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Validace výroby jednodávkových medikovaných nanovlákenných přípravků produkovaných elektrospiningem
[Validation of production of single-dose medicated nanofiber matrices manufactured by electrospinning]
D. Stránská, P. Berka, P. Doležal
Status minimal Language Czech Country Czech Republic
A considerable obstacle of the real nanofiber use in drug dosage forms consists in the low weight of the doses and in the content non-uniformity of medicated nanofiber products, especially of those manufactured on a large scale. The electrospinning nanofiber technology is the most promising in this context; however, no results obtained by validated production have been published so far. Here we present the results of the validation study of electrospun medicated strips intended for administration of rizatriptan as a drug medicated in milligrams per dose. The results obtained demonstrate a compliance with the good manufacturing practice and pharmacopoeial requirements on weight and content uniformity. We have concluded that the tested Nanospider™ electrospinning technology is validable and thus suitable for a wide number of drugs intended for single-dose administration of small drug quantities.
Validation of production of single-dose medicated nanofiber matrices manufactured by electrospinning
Literatura
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- $a Stránská, Denisa $7 _AN102205 $u InStar Technologies a.s., Liberec; Katedra farmaceutické technologie, Farmaceutická fakulta v Hradci Králové, Univerzita Karlova v Praze, Hradec Králové
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- $a Validace výroby jednodávkových medikovaných nanovlákenných přípravků produkovaných elektrospiningem / $c D. Stránská, P. Berka, P. Doležal
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- $a Validation of production of single-dose medicated nanofiber matrices manufactured by electrospinning
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- $a Literatura
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- $a A considerable obstacle of the real nanofiber use in drug dosage forms consists in the low weight of the doses and in the content non-uniformity of medicated nanofiber products, especially of those manufactured on a large scale. The electrospinning nanofiber technology is the most promising in this context; however, no results obtained by validated production have been published so far. Here we present the results of the validation study of electrospun medicated strips intended for administration of rizatriptan as a drug medicated in milligrams per dose. The results obtained demonstrate a compliance with the good manufacturing practice and pharmacopoeial requirements on weight and content uniformity. We have concluded that the tested Nanospider™ electrospinning technology is validable and thus suitable for a wide number of drugs intended for single-dose administration of small drug quantities.
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- $a Berka, Pavel $7 _AN057583 $u InStar Technologies a.s., Liberec; Katedra farmaceutické technologie, Farmaceutická fakulta v Hradci Králové, Univerzita Karlova v Praze, Hradec Králové
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