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

Kód výsledku v 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>

Výsledek na webu

<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>

Jazyk výsledku

angličtina

Název v původním jazyce

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

Popis výsledku v původním jazyce

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.

Název v anglickém jazyce

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

Popis výsledku anglicky

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.

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

—

OECD FORD obor

20401 - Chemical engineering (plants, products)

Projekt

<a href="/cs/project/GA16-12291S" target="_blank" >GA16-12291S: Hierarchický přístup ke studiu rovnováhy mezi pevnou a kapalnou fází v komplexních systémech: teorie, simulace a experiment</a><br>

Návaznosti

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

Rok uplatnění

2019

Kód důvěrnosti údajů

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

Název periodika

AAPS PharmSciTech

ISSN

1530-9932

e-ISSN

—

Svazek periodika

20

Číslo periodika v rámci svazku

1

Stát vydavatele periodika

CH - Švýcarská konfederace

Počet stran výsledku

10

Strana od-do

—

Kód UT WoS článku

000454993900001

EID výsledku v databázi Scopus

2-s2.0-85059460011