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A novel multi-unit tablet for treating circadian rhythm diseases.
AAPS PharmSciTech. 2013 Jun; 14(2):861-9.AP

Abstract

This study aimed to develop and evaluate a novel multi-unit tablet that combined a pellet with a sustained-release coating and a tablet with a pulsatile coating for the treatment of circadian rhythm diseases. The model drug, isosorbide-5-mononitrate, was sprayed on microcrystalline cellulose (MCC)-based pellets and coated with Eudragit(®) NE30D, which served as a sustained-release layer. The coated pellets were compressed with cushion agents (a mixture of MCC PH-200/ MCC KG-802/PC-10 at a ratio of 40:40:20) at a ratio of 4:6 using a single-punch tablet machine. An isolation layer of OpadryII, swellable layer of HPMC E5, and rupturable layer of Surelease(®) were applied using a conventional pan-coating process. Central-composite design-response surface methodology was used to investigate the influence of these coatings on the square of the difference between release times over a 4 h time period. Drug release studies were carried out on formulated pellets and tablets to investigate the release behaviors, and scanning electron microscopy (SEM) was used to monitor the pellets and tablets and their cross-sectional morphology. The experimental results indicated that this system had a pulsatile dissolution profile that included a lag period of 4 h and a sustained-release time of 4 h. Compared to currently marketed preparations, this tablet may provide better treatment options for circadian rhythm diseases.

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Authors+Show Affiliations

Liu Q
Pharmaceutical Research Institute, China Pharmaceutical University, No. 24 Tongjiaxiang, Nanjing 210009, China.
Gong Y
No affiliation info available
Shi Y
No affiliation info available
Jiang L
No affiliation info available
Zheng C
No affiliation info available
Ge L
No affiliation info available
Liu J
No affiliation info available
Zhu J
No affiliation info available

MeSH

Administration, OralAngina PectorisCardiovascular AgentsCelluloseChemistry, PharmaceuticalChronobiology DisordersDelayed-Action PreparationsDrug CarriersExcipientsHypromellose DerivativesIsosorbide DinitrateKineticsMethacrylatesMethylcelluloseMicroscopy, Electron, ScanningPolymersSolubilityTabletsTechnology, Pharmaceutical

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

23649996

Citation

Liu, Qi, et al. "A Novel Multi-unit Tablet for Treating Circadian Rhythm Diseases." AAPS PharmSciTech, vol. 14, no. 2, 2013, pp. 861-9.
Liu Q, Gong Y, Shi Y, et al. A novel multi-unit tablet for treating circadian rhythm diseases. AAPS PharmSciTech. 2013;14(2):861-9.
Liu, Q., Gong, Y., Shi, Y., Jiang, L., Zheng, C., Ge, L., Liu, J., & Zhu, J. (2013). A novel multi-unit tablet for treating circadian rhythm diseases. AAPS PharmSciTech, 14(2), 861-9. https://doi.org/10.1208/s12249-013-9975-8
Liu Q, et al. A Novel Multi-unit Tablet for Treating Circadian Rhythm Diseases. AAPS PharmSciTech. 2013;14(2):861-9. PubMed PMID: 23649996.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A novel multi-unit tablet for treating circadian rhythm diseases. AU - Liu,Qi, AU - Gong,Yinhua, AU - Shi,Yun, AU - Jiang,Liqun, AU - Zheng,Chunli, AU - Ge,Liang, AU - Liu,Jianping, AU - Zhu,Jiabi, Y1 - 2013/05/07/ PY - 2013/02/03/received PY - 2013/04/16/accepted PY - 2013/5/8/entrez PY - 2013/5/8/pubmed PY - 2013/10/18/medline SP - 861 EP - 9 JF - AAPS PharmSciTech JO - AAPS PharmSciTech VL - 14 IS - 2 N2 - This study aimed to develop and evaluate a novel multi-unit tablet that combined a pellet with a sustained-release coating and a tablet with a pulsatile coating for the treatment of circadian rhythm diseases. The model drug, isosorbide-5-mononitrate, was sprayed on microcrystalline cellulose (MCC)-based pellets and coated with Eudragit(®) NE30D, which served as a sustained-release layer. The coated pellets were compressed with cushion agents (a mixture of MCC PH-200/ MCC KG-802/PC-10 at a ratio of 40:40:20) at a ratio of 4:6 using a single-punch tablet machine. An isolation layer of OpadryII, swellable layer of HPMC E5, and rupturable layer of Surelease(®) were applied using a conventional pan-coating process. Central-composite design-response surface methodology was used to investigate the influence of these coatings on the square of the difference between release times over a 4 h time period. Drug release studies were carried out on formulated pellets and tablets to investigate the release behaviors, and scanning electron microscopy (SEM) was used to monitor the pellets and tablets and their cross-sectional morphology. The experimental results indicated that this system had a pulsatile dissolution profile that included a lag period of 4 h and a sustained-release time of 4 h. Compared to currently marketed preparations, this tablet may provide better treatment options for circadian rhythm diseases. SN - 1530-9932 UR - https://www.unboundmedicine.com/medline/citation/23649996/A_novel_multi_unit_tablet_for_treating_circadian_rhythm_diseases_ L2 - https://dx.doi.org/10.1208/s12249-013-9975-8 DB - PRIME DP - Unbound Medicine ER -