Literature: Indonesia Pharmacopoeia III
Inventory was an aerosol is a substance containing one or more efficacious in a given container pressure, contains a propellant or propellant mixture is sufficient to transmit until it runs out, can be used for external drug or drug or with a suitable propellant. If used as a drug in or inhalation, the aerosol is equipped with dosing. Aerosol may contain suspending agent, emulsifier and auxiliary solvent.
Dispersed particle size of between a few percent / μm up to several hundred / μm. For use by inhalation, particle size must not be greater than 10μm.
Important parts of the aerosol is a container, the propellant, which concentrates contain berkaisat, valves and actuators. By making variations of these parts can be produced sprays that mempuanyai certain properties such as particle size, phase dispresi patience, kebsahan degrees and degrees of drought, the uniformity of the spray, great pressure, the shape of the dispersion, temperature, spraying the area, dose in the spray and spray degrees.
Aerosol system consists of two phases or three phase systems. In the particular case of a substance berkasiat or a formulation can be dissolved into an aerosol propellant to produce a two-phase system (gas-liquid). Because in general the propellant has the power to dissolve a small gain of two-phase system, a solvent often needs a maid. If the substance or substances berformulasi berkaisat may not dissolved in the propellant, it should diemulaskikan or suspended to obtain a three-phase (gas-liquid-solid or liquid-liquid-gas).
Container, can be made from glass, plastic, glass, metal or combinations of these materials. Metals used are generally resistant to corrosion, aluminum, tin-plated steel. Can be used to coat plastic containers made of glass to be safe or to or for the coating of the metal container to prevent perkaratan. Containers of glass to be made of pressure-resistant glass.
Valve, the main function of the valves is to regulate the drainage of nutritious substances and propellants. Tebuat valves of rubber plastic, aluminum or stainless steel karatdan be inert. If necessary the valve can be equipped with a regulator that can deliver doses carefully measured doses. Dispersion properties of the aerosol is influenced by the size, number and location of the valve holes. Form of valve is made to get the distance or area spraying a fine spray. Valve allows the propellant out together berkasiat substance or formulation in order to achieve the proper spray characteristics and help achieve the desired equilibrium pressure at the time of aerosol use.
Propellant, intended to generate pressure in the aerosol system so as to push the material from the container and combination with other components can transform the material into a desired form alin physics. Propellant is a liquefied or compressed gas to the vapor pressure of the pressure lebiah outside. As a hydrocarbon propellant can be used especially chloro and fluoro derivatives of methane and ethane, hydrocarbons such as molecular-weight weak butane, pentane, and a compressed gas such as carbon dioxide, nitrogen and dinitrogen-monoxide. Propellant mixture commonly used to obtain pressure, spraying and spray characteristics desired results. A good system should have the propellant vapor pressure of a suitable nature, according to another component of the aerosol. Propellants should have a good dissolve, but this requirement is not a requirement.
Actuator, is associated with the valve stem which when pressed or moved, the valve will open and efficacious substance or formulation to be aerosolized into the desired area. In general, determining the direction of the spray actuator and melindungan hand or finger of the propellant that cools. There are holes on the spray actuator hole whose size can vary. Spray properties are influenced by the size of the hole, the shape of space development, the nature of nutritious substances or propellant formulations.
Auxiliary solvent, used to improve the solubility of a substance or formulation in propellant berkasiat. To obtain single-phase fluid system, auxiliary solvent must be soluble in the propellant. In general, use of ethanol because it mixes easily with most of the propellant and has good solvent power. Can also be used propilenglikol, polypropylene, glycols, dietilenglikol, mono-ethyl-ether or derivatives.
Degree spray, an aerosol is the amount of weight that is sprayed in a certain time, dinyatankan in grams per second. Determination made as follows: select not less than 4 containers, remove the lid, press the actuator of each container for 2 to 3 seconds. Carefully weigh each container, dip into a bath at constant temperature of 25 ± 1 º to constant pressure, was examined in the manner indicated on the pressure test. Remove the container from the bath, remove the water with filter paper, press the actuator of each container for exactly 5.0 seconds using a timer and then weigh each container. Put the container back into the bath temperature remains, repeat the experiment three times for each container, calculate the average degree of spray each container in grams per second.
Leak testers, select the container 12 record date and time by rounding up to 1/2 hours. Weigh the container one by one by rounding mg each, record the weight as W1. Leave the container in an upright position at room sehu for 3 days. Weigh the back of each container, record the weight as W2 and record the date and time by rounding up to 1/2 hours. Calculate time in hours and the trial record as T. Calculate the degree of leakage of each container in mg each year by the formula
Preparations are eligible if the average degree of leakage of 12 containers each year not more than 3.5% of the weight indicated on the eiket and if none is leaking more than 5.0% of the weight indicated on the label. If a container is leaking more than 5.0% per year, set a leak using the 24 other containers. Preparations are eligible if 36 containers examined, not more than 2 containers leak more than 5.0% per year and if none is leaking more than 7.0% per year from the weight indicated on the label.
Pressure testing. Select not less than 4 containers, remove the lid, dip into the bath at a temperature of 25 degrees ± 10 fixed to a constant pressure. Remove the container from the bath, shake well, remove the actuator and remove them if there is a water valve stems. Put each container by placing a pressure gauge on the valve stem. Read the pressure in the container on the pressure gauge.
Measured dose aerosol retrieval
A. Method I: This method is used for aerosol inhalation equipped with actuators.
The tool consists of A = actuator, B = Adaptor, C = the suction tube diameter 5 cm, length 15 cm, one end narrowed to diameter of 8 mm, D = dilengakapi diverter tube with a porous sintered glass filter to roughly evenly distribute the bubbles, E = Space locking gas reservoir in the form of bottles, containing absorbent solution, dihubaungkan with a vacuum system consisting of a suction pump, flow regulator and flow meter.
The adapter must match the actuator checked inhalation and an adapter in the middle of the holes are tapered and the entry of a hermetic can press the aerosol valve is such that it can be released into a vacuum tube.
To avoid loss of material at the time of aerosol into the atmosphere aerosol content removed, then the air from the reservoir chamber and the impregnation solution is inhaled continuously at speeds of 12 to 13 liters per minute.
Other equipment with parts that have the same principle as the tool can be used.
2. Method II. The tool consists of the pressure tube and an adapter. The adapter should match the mouth of the tube to the pressure-tight fluid.
In the middle there is a tapered entry hole and penetrated impermeable udaradapat aerosol valve stem such that it can be issued a number of specific materials in the pressure tube. Other equipment with parts that have the same principle as the tool can be used.
How to manufacture. Generally an aerosol is created by one of the following ways: 1. cool ways: into a container that has been cooled, the input match for propelat and concentrates generally have cooled below the temperature 0º C, each masingdengan certain size. Replace the valve and actuator in a closed container so tight. 2. way pressure: Remove the air in the container by means penghampaan or by adding a little peropelan, fill kosenterat into a container, cover-tight container, with an emphasis peropelan input through the valve hole in the container.
The marking on the label. Must reads: “Warning: Contents under pressure; not perforated or fuel containers; avoid the heat and should not be stored at temperatures above 50 º C; it away from the reach of children.