Comparison between the dissolution profiles of prolonged-release ciprofloxacin tablets available in the Colombian market
Two 1,000 mg prolonged-release ciprofloxacin (CIP) tablets marketed in Colombia were compared for quality control tests and dissolution profile as established in the United States Pharmacopeia 42-NF 37 and the Food and Drug Administration guidance on dissolution testing. The dissolution profiles in...
- Autores:
-
De la Cruz Gómez, Andrés Vicente
- Tipo de recurso:
- Fecha de publicación:
- 2020
- Institución:
- Universidad del Atlántico
- Repositorio:
- Repositorio Uniatlantico
- Idioma:
- eng
- OAI Identifier:
- oai:repositorio.uniatlantico.edu.co:20.500.12834/874
- Acceso en línea:
- https://hdl.handle.net/20.500.12834/874
https://www.scopus.com/record/display.uri?eid=2-s2.0-85125908811&doi=10.7324%2fJAPS.2022.120322&origin=inward&txGid=a7dda39c1201a04b7536b78e6ca0b4d6
- Palabra clave:
- Ciprofloxacin
pharmaceutical equivalence
dissolution profiles
prolonged-release tablets
- Rights
- openAccess
- License
- http://creativecommons.org/licenses/by-nc/4.0/
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dc.title.spa.fl_str_mv |
Comparison between the dissolution profiles of prolonged-release ciprofloxacin tablets available in the Colombian market |
title |
Comparison between the dissolution profiles of prolonged-release ciprofloxacin tablets available in the Colombian market |
spellingShingle |
Comparison between the dissolution profiles of prolonged-release ciprofloxacin tablets available in the Colombian market Ciprofloxacin pharmaceutical equivalence dissolution profiles prolonged-release tablets |
title_short |
Comparison between the dissolution profiles of prolonged-release ciprofloxacin tablets available in the Colombian market |
title_full |
Comparison between the dissolution profiles of prolonged-release ciprofloxacin tablets available in the Colombian market |
title_fullStr |
Comparison between the dissolution profiles of prolonged-release ciprofloxacin tablets available in the Colombian market |
title_full_unstemmed |
Comparison between the dissolution profiles of prolonged-release ciprofloxacin tablets available in the Colombian market |
title_sort |
Comparison between the dissolution profiles of prolonged-release ciprofloxacin tablets available in the Colombian market |
dc.creator.fl_str_mv |
De la Cruz Gómez, Andrés Vicente |
dc.contributor.author.none.fl_str_mv |
De la Cruz Gómez, Andrés Vicente |
dc.contributor.other.none.fl_str_mv |
Ramos Iglesias, Raynni Marcela Ruiz Afanador, Tatiana Sugey Pájaro Bolívar, Indira Beatriz Domínguez Moré, Gina Paola |
dc.subject.keywords.spa.fl_str_mv |
Ciprofloxacin pharmaceutical equivalence dissolution profiles prolonged-release tablets |
topic |
Ciprofloxacin pharmaceutical equivalence dissolution profiles prolonged-release tablets |
description |
Two 1,000 mg prolonged-release ciprofloxacin (CIP) tablets marketed in Colombia were compared for quality control tests and dissolution profile as established in the United States Pharmacopeia 42-NF 37 and the Food and Drug Administration guidance on dissolution testing. The dissolution profiles in three dissolution media (pH 1.2, 4.5, and 6.8) were examined and compared using mathematical methods with model-independent and model-dependent approaches. The results showed that the evaluated products met the pharmacopeial specifications. CIP exhibited poor dissolution in the pH 6.8 medium for both products, and the comparative analysis of dissolution profiles in pH 1.2 and 4.5 media indicated the in vitro similarity between the formulations with drug release adjusted to Weibull function kinetics. Both products can be considered pharmaceutically equivalent, and it is necessary to test their bioequivalence in an in vivo study in order to comply with the requirements established for modified-release formulations in most of the countries. |
publishDate |
2020 |
dc.date.submitted.none.fl_str_mv |
2020-09-04 |
dc.date.accessioned.none.fl_str_mv |
2022-11-15T20:46:15Z |
dc.date.available.none.fl_str_mv |
2022-11-15T20:46:15Z |
dc.date.issued.none.fl_str_mv |
2022-03-05 |
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http://purl.org/coar/version/c_970fb48d4fbd8a85 |
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info:eu-repo/semantics/article |
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info:eu-repo/semantics/publishedVersion |
