Dry Powder Inhalers (DPIs)

SkyeProtect™

The SkyeProtect™ technology is used in dry powder formulations to protect the drug from moisture and to improve the functionality of the device. With SkyeProtect™ inhaler performance is less likely to be affected by storage conditions.  SkyeProtect™ is well validated and fully acceptable for inhalation use.

Dry powder formulations are notoriously sensitive to moisture ingress leading to chemical and physical instability.

DPIs typically rely on external moisture protection:

• Device/packaging
• Unit dose packaging
• Desiccant as device or packaging component
• Foil over-wrapping of entire product (requires out of pouch shelf-life determination and labelling)

SkyeProtect™ formulation technology is the use of the enabling excipient magnesium stearate, which “intrinsically” protects a powder from the detrimental effects of moisture ingress.  Powders do not agglomerate on storage resulting in longer shelf life at elevated temperature and humidity.

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