Polimorfisme Diklofenak Natrium

Soewandhi, Sundani Nurono and Rulyaqien, Azas and Indardini, Reni (2014) Polimorfisme Diklofenak Natrium. Jurnal Sains dan Teknologi Farmasi, 12 (1). pp. 17-24. ISSN 1410-0177

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Abstract

Active compound that have polymorphism, could have a tendency to crystallize into variously different forms and energetic level. The consequence is, it can show the polymorphic transformation that could influence its solubility, dissolution, stability, and bioavailability. Polymorphism of sodium disclofenac has been studies crystallographically, including crystal latdce distance, thermal content and its transformation. The Assay was carried out by polarization microscope, powder X-ray diffraction, differential scanning calorimetry (DSC), and scanning electron microscope (SEM). Treatments given to sodium diclofenac were heating at 50, 70 and 150o C for 1 – 3 hours, pulverizing in grinding mill at 100 rpm for 2 hours, and recrystallizing from its saturated solution in ethanol, acetone, water : etanol (1 : 1) and water : acetone (1 : 1) mixture. Observation under polarization microscope, showed that crystal habits from saturated ethanol was monoclinic, acetone othorhombic. Whilst ethanol : water (1 : 1) and acetone : water (1 : 1) mixture were hexagonal. X-ray diffractogram of crystals that recrystallized from solvent showed different pattern that those of commercial prouct. All samples produced by thermal treatment were mixture of from I and II and showed identical diffractogram, except the heating product at 150oC for 3 hours. Thermogram profile of sodium diclofenac without treatment showed three endothermic curves at 51.5, 69.9 and 285.30 C, indicating a possibility of presence or form II hydrate or co-crystal. Thermogram of product prodiced by both tribomechanic and thermal treatment ≤150oC for 1 hour, have two endothermic curves at 54,8 and 284,9oC. Endothermic curve at 69,8oC dissapeared as a cossequence of the release of hydrate water from their molecules. Loses of hydrate water caused roughness of crystal surface that produced from recrystallization. Observed by SEM microphotograph. Whilst thermogram of heating product at 150oC for 3 hours oly had one endothermic curve, this indicated that all form were totaly transformed to form 1. Keywords : sodium diclofenc, polymorphism, polarization microscope, powder X-ray diffraction, DSC, SEM

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