Therapeutic advantages and potential improvements in patient care and patient compliance make the area of intranasal drug delivery attractive from a business perspective. As a consequence, the number and variety of drugs/biologics and devices explored and eventually marketed for intranasal delivery is likely to grow worldwide. The success of a given “drug idea”, however, depends […]
After the U.S. Food and Drug Administration released its 1998 draft guidance on metered dose inhalers and dry powder drug products, a group of developers, manufacturers, and marketers of orally inhaled and nasal drug products (OINDP) joined together to provide a response. This ad hoc group developed a consensus response to the proposed guidance in […]
A variety of techniques are reviewed for use in solid phase identification and quantification; particle morphology imaging and particle density estimations; surface property and interparticle interaction investigations; and predicting thermal activity and long-term physical and chemical stability.
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 […]
Focusing the early stages of development programs on obtaining regulatory approval and expecting that marketing efforts will convince physicians and patients to use the product, a paradigm that worked over the past several decades, now represents a strategic error, contends Balekdjian. US payers now play such an important role in the pharmaceutical marketplace that you […]
AIM: Proof of Concept The present version of the Abbreviated Impactor Measurement (AIM) Concept was born three years ago, initially as a way of improving productivity in the course of making in vitro measurements of Oral Inhaled Products (OIPs) and related add-on devices, such as spacers and valved holding chambers that are used with pressurized […]
Nasal sprays are now showing great promise in the delivery of drugs for breakthrough pain relief and vaccines. Innovation is set to continue as electronic “smart” devices are being integrated into designs in order to increase patient compliance, a key market driver for nasal aerosols.
This article fosters understanding about the proposed stepwise cascade impactor equivalence test, including the PBE test and the mCSRS. The PBE test is compared with the ABE test and the outcome of the stepwise cascade impactor equivalence test is compared with performing statistical tests on individual stages.
Over the last 20 years, inhalation drug delivery has been adjusting to the phase out of chlorofluorocarbon (CFC) propellants. Following the signature of the Montreal Protocol on September 16, 1987, there has been a rush to re-formulate pressure metered dose inhalers (pMDIs) using alternative propellant systems. This has led to the advent of dry powder […]