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Analytical techniques for structural characterization of proteins in solid pharmaceutical forms : an overview
ID
Bolje, Aljoša
(
Avtor
),
ID
Gobec, Stanislav
(
Avtor
)
PDF - Predstavitvena datoteka,
prenos
(7,49 MB)
MD5: 26776B880FA432A1852D2C5B88BD3310
URL - Izvorni URL, za dostop obiščite
https://www.mdpi.com/1999-4923/13/4/534
Galerija slik
Izvleček
Therapeutic proteins as biopharmaceuticals have emerged as a very important class of drugs for the treatment of many diseases. However, they are less stable compared to conventional pharmaceuticals. Their long-term stability in solid forms, which is critical for product performance, depends heavily on the retention of the native protein structure during the lyophilization (freeze-drying) process and, thereafter, in the solid state. Indeed, the biological function of proteins is directly related to the tertiary and secondary structure. Besides physical stability and biological activity, conformational stability (three-dimensional structure) is another important aspect when dealing with protein pharmaceuticals. Moreover, denaturation as loss of higher order structure is often a precursor to aggregation or chemical instability. Careful study of the physical and chemical properties of proteins in the dried state is therefore critical during biopharmaceutical drug development to deliver a final drug product with built-in quality that is safe, high-quality, efficient, and affordable for patients. This review provides an overview of common analytical techniques suitable for characterizing pharmaceutical protein powders, providing structural, and conformational information, as well as insights into dynamics. Such information can be very useful in formulation development, where selecting the best formulation for the drug can be quite a challenge.
Jezik:
Angleški jezik
Ključne besede:
solid pharmaceuticals
,
lyophilization
,
analytical tools
,
protein characterization
,
protein structure
,
formulation development
,
antibody
,
excipients
,
stable drug product
,
safe drug
Vrsta gradiva:
Članek v reviji
Tipologija:
1.02 - Pregledni znanstveni članek
Organizacija:
FFA - Fakulteta za farmacijo
Status publikacije:
Objavljeno
Različica publikacije:
Objavljena publikacija
Leto izida:
2021
Št. strani:
32 str.
Številčenje:
Vol. 13, iss. 4, art. 534
PID:
20.500.12556/RUL-135221
UDK:
66.047.3:615.45
ISSN pri članku:
1999-4923
DOI:
10.3390/pharmaceutics13040534
COBISS.SI-ID:
60765443
Datum objave v RUL:
01.03.2022
Število ogledov:
654
Število prenosov:
105
Metapodatki:
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Objavi na:
Gradivo je del revije
Naslov:
Pharmaceutics
Skrajšan naslov:
Pharmaceutics
Založnik:
MDPI
ISSN:
1999-4923
COBISS.SI-ID:
517949977
Licence
Licenca:
CC BY 4.0, Creative Commons Priznanje avtorstva 4.0 Mednarodna
Povezava:
http://creativecommons.org/licenses/by/4.0/deed.sl
Opis:
To je standardna licenca Creative Commons, ki daje uporabnikom največ možnosti za nadaljnjo uporabo dela, pri čemer morajo navesti avtorja.
Začetek licenciranja:
11.04.2021
Sekundarni jezik
Jezik:
Slovenski jezik
Ključne besede:
sušenje z zamrzovanjem
,
zgradba proteinov
,
stabilnost zdravil
,
pomožne snovi
,
terapevtske beljakovine
,
protitelesa
,
farmacevtske oblike
Projekti
Financer:
Drugi - Drug financer ali več financerjev
Program financ.:
Republic of Slovenia, Ministry of Education, Science, and Sport
Številka projekta:
5442-1/2018/405
Financer:
ARRS - Agencija za raziskovalno dejavnost Republike Slovenije
Številka projekta:
P1-0208
Naslov:
Farmacevtska kemija: načrtovanje, sinteza in vrednotenje učinkovin
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