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Cocrystals by Design: A Rational Coformer Selection Approach for Tackling the API Problems.

Maan Singh1, Harsh Barua2, Vaskuri G S Sainaga Jyothi3

  • 1Pharmaceutical Solid State Research Laboratory, Department of Pharmaceutical Engineering and Technology, Indian Institute of Technology (Banaras Hindu University), Varanasi 221005, India.

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|April 28, 2023
PubMed
Summary
This summary is machine-generated.

Selecting appropriate coformers is key to improving drug properties through cocrystallization. Carboxylic acid-based coformers are particularly effective for enhancing the solubility and stability of active pharmaceutical ingredients (APIs).

Keywords:
citric acidcocrystalcoformerfumaric acidoxalic acidsolubilitystabilitysuccinic acid

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Area of Science:

  • Pharmaceutical Science
  • Materials Science
  • Drug Delivery

Background:

  • Active pharmaceutical ingredients (APIs) often exhibit poor physicochemical properties and stability, complicating formulation into effective dosage forms.
  • Cocrystallization offers a viable strategy to enhance API solubility and stability, with a growing number of cocrystal-based products available.
  • The selection of coformers is critical for successful cocrystallization, directly impacting drug properties, therapeutic efficacy, and safety profiles.

Purpose of the Study:

  • To review the role of coformers in improving the physicochemical and pharmaceutical properties of APIs.
  • To elucidate the utility of specific coformers, particularly carboxylic acid-based ones, in active pharmaceutical ingredient (API) cocrystal formation.
  • To discuss the patentability and regulatory considerations surrounding pharmaceutical cocrystals.

Main Methods:

  • Literature review summarizing existing research on coformer selection and cocrystal formation.
  • Analysis of commonly used coformers, with a focus on carboxylic acid derivatives (fumaric acid, oxalic acid, succinic acid, citric acid).
  • Discussion of the mechanism of coformer action, including hydrogen bonding interactions with APIs.

Main Results:

  • Coformers significantly enhance the solubility, stability, and overall physicochemical characteristics of APIs.
  • Carboxylic acid-based coformers are frequently employed in marketed cocrystal products due to their ability to form hydrogen bonds and their structural compatibility with APIs.
  • Successful cocrystallization leads to improved therapeutic effectiveness and potentially reduced side effects.

Conclusions:

  • Coformer selection is a crucial determinant of success in developing improved pharmaceutical formulations via cocrystallization.
  • Carboxylic acid-based coformers represent a well-established and effective class for modifying API properties.
  • Further consideration of patentability and regulatory pathways is essential for the advancement of pharmaceutical cocrystal technology.