In Vitro Testing of Ciprofloxacin Formulations and Preliminary Study on BCS Biowaiver
The purpose of this study was to compare the technical quality of ciprofloxacin tablets and examine the feasibility of biopharmaceutical classification system (BCS) biowaiver. Ciprofloxacin is a synthetic quinolone derivative anti-infective agent that has been classified as a Class 3 substance accor...
Saved in:
| Main Author: | |
|---|---|
| Other Authors: | , , , , , |
| Format: | article |
| Published: |
2009
|
| Online Access: | http://hdl.handle.net/10725/2688 https://doi.org/10.38212/2224-6614.2298 https://www.jfda-online.com/journal/vol17/iss2/10/ |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1864513459068076032 |
|---|---|
| author | Kyriacos, Soula Boustani |
| author2 | Boukarim, Chawki Safi, William Mroueh, Mohamad Maroun, Aline Bou El-Khoury, Ghada Shehayeb, Rabih |
| author2_role | author author author author author author |
| author_facet | Kyriacos, Soula Boustani Boukarim, Chawki Safi, William Mroueh, Mohamad Maroun, Aline Bou El-Khoury, Ghada Shehayeb, Rabih |
| author_role | author |
| dc.creator.none.fl_str_mv | Kyriacos, Soula Boustani Boukarim, Chawki Safi, William Mroueh, Mohamad Maroun, Aline Bou El-Khoury, Ghada Shehayeb, Rabih |
| dc.date.none.fl_str_mv | 2009 2015-11-25T10:49:57Z 2015-11-25T10:49:57Z 2015-11-25 |
| dc.identifier.none.fl_str_mv | 1021-9498 http://hdl.handle.net/10725/2688 https://doi.org/10.38212/2224-6614.2298 Kyriacos, S. B., Boukarim, C., Safi, W., Mroueh, M., Maroun, A. B., El-Khoury, G., & Shehayeb, R. (2009). In vitro testing of ciprofloxacin formulations and preliminary study on BCS biowaiver. Journal of food and drug analysis, 17(2). https://www.jfda-online.com/journal/vol17/iss2/10/ |
| dc.language.none.fl_str_mv | en |
| dc.relation.none.fl_str_mv | Journal of Food and Drug Analysis |
| dc.rights.*.fl_str_mv | info:eu-repo/semantics/openAccess |
| dc.title.none.fl_str_mv | In Vitro Testing of Ciprofloxacin Formulations and Preliminary Study on BCS Biowaiver |
| dc.type.none.fl_str_mv | Article info:eu-repo/semantics/publishedVersion info:eu-repo/semantics/article |
| description | The purpose of this study was to compare the technical quality of ciprofloxacin tablets and examine the feasibility of biopharmaceutical classification system (BCS) biowaiver. Ciprofloxacin is a synthetic quinolone derivative anti-infective agent that has been classified as a Class 3 substance according to the biopharmaceutics classification system. Due to the importance of ciprofloxacin as an antibiotic for widely resistant bacteria and the importance of price in a community basis, different ciprofloxacin products available on the market were analyzed. The possibility of extending biowaivers to ciprofloxacin was also examined. Waiver for Class 2 and Class 3 drugs is sometimes scientifically justified. Ciprofloxacin has properties that are intermediate between BCS Classes 2 and 3, as the drug is highly soluble below pH 6 and poorly soluble above this pH. Ten generic brands and the innovator brand were compared on friability, hardness, average weight, content uniformity, disintegration and dissolution. In vitro testing indicates significant variations among some brands in terms of hardness, disintegration and dissolution. Dissolution testing met pharmacopeial requirements for all brands. However, significant variations in dissolution profiles were observed in 0.1N HCl and in phosphate buffer (pH 6.8) with no difference detected in acetate buffer (pH 4.5). The results suggest that the formulation and/or the manufacturing process affect the dissolution and thus the bioavailability of the drug products. The significance of the observed in vitro differences must be confirmed by an in vivo bioequivalence study. |
| eu_rights_str_mv | openAccess |
| format | article |
| id | LAURepo_ba2ecb7aa66dad95f100267c0bb47f04 |
