Dissolution profile evaluation of solid pharmaceutical forms containing chloramphenicol marketed in Brazil

Ferraz, Humberto Gomes; Carpentieri, Letícia Norma; Watanabe, Sayuri Pereira

doi:10.1590/s1516-89132007000100007

Cited by 11 publications

(8 citation statements)

References 17 publications

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“…The lot-to-lot quality assurance fosters the development of new formulations, guarantee quality homogeneity and ensure an acceptable API performance even after being modified. If all these requirements are met, the formulation optimization during the development phase is favoured, and stability studies and manufacturing process quality control can be carried out (Adams et al, 2001, Dressman et al, 1998, Ferraz et al, 2007).…”

Section: Resultsmentioning

confidence: 99%

Comparison between the dissolution profiles of nine meloxicam tablet brands commercially available in Buenos Aires, Argentina

Simionato

Petrone

Baldut

et al. 2018

Saudi Pharmaceutical Journal

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In this work, the dissolution profiles of nine meloxicam tablet brands marketed in Argentina have been evaluated. As meloxicam is a Class 2 Biopharmaceutical Classification System (BSC) drug, interchangeability between commercial products must be demonstrated through bioequivalence studies. However, in our country, such studies remain to be performed. Dissolution studies have been performed according to USP 38 and evaluated by fitting experimental data to the zero and first-order, the Hixson-Crowell, the Higuchi, and the Weibull model-dependent methods. To test the pertinence of these release models, the Akaike Information Criteria (AIC) were used. All brands satisfied the dissolution profiles (phosphate buffer, pH 7.5) established in the USP. The comparison between the dissolution profiles was carried out by model-dependent and model-independent methods. The Weibull model provided the best kinetic curve adjustment. Brands I, II, IV and VI had the best fitting, with the maximum determination coefficient and the smallest AIC values. Model-independent methods included ratio test and the fit factors. The Dissolution Efficiency (DE) and Mean Dissolution Time (MDT) were analysed with ANOVA and the DGC method. In both cases, brand I did not show similarity with the rest of the brands. Using fit factors, only brands I, II and V were similar to each other. Significant differences were found among the dissolution profiles of meloxicam tablets belonging to the nine brands. As meloxicam is a class 2 BCS drug, interchangeability between commercial products must be demonstrated through bioequivalence studies. However, in Argentina, such studies remain to be performed. Our results demonstrate that caution must be exercised as regards interchangeability of generic products.

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Section: Resultsmentioning

confidence: 99%

Comparison between the dissolution profiles of nine meloxicam tablet brands commercially available in Buenos Aires, Argentina

Simionato

Petrone

Baldut

et al. 2018

Saudi Pharmaceutical Journal

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“…In the literature, different methods which can be used to compare dissolution profiles data have been reported 3,4,[11][12][13][14] . However, in this study the two most important and widely engaged methods have been used: the fit factors and dissolution efficiency (D.E.).…”

Section: Discussionmentioning

confidence: 99%

“…Drug absorption from a solid dosage form after oral administration depends on the release of the drug substance from the drug product, the solubilization of the drug under physiological conditions, and the permeability across the gastrointestinal tract. For that reason, the importance of dissolution tests and dissolution profile for the establishment of pharmaceutical equivalence must be highlighted 3,4 . The World Health Organization (WHO) has advocated the use of generic brands in order to make the cost of medicines affordable especially for the developing countries 5 .…”

Section: Introductionmentioning

confidence: 99%

“…However different reported studies over the last years revealed that marketed products with the same amount of active ingredient exhibit marked differences in their therapeutic responses. The presences of generic products that are not interchangeable with that of the innovator and/or with each others have been reported 4,6,[8][9][10] . The study was set up to evaluate and compare the in-vitro dissolution profiles of different generic brands of amoxicillin capsules with the innovator that are available in Ethiopian market.…”

Section: Introductionmentioning

confidence: 99%

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Evaluation and comparison of in-vitro dissolution profiles for different brands of amoxicillin capsules

Kassaye

Genete²

2013

Afr H. Sci.

