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...

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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
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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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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
dc.identifier.reponame.spa.fl_str_mv Repositorio Universidad del Atlántico
dc.identifier.url.none.fl_str_mv 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
language eng
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dc.rights.cc.*.fl_str_mv Attribution-NonCommercial 4.0 International
dc.rights.accessRights.spa.fl_str_mv info:eu-repo/semantics/openAccess
rights_invalid_str_mv http://creativecommons.org/licenses/by-nc/4.0/
Attribution-NonCommercial 4.0 International
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eu_rights_str_mv openAccess
dc.format.mimetype.spa.fl_str_mv application/pdf
dc.publisher.place.spa.fl_str_mv Barranquilla
dc.publisher.discipline.spa.fl_str_mv Química
dc.publisher.sede.spa.fl_str_mv Sede Norte
dc.source.spa.fl_str_mv Journal of Applied Pharmaceutical Science
institution Universidad del Atlántico
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spelling 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. Biofarmacia y farmacocinética: ejercicios y problemas resueltos. 2nd edition, Elsevier, Barcelona, España, 2014.Alkhalidi BA, Alkhatib HS, Khdair AA. Comparative dissolution of diltiazem immediate and extended release products using conventional USP and innovative dissolution paddles. Open Drug Deliv J, 2010; 4(SPEC. ISSUE 1):48–54.Anderson NH, Bauer M, Boussac N, Khan-Malek R, Munden P, Sardaro M. An evaluation of fit factors and dissolution efficiency for the comparison of in vitro dissolution profiles. J Pharm Biomed Anal, 1998; 17(4–5):811–22.Arcaro R, da Veiga CRP, da Silva WV, da Veiga CP. Attitude and purchase intention to generic drugs. Int J Environ Res Public Health, 2021; 18:4579.Asociación Española de Farmacéuticos de la Industria (AEFI). Validación de métodos analíticos. Asociación Española de Farmacéuticos de la Industria, Barcelona, España, 2001.Bayer HealthCare. CIPRO XR. 2021. [ONLINE] Available via https://www.accessdata.fda.gov/drugsatfda_docs/ label/2021/021473s043lbl.pdf (Accesed 20 August 2021).Beg S, Nayak AK, Kohli K, Swain S, Hasnain MS. Antimicrobial activity assessment of time-dependent release bilayer tablets of amoxicillin trihydrate. Braz J Pharm Sci, 2012; 48(2):265–72.Chao YS, Farrah K. Fluoroquinolones for the treatment of respiratory tract infections: a review of clinical effectiveness, costeffectiveness, and guidelines. Canadian Agency for Drugs and Technologies in Health, Ottawa, Canada, 2019.Costa P, Sousa Lobo JM. Modeling and comparison of dissolution profiles. Eur J Pharm Sci, 2001; 13:123–33.Dokoumetzidis A, Papadopoulou V, Macheras P. Analysis of dissolution data using modified versions of Noyes–Whitney equation and the Weibull function. Pharm Res, 2006; 23(2):256–61.European Medicine Agency (EMA). Guideline on the investigation of bioequivalence discussion. 2010. [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. Biowaiver monographs for immediate release solid oral dosage forms: Ciprofloxacin hydrochloride. J Pharm Sci, 2011; 100(1):22–33.Omari DM, Johary D, Salem II, Najib N, Sallam AA. Bioequivalence of two oral extended release formulations of ciprofloxacin tablets in healthymale volunteers under fed and fasting conditions. J Bioequivalence Bioavailab, 2011; 3(2):038–42.Papadopoulou V, Kosmidis K, Vlachou M, Macheras P. On the use of the Weibull function for the discernment of drug release mechanisms. Int J Pharm, 2006; 309(1–2):44–50.Polli JE. In vitro studies are sometimes better than conventional human pharmacokinetic in vivo studies in assessing bioequivalence of immediate-release solid oral dosage forms. AAPS J, 2008; 10(2):289–99.Qiu Y, Chen Y, Zhang G, Yu L, Mantri RV. Developing solid oral dosage forms: pharmaceutical theory and practice. 2nd edition, Boston, MA, Academic Press, 2016.Rashid M, Weintraub A, Nord CE. Comparative effects of the immediate and the extended release formulations of ciprofloxacin on normal human intestinal microflora. J Chemother, 2011; 23(3):145–9.Reddy NHS, Patnala S, Kanfer I. Investigation of biowaivers for immediate release formulations containing BCS III drugs, acyclovir, atenolol, and ciprofloxacin hydrochloride, using dissolution testing. AAPS PharmSciTech, 2017; 18(2):424–31.Roca Jalil ME, Baschini M, Sapag K. Influence of pH and antibiotic solubility on the removal of ciprofloxacin from aqueous media using montmorillonite. Appl Clay Sci, 2015; 114:69–76.Shah VP, Tsong Y, Sathe P, Liu JP. In vitro dissolution profile comparison—statistics and analysis of the similarity factor, f2. Pharm Res, 1998; 15(6):889–96.Straka RJ, Keohane DJ, Liu LZ. Potential clinical and economic impact of switching branded medications to generics. Am J Ther, 2017; 24(3):e278–89.Talan DA, Naber KG, Palou J, Elkharrat D. Extended-release ciprofloxacin (Cipro XR) for treatment of urinary tract infections. Int J Antimicrob Agents, 2004; 23(SUPPL. 1):54–66.United States Pharmacopeial Convention (USP). Ciprofloxacino, tabletas de liberación prolongada. In: The United States Pharmacopeia, 42nd edition, USP, Rockville, MD, pp 1012–15, 2019a. [Spanish version].United States Pharmacopeial Convention (USP). (1216) Friabilidad de las tabletas. In: The United States Pharmacopeia, 42nd edition, USP, Rockville, MD, pp 8355–56, 2019b. [Spanish version].United States Pharmacopeial Convention (USP). (905) Uniformidad de unidades de dosificación. In: The United States Pharmacopeia, 42nd edition, USP, Rockville, MD, pp 7239–42, 2019c. [Spanish version].Torres Serna C, Ángel Medina JC, Klinger Torres HV, Márquez Florez V, Micolta Bejarano JM, Sánchez Suescún JJ. Generic drugs, perception of the doctors. cali, colombia. Rev Científica Cienc Méd, 2018; 21(1):40–9.Wadher KJ, Kakde RB, Umekar MJ. 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). Expert committee on specifications for pharmaceutical preparations - technical report series. 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