Comparison Between Hot-Melt Extrusion and Spray-Drying for Manufacturing Solid Dispersions of the Graft Copolymer of Ethylene Glycol and Vinylalcohol

Guns, Sandra; Dereymaker, Aswin; Kayaert, Peter; Mathot, Vincent; Martens, Johan A.; Mooter, Guy Van den

doi:10.1007/s11095-010-0324-2

Cited by 57 publications

(34 citation statements)

References 12 publications

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“…resulting in a significant increase in solubility. Similar results were previously reported in several researches (Guns et al, 2011;Linn et al, 2012;Thakral et al, 2012).…”

Section: Powder X-ray Diffractionsupporting

confidence: 93%

Design of freeze-dried Soluplus/polyvinyl alcohol-based film for the oral delivery of an insoluble drug for the pediatric use

Shamma

Elkasabgy

2014

Drug Delivery

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Spironolactone (SL) is a poorly water-soluble drug. Being poorly soluble affects its dissolution rate which in turn affects its oral bioavailability. This work aimed to prepare freeze-dried SL-Soluplus Õ /polyvinyl alcohol (PVA) oral thin film in an attempt to enhance the drug solubility on one hand and at the same time prepare a solid dosage form convenient for the pediatric use. SL-Soluplus Õ /PVA films were prepared using polyethylene glycol 400 (PEG 400) as a plasticizer applying the solvent-casting technique. The prepared films were evaluated for their thickness, tensile strength, and in vitro dissolution studies. Box-Behnken design (17 runs) was applied to optimize the effects of the formulation variables on the film properties. The optimized film formulation was freeze-dried after casting so as to enhance the drug dissolution. Moreover, the optimized freeze-dried film was re-characterized in vitro and evaluated in vivo in human volunteers to investigate its palatability and satisfaction. The results showed that the optimized formulation composed of 10% polymer concentration containing Soluplus Õ :PVA (0.33:0.66) and plasticized with 30% PEG 400 possessed the highest desirability value (0.836). Freeze-drying of the optimized formulation succeeded to improve SL in vitro dissolution due to the preparation of a more porous film compared to the non-freeze-dried one. In vivo evaluation of the optimized freeze-dried film showed high satisfaction among the participating volunteers concerning the ease of administration and sensation thereafter, where all the film specimens dissolved without the need for water and no film residues remained in the mouth following film dissolution. In conclusion, freeze-dried Soluplus Õ /PVA-based oral thin film proved to be a successful carrier for the oral delivery of insoluble drugs like SL for pediatrics.

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“…resulting in a significant increase in solubility. Similar results were previously reported in several researches (Guns et al, 2011;Linn et al, 2012;Thakral et al, 2012).…”

Section: Powder X-ray Diffractionsupporting

confidence: 93%

Design of freeze-dried Soluplus/polyvinyl alcohol-based film for the oral delivery of an insoluble drug for the pediatric use

Shamma

Elkasabgy

2014

Drug Delivery

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“…In this respect, understanding of polymer-drug interaction and phase behavior of the binary system is of key importance for the selection of the most suitable carrier. Moreover, the method of preparation, the range of process variables, and the drug/polymer ratio have a substantial influence on physical structure, the solid state solubility/miscibility of drug and polymer in an ASD (6,7).…”

Section: Introductionmentioning

confidence: 99%

Influence of Solvent Composition on the Miscibility and Physical Stability of Naproxen/PVP K 25 Solid Dispersions Prepared by Cosolvent Spray-Drying

Paudel

Mooter

2011

Pharm Res

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“…Moreover, advanced instrumentation permits in situ studies of phase transformation as a function of conditions provided (RH, temperature) to be performed. Many APIs can transform into different polymorphic forms from an amorphous state [156]. Thus, reference powder patterns for that API makes the identification of different polymorphs possible [157][158][159].…”

Section: X-ray Diffraction Techniquesmentioning

confidence: 99%

Pharmaceutical solvates, hydrates and amorphous forms: A special emphasis on cocrystals

Healy

Worku

Kumar

et al. 2017

Advanced Drug Delivery Reviews

283

189

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a b s t r a c t a r t i c l e i n f oActive pharmaceutical ingredients (APIs) may exist in various solid forms, which can lead to differences in the intermolecular interactions, affecting the internal energy and enthalpy, and the degree of disorder, affecting the entropy. Differences in solid forms often lead to differences in thermodynamic parameters and physicochemical properties for example solubility, dissolution rate, stability and mechanical properties of APIs and excipients. Hence, solid forms of APIs play a vital role in drug discovery and development in the context of optimization of bioavailability, filing intellectual property rights and developing suitable manufacturing methods. In this review, the fundamental characteristics and trends observed for pharmaceutical hydrates, solvates and amorphous forms are presented, with special emphasis, due to their relative abundance, on pharmaceutical hydrates with single and two-component (i.e. cocrystal) host molecules.

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Comparison Between Hot-Melt Extrusion and Spray-Drying for Manufacturing Solid Dispersions of the Graft Copolymer of Ethylene Glycol and Vinylalcohol

Cited by 57 publications

References 12 publications

Design of freeze-dried Soluplus/polyvinyl alcohol-based film for the oral delivery of an insoluble drug for the pediatric use

Design of freeze-dried Soluplus/polyvinyl alcohol-based film for the oral delivery of an insoluble drug for the pediatric use

Influence of Solvent Composition on the Miscibility and Physical Stability of Naproxen/PVP K 25 Solid Dispersions Prepared by Cosolvent Spray-Drying

Pharmaceutical solvates, hydrates and amorphous forms: A special emphasis on cocrystals

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