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Predictive potential of acido-basic properties, solubility and food on bioequivalence study outcome : analysis of 128 studies
ID
Krajcar, Dejan
(
Avtor
),
ID
Jereb, Rebeka
(
Avtor
),
ID
Legen, Igor
(
Avtor
),
ID
Opara, Jerneja
(
Avtor
),
ID
Grabnar, Iztok
(
Avtor
)
PDF - Predstavitvena datoteka,
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MD5: 5A085521EC11406EF4C6E8865F064967
URL - Izvorni URL, za dostop obiščite
https://link.springer.com/article/10.1007/s40268-023-00426-6
Galerija slik
Izvleček
Background and Objectives Risk assessment related to bioequivalence study outcome is critical for effective planning from the early stage of drug product development. The objective of this research was to evaluate the associations between solubility and acido-basic parameters of an active pharmaceutical ingredient (API), study conditions and bioequivalence outcome. Methods We retrospectively analyzed 128 bioequivalence studies of immediate-release products with 26 different APIs. Bioequivalence study conditions and acido-basic/solubility characteristics of APIs were collected and their predictive potential on the study outcome was assessed using a set of univariate statistical analyses. Results There was no difference in bioequivalence rate between fasting and fed conditions. The highest proportion of non-bioequivalent studies was for weak acids (10/19 cases, 53%) and neutral APIs (23/95 cases, 24%). Lower non-bioequivalence occurrence was observed for weak bases (1/15 cases, 7%) and amphoteric APIs (0/16 cases, 0%). The median dose numbers at pH 1.2 and pH 3 were higher and the most basic acid dissociation constant (pKa) was lower in the non-bioequivalent group of studies. Additionally, APIs with low calculated effective permeability (cPeff) or low calculated lipophilicity (clogP) had lower non-bioequivalence occurrence. Results of the subgroup analysis of studies under fasting conditions were similar as for the whole dataset. Conclusion Our results indicate that acido-basic properties of API should be considered in bioequivalence risk assessment and reveal which physico-chemical parameters are most relevant for the development of bioequivalence risk assessment tools for immediate-release products.
Jezik:
Angleški jezik
Ključne besede:
bioequivalence studies
,
active pharmaceutical ingredients
,
acido-basic characteristics
,
immediate-release products
,
solubility
Vrsta gradiva:
Članek v reviji
Tipologija:
1.01 - Izvirni znanstveni članek
Organizacija:
FFA - Fakulteta za farmacijo
Status publikacije:
Objavljeno
Različica publikacije:
Objavljena publikacija
Leto izida:
2023
Št. strani:
Str. 211-220
Številčenje:
Vol. 23, iss. 3
PID:
20.500.12556/RUL-152194
UDK:
544.351.3:615
ISSN pri članku:
1179-6901
DOI:
10.1007/s40268-023-00426-6
COBISS.SI-ID:
155412483
Datum objave v RUL:
10.11.2023
Število ogledov:
655
Število prenosov:
30
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Objavi na:
Gradivo je del revije
Naslov:
Drugs in R&D
Skrajšan naslov:
Drugs R&D
Založnik:
Springer Nature, Adis
ISSN:
1179-6901
COBISS.SI-ID:
520363801
Licence
Licenca:
CC BY-NC 4.0, Creative Commons Priznanje avtorstva-Nekomercialno 4.0 Mednarodna
Povezava:
http://creativecommons.org/licenses/by-nc/4.0/deed.sl
Opis:
Licenca Creative Commons, ki prepoveduje komercialno uporabo, vendar uporabniki ne rabijo upravljati materialnih avtorskih pravic na izpeljanih delih z enako licenco.
Sekundarni jezik
Jezik:
Slovenski jezik
Ključne besede:
bioekvivalenčne študije
,
aktivne sestavine učinkovin
,
acido-bazične lastnosti
,
sproščanje učinkovin
,
topnost
Projekti
Financer:
ARRS - Agencija za raziskovalno dejavnost Republike Slovenije
Številka projekta:
P1-0189
Naslov:
Farmacevtska tehnologija: od dostavnih sistemov učinkovin do terapijskih izidov zdravil pri otrocih in starostnikih
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