Solkane® pharma – Special Pharmaceutical Grade
- Highest purity guaranteed by manufacture in dedicated facilities according to cGMP
- Special, additional manufacturing processes developed and applied
- High-level quality control
- Specifically developed sophisticated analytical methods
- Worldwide Regulatory Affairs support in accordance with drug active substances
HFA Propellants for Use in Medical Sprays
Solkane® 227 pharma and Solkane® 134a pharma, also known as:
- HFA 227, HFC 227 or 1,1,1,2,3,3,3-heptafluoropropane and
-
HFA 134a, HFC 134a or 1,1,1,2,-tetrafluoroethane respectively,
are used in medical sprays such as:
- MDIs (Metered Dose Inhalers, also called asthma sprays or pharmaceutical aerosols inhaled by the patient),
- nasal sprays
- foam sprays and
- other oral/ topical sprays
to propel the active ingredient which is dispersed or solubilised in the hydrofluoroalkane (hereinafter referred to as HFA propellant).
Neither HFA 227 nor HFA 134a contain chlorine and are thus non-ozone depleting. Furthermore, they are non flammable and chemically inert. This makes them (from a safety and toxicological point of view) ideal candidates for use in medical products. Moreover, because HFA 227 and HFA 134a have thermodynamic and physical properties closely resembling the chlorofluorocarbons CFC 11, CFC 12 and CFC 114 traditionally used in medical sprays, they were proposed to replace the ozone-depleting CFCs currently being phased out under the terms of the Montreal Protocol.
Accordingly, Solvay developed HFA 227 and HFA 134a in a special pharmaceutical grade as Solkane® 227 pharma and Solkane® 134a pharma specifically for use in medical products. They are of the highest quality as required for sensitive routes of administration – in the case of MDIs, via inhalation to the lung. For other applications, HFA 227 and HFA 134a medical grade are offered.
The main differences to ordinary “technical grade” Solkane® 227 and Solkane® 134a – predominately used as refrigerants and fire extinguishing agents – are:
| (i) |
the higher purity obtained by additional manufacturing processes specifically developed and applied to meet the stringent specifications set out for pharmaceutical grade products, |
| (ii) |
manufacturing in dedicated facilities according to the current good manufacturing practice guidelines, |
| (iii) |
high-level quality control using analytical methods specifically developed to screen more than 60 impurities in the propellants at levels below one part per million, |
| (iv) |
registration of the manufacturing processes and quality control systems according to the standards for drug active substances, although both HFA 227 and HFA 134a are classed as exipients. |
Solkane® pharma – HFA Propellants for Medical Sprays
| Including |
- MDIs (Metered Dose Inhalers) also known as pharmaceutical aerosols
or asthma sprays for the treatment of asthma, COPD (Chronic Obstructive Pulmonary Disorder) and respiratory infections
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- nasal sprays for the treatment of allergic rhinitis
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|
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- oral and topical sprays
(e.g. nerve sensitisation, tooth vitality, pain relaxation)
|
| to replace the fully halogenated ozone depleting chlorofluorocarbons |
| |
- CFC 11, CFC 12 and CFC 114
|
| traditionally used in medical sprays which are being phased out under the terms of the Montreal Protocol by the non-ozone depleting hydrofluoroalkanes |
| |
- HFA 227, or blends thereof
- and HFA 134a.
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