Comparative Study Capsules Containing Amoxicillin Obtained Some of Magistral Pharmacies
Autor(a) principal: | |
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Data de Publicação: | 2011 |
Outros Autores: | , , , |
Tipo de documento: | Artigo |
Idioma: | por |
Título da fonte: | Revista Brasileira Multidisciplinar |
Texto Completo: | http://revistarebram.com/index.php/revistauniara/article/view/111 |
Resumo: | Amoxillin is a semisynthetic antibiotic classified as penicillin of wide action spectrum against gram-positive and gram-negative bacteria, largely used in the treatments of several infections. Besides, amoxicillin is a drug widely used in clinical treatment (the usual dosage is 500 mg). According to RDC n.87/2008, in order to monitoring the manipulation process, pharmacies must analyze their pharmaceutical formulations to assure some important quality parameters, such as average weight, dissolution time and assay, to guarantee the drug concentration and therapeutic efficacy. The objective of this work was to develop a comparative study of three pharmaceutic formulations containing amoxicillin 500 mg (capsules) and to compare the results to those obtained from the generic drug. The analysis was carried out according to Brazilian Pharmacopoeia for amoxicillin. Although the 3 magistral preparations analyzed have been approved in average weight determination, only one pharmaceutical formulation presented satisfactory results for time dissolution and assay determinations (81,30 ± 0,98% and 91,65 ± 0,72%, respectively). The results showed the necessity of a strict quality monitoring by the pharmacies to assure the correct drug dosage and its therapeutic efficacy. The selection of excipients and the weight, blend and encapsulation procedures are very important, as well as the evaluation of the purity and integrity of raw materials. |
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Comparative Study Capsules Containing Amoxicillin Obtained Some of Magistral PharmaciesEstudo Comparativo de Cápsulas Contendo Amoxicilina Obtidas de Algumas Farmácias MagistraisAmoxicillin capsulesPharmaciesQuality control.Cápsulas de amoxicilinaFarmácias magistraisControle de qualidade.Amoxillin is a semisynthetic antibiotic classified as penicillin of wide action spectrum against gram-positive and gram-negative bacteria, largely used in the treatments of several infections. Besides, amoxicillin is a drug widely used in clinical treatment (the usual dosage is 500 mg). According to RDC n.87/2008, in order to monitoring the manipulation process, pharmacies must analyze their pharmaceutical formulations to assure some important quality parameters, such as average weight, dissolution time and assay, to guarantee the drug concentration and therapeutic efficacy. The objective of this work was to develop a comparative study of three pharmaceutic formulations containing amoxicillin 500 mg (capsules) and to compare the results to those obtained from the generic drug. The analysis was carried out according to Brazilian Pharmacopoeia for amoxicillin. Although the 3 magistral preparations analyzed have been approved in average weight determination, only one pharmaceutical formulation presented satisfactory results for time dissolution and assay determinations (81,30 ± 0,98% and 91,65 ± 0,72%, respectively). The results showed the necessity of a strict quality monitoring by the pharmacies to assure the correct drug dosage and its therapeutic efficacy. The selection of excipients and the weight, blend and encapsulation procedures are very important, as well as the evaluation of the purity and integrity of raw materials.A amoxicilina é um antibiótico semissintético pertencente à classe das penicilinas, ativo contra bactérias grampositivas e gram-negativas, empregado no tratamento de diversas infecções, sendo um dos fármacos mais utilizados na antibioticoterapia (dose usual de 500 mg). De acordo com a RDC n.o 87/2008, as farmácias devem analisar seus produtos terminados, a fim de assegurar alguns parâmetros de qualidade essenciais, tais como peso médio, tempo de dissolução e teor de princípio ativo. O objetivo do presente trabalho foi realizar o estudo comparativo de três preparações magistrais contendo amoxicillin 500 mg (cápsulas) e comparar os resultados com aqueles obtidos com o medicamento genérico. A metodologia utilizada foi a preconizada pela Farmacopeia Brasileira para amoxicilina. Das três preparações magistrais analisadas, todas foram aprovadas quanto ao peso médio, porém apenas uma apresentou conformidade com o tempo de dissolução e com o teor (81,30 ± 0,98% e 91,65 ± 0,72%, respectivamente). Os resultados indicaram a necessidade de um monitoramento rigoroso por parte das farmácias magistrais, a fim de assegurar a correta dose do fármaco e a eficácia terapêutica, na escolha dos excipientes e dos procedimentos corretos de pesagem, homogeneização e encapsulação, bem como a avaliação da pureza e integridade das matérias-primas.Revista Brasileira Multidisciplinar - ReBraM2011-07-15info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfhttp://revistarebram.com/index.php/revistauniara/article/view/11110.25061/2527-2675/ReBraM/2011.v14i2.111Revista Brasileira Multidisciplinar - ReBraM; v. 14 n. 2 (2011): Julho/dezembro; 50-602527-26751415-3580reponame:Revista Brasileira Multidisciplinarinstname:Universidade de Araraquara (UNIARA)instacron:UNIARAporhttp://revistarebram.com/index.php/revistauniara/article/view/111/85Paulo, Glauber diasMazzuco, Ana PaulaRodolpho, Juliana CristinaSalgado, Hérida Regina NunesMoreno, Andréia de Haroinfo:eu-repo/semantics/openAccess2018-03-08T13:38:33Zoai:ojs.revistarebram.com:article/111Revistahttp://revistarebram.com/index.php/revistauniaraPRIhttps://revistarebram.com/index.php/revistauniara/oairevistauniara@uniara.com||2527-26752527-2675opendoar:2018-03-08T13:38:33Revista Brasileira Multidisciplinar - Universidade de Araraquara (UNIARA)false |
