• June 10, 2022

Dry powder inhalation (DPI) products basically consist of a powder formulation and a device. The formulation, which contains active pharmaceutical ingredient(s) (APIs) micronized to inhalable particle size and a few excipients may, at first glance, appear simple. However, a large number of factors are critical to the performance of dry powder formulations for inhalation. Furthermore, […]

  • February 11, 2022

This article provides an overview of the considerations for the formulation development of inhaled biologics and the various excipients that are routinely investigated for use in dry powder formulations of biologics intended for oral inhalation, with particular emphasis on protein stabilization. Carbohydrates, including simple sugars, complex sugars and sugar alcohols; amino acids and surfactants are […]

  • December 7, 2021

For many years, the nasal route of administration has been used very successfully for the non-invasive delivery of small molecule drugs. The anatomy and physiology of the nasal cavity have been exploited to deliver 1) locally acting medications, to combat ailments such as seasonal and year-round allergies, 2) systemically delivered drugs, via the highly vascularized […]

  • September 20, 2018

It is known from lactose-based blends, that the choice of blender type and blending conditions can strongly influence aerodynamic properties, whereas this has not yet been examined with mannitol-based blends. In addition, lactose-based blends are sensitive to humidity and their physical properties, as well as their aerodynamic behavior, may change depending on storage conditions. Therefore, […]

  • February 6, 2018

1,1,-difluoroethane (HFC-152a) has potential as a propellant and its safety and formulation behavior are being investigated. Recently, the University of Manchester carried out a comparative study to assess the carbon footprints of the following: pMDI with HFC-134a propellant, pMDI with HFC-152a propellant and blister-based dry powder inhaler (DPI).

Depending on the API, route of delivery, intended deposition and delivery device, the optimal mannitol carrier for a defined delivery objective can be selected from different commercial qualities or from tailor- made spray-dried particles.

  • December 19, 2017

This study investigated the influence of lactose fines in ternary powder mixtures for inhalation by using different inhalers. Mixtures with and without commercially available lactose fines and the hydrophobic model drug budesonide were prepared. Aerodynamic behavior was tested with a Next Generation Impactor and three devices (Novolizer®, Cyclohaler® and Rack), chosen because of their different […]

  • December 12, 2017

As the FDA’s deadline for conversion from chlorofluorocarbons (CFCs) to hydrofluoroalkane (HFA) in MDIs approaches, we ask 3M’s Barbara Davidson, Georgina Fradley, and Simon Cawthorne how the transition is going.

  • November 29, 2017

Among all of the various types of excipients, HFAs are subject to some of the tightest controls and specifications. As HFAs have now replaced chlorofluorocarbons (CFCs) in most parts of the world, it is useful to take a look at how manufacturers produce these gases, the controls used to assure high levels of product quality, […]

Recently, specially-designed devices have emerged that can target the delivery of sprays or powders to the olfactory region of the nose, thereby enabling delivery of the drug directly to the central nervous system. This article examines nasal spray formulation parameters and excipients and their influence on key in vitro tests.