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Inhaled medications are crucial for managing chronic obstructive pulmonary disease (COPD) and asthma. They are essential for effective treatment and control, ensuring optimal respiratory health and well-being. Inhaled medication delivers drugs directly to the lungs, providing a rapid onset of action and reducing systemic side effects compared to oral or injectable medications. Three primary types of inhalation devices are used to administer these medications: nebulizers, metered-dose inhalers...
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Simultaneous Spray Drying for Combination Dry Powder Inhaler Formulations.

Kimberly B Shepard1, Amanda M Pluntze1, David T Vodak1

  • 1Small Molecules R&D, Lonza Group AG, Bend, OR 97703, USA.

Pharmaceutics
|June 24, 2022
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Summary
This summary is machine-generated.

Simultaneous spray drying (simul-spray) creates uniform mixtures of two active pharmaceutical ingredients (APIs) in one step. This novel method enables combination therapies for lung cancer, including biologics and small molecules, for pulmonary delivery.

Keywords:
combination therapydry powder inhalerlung cancerparticle engineeringpulmonary deliveryspray drying

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Area of Science:

  • Pharmaceutical technology
  • Drug delivery
  • Particle engineering

Background:

  • Spray drying is a key technique for producing respirable powders for deep lung delivery.
  • Existing combination therapies for dry powder inhalers often rely on milling small molecule active pharmaceutical ingredients (APIs).
  • Limited options exist for combination treatments involving both small molecule APIs and biotherapeutics.

Purpose of the Study:

  • To describe a novel simultaneous spray-drying process (simul-spray) for creating uniform mixtures of two different APIs.
  • To demonstrate the application of simul-spray drying for preparing combination formulations for pulmonary delivery, particularly for lung cancer treatment.
  • To evaluate the suitability of simul-spray for actives sensitive to milling or requiring high doses.

Main Methods:

  • Simultaneous atomization of two distinct API solutions through separate nozzles into a single spray dryer.
  • Collection of the mixed particles using a single cyclone in one unit operation.
  • Formulation of three combination dry powder inhaler prototypes pairing bevacizumab with erlotinib, cisplatin, or paclitaxel.

Main Results:

  • Simul-spray drying successfully produced uniform mixtures of two different active particles in a single operation.
  • The resulting formulations maintained the biologic activity of bevacizumab (an antibody).
  • Target drug concentrations were achieved, and aerosol properties were suitable for pulmonary delivery.

Conclusions:

  • Simultaneous spray drying (simul-spray) is an effective method for producing uniform dry powder inhaler formulations containing multiple APIs, including biologics.
  • This technique offers a viable alternative to milling for sensitive APIs or high-dose formulations.
  • Simul-spray holds promise for developing novel combination therapies for lung cancer treatment via pulmonary delivery.