Sustained release of nitrofurantoin from inert wax matrixes

El-Shanawany, S.

doi:10.1016/0168-3659(93)90204-i

Cited by 29 publications

(14 citation statements)

References 15 publications

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“…Avicel PH 101 significantly increased the %TBS released compared to DCP (P<0.0001) after 8, 12, and 24 h. This may be attributed to difference in solubility and swelling nature of the two fillers [34][35][36]. Figure 3 shows X 1 X 2 , X 1 X 3 , and X 2 X 3 interaction after 8 h (Y 1 ).…”

Section: Effect Of Filler Typementioning

confidence: 97%

Formulation and In Vitro and In Vivo Evaluation of Lipid-Based Terbutaline Sulphate Bi-layer Tablets for Once-Daily Administration

et al. 2015

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Abstract. The objective of this study was to prepare and evaluate terbutaline sulphate (TBS) bi-layer tablets for once-daily administration. The bi-layer tablets consisted of an immediate-release layer and a sustained-release layer containing 5 and 10 mg TBS, respectively. The sustained-release layer was developed by using Compritol®888 ATO, Precirol® ATO 5, stearic acid, and tristearin, separately, as slowly eroding lipid matrices. A full 4×2 2 factorial design was employed for optimization of the sustainedrelease layer and to explore the effect of lipid type (X 1 ), drug-lipid ratio (X 2 ), and filler type (X 3 ) on the percentage drug released at 8, 12, and 24 h (Y 1 , Y 2 , and Y 3 ) as dependent variables. Sixteen TBS sustained-release matrices (F1-F16) were prepared by melt solid dispersion method. None of the prepared matrices achieved the targeted release profile. However, F2 that showed a relatively promising drug release was subjected to trial and error optimization for the filler composition to develop two optimized matrices (F17 and F18). F18 which consisted of drug-Compritol®888 ATO at ratio (1:6 w/w) and Avicel PH 101/dibasic calcium phosphate mixture of 2:1 (w/w) was selected as sustained-release layer. TBS bilayer tablets were evaluated for their physical properties, in vitro drug release, effect of storage on drug content, and in vivo performance in rabbits. The bi-layer tablets showed acceptable physical properties and release characteristics. In vivo absorption in rabbits revealed initial high TBS plasma levels followed by sustained levels over 24 h compared to immediate-release tablets.

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Section: Effect Of Filler Typementioning

confidence: 97%

Formulation and In Vitro and In Vivo Evaluation of Lipid-Based Terbutaline Sulphate Bi-layer Tablets for Once-Daily Administration

et al. 2015

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“…[15][16][17] The pellets were placed on aluminum foil and subjected to various temperatures and durations ranging from 90ºC to 120ºC and 60 seconds to 240 seconds, respectively, in an oven (Met Lab, 1500W, Mumbai). …”

Section: Sinteringmentioning

confidence: 99%

Sintering of wax for controlling release from pellets

2007

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The purpose of the present study was to investigate incorporation of hydrophobic (ie, waxy) material into pellets using a thermal sintering technique and to evaluate the pellets in vitro for controlled release. Pellets prepared by extrusionspheronization technology were formulated with a watersoluble drug, microcrystalline cellulose, and carnauba wax. Powdered carnauba wax (4%-20%) prepared by grinding or by emulsification was studied with an attempt to retard the drug release. The inclusion of ground or emulsified carnauba wax did not sustain the release of theophylline for more than 3 hours. Matrix pellets of theophylline prepared with various concentrations of carnauba wax were sintered thermally at various times and temperatures. In vitro drug release profiles indicated an increase in drug release retardation with increasing carnauba wax concentration. Pellets prepared with ground wax showed a higher standard deviation than did those prepared with emulsified wax. There was incomplete release at the end of 12 hours for pellets prepared with 20% ground or emulsified wax. The sintering temperature and duration were optimized to allow for a sustained release lasting at least 12 hours. The optimized temperature and duration were found to be 100°C and 140 seconds, respectively. The sintered pellets had a higher hydrophobicity than did the unsintered pellets. Scanning electron micrographs indicated that the carnauba wax moved internally, thereby increasing the surface area of wax within the pellets.

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“…Higher shearing forces will result in higher densification and lower maximum binder concentration. A high shear mixer has most often been applied in melt agglomeration, but other equipment (eg, coating pans, 4 blenders, 5 fluidized bed granulators) 6 has also been used. The maximum amount of binder that can be applied has been reported to be~22% in a high shear mixer 7 and 30% in a fluid bed granulator.…”

Section: Introductionmentioning

confidence: 99%

Investigation of a 2-step agglomeration process performed in a rotary processor using polyethylene glycol solutions as the primary binder liquid

Kristensen

2006

AAPS PharmSciTech

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The purpose of this research was to investigate the use of polyethylene glycol (PEG) solutions as the primary binder liquid in a 2-step agglomeration process performed in a rotary processor and characterize the resulting granules and their tableting characteristics. This was done by granulation of binary mixtures of microcrystalline cellulose (MCC) and either lactose, calcium phosphate, acetaminophen, or theophylline, in a 1:3 ratio, using a 50% (wt/wt) aqueous solution of PEG and water as the binder liquid. Formulations containing lactose were agglomerated using 5 different amounts of the PEG binder solution, giving rise to a PEG content in the range of 6% to 43% (wt/wt). The process outcome was characterized according to adhesion, yield, and water requirement, and the prepared granules were characterized according to size, size distribution, and flow properties as well as tableting properties. The agglomeration of all mixtures resulted in high yields of freeflowing agglomerates and gave rise to good reproducibility of the investigated agglomerate characteristics. The process allowed for the incorporation of 42.5% (wt/wt) PEG, which is higher than the percentage of PEG reported for other equipment. Tablets of sufficient strength could be prepared with all investigated excipients using 20% wt/wt PEG; higher PEG contents gave rise to adhesion and prolonged disintegration. In conclusion, agglomeration in a torque-controlled rotary processor using solutions of PEG as the primary binder liquid was found to be a robust process, suitable for the incorporation of high contents of PEG and/or drug compounds.

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Sustained release of nitrofurantoin from inert wax matrixes

Cited by 29 publications

References 15 publications

Formulation and In Vitro and In Vivo Evaluation of Lipid-Based Terbutaline Sulphate Bi-layer Tablets for Once-Daily Administration

Formulation and In Vitro and In Vivo Evaluation of Lipid-Based Terbutaline Sulphate Bi-layer Tablets for Once-Daily Administration

Sintering of wax for controlling release from pellets

Investigation of a 2-step agglomeration process performed in a rotary processor using polyethylene glycol solutions as the primary binder liquid

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