Shake well. Keep in a cool place away from heat or sunlight. Pressurized can. Keep out of reach of children. Do not expose to temperatures exceeding 50°C. Do not spray near a naked flame or any incandescent material. Do not puncture or burn can even when it is empty.
The biological tests carried out on pharmaceutical aerosols are similar to tests performed on non-aerosol preparations. Basically they are tested for their therapeutic efficacy and toxicity. Therapeutic efficacy—the inhalation aerosols or MDIs are tested for their dose uniformity and particle size distribution along with the pharmacokinetic and pharmacodynamic studies. Topical aerosols are applied to the…
The dosing, performance and the clinical efficacy of aerosol products especially a MDI is dependent on the design of the container and valve. The efficiency and performance of the valve is determined by the following tests. Valve discharge rate gives the amount of contents dispensed in grams per second. The aerosol can is weighed and the…
The vapor pressure is determined using a pressure gauge. Excessive variations in the pressure from container to container may indicate presence of air in the head space. Can puncturing equipments are used to accurately determine the pressure. There are equipments available for both metal and glass containers. Density is determined by hydrometer or a pycnometer. The apparatus is…
Flame extension involves spraying the aerosol in an open flame for 4 seconds. The length to which the flame is extended is observed and measured. The test is to indicate the effect of an aerosol formulation on the extension of an open flame. Flash point is determined using the tag open-cup apparatus. The aerosol product is chilled to a…
Learning Objective Pharmaceutical aerosols can be evaluated by the following series of physical, chemical and biological tests:
Learning Objective The propellants meant to be used in pharmaceutical aerosols should undergo rigid quality control tests. In general, all propellants require special handling procedures and test procedures. A sample propellant is sent to the laboratory to determine its identity by gas chromatography. When a blend of propellant is present, then the composition is estimated and the vapor…
Learning Objectives The complete aerosol package includes both the product and the container. Hence while studying the stability aspects of aerosols, both the effect of the product on the container and the effect of the container on the product should be studied. Moreover, due to the variety of materials used in making an aerosol valve…
Learning Objective Manufacturing and packaging of aerosols requires specialized equipment and skills, special knowledge and rigid quality control. In addition to the equipment used for the compounding of liquids, suspensions, emulsions, creams and ointments, specialized equipment capable of handling and packaging materials at relatively low temperatures about –40°F or under high pressure must be available.…
Learning Objective Solution System These are also referred to as the two-phase systems—a liquid and a vapor phase. They consist of a solution of active ingredients in pure propellant or a mixture of propellant and solvents. If the active ingredient is soluble in the propellant, no other solvent is necessary. These types of systems are…