dc.title.none.fl_str_mv |
Comparative Study Capsules Containing Amoxicillin Obtained Some of Magistral Pharmacies Estudo Comparativo de Cápsulas Contendo Amoxicilina Obtidas de Algumas Farmácias Magistrais |
title |
Comparative Study Capsules Containing Amoxicillin Obtained Some of Magistral Pharmacies |
spellingShingle |
Comparative Study Capsules Containing Amoxicillin Obtained Some of Magistral Pharmacies Paulo, Glauber dias Amoxicillin capsules Pharmacies Quality control. Cápsulas de amoxicilina Farmácias magistrais Controle de qualidade. |
title_short |
Comparative Study Capsules Containing Amoxicillin Obtained Some of Magistral Pharmacies |
title_full |
Comparative Study Capsules Containing Amoxicillin Obtained Some of Magistral Pharmacies |
title_fullStr |
Comparative Study Capsules Containing Amoxicillin Obtained Some of Magistral Pharmacies |
title_full_unstemmed |
Comparative Study Capsules Containing Amoxicillin Obtained Some of Magistral Pharmacies |
title_sort |
Comparative Study Capsules Containing Amoxicillin Obtained Some of Magistral Pharmacies |
author |
Paulo, Glauber dias |
author_facet |
Paulo, Glauber dias Mazzuco, Ana Paula Rodolpho, Juliana Cristina Salgado, Hérida Regina Nunes Moreno, Andréia de Haro |
author_role |
author |
author2 |
Mazzuco, Ana Paula Rodolpho, Juliana Cristina Salgado, Hérida Regina Nunes Moreno, Andréia de Haro |
author2_role |
author author author author |
dc.contributor.author.fl_str_mv |
Paulo, Glauber dias Mazzuco, Ana Paula Rodolpho, Juliana Cristina Salgado, Hérida Regina Nunes Moreno, Andréia de Haro |
dc.subject.por.fl_str_mv |
Amoxicillin capsules Pharmacies Quality control. Cápsulas de amoxicilina Farmácias magistrais Controle de qualidade. |
topic |
Amoxicillin capsules Pharmacies Quality control. Cápsulas de amoxicilina Farmácias magistrais Controle de qualidade. |
description |
Amoxillin is a semisynthetic antibiotic classified as penicillin of wide action spectrum against gram-positive and gram-negative bacteria, largely used in the treatments of several infections. Besides, amoxicillin is a drug widely used in clinical treatment (the usual dosage is 500 mg). According to RDC n.87/2008, in order to monitoring the manipulation process, pharmacies must analyze their pharmaceutical formulations to assure some important quality parameters, such as average weight, dissolution time and assay, to guarantee the drug concentration and therapeutic efficacy. The objective of this work was to develop a comparative study of three pharmaceutic formulations containing amoxicillin 500 mg (capsules) and to compare the results to those obtained from the generic drug. The analysis was carried out according to Brazilian Pharmacopoeia for amoxicillin. Although the 3 magistral preparations analyzed have been approved in average weight determination, only one pharmaceutical formulation presented satisfactory results for time dissolution and assay determinations (81,30 ± 0,98% and 91,65 ± 0,72%, respectively). The results showed the necessity of a strict quality monitoring by the pharmacies to assure the correct drug dosage and its therapeutic efficacy. The selection of excipients and the weight, blend and encapsulation procedures are very important, as well as the evaluation of the purity and integrity of raw materials. |
publishDate |
2011 |
dc.date.none.fl_str_mv |
2011-07-15 |
dc.type.driver.fl_str_mv |
info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion |
format |
article |
status_str |
publishedVersion |
dc.identifier.uri.fl_str_mv |
http://revistarebram.com/index.php/revistauniara/article/view/111 10.25061/2527-2675/ReBraM/2011.v14i2.111 |
url |
http://revistarebram.com/index.php/revistauniara/article/view/111 |
identifier_str_mv |
10.25061/2527-2675/ReBraM/2011.v14i2.111 |
dc.language.iso.fl_str_mv |
por |
language |
por |
dc.relation.none.fl_str_mv |
http://revistarebram.com/index.php/revistauniara/article/view/111/85 |
dc.rights.driver.fl_str_mv |
info:eu-repo/semantics/openAccess |
eu_rights_str_mv |
openAccess |
dc.format.none.fl_str_mv |
application/pdf |
dc.publisher.none.fl_str_mv |
Revista Brasileira Multidisciplinar - ReBraM |
publisher.none.fl_str_mv |
Revista Brasileira Multidisciplinar - ReBraM |
dc.source.none.fl_str_mv |
Revista Brasileira Multidisciplinar - ReBraM; v. 14 n. 2 (2011): Julho/dezembro; 50-60 2527-2675 1415-3580 reponame:Revista Brasileira Multidisciplinar instname:Universidade de Araraquara (UNIARA) instacron:UNIARA |
instname_str |
Universidade de Araraquara (UNIARA) |
instacron_str |
UNIARA |
institution |
UNIARA |
reponame_str |
Revista Brasileira Multidisciplinar |
collection |
Revista Brasileira Multidisciplinar |
repository.name.fl_str_mv |
Revista Brasileira Multidisciplinar - Universidade de Araraquara (UNIARA) |
repository.mail.fl_str_mv |
revistauniara@uniara.com|| |
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1797174604945424384 |