Comparative In vitro Bioequivalence Evaluation of Different Brands of Amoxicillin Capsules Marketed in Tigray, Ethiopia

Hailu, Gebremedhin Solomon; Gutema, Girma; Hishe, Hailemichael Zeru; Ali, Yimer Said; Asfaw, Adissu Alemayehu

doi:10.37285/ijpsn.2013.6.1.7

Cited by 11 publications

(10 citation statements)

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“…The statistical comparison of release profiles of amlodipine besylate tablets indicated that there is no significant difference between the generic brands and Norvasc (p < 0.05). Similar results were recorded for the capsule formulations; however, ABC-3 differed significantly from the innovator, Amlor (p > 0.05), which was found in another study (40). This difference in might indicate reduced in vivo bioavailability and bioequivalence of the products (27).…”

Section: Dissolution Testsupporting

confidence: 72%

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

Adam¹,

Rayes²,

Fatoum³

et al. 2022

Dissolution Technol.

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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.

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Section: Dissolution Testsupporting

confidence: 72%

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

Adam¹,

Rayes²,

Fatoum³

et al. 2022

Dissolution Technol.

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“…The dissolution profiles of the six drug products were statistically compared by using two independent-model parameters, the difference factor f1 and similarity factor f2. These factors were calculated from the obtained data from the drug dissolution studies of the six drug products using equations 4 and 5, respectively [15]. The difference factor, f1, is the average difference between all the points of sampling between two brands: the reference brand and one of the five test brands.…”

Section: Discussionmentioning

confidence: 99%

The Evaluation of Some Brands of Levocetirizine Dihydrochloride Film-Coated Tablets for Quality and Equivalence Sold in Aden, Yemen

Al-Kubati

Ahmed

Saif

2022

Electron. J. Univ. Aden Basic Appl. Sci.

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Generic drugs are less expensive than innovator drugs, and their proliferation has become a problem in low-income countries. They need to be therapeutically and pharmaceutically equivalent to the innovator. Levocetirizine dihydrochloride is an effective drug for relieving the signs of chronic urticaria, perennial allergic rhinitis, and seasonal allergic rhinitis. Our investigation into this drug in private pharmacies in Aden, Yemen, revealed that it is sold under the names of 28 brands from different countries of origin. Because of this, it is difficult for medical professionals and patients who use this medication without a prescription to select a suitable, safe, and cost-effective drug product. We assessed the quality and equivalency of six different brands of levocetirizine dihydrochloride film-coated tablets and assigned codes A, B, C, D, E, and F, with Brand A serving as the reference. The UV analytical method was evaluated for quantifying the drug from the tablets. The results indicated that it was accurate and precise. The tablets were evaluated for weight variation, thickness, hardness, friability, drug content, disintegration time, and dissolution. In order to compare the drug's dissolving profiles, the difference factor (f1) and similarity factor (f2) were used. For all six brands, the physicochemical parameter results met the acceptable limits. All six brands showed evidence of dissolving within 15 minutes, with values ranging from 80.05 ±0.81 to 103.83 ±0.90 which were within the recommended value of 80% within 30 minutes for oral solid dosage forms intended for immediate release. According to the f1 and f2 results, only brands B, D, and E were comparable to brand A and could be used interchangeably. In conclusion, four of the six brands are interchangeable. For high-quality public health, a thorough analysis and ongoing monitoring are needed to ascertain the quality and equivalency of the medications marketed under various brands.

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“…Multiple studies have reported that some multisource amoxicillin capsules marketed in developing countries were not bioequivalent to the innovator product (15)(16)(17). According to the WHO, multisource pharmaceutical products that are not bioequivalent (and thus, not therapeutically equivalent) are not considered interchangeable to innovator product (18).…”

Section: A Gc2mentioning

confidence: 99%

Physicochemical Quality and In Vitro Bioequivalence of Amoxicillin Capsules Marketed in Burkina Faso, Africa

Yaméogo¹,

Zoungrana-Somé²,

Sombié³

et al. 2023

Dissolution Technol.

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Amoxicillin is a penicillin antibiotic widely prescribed to treat many infections. Several brands of oral forms of amoxicillin are available on the local market. The aim of this study was to evaluate the physicochemical quality and in vitro bioequivalence of several brands of amoxicillin capsules (500 mg) marketed in Burkina Faso. Nine different brands of amoxicillin capsules (eight generic and the innovator brand) were purchased from local authorized distributors. Quality control tests (identification, uniformity of weight, disintegration, assay, and dissolution) were performed according to the United States Pharmacopoeia monograph. The comparison of in vitro dissolution profiles was performed in three different pH media (1.2, 4.5, 6.8) using statistical calculations of difference (f1) and similarity (f2) factors. All brands met USP specifications for physicochemical quality. Amoxicillin content was 104.60-116.04% of the label claim. Mean disintegration time was 6.12-13.44 minutes and dissolution exceeded 80% within 60 minutes. When comparing dissolution profiles, f1 values > 15 and f2 values < 50 were obtained for two brands at all three pH levels; these brands cannot be considered interchangeable with the innovator brand. Six out of eight tested generic brands can be considered interchangeable with the innovator product.

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Comparative In vitro Bioequivalence Evaluation of Different Brands of Amoxicillin Capsules Marketed in Tigray, Ethiopia

Cited by 11 publications

References 0 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

The Evaluation of Some Brands of Levocetirizine Dihydrochloride Film-Coated Tablets for Quality and Equivalence Sold in Aden, Yemen

Physicochemical Quality and In Vitro Bioequivalence of Amoxicillin Capsules Marketed in Burkina Faso, Africa

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