Development and characterization of an orodispersible film containing drug nanoparticles

Shen, Biao; Shen, Chengying; Yuan, Xudong; Bai, Jing; Lv, Qingyuan; Xu, He; Dai, Ling; Cao, Yu; Han, Jihong; Yuan, Hailong

doi:10.1016/j.ejpb.2013.09.019

Cited by 78 publications

(49 citation statements)

References 40 publications

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“…This approach has been explored for oral films formulations improvement regarding the delivery of several molecules with pharmaceutical or nutraceutical interest [85,86].…”

Section: Accepted Manuscriptmentioning

confidence: 99%

Oral films as breakthrough tools for oral delivery of proteins/peptides

Castro

Fonte

Sousa

et al. 2015

Journal of Controlled Release

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“…This approach has been explored for oral films formulations improvement regarding the delivery of several molecules with pharmaceutical or nutraceutical interest [85,86].…”

Section: Accepted Manuscriptmentioning

confidence: 99%

Oral films as breakthrough tools for oral delivery of proteins/peptides

Castro

Fonte

Sousa

et al. 2015

Journal of Controlled Release

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“…Therefore, in this study, we made attempt to study the influence of drug physicochemical properties on in vitro transdermal absorption of drug nanosuspension. The techniques for preparing nanosuspensions are classified as top-down process, bottom-up process or a combination of the two methods mentioned 10,11 . Remarkable properties of high-pressure homogenization that belong to one of top-down process, such as simple process, easy scale-up, absent organic solvent and less product contamination, enable its wide applications in pharmaceutical industry 12,13 .…”

Section: Please Scroll Down For Articlementioning

confidence: 99%

Influence of drug physicochemical characteristics onin vitrotransdermal absorption of hydrophobic drug nanosuspensions

Shen¹,

Li²,

Shen³

et al. 2015

Drug Development and Industrial Pharmacy

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The purpose of this paper was to study the influence of drug physicochemical characteristics on in vitro transdermal absorption of hydrophobic drug nanosuspensions. Four drug nanosuspensions were produced by high-pressure homogenization technique, which were the same in stabilizer and similar in particle size. Differential scanning calorimetry and powder X-ray diffraction analysis showed that the crystalline state of the nanocrystals did not change. In vitro permeation study demonstrated that the drug nanosuspensions have a higher rate of permeation that ranged from 1.69- to 3.74-fold compared to drug microsuspensions. Correlation analysis between drug physicochemical properties and Jss revealed that log P and pKa were factors that influenced the in vitro transdermal absorption of hydrophobic drug nanosuspensions, and drugs with a log P value around 3 and a higher pKa value (when pKa < pH+2) would gain higher Jss in this paper.

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“…The two most commonly used methods to overcome these challenges, organic solvent casting (Kumar et al, 2014; Visser et al, 2015) and hot melt extrusion (Prodduturi et al, 2005), both pose inherent limits to drug loading in the film and may lead to instability of the embedded drug (Kipp, 2004). Several particle engineering techniques have demonstrated promise in terms of producing stable poorly water-soluble drug particles for incorporation into and fast dissolution from polymer strip films with less stringent limitations on drug loading, including production of drug nanoparticles via wet stirred media milling (WSMM) (Krull et al, 2015b, 2016; Sievens-Figueroa et al, 2012a; Susarla et al, 2013, 2015), high pressure homogenization (Lai et al, 2015; Shen et al, 2013), liquid antisolvent precipitation (Beck et al, 2013), and melt emulsification (Bhakay et al, 2016). However, none of these studies investigated the impact of plasticizer on film properties as well as dissolution rate.…”

Section: Introductionmentioning

confidence: 99%

Critical material attributes (CMAs) of strip films loaded with poorly water-soluble drug nanoparticles: I. Impact of plasticizer on film properties and dissolution

Krull

Patel

et al. 2016

European Journal of Pharmaceutical Sciences

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Recent studies have demonstrated polymer films to be a promising platform for delivery of poorly water-soluble drug particles. However, the impact of critical material attributes, for example plasticizer, on the properties of and drug release from such films has yet to be investigated. In response, this study focuses on the impact of plasticizer and plasticizer concentration on properties and dissolution rate of polymer films loaded with poorly water-soluble drug nanoparticles. Glycerin, triacetin, and polyethylene glycol were selected as film plasticizers. Griseofulvin was used as a model Biopharmaceutics Classification System class II drug and hydroxypropyl methylcellulose was used as a film-forming polymer. Griseofulvin nanoparticles were prepared via wet stirred media milling in aqueous suspension. A depression in film glass transition temperature was observed with increasing plasticizer concentration, along with a decrease in film tensile strength and an increase in film elongation, as is typical of plasticizers. However, the type and amount of plasticizer necessary to produce strong yet flexible films had no significant impact on the dissolution rate of the films, suggesting that film mechanical properties can be effectively manipulated with minimal impact on drug release. Griseofulvin nanoparticles were successfully recovered upon redispersion in water regardless of plasticizer or content, even after up to 6 months’ storage at 40 °C and 75% relative humidity, which contributed to similar consistency in dissolution rate after 6 months’ storage for all films. Good content uniformity (<4% R.S.D. for very small film sample size) was also maintained across all film formulations.

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Development and characterization of an orodispersible film containing drug nanoparticles

Cited by 78 publications

References 40 publications

Oral films as breakthrough tools for oral delivery of proteins/peptides

Oral films as breakthrough tools for oral delivery of proteins/peptides

Influence of drug physicochemical characteristics onin vitrotransdermal absorption of hydrophobic drug nanosuspensions

Critical material attributes (CMAs) of strip films loaded with poorly water-soluble drug nanoparticles: I. Impact of plasticizer on film properties and dissolution

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