title: Study of polymorphs of progesterone by novel melt sonocrystallization technique: a technical note.
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.
authors.affiliation: Department of Pharmaceutics, Poona College of Pharmacy and Research Center, Bharati Vidyapeeth University, Erandwane, Pune, 411 038, Maharashtra, India.
authors.forename: R
authors.initials: R
authors.lastname: Tripathi
authors.forename: Shailesh V
authors.initials: SV
authors.lastname: Biradar
authors.forename: B
authors.initials: B
authors.lastname: Mishra
authors.forename: Anant R
authors.initials: AR
authors.lastname: Paradkar
mesh_terms: D003460:Crystallization / Q000379:methods*; D004353:Drug Evaluation, Preclinical / Q000379:methods*; D006358:Hot Temperature; D011374:Progesterone / Q000737:chemistry* / Q000528:radiation effects*; D012995:Solubility; D013010:Sonication; D044366:Transition Temperature
chemical_list: D011374:Progesterone