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Saturated fatty acids and fatty acid esters promote the polymorphic transition of clarithromycin metastable form I crystal.

Abstract：

:The phase transition of active pharmaceutical ingredients should be taken into account during manufacturing, processing- and storage, because different crystal forms lead to different physical properties of formulations. The phase transition of clarithromycin (CAM) metastable form I to stable form II was investigated on heating with additives such as fatty acids or fatty acid esters. Differential scanning calorimetry analyses revealed that when form I was heated with additives, the phase transition temperature of form I decreased close to the melting points of the additives. Powder X-ray diffraction analyses indicated the tentative presence of a non-crystalline component during the transition of form I to form II on heating with additives. These observations implied that CAM form I dissolved in the melted additives on heating and the dissolved CAM crystallized to form II. Reduction of transition temperatures in the presence of additives were also observed for the crystals of nifedipine form B and carbamazepine form III. These results suggested that the phenomena can be widely applicable for simultaneous crystalline phase transition and granulation using binder additives.

journal_name

Int J Pharm

journal_title

International journal of pharmaceutics

authors

Watanabe M,Mizoguchi M,Aoki H,Iwao Y,Noguchi S,Itai S

doi

10.1016/j.ijpharm.2016.08.041

subject

Has Abstract

pub_date

2016-10-15 00:00:00

pages

108-117

issue

1

eissn

0378-5173

issn

1873-3476

pii

S0378-5173(16)30781-5

journal_volume

512

pub_type

杂志文章

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