Fatty Acid and Water-Soluble Polymer-Based Controlled Release Drug Delivery System

Desai, Divyakant; Kothari, Suresh; Chen, Wei; Wang, Jennifer; Huang, Ming; Sharma, Laxmi Kant

doi:10.1002/jps.22397

Cited by 17 publications

(5 citation statements)

References 13 publications

(10 reference statements)

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“…The slower drug release using behenic acid could be attributed to its longer fatty acid chain relative to stearic acid. In a study performed by Desai et al (2010), a similar influence of chain length on drug release was reported [28]. Since behenic acid released MPT over longer periods, only the combination of MPT and behenic acid is discussed further on in this study.…”

Section: In Vitro Drug Releasesupporting

confidence: 71%

Prilling as manufacturing technique for multiparticulate lipid/PEG fixed-dose combinations

Vervaeck

Monteyne

Saerens

et al. 2014

European Journal of Pharmaceutics and Biopharmaceutics

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Section: In Vitro Drug Releasesupporting

confidence: 71%

Prilling as manufacturing technique for multiparticulate lipid/PEG fixed-dose combinations

Vervaeck

Monteyne

Saerens

et al. 2014

European Journal of Pharmaceutics and Biopharmaceutics

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“…Compared to the CFD approach above which can be used in more detail to evaluate the effect of the tablet size and (12) to Eq. 1.…”

Section: Resultsmentioning

confidence: 99%

Mathematical Model-Based Accelerated Development of Extended-release Metformin Hydrochloride Tablet Formulation

Chen

Desai²,

Good³

et al. 2015

AAPS PharmSciTech

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Abstract. A computational fluid dynamic (CFD) model was developed to predict metformin release from a hydroxypropylmethylcellulose (HPMC) matrix-based extended-release formulation that took into consideration the physical and chemical properties of the drug substance, composition, as well as size and shape of the tablet. New high dose strength (1000 mg) tablet geometry was selected based on the surface area/volume (SA/V) approach advocated by Lapidus/Lordi/Reynold to obtain the desired equivalent metformin release kinetics. Maintaining a similar SA/V ratio across all extended-release metformin hydrochloride (Met XR) tablet strengths that had different geometries provided similar simulations of dissolution behavior. Experimental dissolution profiles of three lots of high-strength tablets agreed with the simulated release kinetics. Additionally, a pharmacokinetic absorption model was developed using GastroPlus™ software and known physicochemical, pharmacokinetic, and in vitro dissolution properties of metformin to predict the clinical exposure of the new high strength (1000 mg) tablet prior to conducting a human clinical bioequivalence study. In vitro metformin release kinetics were utilized in the absorption model to predict exposures in humans for new 1000-mg Met XR tablets, and the absorption model correctly projected equivalent in vivo exposure across all dose strengths. A clinical bioequivalence study was pursued based on the combined modeling results and demonstrated equivalent exposure as predicted by the simulations.

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“…A mixture of sodium fluorescein with stearic acid was loaded into the tubes. Lipids such as stearic acid and palmitic acid have been previously used to control the release of hydrophilic drugs [11][12][13]. In this study, stearic acid along with device parameters such as tube size, hole size, and hole number were used to control the release of sodium fluorescein from the perforated tubes.…”

Section: Introductionmentioning

confidence: 99%

Evaluation of a perforated drug delivery system in mice for prolonged and constant release of a hydrophilic drug

Rastogi

Bowman

Stavchansky

2012

Drug Deliv. and Transl. Res.

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A drug delivery system (DDS) consisting of a perforated microtube (polyimide, inside diameter = 1.8 mm, tube length = 20 mm, hole size = 0.15 mm) was characterized in vitro and in vivo for its usefulness for long-term release of hydrophilic drugs at a constant rate. Sodium fluorescein mixed with stearic acid was used as the model drug. The DDS was packed with sodium fluorescein and stearic acid in ratios of 50:50, 40:60, and 25:75, respectively, and in vitro drug release studies were performed in saline. Linear release rates with R (2) > 0.9700 were obtained for all groups. Release rates of 1,077.3 ± 264.6, 342.6 ± 146.4, and 14.4 ± 7.0 μg/day for sodium fluorescein were obtained from the three groups, respectively. After monitoring the in vitro release of fluorescein for 11 days, 7 tubes from the 40:60 group were implanted subcutaneously in each individual mice to study the in vivo release of fluorescein from the tubes by measuring the fluorescein in the urine for 84 days. An initial rapid release during the first 4 days was followed by a near zero order fluorescence from the tubes (R (2) = 0.9870). Following completion of the study, the DDSs were retrieved for histology. Morphological analysis indicated no clinical adverse reaction at the site of device implantation specific to the device. The DDS was found to be biocompatible and capable of long-term constant release of a hydrophilic drug such as sodium fluorescein.

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Fatty Acid and Water-Soluble Polymer-Based Controlled Release Drug Delivery System

Cited by 17 publications

References 13 publications

Prilling as manufacturing technique for multiparticulate lipid/PEG fixed-dose combinations

Prilling as manufacturing technique for multiparticulate lipid/PEG fixed-dose combinations

Mathematical Model-Based Accelerated Development of Extended-release Metformin Hydrochloride Tablet Formulation

Evaluation of a perforated drug delivery system in mice for prolonged and constant release of a hydrophilic drug

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