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Alternate Routes of Administration

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Translating Molecules into Medicines

Part of the book series: AAPS Advances in the Pharmaceutical Sciences Series ((AAPS,volume 25))

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Abstract

Patients, caregivers, payers, drug developers, and the continually evolving standard of care all play a critical role in shaping the drug product and formulation requirements to better meet unmet medical needs of patients. A significant area of growth in recent years has been in the non-oral route of administration (alternate route and injectable route of administration, RoA). The use of drug products for alternate route of administration or the use of drug-device combination products offers an opportunity to enable a product in situations where there are significant oral challenges, such as extensive gastrointestinal metabolism, low oral bioavailability, suboptimal oral PK, local gastrointestinal toxicity, or other adverse reactions. Additionally, drug-device combination products (both injectable and non-injectable for alternate route products) present an opportunity to consider an enhanced product that improves patient compliance and increases treatment options to manage diseases.

In this chapter, alternate routes of administration such as intranasal, inhalation, buccal/sublingual, and transdermal approaches for delivery of drug candidates to systemic molecular targets are discussed. The rationale for each route of administration, including their strengths and limitations, drug molecule developability criteria, and recommended preclinical testing experiments to enable such products, is reviewed.

There has been a steady trend over the past decade in which self-administration has become more and more prevalent among patients. As a result, devices are being developed that incorporate more patient requirements, such as portability, intuitiveness, ease of use, and other human factor considerations. In addition, with the growth of mobile health applications, devices are becoming more connected with mobile devices, enabling better patient compliance with treatment regimens and advancement in standards of care. Product trends and recent advances are outlined in this chapter together with strategies to consider for clinical testing.

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Abbreviations

B/SL:

Buccal/sublingual

BCS:

Biopharmaceutical classification system

CVC:

Central venous catheters

DPI:

Dry-powder inhaler

ID:

Intradermal

IM:

Intramuscular

IN:

Intranasal

INH:

Inhalation

IV:

Intravenous

MDI:

Metered-dose inhaler

MN:

Microneedles

NME:

New molecular entity

PD:

Pharmacodynamic

PFSs:

Prefilled syringes

PICCs:

Peripherally inserted central catheters

PK:

Pharmacokinetic

RoA:

Route of administration

SC:

Subcutaneous

TD:

Transdermal

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Authors and Affiliations

  1. Drug Product Science & Technology, Bristol-Myers Squibb Co., One Squibb Drive, New Brunswick, NJ, 08903, USA

    Neil Mathias & Srini Sridharan

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  1. Neil Mathias
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  2. Srini Sridharan
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Correspondence to Neil Mathias .

Editor information

Editors and Affiliations

  1. Small Molecule Design and Development, Eli Lilly and Company, Indianapolis, Indiana, USA

    Shobha N. Bhattachar

  2. Pharmaceutical Candidate Optimization, Bristol-Myers Squibb, Wallingford, Connecticut, USA

    John S. Morrison

  3. ADME, Drug Disposition, Eli Lilly and Company, Indianapolis, Indiana, USA

    Daniel R. Mudra

  4. Small Molecule Design and Development, Eli Lilly and Company, Indianapolis, Indiana, USA

    David M. Bender

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Mathias, N., Sridharan, S. (2017). Alternate Routes of Administration. In: Bhattachar, S., Morrison, J., Mudra, D., Bender, D. (eds) Translating Molecules into Medicines. AAPS Advances in the Pharmaceutical Sciences Series, vol 25. Springer, Cham. https://doi.org/10.1007/978-3-319-50042-3_13

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