Emerging role of novel excipients in drug product development and their safety concerns

Polaka, Suryanarayana; Pawar, Bhakti; Tekade, Muktika; Satvase, Rutuja; Manchikalapudi, Aparna Lakshmi; Sharma, Mukesh C.; Pandey, Vikas; Jhariya, Aditya Narayan; Tekade, Rakesh K.

doi:10.1016/b978-0-323-98367-9.00015-9

Cited by 5 publications

(3 citation statements)

References 42 publications

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“…It is a given that a developer must demonstrate the safety of a new active ingredient used in a nanoparticle that has not previously been approved. However, per the current guidelines, a novel lipid or polymer requires a comprehensive non-clinical development program equivalent to that required for introducing a new active ingredient, including expensive toxicological evaluation 10 . This type of componentwise in vivo evaluation is ) 16 .…”

Section: Should the Composite Nanoparticle Be Considered As The Activ...mentioning

confidence: 99%

Active ingredient vs excipient debate for nanomedicines

Hemmrich

McNeil

2023

Nat. Nanotechnol.

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Nanomedicines are complex drugs where components that have typically been regarded as excipients may now be considered part of the active ingredient. The distinction between the active ingredient and excipients for nanomedicines has important consequences for regulatory review and product development. The dissimilarity in the review of the recent ribonucleic acid (RNA)-based lipid nanoparticles highlights the need for further regulatory alignment on this topic.

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Section: Should the Composite Nanoparticle Be Considered As The Activ...mentioning

confidence: 99%

Active ingredient vs excipient debate for nanomedicines

Hemmrich

McNeil

2023

Nat. Nanotechnol.

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“…Given the evolving landscape in drug development (e.g., introduction of new modalities and advanced drug delivery technologies), the need for new excipients is expected to increase with the global pharmaceutical excipient market projected to exceed $8 billion by 2023. 6 The contribution to the overall safety, effectiveness, and quality of a drug product must be recognized. Existing regulatory guidance (FDA, EMA, ICH, etc.)…”

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Pharmaceutical Industry Perspective on the Non-Clinical Evaluation of Novel Excipients: Results From an Industry Survey Conducted by the IQ Novel Excipient Working Group

2023

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Excipients are essential components within drug products that contribute significantly to their overall quality, effectiveness, and safety. There is a lack of global, harmonized guidance relating to the non-clinical testing of novel excipients which is perceived to create uncertainty and strategic risk, potentially hindering innovation and disincentivizing their use. To test these perceptions, the IQ Novel Excipient Working Group surveyed member companies regarding their main concerns and prior experience regarding the non-clinical evaluation of excipients. Of the 19 respondents, 13 provided, collectively, 33 non-clinical program examples supporting the development of novel excipients. Programs were distributed across a range of therapeutic areas and included a variety of drug modalities and administration routes. Package designs were variable, but where possible, employed the use of existing data, supplemented with new toxicology studies as appropriate. Of the programs which had submitted data to regional health authorities, only three received feedback requesting additional studies or that demonstrated differences in regional opinion. In addition, companies provided recommendations on how the current (or new) guidance related to non-clinical excipient evaluation (and other areas, such as Chemistry, Manufacturing, and Controls and databases) may be improved.

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