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R Ravichandra Babu, Mater Sci Nanotechnol 2018, Volume 2
ISO-STRUCTURALITY INDUCED SOLID
PHASE TRANSFORMATIONS: A CASE
STUDY WITH LENALIDOMIDE
R Ravichandra Babu
Gitam University, India
C
omprehensive study for the isolation/characterization on pharmaceutical
solids like polymorphs, salts, hydrates, solvates, co-crystals etc. are integral
part of pharmaceutical industry. Further the selected solid form should meet the
basic requirements of optimal stability, reproducibility and scalability which will
eventually lead to devise a robust and reliable process for its manufacture. The
existence of more than one crystal structure for a chemical substance is referred
as polymorphism. Polymorphs of active pharmaceutical ingredients (API’s)
have always drawn attention in view of their physical and intellectual property.
The importance of polymorph screening can be visualized by a fact of sudden
appearance or disappearance of a polymorphic form during manufacturing and
storage. These transformations will lead to a series of serious consequences
in terms of, patient safety, finance and brand value of the company and so on.
The probability of getting polymorphs of an API depends on the conformational
flexibility existing in the molecular structure and diversity in the crystal packing.
The main objective of the current work was to discover novel polymorphs of LDM
and investigate the existence of iso-structurality in them. Thorough investigations
were carried out to find the relationship of iso-structurality with de-hydration and
de-solvation behavior. In the process of polymorph screening various novel forms
along with the reported forms of LDM were isolated and analyzed by various
analytical techniques. In the current paper, we have selectively focused on
polymorphism, iso-structurality and mechanism of de-solvation/de-hydration in
pseudo polymorphs of Lenalidomide.
R Ravichandra Babu has completed his PhD from
Andhra University, Visakhapatnam, India. He is the
Director/Professor of Gitam University, India. He had
several years of experience in the QA and QC depart-
ments of a chemical industry, where he has developed
many analytical methods for process related impuri-
ties determination. He has over 40 publications and
has been serving as an editorial board member of
reputed journals.
rrcbabu7@yahoo.inBIOGRAPHY