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Background: Amoxicillin is an oral semi-synthetic, β-lactam antibiotic used to treat bacterial infections caused by susceptible micro organisms. It is usually prepared in capsule, tablet and powder for oral suspension form. Solid dosage forms for oral administration pose bioavailability problems related to the absorption process The World Health Organization (WHO) has promoted the use of generic brands in order to make the cost of medicines affordable. Generic substitution could be considered when a generic copy of a reference drug contains identical amounts of the same active ingredient in the same dose formulation and route of administration. However, the presences of generic products those are not interchangeable with that of the innovator and/or with each others have been reported. Objective: To evaluate and compare the in-vitro dissolution profiles of different generic brands of amoxicillin capsules with the innovator that are available in Ethiopian market. Methods: Dissolution profiles for nine brands of amoxicillin capsules contained amoxicillin 500 mg which are available in Ethiopian market were determined using a method from the United States Pharmacopoeia (USP, 2009). The obtained dissolution profile data of the eight brands were evaluated and compared with the innovator brand (Amoxil TM ) using two different statistical methods: the fit factors (f1 & f2) and the dissolution efficiency (D.E.) model. Most generic brands of amoxicillin capsules (62.5% of the tested brands) are not interchangeable with the innovator brand. Results: The calculated f1 factor for Brand A and Brand G are 10.1 and 1.1 respectively. However, for the rest six brands the f1 factors are greater than 15. The f2 factor for Brand G is 74.1 and for Brand A is 48.5 which is near to 50. Similarly, the f2 factors for the six brands are less than 50 which support the result of the f1 factors for the dissimilarity of these brands with the innovator brand. The mean dissolution efficiencies as well as the 95% confidence intervals are within ±10% only for two brands, Brand F and Brand G. Conclusion: Most generic brands of amoxicillin capsules (62.5%) are not interchangeable with the innovator brand (Amoxil TM ).

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“…Chloramphenicol palmitate is quickly and almost completely hydrolyzed by intestinal esterase, being distributed widely throughout corporal liquids and quickly achieving therapeutic levels. [2]…”

Section: Introductionmentioning

confidence: 99%

Construction of New Ion Selective Electrodes for Determination Chloramphenicol Sodium Succinate and Their Application in Pharmaceutical Samples

Al-Saidi¹,

Aziz²

2012

JNUS

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A liquid membrane electrodes for the determination chloramphenicol sodium succinate were constructed based on chloramphenicol palmitate and sodium tetraphenyl borate, and with four plasticizers, Di-butyl phthalate (DBPH); Di-butyl phosphate (DBP); Di-octyl phthalate (DOP); Tributyl phosphate (TBP); in PVC matrix. These electrodes give sub-Nernstian slopes (53.98, 51.45, 49.66 and 48.98 mV/decade) and linear ranges from (1x10-4-1x10-1 , 5x10-4-1x10-1 , 1x10-4-1x10-1 , 5x10-4-1x10-1 M) respectively. The best electrode was based on DBPH plasticizer which gave a slope 53.98 mV/decade, correlation coefficient 0.9999, detection limit of 5 x 10-5 M, lifetime 50 day displayed good stability and reproducibility and used to determine the Chloramphenicol sodium succinate in pharmaceutical samples. The measurement interferences in the presence of K + , Na + , Fe +3 , Al +3 , Cu +2 , Mn +2 , sucrose, Gelatine and Chloramphenicol palmitate were studied using the separated and mixed methods for selectivity coefficient determination. The pH and life time of the electrodes were also studied. The results were compared statistically with UV-spectrophotometeric technique by using F-test.

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Dissolution profile evaluation of solid pharmaceutical forms containing chloramphenicol marketed in Brazil

Abstract: The dissolution profile for solid pharmaceutical forms containing chloramphenicol 250 mg available in Brazil was determined using a method from the American Pharmacopoeia (United States Pharmacopoeia, 2004)

Cited by 11 publications

References 17 publications

Comparison between the dissolution profiles of nine meloxicam tablet brands commercially available in Buenos Aires, Argentina

Comparison between the dissolution profiles of nine meloxicam tablet brands commercially available in Buenos Aires, Argentina

Evaluation and comparison of in-vitro dissolution profiles for different brands of amoxicillin capsules

Construction of New Ion Selective Electrodes for Determination Chloramphenicol Sodium Succinate and Their Application in Pharmaceutical Samples

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