Study of Polymorphs of Progesterone by Novel Melt Sonocrystallization Technique: A Technical Note |
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| Authors: | R Tripathi Shailesh V Biradar B Mishra Anant R Paradkar |
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| Institution: | (1) Department of Pharmaceutics, Poona College of Pharmacy and Research Center, Bharati Vidyapeeth University, Erandwane, Pune, 411 038, Maharashtra, India;(2) Department of Pharmaceutics, Institute of Technology, Banaras Hindu University, Varanasi, 221 005, India;(3) Institute of Pharmaceutical Innovation, and IRC in Polymer Science and Technology, University of Bradford, West Yorkshire, BD7 1DP, UK; |
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| Abstract: | A large number of pharmaceuticals exhibit polymorphism; 23% steroids, 60% sulfonamides, and 70% of barbiturates have shown
this property. In this study, we have investigated and compared a new technique termed as melt sonocrystallization (MSC) with
melt and sonocrystallization (SC) for induction of polymorphism in progesterone (PRG). Polymorphs were characterized by DSC,
XRD, FT-IR, and FT Raman spectroscopy. Melt sonocrystallized progesterone (MSC-PRG) contained both the polymorphs, more soluble
form II along with less soluble form I, whereas melt progesterone (M-PRG) and sonocrystallized progesterone (SC-PRG) contained
only form I. Improvement in dissolution characteristics of both the polymorphs were compared and form II was found to be more
readily soluble than form I in deionized water. Reduction in mean particle size of PRG during SC was also determined using
laser diffractometer. During stability testing (40°C/75% RH) for 1 month, metastable form II of MSC-PRG was found to be transformed
into its more stable state. MSC technique was thus found as a useful tool for induction of polymorphism. |
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