Strategies for overcoming the biological barriers associated with the administration of inhaled monoclonal antibodies for lung diseases

ABSTRACT

Introduction

Monoclonal antibodies (mAbs) should be administered by inhalation rather than parenterally to improve their efficiency in lung diseases. However, the pulmonary administration of mAbs in terms of aerosol technology and the formulation for inhalation is difficult.

Areas covered

The feasible or suitable strategies for overcoming the barriers associated with administering mAbs are described.

Expert opinion

Providing mAbs via inhalation to individuals with lung disorders is still difficult. However, inhalation is a desirable method for mAb delivery. Inhaled mAb production needs to be well thought out. The illness, the patient group(s), the therapeutic molecule selected, its interaction with the biological barriers in the lungs, the formulation, excipients, and administration systems must all be thoroughly investigated. Therefore, to create inhaled mAbs that are stable and efficacious, it will be essential to thoroughly examine the problems linked to instability and protein aggregation. More excipients will also need to be manufactured, expanding the range of formulation design choices. Another crucial requirement is for novel carriers for topical delivery to the lungs since carriers might significantly enhance proteins’ stability and pharmacokinetic profile.

KEYWORDS:

• Monoclonal antibodies
• inhalation route
• biological barriers
• inhalers
• formulation

Article highlights

• In several experimental situations, mAbs achieve a better therapeutic response when given via the pulmonary route than when supplied systemically.

• Direct administration of high local doses to the lungs offers the advantage of achieving therapeutic equivalence to considerably higher doses administered systemically by parenteral methods.

• The pulmonary administration of mAbs in terms of aerosol technology and the formulation for inhalation is complex because they are macromolecules.

• Several anatomical, physiological, and immunological barriers influence the effectiveness of inhaled biologics delivery.

• Selecting appropriate formulation excipients and other formulation parameters and the aerosol technology to deliver mAbs is a fundamental need.

• The absorption and disposition of each inhaled mAb being considered for therapeutic use must be studied individually because there is insufficient knowledge to make accurate predictions with the currently available data.

Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Additional information

Funding

This paper was not funded.