Quality control & evaluation test of aerosal

Pharmaceutical quality control & Evaluation test.

1. Quality control tests and Evaluation tests of Pharmaceutical Aerosol ~ Prepared by Pritom Sinha ID – 17100086 (9 th Batch) Department of Pharmacy Ranada Prasad Shaha University

2. Aerosol “Aerosol is a pressurized dosage forms containing one or more therapeutic active ingredients which upon actuation emit a fine dispersion of liquid and/or solid materials in a gaseous medium”. In 1942 - First aerosol was developed. (insecticide) In 1950 - Pharmaceutical aerosol for topical administration was developed. In 1955 - Aerosol for the local activity in the respiratory tract was developed (Epinephrine).

3. Aerosol Components Propellant Container Valve and actuator Product concentrate

4. Advantages Easily withdrawn of drug. Easy and convenient to apply. Faster Onset of action. No manual/ direct contact with the medicament. Avoid the first pass metabolism. A specific amount of dose or drug can be removed. No microorganism can enter. Release the contents in Controlled and Uniformly. Protect the photosensitive medicaments and oxygen sensitive material. Provides efficacy of a drug. Irritation can be reduced.

5. Disadvantage Expensive. Chlorofluorocarbon propellants cause Ozonelayer depletion. Inflammability. Toxicity. Explosivity .

6. Quality control tests It include tests of : Propellants Valves, Actuators, Dip tubes Containers Weight Checking Leak testing Spray testing

7. Quality control tests Propellants A sample is taken out & vapor pressure is determined which is then compared to specifications. Gas chromatography is used to determined the identity of the propellant. Purity of the propellant is checked by moisture, halogen & non volatile residual determinations.

8. Quality control tests Valves, Actuator & Dip Tube (Testing Procedure) Take 25 valves and placed on containers filled with specific test solution. Actuator with 0.020 inch orifice is attached. Temperature 25±1°C . Valve is actuated to fullest extent for 2 sec and weighed. Again the valve is actuated for 2 sec and weighed. Difference between them represents delivery in mg. Repeat this for a total of 2 individual deliveries from each of 25 test units . Valve Delivery per actuation in µL = Individual delivery weight in mg / Specific gravity of test solution Valve Acceptance : Deliveries Limit’s 54µL or less ± 15% 55 to 200 µL ± 10%

9. Quality control tests Valves, Actuator & Dip Tube (Testing Procedure) Out of 50 deliveries: If 4 or more deliveries are outside limits, then valves are rejected. If 3 or more deliveries are outside limits, another 25 valves are tested. Lot is rejected if more than 1 delivery is outside specification. If 2 deliveries from 1 valve are beyond limits: another 25 valves are tested. Containers Containers are examined for defects in linings. Quality control aspects include degree of conductivity of electric current as measure of exposed metals. Glass containers examined for flaws. The dimension of neck and other must be checked & weight should be determined.

10. Quality control tests Weight checking It is done by periodically adding empty tared containers to filling lines which after filling with product concentrate are removed and reweighed. Same procedure is used for checking weight of the propellant. Leak Test It is done by measuring the crimp’s valve dimension and comparing. Final testing of valve enclosure is done by passing filled containers through the water bath. Spray Testing It is done to clear up dip tube of pure propellant and concentrate and to check any defects in the valve and the spray pattern.

11. Evaluation Test For Pharmaceutical Aerosol ( Flammability and combustibility) Flame Projection The aerosol product is sprayed to an open flame for about 4 second and the extension of the flame is measured with the help of a ruler. Flash Point The aerosol product is chilled to a temperature of about - 25 F and transferred to the test apparatus. The temperature of the test liquid is increased slowly and the temperature at which the vapors ignite is taken as the flash point . Fig : Tag open cup apparatus

12. Evaluation Test For Pharmaceutical Aerosol (Physicochemical characteristics) 1. Vapor Pressure » Pressure gauge, » Can Puncturing Device. 2. Density » Hydrometer, » Pycnometer. 3. Moisture » Karl Fisher Method, » Gas Chromatography. 4. Identification of propellants » Gas Chromatography, » IR Spectroscopy. Property Method

13. Evaluation Test For Pharmaceutical Aerosol (Performance Tests) Spray Patterns The method involves the impingement of sprays on a piece of paper that has been treated with dye-talc mixture. It gives a record of the spray pattern. Aerosol Valve Discharge Rate An aerosol product of known weight is taken and its contents are discharged using standard apparatus for a given period of time. The container is reweighed. Then the change in weight per time dispensed is the discharge rate. The discharge rate can also be expressed as grams per second. Dosage with metered valves The doses are dispensed into the solvents or onto a material that absorbs the active ingredients. The assay of the solution gives the amount of active ingredients present.

14. CONTD… Net contents The tared cans are placed onto the filling line are weighed, the difference in weight is equal to the net contents. The other method is a Destructive method and consists of weighing a full container and then dispensing the contents. The contents are then weighed. The difference in weight gives the amount of contents present in the container. Foam stability The life of a foam ranges from a few seconds (for quick breaking foam) to one hour or more depending on the formulation. The methods which are used to determine the foam stability includes visual evaluation, time for a given mass to penetrate the foam, time for a given rod that is inserted into the foam to fall and rotational viscometer. Particle size determination Cascade impactor and light scattering decay methods are used for particle size determination.

15. Evaluation Test For Pharmaceutical Aerosol (Biological Testing) Therapeutic Activity For Inhalation Aerosols - The determination of therapeutic activity is dependent on the particle size. For Topical Aerosols - Therapeutic activity of aerosol products are determined by applying the therapeutically active ingredients topically to the test areas and the amount of therapeutically active substances absorbed is determined. Toxicity study For Topical Aerosols - The topically administered aerosols are checked for chilling effect or irritation in the skin. For Inhalation Aerosols: Inhalation toxicity study is done by exposing test animals to vapors sprayed from the aerosol container.