Establishment of a BioequivalenceIndicating Dissolution Specification for Candesartan Cilexetil Tablets Using a Convolution Model Article Swipe
Hassan Ali Hassan
,
Naseem A. Charoo
,
Areeg Anwer Ali
,
Sumaiya Ser Alkhatem
·
YOU?
·
· 2015
· Open Access
·
· DOI: https://doi.org/10.14227/dt220115p36
YOU?
·
· 2015
· Open Access
·
· DOI: https://doi.org/10.14227/dt220115p36
The aim of the present work was to establish a bioequivalence-indicating dissolution specification for candesartan cilexetil tablets.The discriminating power of the selected medium (0.25% Polysorbate 20 in pH 6.5 phosphate buffer) was assessed relative to that of 0.35% Polysorbate 20 in pH 6.5 phosphate buffer, a medium recommended by the U.S. FDA.Plasma concentration-time profiles of candesartan cilexetil tablets were derived from in vitro dissolution data by a convolution model.In solubility studies, 0.25% Polysorbate 20 in pH 6.5 phosphate buffer provided sink conditions for candesartan cilexetil 16-mg tablets.The method was more sensitive to the concentration of Polysorbate 20 than to paddle rotation speed and was able to distinguish depressed dissolution of mismanufactured tablets in samples taken at 20-and 30-min intervals.Verification of the model performed on innovator samples revealed the closeness of the predicted C max and AUC 0-α values to the reported values.A two-point dissolution specification is proposed for post-approval changes, and a one-point dissolution specification for quality control release of production batches.
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Metadata
- Type
- article
- Language
- en
- Landing Page
- https://doi.org/10.14227/dt220115p36
- https://doi.org/10.14227/dt220115p36
- OA Status
- bronze
- Cited By
- 17
- References
- 25
- Related Works
- 10
- OpenAlex ID
- https://openalex.org/W2322099677
All OpenAlex metadata
Raw OpenAlex JSON
- OpenAlex ID
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https://openalex.org/W2322099677Canonical identifier for this work in OpenAlex
- DOI
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https://doi.org/10.14227/dt220115p36Digital Object Identifier
- Title
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Establishment of a BioequivalenceIndicating Dissolution Specification for Candesartan Cilexetil Tablets Using a Convolution ModelWork title
- Type
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articleOpenAlex work type
- Language
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enPrimary language
- Publication year
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2015Year of publication
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2015-01-01Full publication date if available
- Authors
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Hassan Ali Hassan, Naseem A. Charoo, Areeg Anwer Ali, Sumaiya Ser AlkhatemList of authors in order
- Landing page
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https://doi.org/10.14227/dt220115p36Publisher landing page
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https://doi.org/10.14227/dt220115p36Direct link to full text PDF
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YesWhether a free full text is available
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bronzeOpen access status per OpenAlex
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https://doi.org/10.14227/dt220115p36Direct OA link when available
- Concepts
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Candesartan, Dissolution, Pharmacology, Convolution (computer science), Chemistry, Computer science, Medicine, Angiotensin II, Physical chemistry, Biochemistry, Receptor, Machine learning, Artificial neural networkTop concepts (fields/topics) attached by OpenAlex
- Cited by
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17Total citation count in OpenAlex
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2025: 3, 2024: 4, 2022: 3, 2021: 1, 2020: 1Per-year citation counts (last 5 years)
- References (count)
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25Number of works referenced by this work
- Related works (count)
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10Other works algorithmically related by OpenAlex
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| abstract_inverted_index.changes, | 149 |
| abstract_inverted_index.model.In | 68 |
| abstract_inverted_index.profiles | 53 |
| abstract_inverted_index.proposed | 146 |
| abstract_inverted_index.provided | 79 |
| abstract_inverted_index.relative | 33 |
| abstract_inverted_index.reported | 140 |
| abstract_inverted_index.revealed | 126 |
| abstract_inverted_index.rotation | 100 |
| abstract_inverted_index.selected | 21 |
| abstract_inverted_index.studies, | 70 |
| abstract_inverted_index.values.A | 141 |
| abstract_inverted_index.cilexetil | 15, 56, 84 |
| abstract_inverted_index.closeness | 128 |
| abstract_inverted_index.depressed | 107 |
| abstract_inverted_index.establish | 8 |
| abstract_inverted_index.innovator | 124 |
| abstract_inverted_index.one-point | 152 |
| abstract_inverted_index.performed | 122 |
| abstract_inverted_index.phosphate | 29, 43, 77 |
| abstract_inverted_index.predicted | 131 |
| abstract_inverted_index.sensitive | 90 |
| abstract_inverted_index.two-point | 142 |
| abstract_inverted_index.FDA.Plasma | 51 |
| abstract_inverted_index.conditions | 81 |
| abstract_inverted_index.production | 160 |
| abstract_inverted_index.solubility | 69 |
| abstract_inverted_index.Polysorbate | 24, 38, 72, 95 |
| abstract_inverted_index.candesartan | 14, 55, 83 |
| abstract_inverted_index.convolution | 67 |
| abstract_inverted_index.dissolution | 11, 63, 108, 143, 153 |
| abstract_inverted_index.distinguish | 106 |
| abstract_inverted_index.recommended | 47 |
| abstract_inverted_index.tablets.The | 16, 86 |
| abstract_inverted_index.concentration | 93 |
| abstract_inverted_index.post-approval | 148 |
| abstract_inverted_index.specification | 12, 144, 154 |
| abstract_inverted_index.discriminating | 17 |
| abstract_inverted_index.mismanufactured | 110 |
| abstract_inverted_index.concentration-time | 52 |
| abstract_inverted_index.intervals.Verification | 118 |
| abstract_inverted_index.bioequivalence-indicating | 10 |
| cited_by_percentile_year.max | 98 |
| cited_by_percentile_year.min | 89 |
| corresponding_author_ids | https://openalex.org/A5028319878 |
| countries_distinct_count | 2 |
| institutions_distinct_count | 4 |
| sustainable_development_goals[0].id | https://metadata.un.org/sdg/10 |
| sustainable_development_goals[0].score | 0.6299999952316284 |
| sustainable_development_goals[0].display_name | Reduced inequalities |
| citation_normalized_percentile.value | 0.65808824 |
| citation_normalized_percentile.is_in_top_1_percent | False |
| citation_normalized_percentile.is_in_top_10_percent | False |