Formulation and Manufacturing of Aerosols and their Evaluation

Formulation and Manufacturing of Aerosols and their Evaluation

1. Pharmaceutical Aerosols their Formulation and Evaluations ~ Anurag Gupta

2. Outlines 1 2 3 5 6 4 Aerosols Component of Aerosols Types of Aerosol System Formulation of Aerosols Manufacturing Evaluation

3. Aerosols Aerosol is a pressurized dosage forms containing one or more therapeutic active ingredients which upon actuation emit a fine dispersion of liquid or solid materials .

4. Principle Aerosol system are composed of two components i.e. product concentrate and propellant . Upon actuation of the aerosol valve, the pressure built up by the vaporized propellant pushes the liquid phase up in the dip tube and out of the container. The expelled contents are exposed to the atmosphere As a result, the propellant present in these contents expands and evaporates due to the sudden drop in pressure, leaving behind the product concentrate as airborne liquid droplets or dry particles.

5. Advantage Easy to carry and convenient to use. Onset of action is quick. The products are protected from light and oxidation , hence stability is increased. It is clean process to as it requires no wash-up. The desired dose can be removed.

6. Disadvantage It is expensive Irritation may occur upon topical administration of aerosol Valve clogging may takes place

7. COMPONENTS OF AEROSOLS Valve and actuator Propellant Container Product concentrate

8. PROPELLANTS Propellant are the important constituents of an aerosol formulation. It Responsible for developing proper pressure within the container. Provide driving force to expel the product from the container in the form of a fine spray or foam through the valve.

9. TYPES OF PROPELLANTS 1) Liquefied gases Propellants e.g. Chlorofluorocarbon , Hydrofluorocarbon 2) Compressed gases Propellants e.g. Nitrogen , carbon-dioxide , nitrous oxide

10. CONTAINERS Containers are used to fill the aerosols. Usually, aerosol spray containers are primarily made up of metal, glass, plastics depend on the behavior and characteristic of solvent and propellant used. For the aerosol , the container material should be enough to withstand pressures as high as 140 to 180 psig (pounds per sq. inch gauge) at 130 ° F.

11. VALVES A valve is an important part of aerosol containers. It helps in expelling the contents from the container in the desired form, at the desired rate and in the desired amount . The performance of an aerosol depends on the type of formulation and valve. They help in preventing the loss of product when the container is not in use. The materials used in the manufacture of valve should be inert to the formulation.

12. Components of Valves

13. Actuators Actuator is an integral part of an aerosol package. It is a specially designed button placed on the valve stem which helps in easy opening and closing of the valve and aids in rapid and proper release of the products from the container. It also helps in delivering the product in the desired form i.e., spray, wet stream, foam or solid stream.

14. TYPES OF AEROSOL SYSTEMS Solution system Water based system Suspension or Dispersion systems Foam systems Intranasal aerosols Aerosols are classified as follows :

15. FORMULATION OF AEROSOLS It consist of two essential components : i.e. Product concentrate and Propellant Product concentrate : Active ingredient or mixture of active ingredients and other necessary agents such as solvents, anti oxidants and surfactants. Propellant : Single or mixture of various propellants is used. The propellant are selected on the basis of desired vapour-pressure , particle size and solubility characteristics .

16. Manufacturing of Pharmaceutical Aerosols Apparatus Pressure filling apparatus Cold filling apparatus Compressed gas filling apparatus

17. Evaluation Flammability & combustibility Physio-chemical Performance Biological Flash point Flame Extension Vapor pressure Density Moisture Aerosol valve discharge rate Spray pattern Net contents Foam stability Particle size determination Therapeutic Activity Toxicity

18. Cyanide