Comparison of dissolution profile of extended-release oral dosage forms - two one-sided equivalence test

Lourenço, Felipe Rebello; Ghisleni, Daniela Dal Molim; Yamamoto, Rosa Noriko; Pinto, Terezinha de Jesus Andreoli

doi:10.1590/s1984-82502013000200019

Cited by 5 publications

(5 citation statements)

References 5 publications

(2 reference statements)

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…ABT-3 and ABC-2 were the most similar generic product to their innovators (Norvasc and Amlor, respectively). One brand of capsules, ABC-3, was not similar to the innovator, i.e., f2 < 50 and f1 > 50% (38,39). Statistical analysis was conducted for the pharmacopeial specified time, 60 min, using Tukey's one-way ANOVA.…”

Section: Dissolution Testmentioning

confidence: 99%

Comparative Evaluation of Amlodipine Besylate Generic Tablet and Capsule Brands in Riyadh, Saudi Arabia

Adam¹,

Rayes²,

Fatoum³

et al. 2022

Dissolution Technol.

View full text Add to dashboard Cite

The objective of this study was to evaluate the physicochemical quality control parameters and pharmaceutical equivalence of amlodipine besylate generic tablets and capsules with the innovator brands (Norvasc and Amlor, respectively) available in Riyadh, Saudi Arabia. Five brands of amlodipine besylate tablets and capsules (5 mg) were compared via quality control tests according to the United States Pharmacopoeia (i.e., hardness, thickness, diameter, weight variation, uniformity of dosage content, friability, disintegration, dissolution by ultraviolet spectrophotometry, and Fourier-transform infrared spectroscopy (FTIR)). All selected brands were found to comply with USP-NF specifications concerning weight variation, hardness, friability, disintegration time, FTIR, and drug content analysis. The dissolution profiles for all products satisfied the USP-NF specifications. Regarding, model-dependent data, all the tested brands followed the Higuchi model of release. Using the model-independent approach (i.e., similarity factor analysis), all products were considered similar except for one generic product (ABC-3). All brands had no significant difference in mean dissolution efficiency compared to the innovator, except ABC-3.

show abstract

Section: Dissolution Testmentioning

confidence: 99%

Comparative Evaluation of Amlodipine Besylate Generic Tablet and Capsule Brands in Riyadh, Saudi Arabia

Adam¹,

Rayes²,

Fatoum³

et al. 2022

Dissolution Technol.

View full text Add to dashboard Cite

show abstract

“…Literature survey shows that, several studies [39][40][41][42][43][44][45][46][47][48] have successfully used the similarity factor (f2) to compare dissolution profiles of drug samples. For example, Emami 41 compared the in vitro and in vivo performances of amiodarone generics using the similarity factor and concluded that the products were not equivalent as f2 values obtained were not within the acceptable range.…”

Section: Fig 1: Release Profile Of Azithromycin From Four Brands Azimentioning

confidence: 99%

“…Papneja et al, 45 used the fit factors to compare the dissolution of optimized ketoconazole solid dispersion tablet with the conventional immediate release tablets and found them to possess similar dissolution profiles. On their part, Lourenço et al, 46 compared the rate of drug release from prolonged release formulations using the similarity factor and the two one-sided equivalence test. The authors concluded that the two one-sided equivalence test was a simpler approach.…”

Section: Fig 1: Release Profile Of Azithromycin From Four Brands Azimentioning

confidence: 99%

Untitled

2018

IJPSR

View full text Add to dashboard Cite

Counterfeit and substandard pharmaceutical products circulate widely in developing countries, yet adequate techniques to monitor quality is lacking. We report herein a quick and reliable approach to predict the in-vitro bioequivalence and interchangeability of common antibiotics using nine model drugs; four brands of azithromycin and five brands of clarithromycin tablets marketed in Nigeria. Pharmacopoeia guidelines (British and United States) were used to assess tablet quality such as friability, disintegration and dissolution times. All the brands tested passed the British Pharmacopoeia standard for disintegration time and their hardness and friability values were also considered adequate. There were no significant differences in the dissolution profiles of the brands, however, the azithromycin brands released >70% of the active drug within 30 min. The calculated similarity factor values for the azithromycin and clarithromycin brands were between 61 to 100 and 46 to 100 respectively. Based on the in-vitro tests, all the brands of azithromycin were considered bioequivalent with the innovator brand. However, only one brand had a similarity factor very close to that of the innovator brand and could be considered interchangeable. All the brands of clarithromycin were also considered bioequivalent, except one brand. Our results show that, the concept of dissolution efficiency could be a reliable method of predicting bioequivalence of antibiotics thereby serving as a tool to monitor and prevent the circulation of fake and counterfeited drug products.

show abstract

“…The absorption of a solid dosage form after oral administration depends on three factors: the release of the substance taken, the dissolution of the drug under physiological conditions and the permeability across the gastrointestinal tract. Due to the critical nature of the first two of these steps, an vitro dissolution may be relevant to the prediction of in vivo performance [3,4].…”

Section: Introductionmentioning

confidence: 99%

Impact Evaluation of Changes in the Manufacturing Line of Cyproterone Acetate through Analysis of Comparative Dissolution Profile

Pinto¹,

Okamoto²,

Oliveira³

et al. 2014

AJS

View full text Add to dashboard Cite

The mean final results (45 minutes) were equivalent to 107.73 % (RSD = 2.98 %) and 108.58 % (RSD = 1.44 %), respectively, independently of the changes on the compression machine used in the manufacturing line. The statistical analysis was used to evaluate result variability and to determine the similarity factor among the different batches of drugs tested (f2 = 57.64), what allowed to conclude that the drugs tested showed similar dissolution profile. The results of dissolution efficiency calculation are: 83.14 % (RSD = 1.89) to dissolution profiles obtained to the cyproterone tablets manufactured with compression machine 1 and 79.83 % (RSD = 1.93) to the cyproterone tablets manufactured with compression machine 2. Statistical analysis showed that the differences observed between the results. The results based on the statistical calculations of f2 showed equivalence in the dissolution profile, and different performances based on calculation of the dissolution efficiency (D.E.). However, the dissolution method could be reevaluated to analyze properly the product in study, fast dissolving formulation, using discriminative conditions.

show abstract

Comparison of dissolution profile of extended-release oral dosage forms - two one-sided equivalence test

Cited by 5 publications

References 5 publications

Comparative Evaluation of Amlodipine Besylate Generic Tablet and Capsule Brands in Riyadh, Saudi Arabia

Comparative Evaluation of Amlodipine Besylate Generic Tablet and Capsule Brands in Riyadh, Saudi Arabia

Untitled

Impact Evaluation of Changes in the Manufacturing Line of Cyproterone Acetate through Analysis of Comparative Dissolution Profile

Contact Info

Product

Resources

About