Development and Comparison of Various Coated Hard Capsules
Suitable for Enteric Administration to Small Patient Cohorts

J 2022

Development and Comparison of Various Coated Hard Capsules Suitable for Enteric Administration to Small Patient Cohorts

FÜLÖPOVÁ, Nicole, Sylvie PAVLOKOVÁ, DeBono IVAN, David VETCHÝ, Aleš FRANC et. al.

Základní údaje

Originální název

Development and Comparison of Various Coated Hard Capsules Suitable for Enteric Administration to Small Patient Cohorts

Autoři

FÜLÖPOVÁ, Nicole (703 Slovensko, domácí), Sylvie PAVLOKOVÁ (203 Česká republika, domácí), DeBono IVAN, David VETCHÝ (203 Česká republika, domácí) a Aleš FRANC (203 Česká republika, garant, domácí)

Vydání

Pharmaceutics, Basel, MDPI, 2022, 1999-4923

Další údaje

Jazyk

angličtina

Typ výsledku

Článek v odborném periodiku

Obor

30104 Pharmacology and pharmacy

Stát vydavatele

Švýcarsko

Utajení

není předmětem státního či obchodního tajemství

Odkazy

URL

Impakt faktor

Impact factor: 5.400

Kód RIV

RIV/00216224:14160/22:00126355

Organizační jednotka

Farmaceutická fakulta

DOI

http://dx.doi.org/10.3390/pharmaceutics14081577

UT WoS

000846546700001

Klíčová slova anglicky

DRcapsTM capsules; hard gelatin capsules; Eudragit® S; enteric coating; immersion method; principal component analysis

Štítky

rivok, ÚFT

Příznaky

Mezinárodní význam

Změněno: 31. 10. 2022 11:19, JUDr. Sabina Krejčiříková

Anotace

V originále

Pharmaceutical technology offers several options for protecting substances from acidic environments, such as encapsulation in enteric capsules or dosage form with enteric coating. However, commercial enteric capsules do not always meet limits for pharmacopeial delayed release, and the coating process is generally challenging. Preparing small enteric batches suitable for clinical use is, therefore, an unsolved problem. This experiment offers a simple coating process of DRcapsTM capsules based on hypromellose (HPMC) and gellan gum to achieve small intestine administration. In addition, DRcapsTM capsules were compared to hard gelatin capsules to evaluate the suitability of the coating method. Both capsules were immersed in dispersions of Eudragit® S 100, Acryl-EZE®, and Cellacefate at concentrations of 10.0, 15.0, and 20.0% and dried. Coated capsules were evaluated by electron microscopy, disintegration, and dissolution test with a two-step pH change (from 1.2 to 6.8, then to 7.5) to simulate passage through the digestive tract. DRcapsTM capsules coated with Eudragit® S and Cellacefate achieved acid resistance. While samples coated with Eudragit® S released their contents within 360 min at pH 6.8 (small intestine), regardless of polymer concentration, capsules with 15.0 and 20.0% coatings of Cellacefate released content at pH 7.5 (colon) within 435 and 495 min, respectively.

Návaznosti

MUNI/A/1574/2020, interní kód MU

Název: Pokročilé technologie pro přípravu a hodnocení částicových systémů

Investor: Masarykova univerzita, Pokročilé technologie pro přípravu a hodnocení částicových systémů

Citovat

FÜLÖPOVÁ, Nicole, Sylvie PAVLOKOVÁ, DeBono IVAN, David VETCHÝ a Aleš FRANC. Development and Comparison of Various Coated Hard Capsules Suitable for Enteric Administration to Small Patient Cohorts. Pharmaceutics. Basel: MDPI, 2022, roč. 14, č. 8, s. 1-19. ISSN 1999-4923. Dostupné z: https://dx.doi.org/10.3390/pharmaceutics14081577.

@article{1883419,
   author = {Fülöpová, Nicole and Pavloková, Sylvie and Ivan, DeBono and Vetchý, David and Franc, Aleš},
   article_location = {Basel},
   article_number = {8},
   doi = {http://dx.doi.org/10.3390/pharmaceutics14081577},
   keywords = {DRcapsTM capsules; hard gelatin capsules; Eudragit® S; enteric coating; immersion method; principal component analysis},
   language = {eng},
   issn = {1999-4923},
   journal = {Pharmaceutics},
   title = {Development and Comparison of Various Coated Hard Capsules Suitable for Enteric Administration to Small Patient Cohorts},
   url = {https://www.mdpi.com/1999-4923/14/8/1577/htm},
   volume = {14},
   year = {2022}
}

TY  - JOUR
ID  - 1883419
AU  - Fülöpová, Nicole - Pavloková, Sylvie - Ivan, DeBono - Vetchý, David - Franc, Aleš
PY  - 2022
TI  - Development and Comparison of Various Coated Hard Capsules Suitable for Enteric Administration to Small Patient Cohorts
JF  - Pharmaceutics
VL  - 14
IS  - 8
SP  - 1-19
EP  - 1-19
PB  - MDPI
SN  - 19994923
KW  - DRcapsTM capsules
KW  - hard gelatin capsules
KW  - Eudragit® S
KW  - enteric coating
KW  - immersion method
KW  - principal component analysis
UR  - https://www.mdpi.com/1999-4923/14/8/1577/htm
N2  - Pharmaceutical technology offers several options for protecting substances from acidic environments, such as encapsulation in enteric capsules or dosage form with enteric coating. However, commercial enteric capsules do not always meet limits for pharmacopeial delayed release, and the coating process is generally challenging. Preparing small enteric batches suitable for clinical use is, therefore, an unsolved problem. This experiment offers a simple coating process of DRcapsTM capsules based on hypromellose (HPMC) and gellan gum to achieve small intestine administration. In addition, DRcapsTM capsules were compared to hard gelatin capsules to evaluate the suitability of the coating method. Both capsules were immersed in dispersions of Eudragit® S 100, Acryl-EZE®, and Cellacefate at concentrations of 10.0, 15.0, and 20.0% and dried. Coated capsules were evaluated by electron microscopy, disintegration, and dissolution test with a two-step pH change (from 1.2 to 6.8, then to 7.5) to simulate passage through the digestive tract. DRcapsTM capsules coated with Eudragit® S and Cellacefate achieved acid resistance. While samples coated with Eudragit® S released their contents within 360 min at pH 6.8 (small intestine), regardless of polymer concentration, capsules with 15.0 and 20.0% coatings of Cellacefate released content at pH 7.5 (colon) within 435 and 495 min, respectively.
ER  -

FÜLÖPOVÁ, Nicole, Sylvie PAVLOKOVÁ, DeBono IVAN, David VETCHÝ a Aleš FRANC. Development and Comparison of Various Coated Hard Capsules Suitable for Enteric Administration to Small Patient Cohorts. \textit{Pharmaceutics}. Basel: MDPI, 2022, roč.~14, č.~8, s.~1-19. ISSN~1999-4923. Dostupné z: https://dx.doi.org/10.3390/pharmaceutics14081577.

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