When approaching a DPI development program, R&D teams often appear to be surprised by the wide and diverse range of technical challenges involved. Efficient internal communication between the groups responsible for formulation development, device design, regulatory affairs, marketing and commercialization is absolutely essential. The device is the interface between the user and the drug. The […]
Recently, regulatory agencies have put greater emphasis on the need to understand pharmaceutical process, product quality and risk management to ensure that patient needs continue to be met. The United States Food and Drug Administration (FDA) Quality by Design (QbD) initiative encompasses these considerations, building on previous concepts covered in the International Conference on Harmonization […]
Designing a simple, easy-to-use DPI that also satisfies the needs of regulators and manufacturers presents a major challenge because solutions that satisfy one constituency often clash with solutions that satisfy the other. For example, a breath activated passive device may make coordination of inhalation and activation easier for the patient, but the inspiratory effort applied […]
The complexity of current inhalation devices requires thorough testing of all aspects of device reliability. In reproducibility, automation can provide strictly predefined handling at high throughput, which may be beneficial in obtaining the low variability required for the prediction of reliability. This article addresses the challenges of automated testing in early development. Testing is presented […]
An innovative approach to the problem of linking medication delivery to patient inspiration has been adopted in the mechanically-operated, breath-actuated jet nebulizer (BAN). By virtue of its design, it also takes advantage of air entrainment during the inhalation portion of each breathing cycle to help increase delivery of respirable fine particles. The AeroEclipse-II BAN (Trudell […]
Blockbuster MDI and DPI products have usually been brought to market by large pharmaceutical companies who have in-house capabilities in every aspect of product development, industrialization and supply. As these products approach the end of the exclusivity afforded them by intellectual property rights, smaller development companies (developers) have emerged. These companies focus on gaining a […]
The pMDI looks set to continue as a very popular inhaler device. In the early 1990s, the pMDI was often seen as inefficient, somewhat old-fashioned, difficult to use correctly and environmentally unfriendly. Today, it is recognizable as the 1956 device, but it contains many modern enhancements and is viewed as durable, adaptable and cost-effective.
Drug suspensions in pMDIs and micronized powders and mixtures in DPIs can be sensitive to moisture ingress. Moisture management plays a major role in ensuring that the drug formulation remains stable and that the correct dosage is delivered.
DPIs offer ease of coordination with the respiratory cycle compared to pMDIs and a reduced amount of drug trapped in the oropharynx. In addition, devices that do not use chlorofluorocarbon propellants are better for the environment. Within the sphere of DPIs, HPMC-capsule-based DPIs are a compelling alternative due to capsule properties of puncturing, powder aerosolization, […]
This article lays the groundwork for a re-think concerning the ways in which the patient or caregiver is intended to use OIPs and related devices. A case is made for advocating an approach by all stakeholders in the OIP life-cycle that ultimately results in simple-to-use and “patient-friendly” OIPs and related devices that will prove to […]