Dry powder inhaler device-formulation combination has been shown to be an effective method for delivering drugs to the lung for treatment of asthma, chronic obstructive pulmonary disease and cystic fibrosis.
The optimized device and formulation combination was then tested in a realistic in vitro mouth-throat – tracheobronchial (MT TB) model.
While a perfect DPI may never exist, both device and formulation technology are evolving to rectify perceived deficiencies in earlier systems.
DPIs represent a type of delivery system where the system's thinking approach integrating the device, the formulation and the patient represent a major challenge to be met.
In a recent example, a mechanistic model was applied to predict systemic exposure following inhaled administration of SGRM in healthy volunteers using six different devices and formulation.
Fig. 12 Observed and predicted systemic exposure (AUC) following inhaled administration of SGRM using six different devices and formulations (12 18 healthy volunteers).
Fig. 6 A comparison of the systemic exposure (AUC) of a poorly soluble selective glucocorticoid modulator (SGRM) and the predicted total lung dose for six different devices and formulations (number of healthy volunteers ranging between 12 and 18).
Many new areas of interest for dry powder inhalation are explored and with the assistance of new techniques like computational fluid dynamics and emerging particle engineering technologies, this is likely to result in a new generation of inhaler devices and formulations, that will enable the introduction of new therapies based on inhaled medicines.
For example, influenza-like symptoms can be treated using non-steroidal anti-inflammatory drugs, such as ibuprofen, and novel injection devices and formulations have been developed to minimize injection-site reactions [ 22].
Patients treated with BDP/F extrafine pMDI achieved a greater level of asthma control as compared to patients treated with FP/S or BUD/F larger particle combinations, suggesting that differences in inhaler devices and formulations can have an impact on important clinical outcomes and should be therefore taken into consideration when managing patients with asthma.
A range of factors including candidate drug, formulation, device selection, drug product testing for proof of concept, and preclinical and clinical purposes all demand different considerations.
