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.

journal_name

AAPS PharmSciTech

journal_title

AAPS PharmSciTech

authors

Tripathi R,Biradar SV,Mishra B,Paradkar AR

doi

10.1208/s12249-010-9508-7

subject

Has Abstract

pub_date

2010-09-01 00:00:00

pages

1493-8

issue

3

issn

1530-9932

journal_volume

11

pub_type

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