Abstract：
:In the present work, authors produced tablets of anhydrous sodium naproxen by wet granulation using a high-shear mixer-granulator. Drug hydrated to the tetrahydrated form, as observed by X-ray powder diffractometry. After wet granulation, authors then performed two different drying procedures, obtaining granules of different water content and crystallographic characteristics. The first procedure dried granules in the high-shear mixer-granulator by applying vacuum at room temperature (batch A), while the second employed the same apparatus and time, under vacuum at 40 degrees C (batch B). X-ray powder diffractometry revealed that the sodium naproxen (SN) contained in batch A granules was a mixture of dihydrated and tetrahydrated forms (as demonstrated by the coexistence of peaks typical of both hydrated forms), while that of batch B granules was a mixture of monohydrated and tetrahydrated forms. This means that differences in drying procedures could lead to products of different crystallographic properties. The behavior under compression was evaluated, revealing that batch A offered the best tabletability and compressibility. These results make it possible to conclude that differences in the crystallographic properties and water content of SN are such that different hydration/drying processes can alter the drug crystal form and thus the tabletability of the resulting granules.
journal_name
J Pharm Scijournal_title
Journal of pharmaceutical sciencesauthors
Di Martino P,Malaj L,Censi R,Martelli Sdoi
10.1002/jps.21400subject
Has Abstractpub_date
2008-12-01 00:00:00pages
5263-73issue
12eissn
0022-3549issn
1520-6017pii
S0022-3549(16)32805-2journal_volume
97pub_type
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