Evaluation Of Pharmaceutical Aerosol : Evaluation Of Pharmaceutical Aerosol By, Dhaval Vikani EVALUATION : EVALUATION Flammability & Combustibility
Flame extension, including flashback
Identification of propellant (s)
Aerosol valve discharge rate
Dosage with metered valves
Particle Size determination
Biologic Characteristics 2 11/29/2010 DHAVAL VIKANI Flame Projection : Flame Projection Effect of an aerosol formulation on an open flame.
The product is sprayed for about 4 sec into a flame
Depending on the nature of the formulation, the flame is extended, the exact length is measured with a ruler. 3 11/29/2010 DHAVAL VIKANI Flash Point : Flash Point Determined by using the Standard Tag Open Cup Apparatus.
The aerosol product is allowed to chilled to a temp of about -250F & transferred to test apparatus.
The test liquid is allowed to increase slowly in a temperature & the temp at which the vapor ignites is taken as the flash point.
Calculated for flammable components, which in case of topical hydrocarbons. 4 11/29/2010 DHAVAL VIKANI Measurement Of Vapor Pressure : Measurement Of Vapor Pressure To determine pressure variation from container to container.
Determine by pressure gauge or can puncturing device.
Variation in pressure indicates the presence of air in headspace. 5 11/29/2010 DHAVAL VIKANI Measurement Of Density : Measurement Of Density Determination by Hydrometer or a Pycnometer.
A pressure tube is fitted with metal fingers and hoke valve, which allow for the introduction of liquids under pressure.
The hydrometer is placed in to the glass pressure tube.
Sufficient sample is introduced through the valve to cause the hydrometer to rise half way up the length of the tube.
The density can be read directly. 6 11/29/2010 DHAVAL VIKANI Identification of Propellants : Identification of Propellants GC & IR spectroscopy.
These methods are used for the identification as well as measurement for proportion of each components in blend. Moisture Karl Fischer Method
GC 7 11/29/2010 DHAVAL VIKANI Aerosol Valve Discharge Rate : Aerosol Valve Discharge Rate This is determine by taking an aerosol product of known weight and discharge the content for a given period of time using standard apparatus.
By reweighing the container after the time limit has expired, the change in weight per time dispensed is the discharge rate, which can then be expressed as grams per second. 8 11/29/2010 DHAVAL VIKANI Spray pattern : Spray pattern Method is based on the impingement of the spray on a piece of paper that has been treated with a dye-talc mixture.
Depending on the nature of the aerosol, an oil-soluble or water-soluble dye is used.
The particles that strike the paper cause the dye to go into solution and to be absorbed onto the paper.
These gives the record of the spray, which can then be used for comparison. 9 11/29/2010 DHAVAL VIKANI Dosage With Metered Valve : Dosage With Metered Valve Reproducibility of dosage each time the valve is depressed.
Amount of medication actually received by the patient.
It is done by assay method.
Either by spraying the content into the solvent or on the material which absorb the API. Which then assay for the content uniformity. 10 11/29/2010 DHAVAL VIKANI Net content : Net content Weight of empty container =W1 gm
Weight of the filled container = W2gm
Difference in the weight = W1-W2gm net content.
Distractive method: weight the filled container, dispensing the content and than contents are weigh. 11 11/29/2010 DHAVAL VIKANI Foam Stability : Foam Stability Visual evaluation
Time for a given mass to penetrate the foam
Time for a given rod that is inserted into the foam to fall
Rotational viscometer 12 11/29/2010 DHAVAL VIKANI Particle Size Determination : Particle Size Determination Cascade impector.
Operates on the principle that in a stream of particles projected through a series of nozzles and glass slides at high velocity, larger particles became impacted first on the lower velocity stages and the smaller particles pass on and are collected at higher velocity stages.
Particle size = 2-8 µ. 13 11/29/2010 DHAVAL VIKANI Light Scatter Decay : Light Scatter Decay As the aerosol settles under turbulent conditions, the change in the light intensity of a Tindal beam is measured. 14 11/29/2010 DHAVAL VIKANI Leakage : Leakage Select 12 pressurized containers at random, and
record the date and time to the nearest half-hour.
Weigh each container to the nearest mg, and record the weight, in mg, of each as W1.
Allow the container to stand in an upright position at room temperature for not less than 3 days,
and again weigh each container, recording the weight, in mg, of each as W2 . 15 11/29/2010 DHAVAL VIKANI Cont…. : Cont…. recording the date and time to the nearest half-hour.
Determine the time, T, in hours, during which the containers were under test.
Calculate the leakage rate, in mg per year, of each container from the expression .
365 x 24/T x (W1 - W2). 16 11/29/2010 DHAVAL VIKANI Biological Test : Biological Test Therapeutic activity
toxicity 17 11/29/2010 DHAVAL VIKANI Official Test : Official Test Content uniformity
Uniformity of delivered dose
Particle size and
Leak test 18 11/29/2010 DHAVAL VIKANI References : References Remington: the science and practice of pharmacy, volume 1, pg no.974-978.
The Theory and Practice of Industrial Pharmacy, By Lahman and Lieberman (3rd Edition),pg no.613-618.
Pharmaceutical dosage forms: disperse systems, volume 2, pg no.353-355.
Indian pharmacopoeia 2007, volume 2.
www.google.com , images. 19 11/29/2010 DHAVAL VIKANI Thank You …. : Thank You ….