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Aerodynamic Particle Size Analysis Of A Metered Dose Inhalation Containing 100μG Salbutamol Sulphate In A Single Dose

1770 words - 8 pages

The product being tested is a salamol CFC-free Easi-Breathe inhalerEach actuation of the inhaler delivers Salbutamol Sulphate Ph Eur equivalent to Salbutamol 100 micrograms into the mouthpiece of the adapter.Salbutamol is a selective β2-adrenoceptor agonist. At therapeutic doses it acts on the β2-adrenoceptors of bronchial smooth muscle providing short acting (4-6 hour) bronchodilatation with a fast onset (within 5 minutes) in reversible airways obstruction.Salamol is indicated in the management of bronchial asthma, for the relief of wheezing and shortness of breath used on an as required basis. The inhaler may be used as necessary to relieve attacks of acute dyspnoea and may be ...view middle of the document...

As a result the propellant evaporates in order to restore the equilibrium in the container maintaining constant pressure and spray characteristics. It is as a result of this that the propellant is considered an integral part of the MDI system and lengthy consideration must be taken to establish a suitable propellant for a given formulation.Salbutamol it is not freely soluble in the propellant. As a result it is dissolved in a solvent, in this case being ethanol. This can commonly occur were the active ingredient in the inhaler dose not dissolve in the propellant.Chemical analysis was applied in this case rather than microscopic analysis when investigating the collection plates, as microscopic analysis is laborious and time consuming. Microscopic analysis is also limited in the fact that the higher the magnification the smaller the sample area being investigated.MethodThe method for the experiment is outlined in the module guide.The impactor to be used is the Anderson Cascade Impactor (ACI), using a glass throat and an airflow-rate of 28.3L/Min (BP).Using the ACI for particle size analysis allows us to measure the particle deposition characteristics of an MDI in humid airways whilst being carried in an air stream. The bend in the glass throat mimics that of the throat allowing us to accurately depict the effect on particle deposition and to take this factor in consideration.There however with most artificial systems a number of limitations associated with using an ACI. The high airflow-rate of the vacuum pump means the solvent has to evaporate rapidly and droplets may be re-entrained on the airstream. Particles may bounce off the hard dry surface of the collection plates this may be reduced by coating the plates in silicone fluid or glycerol.One of the major discrepancies or limitations associated with using the ACI is that a constant airflow-rate is applied. In real life when a patient is taking a dose from a MDI the initial airflow-rate is quite high but will gradually decrease as inhalation continues as the lungs are filling up. This is an extremely difficult thing to duplicate using the ACI and cannot be done accurately.Other problems can also arise when using the ACI such as drug loss during operation.If the mouth piece of the MDI is not properly fitted to the glass throat then drug may be lost when the MDI is fired this can also allow the introduction of contaminants in to the system. This fact also holds true for the ACI, if it not properly assembled then drug may be allowed to escape through gaps in the collection plates and contamination may also arise.The largest loss of drug will more than likely occur after ACI as a result of careless practice during the washing of the plates. When each plate is washed it is essential that the whole surface area of the plate be covered, as any drug that is not dissolved will not be accounted for. This is of great importance when washing the glass throat as it contains the highest proportion of drug...

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