Manufacturing of Multi-drug Formulations with Customised Dose by Solvent Impregnation of Mesoporous Silica Tablets

Result code in IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F60461373%3A22340%2F19%3A43919131" target="_blank" >RIV/60461373:22340/19:43919131 - isvavai.cz</a>

Result on the web

<a href="https://link.springer.com/article/10.1208%2Fs12249-018-1224-8" target="_blank" >https://link.springer.com/article/10.1208%2Fs12249-018-1224-8</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1208/s12249-018-1224-8" target="_blank" >10.1208/s12249-018-1224-8</a>

Result language

angličtina

Original language name

Manufacturing of Multi-drug Formulations with Customised Dose by Solvent Impregnation of Mesoporous Silica Tablets

Original language description

The manufacture of personalised medicines where specific combinations of active pharmaceutical ingredients (APIs) and their dose within a tablet would be adjusted to the needs of individual patients, would require new manufacturing approaches compared to the established practice. In the case of low-dose formulations, the required precision of API content might not be achievable by traditional unit operations such as solid powder blending. The aim of the present work was to explore an alternative approach, based on the concept of pre-formulated placebo tablets containing mesoporous silica particles capable of absorbing APIs in the form of solutions, which can be precisely dosed at arbitrarily low quantities. The precision of the liquid dosing system has been validated; it was shown that the mechanical properties of the tablets were satisfactory even after multiple impregnation-drying cycles and that pharmacopoeia specifications on content uniformity could be met. Using model APIs, the spatial distribution of the API within the tablet after impregnation was investigated and shown to depend on the number and order of the impregnation-drying cycles. It was found that when an API was loaded to the tablet in a single step, a different dissolution profile was obtained compared to the same quantity dosed in multiple smaller steps. Overall, the approach of loading multiple API to a pre-formulated tablet at defined quantities using drop-on-demand liquid dosing was found to be feasible from the dose uniformity point of view. Further research should focus on potential API interactions and storage stability of tablets manufactured in this way.

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/GA16-12291S" target="_blank" >GA16-12291S: Hierarchical approach to the study of solid-fluid equilibria in complex system: theory, simulation and experiment</a><br>

Continuities

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

Publication year

2019

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

20

Issue of the periodical within the volume

1

Country of publishing house

CH - SWITZERLAND

Number of pages

10

Pages from-to

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UT code for WoS article

000454993900001

EID of the result in the Scopus database

2-s2.0-85059460011