A comparative single-dose bioequivalence study of two enteric coated Aspirin brands among healthy volunteers. (c2001)
(Aspicot®) is an enteric coated aspirin that is being extensively used among patients in the Middle East, including Lebanon where this drug is manufactured, without any clinical in-vivo implication showing or confirming its bioequivalence. Therefore, this investigation was carried out LO evaluate th...
محفوظ في:
| المؤلف الرئيسي: | |
|---|---|
| التنسيق: | masterThesis |
| منشور في: |
2001
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| الموضوعات: | |
| الوصول للمادة أونلاين: | http://hdl.handle.net/10725/461 https://doi.org/10.26756/th.2001.3 |
| الوسوم: |
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| _version_ | 1864513453868187648 |
|---|---|
| author | Zeitoun, Abeer Abbas |
| author_facet | Zeitoun, Abeer Abbas |
| author_role | author |
| dc.creator.none.fl_str_mv | Zeitoun, Abeer Abbas |
| dc.date.none.fl_str_mv | 2001 2001-06-17 2011-05-13T09:15:12Z 2011-05-13T09:15:12Z 2011-05-13 |
| dc.identifier.none.fl_str_mv | http://hdl.handle.net/10725/461 https://doi.org/10.26756/th.2001.3 |
| dc.language.none.fl_str_mv | en |
| dc.rights.*.fl_str_mv | info:eu-repo/semantics/openAccess |
| dc.subject.none.fl_str_mv | Aspirin Aspirin -- Drug effects |
| dc.title.none.fl_str_mv | A comparative single-dose bioequivalence study of two enteric coated Aspirin brands among healthy volunteers. (c2001) |
| dc.type.none.fl_str_mv | Thesis info:eu-repo/semantics/publishedVersion info:eu-repo/semantics/masterThesis |
| description | (Aspicot®) is an enteric coated aspirin that is being extensively used among patients in the Middle East, including Lebanon where this drug is manufactured, without any clinical in-vivo implication showing or confirming its bioequivalence. Therefore, this investigation was carried out LO evaluate the in-vitro dissolution as well as the bioavailability and pharmacokinetic properties of two tablet oral dosage forms of enteric coated aspirin, Aspirin Protect® (Bayer©, Germany) and Aspicot® (Pharmaline©, Lebanon) in a single dose of 200 mg among healthy volunteers. Method: Twelve healthy volunteers (seven males, five females), were enrolled in the study. Each volunteer received a single dose of each drug in an open randomized two-way crossover study, with a washout period of seven days. Blood samples were obtained at different time intervals over a period of 12 hours. These samples were then analyzed for serum acetylsalicylic acid and salicylic acid levels, using a sensitive HPLC assay. Results: The two products were found to comply with the compendial requirements for both disintegration and content uniformity; and their in -vitro dissolution characteristics were similar. Moreover, there was no statistically significant difference with respect to peak serum concentration (The Cmax values for Aspicot® (23,66 ± 16,26 ~g / mL) and Aspirin Protect® (21.73 ± 11.33 ug / mL) or to corresponding peaks time (the Tmax values ( 4,92 ± 2.35 hours and 4,58 ± 1,5 1 hours for Aspicot® and Aspirin Protect® respectively), Furthermore, the difference between area under the serum concentration time curve for the two products (the AUC for Aspicot® (66,20 ± 42,90 ug / mL) and Aspirin Protect® (64,79 ± 38,02 ug / mL) was not statistically significant, with P > 0,05. Conclusion: The findings in this study indicate that the two products are bioequivalent in terms of bioavailability and pharmacokinetic properties on healthy volunteers. |
| eu_rights_str_mv | openAccess |
| format | masterThesis |
| id | LAURepo_0bbf7e4cbff29d5dc8c4d14259826e3e |
| language_invalid_str_mv | en |
| network_acronym_str | LAURepo |
| network_name_str | Lebanese American University repository |
| oai_identifier_str | oai:laur.lau.edu.lb:10725/461 |
| publishDate | 2001 |
| repository.mail.fl_str_mv | |
| repository.name.fl_str_mv | |
| repository_id_str | |
| spelling | A comparative single-dose bioequivalence study of two enteric coated Aspirin brands among healthy volunteers. (c2001)Zeitoun, Abeer AbbasAspirinAspirin -- Drug effects(Aspicot®) is an enteric coated aspirin that is being extensively used among patients in the Middle East, including Lebanon where this drug is manufactured, without any clinical in-vivo implication showing or confirming its bioequivalence. Therefore, this investigation was carried out LO evaluate the in-vitro dissolution as well as the bioavailability and pharmacokinetic properties of two tablet oral dosage forms of enteric coated aspirin, Aspirin Protect® (Bayer©, Germany) and Aspicot® (Pharmaline©, Lebanon) in a single dose of 200 mg among healthy volunteers. Method: Twelve healthy volunteers (seven males, five females), were enrolled in the study. Each volunteer received a single dose of each drug in an open randomized two-way crossover study, with a washout period of seven days. Blood samples were obtained at different time intervals over a period of 12 hours. These samples were then analyzed for serum acetylsalicylic acid and salicylic acid levels, using a sensitive HPLC assay. Results: The two products were found to comply with the compendial requirements for both disintegration and content uniformity; and their in -vitro dissolution characteristics were similar. Moreover, there was no statistically significant difference with respect to peak serum concentration (The Cmax values for Aspicot® (23,66 ± 16,26 ~g / mL) and Aspirin Protect® (21.73 ± 11.33 ug / mL) or to corresponding peaks time (the Tmax values ( 4,92 ± 2.35 hours and 4,58 ± 1,5 1 hours for Aspicot® and Aspirin Protect® respectively), Furthermore, the difference between area under the serum concentration time curve for the two products (the AUC for Aspicot® (66,20 ± 42,90 ug / mL) and Aspirin Protect® (64,79 ± 38,02 ug / mL) was not statistically significant, with P > 0,05. Conclusion: The findings in this study indicate that the two products are bioequivalent in terms of bioavailability and pharmacokinetic properties on healthy volunteers.1 bound copy: 70 leaves available at RNL.2011-05-13T09:15:12Z2011-05-13T09:15:12Z20012011-05-132001-06-17Thesisinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/masterThesishttp://hdl.handle.net/10725/461https://doi.org/10.26756/th.2001.3eninfo:eu-repo/semantics/openAccessoai:laur.lau.edu.lb:10725/4612017-09-25T07:06:55Z |
| spellingShingle | A comparative single-dose bioequivalence study of two enteric coated Aspirin brands among healthy volunteers. (c2001) Zeitoun, Abeer Abbas Aspirin Aspirin -- Drug effects |
| status_str | publishedVersion |
| title | A comparative single-dose bioequivalence study of two enteric coated Aspirin brands among healthy volunteers. (c2001) |
| title_full | A comparative single-dose bioequivalence study of two enteric coated Aspirin brands among healthy volunteers. (c2001) |
| title_fullStr | A comparative single-dose bioequivalence study of two enteric coated Aspirin brands among healthy volunteers. (c2001) |
| title_full_unstemmed | A comparative single-dose bioequivalence study of two enteric coated Aspirin brands among healthy volunteers. (c2001) |
| title_short | A comparative single-dose bioequivalence study of two enteric coated Aspirin brands among healthy volunteers. (c2001) |
| title_sort | A comparative single-dose bioequivalence study of two enteric coated Aspirin brands among healthy volunteers. (c2001) |
| topic | Aspirin Aspirin -- Drug effects |
| url | http://hdl.handle.net/10725/461 https://doi.org/10.26756/th.2001.3 |