Stability study of Fluconazole capsules with Bracketing Design
International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines provide guidance for stability monitoring of medicines which Food and Drug Administration (FDA) and European Medicines Agency (EMA) refer to. A full stability study design is descri...
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| Format: | Article |
| Language: | English |
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University Ss Cyril and Methodius in Skopje, Faculty of Pharmacy and Macedonian Pharmaceutical Association
2024-12-01
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| Series: | Makedonsko Farmacevtski Bilten |
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| Online Access: | https://bulletin.mfd.org.mk/volumes/Volume%2069_1/69_1_007.pdf |
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| author | Aleksandra Chakarjanevska¹ Marika Bogoevska Nikolovska Mirsada Dervisevic Andonova Irena Slaveska Spirevska Marija Karapandzova Suzana Trajkovic Jolevska Jasmina Tonic Ribarska |
| author_facet | Aleksandra Chakarjanevska¹ Marika Bogoevska Nikolovska Mirsada Dervisevic Andonova Irena Slaveska Spirevska Marija Karapandzova Suzana Trajkovic Jolevska Jasmina Tonic Ribarska |
| author_sort | Aleksandra Chakarjanevska¹ |
| collection | DOAJ |
| description | International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines provide
guidance for stability monitoring of medicines which Food and Drug Administration (FDA) and European Medicines Agency (EMA) refer
to. A full stability study design is described as a model in which samples under the influence of appropriate factors are tested at all-time
points. Bracketing and matrixing stability study designs represent reduced designs that may be a suitable alternative to a full stability design.
Bracketing design refers to the stability such that only samples on the extremes of certain design are tested at all-time points as in a full
design, whereas the stability of the intermediate levels is represented by the stability of the tested extremes, which reduces costs and time
analysis. The design assumes that the stability of any intermediate levels is represented by the stability of the extremes tested.
Bracketing design of four different dosage strengths of Fluconazole hard capsules is included in this research. The extreme strengths
were chosen and parameters average mass of capsule contents, disintegration, dissolution, assay of active and related substances, according
to shelf-life specification were tested in accelerated and long-term stability conditions. Based on the obtained results, the stability of any
intermediate levels is confirmed by the stability of the tested extremes and show that this reduced design is suitable.
|
| format | Article |
| id | doaj-art-a477d97546c6442a8645b8372c998164 |
| institution | Kabale University |
| issn | 1857-8969 |
| language | English |
| publishDate | 2024-12-01 |
| publisher | University Ss Cyril and Methodius in Skopje, Faculty of Pharmacy and Macedonian Pharmaceutical Association |
| record_format | Article |
| series | Makedonsko Farmacevtski Bilten |
| spelling | doaj-art-a477d97546c6442a8645b8372c9981642025-01-11T12:15:35ZengUniversity Ss Cyril and Methodius in Skopje, Faculty of Pharmacy and Macedonian Pharmaceutical AssociationMakedonsko Farmacevtski Bilten1857-89692024-12-01691778610.33320/maced.pharm.bull.2023.69.01.007Stability study of Fluconazole capsules with Bracketing DesignAleksandra Chakarjanevska¹0Marika Bogoevska Nikolovska1Mirsada Dervisevic Andonova2Irena Slaveska Spirevska3Marija Karapandzova4Suzana Trajkovic Jolevska5Jasmina Tonic Ribarska6Replek Farm Ltd., Quality Control Department, Kozle 188, 1000 Skopje, Republic of North MacedoniaReplek Farm Ltd., Quality Control Department, Kozle 188, 1000 Skopje, Republic of North MacedoniaReplek Farm Ltd., Quality Control Department, Kozle 188, 1000 Skopje, Republic of North MacedoniaReplek Farm Ltd., Quality Control Department, Kozle 188, 1000 Skopje, Republic of North MacedoniaSs. Cyril and Methodius University in Skopje, Faculty of Pharmacy, Institute of Pharmacognosy, Mother Theresa 47, 1000 Skopje, Republic of North MacedoniaSs. Cyril and Methodius University in Skopje, Faculty of Pharmacy, Institute of Applied Chemistry and Pharmaceutical Analysis, Mother Theresa 47, 1000 Skopje, Republic of North MacedoniaSs. Cyril and Methodius University in Skopje, Faculty of Pharmacy, Institute of Applied Chemistry and Pharmaceutical Analysis, Mother Theresa 47, 1000 Skopje, Republic of North MacedoniaInternational Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines provide guidance for stability monitoring of medicines which Food and Drug Administration (FDA) and European Medicines Agency (EMA) refer to. A full stability study design is described as a model in which samples under the influence of appropriate factors are tested at all-time points. Bracketing and matrixing stability study designs represent reduced designs that may be a suitable alternative to a full stability design. Bracketing design refers to the stability such that only samples on the extremes of certain design are tested at all-time points as in a full design, whereas the stability of the intermediate levels is represented by the stability of the tested extremes, which reduces costs and time analysis. The design assumes that the stability of any intermediate levels is represented by the stability of the extremes tested. Bracketing design of four different dosage strengths of Fluconazole hard capsules is included in this research. The extreme strengths were chosen and parameters average mass of capsule contents, disintegration, dissolution, assay of active and related substances, according to shelf-life specification were tested in accelerated and long-term stability conditions. Based on the obtained results, the stability of any intermediate levels is confirmed by the stability of the tested extremes and show that this reduced design is suitable. https://bulletin.mfd.org.mk/volumes/Volume%2069_1/69_1_007.pdfstability studybracketing designquality control methodscapsulesfluconazole |
| spellingShingle | Aleksandra Chakarjanevska¹ Marika Bogoevska Nikolovska Mirsada Dervisevic Andonova Irena Slaveska Spirevska Marija Karapandzova Suzana Trajkovic Jolevska Jasmina Tonic Ribarska Stability study of Fluconazole capsules with Bracketing Design Makedonsko Farmacevtski Bilten stability study bracketing design quality control methods capsules fluconazole |
| title | Stability study of Fluconazole capsules with Bracketing Design |
| title_full | Stability study of Fluconazole capsules with Bracketing Design |
| title_fullStr | Stability study of Fluconazole capsules with Bracketing Design |
| title_full_unstemmed | Stability study of Fluconazole capsules with Bracketing Design |
| title_short | Stability study of Fluconazole capsules with Bracketing Design |
| title_sort | stability study of fluconazole capsules with bracketing design |
| topic | stability study bracketing design quality control methods capsules fluconazole |
| url | https://bulletin.mfd.org.mk/volumes/Volume%2069_1/69_1_007.pdf |
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