Exploring the Patent Landscape and Regulatory Prospective on Pharmaceutical Cocrystals

Abstract

Background: Cocrystals are not new, they have sparked considerable interest among scientists and the pharmaceutical business in the last decade. Cocrystals are multiphase formations composed of at least two particles that are held together by noncovalent bonds. Cocrystal offers unmatched physio-engineered attributes (like stability, melting point, taste concealment, dissolvability, purity, bioavailability, etc.) without changing the pharmacological capabilities of the drug. Recently, as pharmaceutical cocrystal development has increased, we have given more attention to the absurd state of cocrystals.

Purpose: The purpose of the current review is to explore the patent perspective on pharmaceutical cocrystals. And to discuss the new regulations that came up from the U.S. Food and Drug Administration (USFDA) and European Medicines Agency (EMA).

Methods: In order to accomplish the said objectives, literature was surveyed from GOOGLE PATENTS, GOOGLE SCHOLAR, PUBMED, EBSCO, etc. type for search engines for a detailed overview of the patentability and regulatory status of pharmaceutical cocrystals.

Conclusions: The journey of pharmaceutical cocrystals is bit challenging and still going on. In addition, if attention is drawn on some challenging aspects such as scalability, reproducibility, herbal bioactives cocrystals and 3D printed cocrystals related preparation and stability challenges, it can prove to be a paradigm shift in drug discovery processes.

  • Page Number : 49-60
  • Published Date : 2023-04-15
  • Keywords
    Pharmaceutical Cocrystals, USFDA, EMA, Patent, Regulatory Consideration paper in rows
  • DOI Number
  • Authors
    Ritu Rathi, Yukta Guggal, Twinkle, Varneet Sandhu, Inderbir Singh

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