eBook: Formulation of Dry Powder Inhaler - 20

Simultaneous Spray Drying
for Combination Dry Powder
Inhaler Formulations
Kimberly B. Shepard,* Amanda M. Pluntze and David T. Vodak
Small Molecules R&D, Lonza Group AG, Bend, OR 97703, USA
* Correspondence: kimberly.shepard@lonza.com
Abstract
Spray drying is a particle engineering technique used
to manufacture respirable pharmaceutical powders
that are suitable for delivery to the deep lung. It is
amenable to processing both small molecules and
biologic actives, including proteins. In this work, a
simultaneous spray-drying process, termed simulspray,
is described; the process involves two different
active pharmaceutical ingredient (API) solutions
that are simultaneously atomized through separate
nozzles into a single-spray dryer. Collected by a single
cyclone, simul-spray produces a uniform mixture
of two different active particles in a single-unit operation.
While combination therapies for dry powder
inhalers containing milled small molecule API
are commercially approved, limited options exist
for preparing combination treatments that contain
both small molecule APIs and biotherapeutic molecules.
Simul-spray drying is also ideal for actives
which cannot withstand a milling-based particle engineering
process, or which require a high dose that
is incompatible with a carrier-based formulation.
Three combination case studies are demonstrated
here, in which bevacizumab is paired with erlotinib,
cisplatin, or paclitaxel in a dry powder inhaler formulation.
These model systems were chosen for their
potential relevance to the local treatment of lung
cancer. The resulting formulations preserved the biologic
activity of the antibody, achieved target drug
concentration, and had aerosol properties suitable
for pulmonary delivery.
Keywords: spray drying; dry powder inhaler; pulmonary
delivery; combination therapy; lung cancer;
particle engineering
Introduction
Pulmonary delivery by inhalation is the preferred
method of administration for the treatment of lung
diseases such as asthma, COPD, pulmonary arterial
hypertension, and pulmonary infections.1,2
Inhaled
treatments for additional indications such as lung
cancer3
are in clinical trials. Combination therapies
delivered by dry powder inhaler (DPI) are of particular
interest for improving patient experience and
compliance while managing complex lung conditions.4
To
date, at least seven DPI combination therapies
have been approved by the FDA (Breo Ellipta,
20

eBook: Formulation of Dry Powder Inhaler

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