| identifier_str_mv | 1021-9498 Kyriacos, S. B., Boukarim, C., Safi, W., Mroueh, M., Maroun, A. B., El-Khoury, G., & Shehayeb, R. (2009). In vitro testing of ciprofloxacin formulations and preliminary study on BCS biowaiver. Journal of food and drug analysis, 17(2). |
| language_invalid_str_mv | en |
| network_acronym_str | LAURepo |
| network_name_str | Lebanese American University repository |
| oai_identifier_str | oai:laur.lau.edu.lb:10725/2688 |
| publishDate | 2009 |
| repository.mail.fl_str_mv | |
| repository.name.fl_str_mv | |
| repository_id_str | |
| spelling | In Vitro Testing of Ciprofloxacin Formulations and Preliminary Study on BCS BiowaiverKyriacos, Soula BoustaniBoukarim, ChawkiSafi, WilliamMroueh, MohamadMaroun, Aline BouEl-Khoury, GhadaShehayeb, RabihThe purpose of this study was to compare the technical quality of ciprofloxacin tablets and examine the feasibility of biopharmaceutical classification system (BCS) biowaiver. Ciprofloxacin is a synthetic quinolone derivative anti-infective agent that has been classified as a Class 3 substance according to the biopharmaceutics classification system. Due to the importance of ciprofloxacin as an antibiotic for widely resistant bacteria and the importance of price in a community basis, different ciprofloxacin products available on the market were analyzed. The possibility of extending biowaivers to ciprofloxacin was also examined. Waiver for Class 2 and Class 3 drugs is sometimes scientifically justified. Ciprofloxacin has properties that are intermediate between BCS Classes 2 and 3, as the drug is highly soluble below pH 6 and poorly soluble above this pH. Ten generic brands and the innovator brand were compared on friability, hardness, average weight, content uniformity, disintegration and dissolution. In vitro testing indicates significant variations among some brands in terms of hardness, disintegration and dissolution. Dissolution testing met pharmacopeial requirements for all brands. However, significant variations in dissolution profiles were observed in 0.1N HCl and in phosphate buffer (pH 6.8) with no difference detected in acetate buffer (pH 4.5). The results suggest that the formulation and/or the manufacturing process affect the dissolution and thus the bioavailability of the drug products. The significance of the observed in vitro differences must be confirmed by an in vivo bioequivalence study.PublishedN/A2015-11-25T10:49:57Z2015-11-25T10:49:57Z20092015-11-25Articleinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/article1021-9498http://hdl.handle.net/10725/2688https://doi.org/10.38212/2224-6614.2298Kyriacos, S. B., Boukarim, C., Safi, W., Mroueh, M., Maroun, A. B., El-Khoury, G., & Shehayeb, R. (2009). In vitro testing of ciprofloxacin formulations and preliminary study on BCS biowaiver. Journal of food and drug analysis, 17(2).https://www.jfda-online.com/journal/vol17/iss2/10/enJournal of Food and Drug Analysisinfo:eu-repo/semantics/openAccessoai:laur.lau.edu.lb:10725/26882024-01-31T15:22:35Z |
| spellingShingle | In Vitro Testing of Ciprofloxacin Formulations and Preliminary Study on BCS Biowaiver Kyriacos, Soula Boustani |
| status_str | publishedVersion |
| title | In Vitro Testing of Ciprofloxacin Formulations and Preliminary Study on BCS Biowaiver |
| title_full | In Vitro Testing of Ciprofloxacin Formulations and Preliminary Study on BCS Biowaiver |
| title_fullStr | In Vitro Testing of Ciprofloxacin Formulations and Preliminary Study on BCS Biowaiver |
| title_full_unstemmed | In Vitro Testing of Ciprofloxacin Formulations and Preliminary Study on BCS Biowaiver |
| title_short | In Vitro Testing of Ciprofloxacin Formulations and Preliminary Study on BCS Biowaiver |
| title_sort | In Vitro Testing of Ciprofloxacin Formulations and Preliminary Study on BCS Biowaiver |
| url | http://hdl.handle.net/10725/2688 https://doi.org/10.38212/2224-6614.2298 https://www.jfda-online.com/journal/vol17/iss2/10/ |