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.
