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Evaluation of silicone elastomers fo...
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Schulze Nahrup, Julia.
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Evaluation of silicone elastomers for tablet coating.
紀錄類型:
書目-電子資源 : Monograph/item
正題名/作者:
Evaluation of silicone elastomers for tablet coating./
作者:
Schulze Nahrup, Julia.
面頁冊數:
157 p.
附註:
Source: Dissertation Abstracts International, Volume: 64-06, Section: B, page: 2619.
Contained By:
Dissertation Abstracts International64-06B.
標題:
Health Sciences, Pharmacy. -
電子資源:
http://pqdd.sinica.edu.tw/twdaoapp/servlet/advanced?query=3093394
Evaluation of silicone elastomers for tablet coating.
Schulze Nahrup, Julia.
Evaluation of silicone elastomers for tablet coating.
- 157 p.
Source: Dissertation Abstracts International, Volume: 64-06, Section: B, page: 2619.
Thesis (Ph.D.)--University of Cincinnati, 2003.
The objective of this project was to study the effect of modifications of endhydroxylated poly(dimethylsiloxane) (PDMS) formulations on tablet drug release. Emulsions of crosslinked endhydroxylated PDMS, a novel film-forming polymer, were characterized and investigated for their ability to be applied onto tablet cores in a spray-coating process for controlled drug release.Subjects--Topical Terms:
1017737
Health Sciences, Pharmacy.
Evaluation of silicone elastomers for tablet coating.
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Thesis (Ph.D.)--University of Cincinnati, 2003.
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The objective of this project was to study the effect of modifications of endhydroxylated poly(dimethylsiloxane) (PDMS) formulations on tablet drug release. Emulsions of crosslinked endhydroxylated PDMS, a novel film-forming polymer, were characterized and investigated for their ability to be applied onto tablet cores in a spray-coating process for controlled drug release.
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Modifications of the crosslinking agent from the most commonly used tetraethylorthosilicate (TEOS) to the trifunctional 3-(2,3-epoxypropoxy)propyltrimethoxysilane (SIG) and a 1:1-mixture of the two crosslinker were undertaken.
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Addition of vermiculate clay, copolymeric substances and different channeling-agents were studied. Copolymers of methylpolysiloxane with polyoxyethylene (DC193 and DC5324) or dimethyl,methyl (polyoxyethylene) (DCQ2-5220) as well as poly (acrylamide-co-acrylic acid) were used. Lactose, microcrystalline cellulose (MCC) and polyethyleneglycol 8000 (PEG) were the channeling-agents applied.
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A change in molecular weight of the PDMS was analyzed.
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Effects on dispersion properties were characterized by particle size distribution, viscosity and visual observation of phase-separation. Mechanical properties of resulting cast and sprayed films were studied to determine applicability in a pan-coating process. Release of Hydrochlorothiazide (marker-drug) was studied from tablets coated in a lab-size conventional coating pan.
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Dispersions were found suitable for a spray-coating process. Only the formulation with acrylic-copolymer addition was unstable as phase separation occurred.
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Preparation of free films showed that methylpolysiloxane-copolymers negatively affected the mechanical properties so that coating onto tablet cores was not possible.
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Tablets coated with formulations crosslinked using the 1:1-mixture of SIG/TEOS and containing polyethyleneglycol were most suitable to control drug release, at 5% coating weight. Constant release rates were achieved for formulations with up to 25% (w/w of PDMS) PEG; higher amounts resulted in a non-linear release pattern. Upon adding 50% PEG, a drug release of 62% over 24 hours could be achieved.
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Formulations containing 25 and 50% (w/w of PDMS) PEG were stable for at least 3 months when tested according to ICH-guidelines.
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In comparison with Eudragit NE (copolymeric product of 2:1 ethylacrylate/methylmethacrylate) PDMS-formulations showed similar mechanical and improved spray-application properties. Addition of channeling agents was necessary for both products to achieve drug release. The effect of polyethyleneglycol was greater on formulations based on PDMS than for Eudragit NE.
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