Co-Crystals for Generic Pharmaceuticals: An Outlook on Solid Oral Dosage Formulations

Title:Co-Crystals for Generic Pharmaceuticals: An Outlook on Solid Oral Dosage Formulations

Volume: 15 Issue: 1

Author(s): Maniyam Arun Pandian Rajendran*, Ravikiran Allada and Syed Shahnawaz Sajid

Affiliation:

• Research and Development Department, Novugen Pharma (Malaysia) Sdn. Bhd, Hicom-Glenmarie Industrial Park, Shah Alam 40150, Selangor,Malaysia

Keywords: Co-crystals, crystal engineering, generic pharmaceuticals, solid oral dosage form, regulatory perspective, polymorphism, solubility.

Abstract: Co-crystal is an attractive alternative and a new class of solid forms because that can be engineered to have desired physicochemical properties. Co-crystals have gained considerable attention from the generic pharmaceutical industry after the USFDA released its finalized guidlines in the year 2018 on the regulatory classification of co-crystals. In this review, we discussed how co-crystals could be explored as a potential alternative solid form for the development of a generic product that meets the legal, regulatory, and bioequivalence requirements. In the contents, we discussed in detail concepts such as the selection of coformers, various ways of making co-crystals, the strategy of characterization to discriminate between co-crystal and salt, polymorphism in co-crystals, the aspects of intellectual property and, finally, the regulatory aspects of co-crystals.

Cite this article as:

Rajendran Arun Pandian Maniyam*, Allada Ravikiran and Sajid Shahnawaz Syed , Co-Crystals for Generic Pharmaceuticals: An Outlook on Solid Oral Dosage Formulations, Recent Advances in Drug Delivery and Formulation 2021; 15 (1) . https://dx.doi.org/10.2174/2667387815666210203151209