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Role of Innovator Product Characterization in Generic Product Development

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Excipient Applications in Formulation Design and Drug Delivery

Abstract

Generic drug products are defined as drug products that are comparable to the innovator/reference listed drug products (RLD) in dosage form, strength, route of administration, quality and performance characteristics, and intended use. These products play a critical role in the healthcare systems and contribute to more than 50 % of the total prescriptions by volume. Generic products are accorded regulatory approval based on the concept of therapeutic equivalence to the RLD. Therapeutic equivalence comprises of pharmaceutical equivalence and bioequivalence. Speed to the marketplace is the key for success in generic market. Development of generic products can be accelerated by performing characterization of the RLD, also referred as de-formulation studies. These studies, related to quantification of critical excipients, and solid state characterization of the active pharmaceutical ingredient, could provide critical inputs for formulation development of generic products. This chapter highlights the role of innovator product characterization in accelerating formulation development of generic products. Role of such studies in simplifying regulatory approval process has also been highlighted.

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Abbreviations

ANDA:

Abbreviated new drug application

API:

Active pharmaceutical ingredient

CFR:

Code of federal regulations

FTIR:

Fourier transform infrared spectroscopy

HPLC:

High performance liquid chromatography

HPMC:

Hydroxypropyl methylcellulose

HPTLC:

High performance thin layer chromatography

LC-MS:

Liquid chromatography-mass spectrometry

MCC:

Microcrystalline cellulose

NDA:

New drug application

NIR:

Near infrared spectroscopy

NIRCI:

NIR Chemical Imaging

PEG:

Polyethylene glycol

PSD:

Particle size distribution

QbD:

Quality by Design

RLD:

Reference listed drug

USFDA:

United States Food and Drug Administration

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Author information

Authors and Affiliations

  1. Department of Pharmaceutics, National Institute of Pharmaceutical Education & Research (NIPER), 160062, SAS Nagar, Punjab, India

    Bhushan Munjal & Arvind K. Bansal

  2. Technical Research & Development, Novartis Pharma AG, 4056, Basel, Switzerland

    Vishal Koradia

  3. Department of Pharmacy Practice, The University of Toledo, Health Science Campus, 3000 Arlington Ave. (114G), 43614, Toledo, OH, USA

    Sai HS. Boddu

Authors
  1. Bhushan Munjal
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  2. Vishal Koradia
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  3. Sai HS. Boddu
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  4. Arvind K. Bansal
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Editor information

Editors and Affiliations

  1. Bristol-Myers Squibb, Co., New Brunswick, New Jersey, USA

    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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Munjal, B., Koradia, V., Boddu, S., Bansal, A. (2015). Role of Innovator Product Characterization in Generic Product Development. 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_17

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