented in a pressurized canister fitted with a metering valve.
Containers: Thin plated steel , plastic coated glass or aluminium containers.
Propellants: Cholro fluoro carbons, hydrofluoro alkanes.
Metering valves: It permits reproducible delivery of small volumes of product . It is used in inverted position. Slide 15: Filling metered dose inhaler canisters:
Advantages of MDIs:
Disadvantages of MDTs :
2.Inefficient at drug delivery. Slide 16: Dry powder inhalers:
In this drug is inhaled as cloud of fine particles. The drug is either preloaded in a inhalation device or into hard gelatin capsules or foil blister discs.They are propellant free and do not contain any excipient other than carrier like lactose.
1. It is useful for young children.
2.It delivers larger drug doses than MDIs.
1.Liberation of powders from the device.
2.Less efficient. Slide 17: 1.Unit dose.
Dischaler. Slide 18: Spinhaler:The capsule is placed in a loose-fitting rotar is pierced through 2 needles.Inhaled air flow through the device causes rotation of rotar resulting in the powder being dispersed to the capsule walls and out through the perforations into the air.
Rotahaler:The capsule is inserted into an orifice at rear of the device and when the two sections are rotated a fin on the inhaler barrel pulls the two halves of the capsule spins,dispersing its contents,which are inhaled through the mouthpiece. Slide 19: Diskhaler:Here aluminium foil blisters are placed in disc.Needle will pierce the blisters as air flows the blisters causes the powder to disperse as the patient will inhales through the mouthpiece.
Turbohaler:Here drug is present in reservoir from which it flows to disc.The disc is rotated by moving the turning grip back and forth thus drug is released which is inhaled by patient. Slide 20: Moisture content.
Particle size determination.
Microbial limits. Slide 21: Evaluation of aerosols:
1.Flammability and combustion test.
1.Flash point test.
2.Flame projection test.
2.Physico chemical properties test.
4. Propellant identification.
1. Valve discharge test.
2. pattern of spray.
3.Metered valve test.
4.Determination of particle size.
4. Biological test. Slide 22: Quality control tests for aerosols:
3.Valves, Actuators and Dip tubes.
4.Weight checking of the container.
5.Test for leakage.
6.Spray test. Slide 23: Applications:
1.Aerosols are used for oral or topical administration.
2.They exhibit systemic effect.
3.These preparations are easy to carry.
4.They are uniformly applied without touching the affected area. Slide 24: