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Preparation, physicochemical characterisation and doe optimisation of a spray-dried dry emulsion platform for delivery of a poorly soluble drug, simvastatin [Elektronski vir]Pohlen, Mitja ...In the presented study, insight into the development and optimisation of the dry emulsion formulation and spray drying process is provided. The aim was to facilitate the dissolution of the poorly ... soluble, highly lipophilic drug, simvastatin, by forming spray-dried dry emulsion particles having adequate powder flow properties, while assuring sufficient drug content. Simvastatin and a mixture of caprylic, capric triglyceride and 1-oleoyl-rac-glycerol were employed as a model drug and solubilising oils, respectively. A matrix of the dry emulsions was composed at a fixed ratio mixture of mannitol and HPMC. Tween 20 was used in low amounts as the primary emulsion stabiliser. To facilitate process optimisation, a DoE surface response design was used to study the influence of formulation and process parameters on the particle size distribution, powder bulk properties, emulsion reconstitution ability, drug stability and process yield of spray-dried products. Two-fluid nozzle geometry was identified, studied and confirmed to be important for most product critical quality attributes. Models obtained after the study showed acceptable coefficients of determination and provided good insight in the relationship governing the process and product characteristics. Five model optimised products showed adequate process yield, suitable particle size distribution, good reconstitution ability and improved dissolution profile, when compared to a non-lipid-based tablet and the pure drug. However, the obtained dry emulsion powders exhibited poor flow character according to the Carr index. The optimised product was further analysed with NMR during lipolysis to gain insight into the species formed during digestion and the kinetics of their formation.Vir: AAPS PharmSciTech [Elektronski vir]. - ISSN 1530-9932 (Vol. 21, 2020, str. 1-19)Vrsta gradiva - e-članek ; neleposlovje za odrasleLeto - 2020Jezik - angleškiCOBISS.SI-ID - 4904561
Avtor
Pohlen, Mitja |
Lavrič, Zoran |
Prestidge, Clive A. |
Dreu, Rok
Teme
Farmacevtska tehnologija |
dry emulsion |
spray drying |
simvastatin |
lipolysis |
flow properties |
sušenje z zmrzovanjem |
liofilizacija |
simvastatin |
suhe emulzije |
lipoliza
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Leto | Faktor vpliva | Izdaja | Kategorija | Razvrstitev | ||||
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JCR | SNIP | JCR | SNIP | JCR | SNIP | JCR | SNIP |
Baze podatkov, v katerih je revija indeksirana
Ime baze podatkov | Področje | Leto |
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Povezave do osebnih bibliografij avtorjev | Povezave do podatkov o raziskovalcih v sistemu SICRIS |
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Pohlen, Mitja | 50269 |
Lavrič, Zoran | 32037 |
Prestidge, Clive A. | ![]() |
Dreu, Rok | 21455 |
Vir: Osebne bibliografije
in: SICRIS
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