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Artículo |
status_str |
publishedVersion |
dc.identifier.citation.spa.fl_str_mv |
De la Cruz Gómez AV, Ramos Iglesias RM, Ruiz Afanador TS, Pájaro Bolívar IB, Domínguez Moré GP. Comparison between the dissolution profiles of prolonged-release ciprofloxacin tablets available in the Colombian market. J Appl Pharm Sci, 2022; 12(03):209–217. |
dc.identifier.uri.none.fl_str_mv |
https://hdl.handle.net/20.500.12834/874 |
dc.identifier.doi.none.fl_str_mv |
10.7324/JAPS.2022.120322 |
dc.identifier.instname.spa.fl_str_mv |
Universidad del Atlántico |
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Repositorio Universidad del Atlántico |
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https://www.scopus.com/record/display.uri?eid=2-s2.0-85125908811&doi=10.7324%2fJAPS.2022.120322&origin=inward&txGid=a7dda39c1201a04b7536b78e6ca0b4d6 |
identifier_str_mv |
De la Cruz Gómez AV, Ramos Iglesias RM, Ruiz Afanador TS, Pájaro Bolívar IB, Domínguez Moré GP. Comparison between the dissolution profiles of prolonged-release ciprofloxacin tablets available in the Colombian market. J Appl Pharm Sci, 2022; 12(03):209–217. 10.7324/JAPS.2022.120322 Universidad del Atlántico Repositorio Universidad del Atlántico |
url |
https://hdl.handle.net/20.500.12834/874 https://www.scopus.com/record/display.uri?eid=2-s2.0-85125908811&doi=10.7324%2fJAPS.2022.120322&origin=inward&txGid=a7dda39c1201a04b7536b78e6ca0b4d6 |
dc.language.iso.spa.fl_str_mv |
eng |
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eng |
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http://creativecommons.org/licenses/by-nc/4.0/ |
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Attribution-NonCommercial 4.0 International |
dc.rights.accessRights.spa.fl_str_mv |
info:eu-repo/semantics/openAccess |
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http://creativecommons.org/licenses/by-nc/4.0/ Attribution-NonCommercial 4.0 International http://purl.org/coar/access_right/c_abf2 |
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openAccess |
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dc.publisher.discipline.spa.fl_str_mv |
Química |
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Sede Norte |
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Journal of Applied Pharmaceutical Science |
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Universidad del Atlántico |
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De la Cruz Gómez, Andrés Vicentefc148039-3341-4cdf-905d-cf2878d72a19Ramos Iglesias, Raynni MarcelaRuiz Afanador, Tatiana SugeyPájaro Bolívar, Indira BeatrizDomínguez Moré, Gina Paola2022-11-15T20:46:15Z2022-11-15T20:46:15Z2022-03-052020-09-04De la Cruz Gómez AV, Ramos Iglesias RM, Ruiz Afanador TS, Pájaro Bolívar IB, Domínguez Moré GP. Comparison between the dissolution profiles of prolonged-release ciprofloxacin tablets available in the Colombian market. J Appl Pharm Sci, 2022; 12(03):209–217.https://hdl.handle.net/20.500.12834/87410.7324/JAPS.2022.120322Universidad del AtlánticoRepositorio Universidad del Atlánticohttps://www.scopus.com/record/display.uri?eid=2-s2.0-85125908811&doi=10.7324%2fJAPS.2022.120322&origin=inward&txGid=a7dda39c1201a04b7536b78e6ca0b4d6Two 1,000 mg prolonged-release ciprofloxacin (CIP) tablets marketed in Colombia were compared for quality control tests and dissolution profile as established in the United States Pharmacopeia 42-NF 37 and the Food and Drug Administration guidance on dissolution testing. The dissolution profiles in three dissolution media (pH 1.2, 4.5, and 6.8) were examined and compared using mathematical methods with model-independent and model-dependent approaches. The results showed that the evaluated products met the pharmacopeial specifications. CIP exhibited poor dissolution in the pH 6.8 medium for both products, and the comparative analysis of dissolution profiles in pH 1.2 and 4.5 media indicated the in vitro similarity between the formulations with drug release adjusted to Weibull function kinetics. Both products can be considered pharmaceutically equivalent, and it is necessary to test their bioequivalence in an in vivo study in order to comply with the requirements established for modified-release formulations in most of the countries.application/pdfenghttp://creativecommons.org/licenses/by-nc/4.0/Attribution-NonCommercial 4.0 Internationalinfo:eu-repo/semantics/openAccesshttp://purl.org/coar/access_right/c_abf2Journal of Applied Pharmaceutical ScienceComparison between the dissolution profiles of prolonged-release ciprofloxacin tablets available in the Colombian marketPúblico generalCiprofloxacinpharmaceutical equivalencedissolution profilesprolonged-release tabletsinfo:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionArtículohttp://purl.org/coar/version/c_970fb48d4fbd8a85http://purl.org/coar/resource_type/c_2df8fbb1BarranquillaQuímicaSede NorteAguilar-Ros A, Camaño-Somoza M, Martin-Martin, FR, Montejo-Rubio MC. 