Aerodynamic particle size analysis of a metered dose inhalation containing 100μg salbutamol sulphate in a single dose

Essay by rageracerUniversity, Master'sB, June 2005

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The product being tested is a salamol CFC-free Easi-Breathe inhaler

Each 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 used prophylactically before exertion or to prevent exercise-induced asthma.

The inhaler may also be used in the treatment of the reversible component of airways obstruction.

The metered dose inhaler (MDI) being is used in this experiment is the salamol inhaler as previously mentioned. It is a relatively new inhaler on the british market.

The contents of the MDI are Norflurane (HFA 134a) Ethanol anhydrous and Salbutamol Sulphate.

The inhaler contains a new propellant and does not contain chlorofluorocarbons (CFCs).

In the past the main propellants used in inhalers were all CFC based which had a detrimental effect on the Ozone layer. Due to the International Legislation of the Montreal Protocol, an international agreement on targets for the elimination of CFC's and HCFC's signed by 58 countries in 1990, the pharmaceutical industry are currently exempted from this ban on CFCs, but this exemption is reviewed annually. This has forced the pharmaceutical industry to seek more ozone friendly propellants.

The norflurane (HFA 134a) acts as the propellant, in the easi-breathe, which is a hydroflurocarbon (HFA) and is Ozone friendly. The drug substance is dispersed in the propellant, upon spraying the propellant and the...