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Excipient Applications in Formulation Design and Drug Delivery pp 273–310Cite as

Impact of Excipient Interactions on Drug Bioavailability from Solid Dosage Forms

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Abstract

Excipients are generally pharmacologically inert, but can interact with drugs in the dosage form and the physiological factors at the site of absorption to affect the bioavailability of a drug product. A general mechanistic understanding of the basis of these interactions is essential to design robust drug products. This chapter focuses on drug-excipient interactions in solid dosage forms that impact drug bioavailability, the drug substance and drug product properties affected by excipients, and the impact of excipients on physiologic processes. The extent to which drug bioavailability is affected by these interactions would vary on a case-by-case basis depending upon factors such as the potency and dose of the drug, therapeutic window, site of absorption, rate limiting factor in drug absorption (e.g., permeability or solubility limited), whether drug metabolism, efflux, complexation, or degradation at the site of absorption plays a role in determining its bioavailability. Nonetheless, a mechanistic understanding of drug-excipient interactions and their impact on drug release and absorption can help develop formulations that exhibit optimum drug bioavailability.

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Abbreviations

API:

Active pharmaceutical ingredient

CCS:

Croscarmellose sodium

CMC:

Carboxymethyl cellulose

GIT:

Gastro-intestinal tract

HPMC:

Hydroxypropyl methylcellulose

ITC:

Isothermal titration calorimetry

IVIVC:

In vitro in vivo correlation

PVP:

Polyvinyl pyrrolidone or povidone

PEG:

Polyethylene glycol

P-gp:

P-glycoprotein

RT-PCR:

Reverse transcription—polymerase chain reaction

SEDDS:

Self-emulsifying drug delivery systems

SDS:

Sodium dodecyl sulfate

SMEDDS:

Self-microemulsifying drug delivery systems

SSG:

Sodium starch glycollate

TPGS:

d-α-tocopheryl-polyethylene glycol-1000 succinate

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Acknowledgements

The majority of this chapter and illustrations are reprinted from Pharmaaceutical Research, Vol. 29 (© 2012) pp. 2639–2659, with permission from Springer.

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  1. Department of Biopharmaceutical Sciences, Roosevelt University, 1400 N Roosevelt Blvd, SCH 250, 60173, Schaumburg, IL, USA

    Ravikiran Panakanti

  2. Drug Product Science and Technology, Bristol-Myers Squibb, Co., One Squibb Dr., New Brunswick, 08903, NJ, USA

    Ajit S. Narang

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    Ajit S Narang

  2. Division of Industrial Pharmacy, Department of Pharmacy Practice, The University of Toledo, TOLEDO, Ohio, USA

    Sai H S. Boddu

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Panakanti, R., Narang, A. (2015). Impact of Excipient Interactions on Drug Bioavailability from Solid Dosage Forms. In: Narang, A., Boddu, S. (eds) Excipient Applications in Formulation Design and Drug Delivery. Springer, Cham. https://doi.org/10.1007/978-3-319-20206-8_10

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