• YAKHAK HOEJI
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• v.48 no.1
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• pp.60-64
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• 2004

Near-infrared (NIR) spectroscopy was used to determine rapidly and nondestructively the content of ambroxol in intact ambroxol tablets containing 30 mg (12.5％ m/m nominal concentration) by collecting NIR spectra in range 1100-1750 nm. The laboratory-made samples had 10.3∼15.9％ m/m nominal ambroxol concentration. The measurements were made by reflection using a fiber-optic probe and calibration was carried out by partial least square regression (PLSR) with autoscaling. Model validation was performed by randomly splitting the data set into calibration and validation data set (7 samples as a calibration data set and 5 samples as a validation data set). The developed NIR method gave results comparable to the known values of tablets in a laboratorial manufacturing Process, standard error of calibration (SEC) and standard error of prediction (SEP) being 0.49％ and 0.49％ m/m respectively. The method showed good accuracy and repeatability NIR spectroscopic determination in intact tablets allowed the potential use of real time monitoring for a running production process.

• Proceedings of the PSK Conference
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• 2003.04a
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• pp.279.1-279.1
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• 2003

NIR reflectance spectroscopy, using a fiber-optic probe was used to determine rapidly and non-destructively the content of ambroxol in intact ambroxol 30 mg (nominal content 12.5％ m/m ambroxol) tablets by collecting NIR spectra in range 1100 - 1750 nm and using PLSR calibration method. The tablets (10.3 - 15.9％ m/m ambroxol, i.e., 82 - 127％ of the nominal label content) were used 7 calibration set and 5 validation set. (omitted)

• Proceedings of the PSK Conference
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• 2003.10b
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• pp.213.2-213.2
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• 2003

A simple analytical procedure using FT-NIR for the rapid determination of individual ingredients was evaluated. Direct measurements were made by reflection using a reflectance accessory, by transmittance using tablet accessory and turn table. FT-NIR spectral data were transformed to the first derivative. Partial Least Square Regression(PLSR) was applied to quantify near-infrared (NIR) spectra of 2 ingredients. These calibration models were cross-validated (leave-one-out approach). The prediction ability of the models was evaluated on ambroxol tablets and compared with the real values in manufacturing procedure. (omitted)

• Proceedings of the Korean Society of Near Infrared Spectroscopy Conference
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• 2001.06a
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• pp.4111-4111
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• 2001

When a drug is prepared in a tablet, the active component represents only a small portion of the dosage form. The other components of the formulation include materials to assist in the dissolution, antioxidants, coloring agents and bulk fillers. The tablets are tested using approved testing methods usually involving separation and subsequent quantification of the active component. Tablets may also be tested by near-Infrared Reflectance spectrometry (NIRS). In the present study, based on NIRS and multivariate calibration methods, a novel and precise method is developed for direct determination of ascorbic acid in vitamin C tablet. Two different tablet formulations were powdered in three different sizes, 63-125 ${\mu}{\textrm}{m}$, and examined. Spectral region of 4750-4950 $cm^{-1}$ / was used and optimized for quantitative operations. Partial least squares (PLS) and multiple linear regression (MLR) methods were performed for this spectral region. The results of optimized PLS and MLR methods showed that reproducibility increase with decreasing grain size and standard error of calibration (SEP) of less than 1% w/w of ascorbic acid and a correlation coefficient of 0.998 can be achieved. The PLS method showed better results than MLR. Seven overdose and underdose samples (prepared in the laboratory to match marketed products) were tested by proposed and iodometric standard methods. A correlation between NIRS predicted ascorbic acid values and iodomet.ic values was calculated ($R^2$=0.9950). Finally, the direct analysis of individual intact tablets in their unit-dose packages (Blistering in aluminum and PVC foils) obtained from market were also carried out and a correlation coefficient of 0.9989 and SEP of 0.931% w/w of ascorbic acid were achieved.

• Journal of Pharmaceutical Investigation
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• v.32 no.3
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• pp.185-190
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• 2002

To improve the solubility of poorly water-soluble drug and to develop a sustained release tablets, the need for the technique, the formation of solid dispersion with polymeric materials that can potentially enhance the dissolution rate and extent of drug absorption was considered in this study. The 1:1, 1:4, and 1:5 solid dispersions were prepared by spray drying method using PVP K30, ethanol and methylene chloride. The dissolution test was carried out at in phosphate buffer solution at $37^{\circ}C$ in 100 rpm. Solid dispersed drugs were examined using differential scanning calorimetry and scanning electron microscopy, wherein it was found that felodipine is amorphous in the PVP K30 solid dispersion. Felodifine SR tablets were prepared by direct compressing the powder mixture composed of solid dispersed felodipine, lactose, Eudragit and magnesium stearate using a single punch press. In order to develop a sustained-release preparation containing solid dispersed felodipine, a comparative dissolution study was done using commercially existing product as control. The dissolution rate of intact felodipine, solid dispersed felodipine and its physical mixture, respectively, were compared by the dissolution rates for 30 minutes. The dissolution rates of felodipine for 30 minutes from 1:1, 1:4, 1:5 PVP K30 solid dispersion were 70%, 78% and 90%. However, dissolution rate offelodipine from the physical mixture was 5% of drug for 30 minutes. Our developed product Felodipine SR Tablet showed dissolution of 17%, 50% and 89% for 1, 4, and 7 hours. This designed oral delivery system is easy to manufacture, and drug releases behavior is highly reproducible and offers advantages over the existing commercial product. The dissolution rate of felodipine was significantly enhanced, following the formation of solid dispersion. The solid dispersion technique with water-soluble polymer could be used to develop a solid dispersed felodipine SR tablet.