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[ONLINE] Available via https://www.ema.europa.eu/en/documents/scientific-guideline/guidelineinvestigation- bioequivalence-rev1_en.pdf (Accesed 16 October 2019).Food and Drug Administration (FDA). Guidance for industry, dissolution testing of immediate release solid oral dosage forms. 1997. [ONLINE] Available via https://doi.org/10.14227/DT040497P15 (Accesed 16 October 2019).Gao P, Nie X, Zou M, Shi Y, Cheng G. Recent advances in materials for extended-release antibiotic delivery system. J Antibiot (Tokyo), 2011; 64(9):625–34.Gohel MC, Ramkishan A, Patel TM, Pandya R, Suthar V, Koradia H, Madat DV, Bariya S, Mehta T. Nomogram for computing the value of similarity factor. Indian J Pharm Sci, 2014; 76(3):245–51.Gomez-Mantilla JD, Schaefer UF, Casabo VG, Lehr T, Lehr CM. Statistical comparison of dissolution profiles to predict the bioequivalence of extended release formulations. AAPS J, 2014; 16(4):791–801.Instituto Nacional de Salud de Colombia (INS). Informe Final de evento consumo de antibióticos en el ámbito hospitalario, Colombia, 2016. 2016. [ONLINE] Available via https://www.ins.gov.co/buscadoreventos/ Informesdeevento/Consumo de antibiotico intrahospitalario 2016. pdf (Accesed 14 October 2019).Meagher AK, Forrest A, Dalhoff A, Stass H, Schentag JJ. Novel pharmacokinetic-pharmacodynamic model for prediction of outcomes with an extended-release formulation of ciprofloxacin. Antimicrob Agents Chemother, 2004; 48(6):2061–8.Ministerio de Salud y Protección Social, República de Colombia (Minsalud Colombia). Resolución 1124 de 2016. 2016. [ONLINE] Available via https://www.invima.gov.co/documents/20143/453029/ R e s o l u c i ó n + 11 2 4 + d e + 2 0 1 6 . p d f / 9 7 e c b 5 7 4 - 0 1 0 1 - 0 9 a 1 - 9 e b 1 - d7594a5bd8e2?t=1540931891213 (Accesed 14 October 2019).Olivera ME, Manzo RH, Junginger HE, Midha KK, Shah VP, Stavchansky S, Dressman JB, Barends DM. 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Formulation and evaluation of a sustained-release tablets of metformin hydrochloride using hydrophilic synthetic and hydrophobic natural polymers. Indian J Pharm Sci, 2011; 73(2):208–15.World Health Organization (WHO). WHO Expert Committee on specifications for pharmaceutical preparations. 2006. [ONLINE] Available via https://apps.who.int/iris/handle/10665/43443 (Accesed 14 October 2019).World Health Organization (WHO). WHO Global surveillance and monitoring system for substandard and falsified medical products. 2017. [ONLINE] Available via https://ahpsr.who.int/publications/i/item/978-92- 4-151342-5 (Accesed 13 October 2019).World Health Organization (WHO). Addressing the global shortage of, and access to, medicines and vaccines: Report by the Director- General. 2018. [ONLINE] Available via http://apps.who.int/gb/ebwha/pdf_ files/EB142/B142_13-en.pdf (Accesed 13 October 2019).World Health Organization (WHO). 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World Health Organization, Geneva, Switzerland, 2020.http://purl.org/coar/resource_type/c_2df8fbb1ORIGINAL3596_pdf.pdf3596_pdf.pdfapplication/pdf564628https://repositorio.uniatlantico.edu.co/bitstream/20.500.12834/874/1/3596_pdf.pdf060613fc15d198b317ee0250bd71dbd0MD51CC-LICENSElicense_rdflicense_rdfapplication/rdf+xml; charset=utf-8914https://repositorio.uniatlantico.edu.co/bitstream/20.500.12834/874/2/license_rdf24013099e9e6abb1575dc6ce0855efd5MD52LICENSElicense.txtlicense.txttext/plain; charset=utf-81306https://repositorio.uniatlantico.edu.co/bitstream/20.500.12834/874/3/license.txt67e239713705720ef0b79c50b2ececcaMD5320.500.12834/874oai:repositorio.uniatlantico.edu.co:20.500.12834/8742022-11-15 15:46:16.811DSpace de la Universidad de Atlánticosysadmin@mail.uniatlantico.edu.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 |