Pharmaceutical Product Characterization and Manufacturability of Surfactant-Enriched Oil Marbles with Abiraterone Acetate

Result code in IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F60461373%3A22340%2F22%3A43924673" target="_blank" >RIV/60461373:22340/22:43924673 - isvavai.cz</a>

Alternative codes found

RIV/60461373:22810/22:43924673 RIV/00216208:11310/22:10454713

Result on the web

<a href="https://link.springer.com/article/10.1208/s12249-022-02430-6#citeas" target="_blank" >https://link.springer.com/article/10.1208/s12249-022-02430-6#citeas</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1208/s12249-022-02430-6" target="_blank" >10.1208/s12249-022-02430-6</a>

Result language

angličtina

Original language name

Pharmaceutical Product Characterization and Manufacturability of Surfactant-Enriched Oil Marbles with Abiraterone Acetate

Original language description

The present study investigates the physicochemical properties and stability of a novel lipid-based formulation-surfactant-enriched oil marbles containing abiraterone acetate. While the biopharmaceutical performance of this formulation has been reported recently, this study aims to fill the gap between a promising in vivo performance and industrial applicability. A series of techniques were employed to assess the solid-state characteristics of oil marble cores along with their physicochemical properties upon stability testing. The chemical stability of abiraterone acetate in the formulation was also investigated. The core of the formulation was found to be stable both physically and chemically over 12 months of storage. The in vitro performance of stressed samples was evaluated using a dissolution experiment. The formulation has successfully self-emulsified upon incubation in bio-relevant media, resulting in a fast and complete API release. An important issue connected with the excipient used as a covering material of oil marbles has been identified. The seemingly insignificant water sorption caused agglomeration of the oil marbles and consequently compromised the dissolution rate in some of the stressed samples. Replacing HPMC with lactose as a covering material resulted in more favorable properties upon storage. Overall, it has been shown that oil marbles are an industrially applicable concept of the solidified lipid-based formulation.

Czech name

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Czech description

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Type

J_imp - Article in a specialist periodical, which is included in the Web of Science database

CEP classification

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OECD FORD branch

20401 - Chemical engineering (plants, products)

Project

<a href="/en/project/GX19-26127X" target="_blank" >GX19-26127X: The robotic nano-pharmacist: Next-generation manufacturing processes for personalised therapeutic agents</a><br>

Continuities

P - Projekt vyzkumu a vyvoje financovany z verejnych zdroju (s odkazem do CEP)

Publication year

2022

Confidentiality

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Name of the periodical

AAPS PharmSciTech

ISSN

1530-9932

e-ISSN

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Volume of the periodical

23

Issue of the periodical within the volume

7

Country of publishing house

CH - SWITZERLAND

Number of pages

15

Pages from-to

nestrankovano

UT code for WoS article

000865102700001

EID of the result in the Scopus database

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