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        Formulation optimization of orally disintegrating tablets containing solid dispersion of felodipine and hydroxypropyl methylcellulose using face-centered central composite design

        Nguyen-Thach Tung,Man-Van Hung,Xuan-Minh Vo,Thanh-Hai Nguyen,Thi-Minh-Hue Pham 한국약제학회 2014 Journal of Pharmaceutical Investigation Vol.44 No.2

        A novel dosage form integrating solid dispersion(SD) in orally disintegrating tablets (ODTs) wasdeveloped and optimized by the face-centered centralcomposite design to improve poorly soluble property andslow onset action time of felodipine (Fel). SD of Fel andhydroxypropyl methylcellulose E6 was prepared by solventevaporation method. Differential scanning calorimetry andfourier transforms infrared spectroscopy indicated that Feltransformed from crystalline to amorphous state by theformation of hydrogen bond between –N–H in Fel and O–Rin HPMC. The accelerated stability test in 45 C, 75 % RHdemonstrated that the optimized SD was stable in terms ofthe dissolution rate of Fel and thermodynamic property. The ODTs containing SD (Fel:HPMC E6 = 1:3) wereprepared by direct compression technique. The face-centeredcentral composite design with the ODT-SD wasemployed to investigate the effect of mannitol (X1),crospovidone XL (X2) on the ODT-SD disintegration time(Y1), % Fel released after 5 min (Y2) and the ODT-SDfriability (Y3). ANOVA test showed that X2 and X2 * X2had a significant effect on the ODT-SD disintegration time(p\0.05). Meanwhile, the dissolution rate of Fel after5 min did not remarkably depend on any independentvariables (p[0.05). The ODT-SD friability was substantiallyproportional to the amount of mannitol (X1)(p\0.05). The optimized ODT-SD disintegration time, %Fel released after 5 min, and friability were 27.67 s, 88.35and 0.48 %, respectively.

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        Formulation and in vivo imaging evaluation of colonic targeting tablets prepared by a simple dry powder coating technique

        Tung Nguyen-Thach,Nguyen Canh-Hung,Nguyen Van-Duong,Nguyen Thi-Hong-Thuy,Nguyen Van-Lam,Tran Cao-Son,Pham Thi-Minh-Hue 한국약제학회 2020 Journal of Pharmaceutical Investigation Vol.50 No.4

        Purpose The study aimed firstly to determine the release behavior of the model drug (berberine chloride) from the dry coated tablets. The second objective of this study was to evaluate the exact location of the dry coated tablets in in vivo. Methods The colon targeting tablets were developed by dry powder coating technique on pan coater. The drug release behavior was determined in the three continuous mediums: pH 1.2; 7.4 and 6.8 plus pectinase. The location of the dry coated tablets in the gastrointestinal tract of human volunteers was observed through the X-ray imaging of the dry coated tablets containing the optimized radiocontrast agents. Results The release kinetics of berberine chloride from the dry coated tablets was mainly controlled by erosion and enzyme sensitive mechanism. The optimum dry coated tablets having the coating powders of pectin 102:HPMC K4 M (2:1) with the coating level of 200%, and the tablet core with BaSO4 10% and iobitridol 30% as radiocontrast agents were observed in the caecum and ascending colon of human volunteers after 5–6 h of oral administration. Conclusion The successful development of these dosage forms is believed to have a high potential in precisely monitoring the release of highly potent drugs such as anti-inflammatory drugs in bowel diseases.

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