Analytical method development for characterizing ingredient-specific particle size distributions of nasal spray suspension products.

Particle size characterization for active pharmaceutical ingredients (APIs) in nasal spray suspension products presents unique challenges because both the API and excipient particles are present in the final dosage form. Currently, an established method is lacking because traditional particle sizing technologies do not distinguish the chemical identity of the particles. In this study, a non-destructive, ingredient-specific particle sizing method was developed for characterization of mometasone furoate (MF) nasal spray suspensions using Morphology Directed Raman Spectroscopy (MDRS).

A Comprehensive Updated Review on SARS-CoV-2 and COVID-19.

This literature review aims to provide a comprehensive current summary of the pathogenesis, clinical features, disease course, host immune responses, and current investigational antiviral and immunomodulatory pharmacotherapies to facilitate the development of future therapies and measures for prevention and control.

Addressing the Regulatory and Scientific Challenges with Generic Orally Inhaled Drug Products.

Generic products offer a considerable cost savings for American consumers and the US healthcare industry. While generics for many products have become available, the approval and adoption of generics for orally inhaled drug products (OIDPs) has lagged behind, owing to the difficulties in bringing these complex generic products to the market. As a complex product, OIDP performance is impacted by numerous factors derived from the product's formulation, delivery to a local site of action within the lung, the performance of the device, and the patient population that uses the medication.

Generic drug device combination products: Regulatory and scientific considerations.

Complex regulatory and scientific considerations exist for drug-device combination products submitted under an Abbreviated New Drug Application. The Agency has published several guidances to aid industry in the development of a generic drug-device combination product: providing recommendations on the types of studies necessary to establish bioequivalence, providing considerations on product quality and performance for certain types of device constituents, and most recently, providing tools to assess the proposed user interface when compared to the user interface of the Reference Listed Drug. In addition, the Office of Generic Drugs has established a regulatory science research program intended to support projects that examine scientific questions relating to the development of generic combination products and their associated regulatory review.

Change in sweat chloride as a clinical end point in cystic fibrosis clinical trials: the ivacaftor experience.

Cystic fibrosis (CF) is a life-shortening inherited disease caused by mutations in the CF transmembrane conductance regulator gene (CFTR), which encodes for the CF transmembrane conductance regulator (CFTR) ion channel that regulates chloride and water transport across the surface of epithelial cells. Ivacaftor, a drug recently approved by the US Food and Drug Administration, represents the first mutation-specific therapy for CF. It is a CFTR channel modulator and improves CFTR function in patients with CF who have a G551D mutation.