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Nocturnal Leg Cramps (NLC) are involuntary lower limb contractions that are painful and occur during long rest periods. Magnesium is thought to have potential in the treatment of NLC as one of the precipitating factors of NLC is low levels of certain minerals, such as magnesium deficiency. This study aimed to assess the effectiveness of magnesium adjunctive therapy in reducing cramping pain intensity in patients with NLC. This study was a randomized clinical trial, open-label, controlled group that was followed up for 2 weeks. 30 subjects who have been diagnosed with the NLC short-form adaptation of ICSD 2005 were divided into 2 groups; (1) the intervention group who was given standard NLC therapy (calcium and gabapentin) with additional therapy of magnesium citrate 100 mg (Hi-Mg100) one tablet a day, (2) the control group who was only given standard NLC therapy. NLC cramping pain was measured using the Numeric Rating Scale (NRS) before the administration of therapy (baseline) and at week 2 after therapy. The results obtained were the addition of magnesium to standard therapy provided a significant reduction in cramping pain intensity between before and after treatment based on the Wilcoxon signed rank test (p=0.000). However, there was no statistically significant difference effect between the two therapy groups based on the Mann-Whitney test (p=0.073). In conclusion, magnesium adjunctive therapy was not significantly more effective in reducing cramping pain than standard drug therapy in patients with NLC.

Background: One of the vital variables affecting the stability and the characteristics of the Nanostructured Lipid Carrier (NLC) is the surfactant concentration. Using the two combinations of surfactants can cause higher stability and a better characteristic of NLC. Tween 80 and Span 20 are anionic surfactants whose combination has not been studied for use in NLC systems. Objective: Determine the effect of different surfactant ratios of Tween 80 and Span 20 on the physicochemical characteristics, stability, and irritability of NLC using the High Shear Homogenization (HSH) method. Methods: Four different surfactant ratios were used in the NLC formulation, in which the ratio of Tween 80:Span 20 were 5:5, 6:6, 7:7, and 8:8, respectively. In this NLC system, cetyl palmitate served as solid lipid, medium-chain triglyceride (CrodamolTM) as liquid lipid, Tween 80, and Span 20 as surfactant components. NLC was characterized for organoleptic, viscosity, pH, zeta potential, particle morphology, particle size, and polydispersity index (PDI), then evaluated for stability using the real-time and freeze-thaw method, and irritability effect. Results: The different ratios of Tween 80 and Span 20 had no significant effect on the particle size, PI, and irritation score of the NLC system. On the other hand, it influenced all formulas' pH value, viscosity, zeta potential, and stability. Conclusions: The different ratios of surfactant combination affect the characteristics and stability of the NLC system.

Karakteristik kritis nano-structured lipid carrier (NLC) sangat dipengaruhi oleh komponen lipid padat dan lipid cair dalam sistem. Penelitian ini bertujuan untuk mengkaji pengaruh panjang rantai karbon dalam lipid padat terhadap karakteristik NLC. Resveratrol sebagai senyawa antioksidan digunakan sebagai model obat. Sebanyak 3 formula NLC dibuat dengan variasi tipe lemak padat yaitu asam stearat, asam palmitat, dan asam miristat. Lemak padat dengan loading 5%, lemak cair dengan loading 2%, dan Tween 80 dengan loading 4,2% sebagai surfaktan. NLC dibuat dengan metode emulsi diikuti dengan sonikasi untuk memperkecil ukuran partikel. NLC resveratrol dikarakterisasi dengan parameter ukuran partikel, zeta potensial, efisiensi penjerapan, kecepatan pelepasan obat (fluks), dan stabilitas aktivitas antioksidan. Ketiga NLC resveratrol yang diperoleh memiliki karakteristik ukuran partikel 150-280 nm, potensial zeta (-4 mV) – (-15mV), efisiensi penjerapan >80%, nilai fluks 0,02-0,12 mg.cm-2.menit-1, dan penurunan aktivitas antioksidan 5-8% selama penyimpanan 30 hari. Panjang rantai karbon mempengaruhi pembentukan partikel nano dari NLC dengan hubungan parabola dan panjang rantai karbon optimum akan menghasilkan partikel dengan ukuran minimum. Zeta potensial dari ketiga formula menunjukkan perbedaan yang tidak bermakna (p>0,05). Panjang rantai karbon memberikan pengaruh terhadap efisiensi penjerapan secara bermakna (p0,05).

The aim this study was to determine the effect of Monostearin and Miglyol 808 lipid ratio in NLC system formulation resulting in physicochemical characteristics, release rate, and penetration rate. The NLC making was done by using emulsification method. In the formulation of NLC meloxicam, 3 different lipid ratios were used, including ratios of 6:4, 7:3, 8:2. Meloxicam served as active ingredient, monostearin served as solid lipid, miglyol 808 served as a liquid lipid, and tween 80 was surfactant. NLC meloxicam physicochemical characteristics include tests of organoleptic, pH, viscosity, particle size, particle morphology and entrapment efficiency. NLC meloxicam belongs to semisolid preparations with pH value range of 5,72-5,87. Increasing viscosity of NLC system are cause by increase of solid lipid. The measurement results of particle size of three different lipid formulas indicated that the lipid particle size was 80%). The determination of release rate (flux) and penetration rate (flux) was conducted by using Franz diffusion cells with a cellophane membrane for the release and Wistar rat’s skin membrane for the penetration. The release rate values of three NLC meloxicam formulas showed p value (sig) 0,005, while the penetration rate obtained p value (sig) 0,091. Keywords: NLC, meloxicam, physicochemical characterization, release rate and penetration rate