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In spray-dried formulations, various excipients or carriers are incorporated to improve the aerosolization behavior, stability and mechanical properties of active pharmaceutical ingredients (APIs) as well as to modify the pharmacokinetics and pharmacodynamics of APIs. Sugars are the most common excipients used as diluents and flow enhancers. In addition, sugars can provide hydrogen bonding and act […]

The four parts of a dry powder formulation (the formulation, excipient, composition and processing) must be thoroughly understood in order to develop and optimize adhesive mixtures for inhalation. In addition, their interactions can be highly complex. This article gives examples and discusses the complex interaction between the formulation and the device. The articles in this […]

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, […]

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 […]

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 […]

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, […]

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.

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 […]

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.