Selection of appropriate manufacturing technology for development of Oxycodone prolonged release film-coated tablets using QbD approach-Reference-Cited by-同舟云学术

Selection of appropriate manufacturing technology for development of Oxycodone prolonged release film-coated tablets using QbD approach

Published:2022-12-31 Issue:03 Volume:68 Page:259-260
ISSN:1857-8969
Container-title:Macedonian Pharmaceutical Bulletin
language:en
Short-container-title:Maced. Pharm. Bull.

Author:

Memed Oja¹,Hadzieva-Gigovska Maja¹,Simonoska Crcarevska Maja²,Glavas Dodov Marija²

Affiliation:

1. Research & Development, Alkaloid AD Skopje, Blvd. Aleksandar Makedonski 12, 1000 Skopje, North Macedonia

2. Center for Pharmaceutical Nanotehnology, Faculty of Pharmacy, Ss. Cyril and Methodius University in Skopje, Majka Tereza 47, 1000 Skopje, Macedonia.

Publisher

Macedonian Pharmaceutical Association

Subject

General Medicine

Link

https://bulletin.mfd.org.mk/volumes/Volume%2068_3/68_3_124.pdf

Reference5 articles.

1. EMEA, 2010. Guideline on the investigation of bioequivalence.1-27. https://doi.org/CPMP/EWP/QWP/1401/9 8 .

2. Huang, Y., Khanvilkar, K., Moore, A., Hilliard-Lott, M., 2003. Effects of manufacturing process variables on in vitro dissolution characteristics of extended-release tablets formulated with hydroxypropyl methylcellulose. Drug Dev. Ind. Pharm. 29(1), 79-88. https://doi.org/10.1081/DDC-120016686.

3. ICH, 2009. Pharmaceutical Development Q8’, ICH Harmonised Tripartite Guideline 8(August), 1–28.

4. Singh, L. and Sharma, V., 2015. Quality by Design (QbD) approach in pharmaceuticals: Status, challenges and next steps. Drug Del. Lett.. 5(1), 2-8. Doi: 10.2174/2210303104666141112220253.

5. Thapa, P., Choi, D., Kim, M., Jeong, S., 2019. Effects of granulation process variables on the physical properties of dosage forms by combination of experimental design and principal component analysis. AJPS 14(3), 287-304. https://doi.org/10.1016/j.ajps.2018.08.006.