Comparing the Dissolution Profiles of Seven Metformin Formulations in Simulated Intestinal Fluid

Stuart, Arlene Villarroel; Clement, Y; Sealy, P.; Löbenberg, Raimar; Montane-Jaime, L.; Maharaj, Rohan G; Maxwell, Adam D.

doi:10.14227/dt220115p17

Cited by 14 publications

(33 citation statements)

References 8 publications

(6 reference statements)

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“…In case of R1 and R2, our results that show dissolution dissimilarity is in consistence with Stuart et al [31] who assumed that the two MH innovator products having similar trade name (Glucophage), but came from different manufacturers, were statistically different regarding their dissolution profiles. Likewise, Crison et al [44] stated that MH IR tablets obtained from different markets showed diverse drug release profiles.…”

Section: Usp Apparatus IVsupporting

confidence: 88%

“…This variability in MH release may be due to differences in particle size and/or surface area of MH particles, uneven distribution of hydrodynamic force [50] or differences in the method of manufacturing, compression force or machinery [52]. [31,53] stated that the difference in dissolution profiles of products could be attributed to the excipients and/or the manufacturing process. Furthermore, Berthelsen et al [54] reported that excipients might disturb the drug-filter interaction/adsorption in USP apparatus IV, causing differences in dissolution profiles and interfering with the prediction of in vivo data.…”

Section: Comparative In Vitro Release Study Of Mh Cr Productsmentioning

confidence: 99%

“…This may be due to differences in rate and extent of absorption [26], excipients and manufacturing processes [27] or the manufacturing variables such as the mixing effect and granulation procedure [7]. Few studies compared the performance of innovator and generic products of MH in different countries [26,[28][29][30][31][32][33][34][35].…”

Section: Introductionmentioning

confidence: 99%

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Comparative in Vitro Dissolution Study on Metformin Market Products Using Different Dissolution Apparatuses

Hashem

Abdou

Mursi

et al. 2019

Int J Pharm Pharm Sci

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Objective: This study was proposed to evaluate and compare the in vitro dissolution profiles of six Metformin Hydrochloride (MH) market products.Methods: Different dissolution apparatuses (USP apparatus II, IV and beaker method) were used to evaluate the dissolution profiles (in phosphate buffer, pH 6.8) of two immediate release (IR) generic products of Metformin Hydrochloride (MH): Cidophage® 1000 mg (G1, Egyptian market) and Metformin arrow® 1000 mg (G2, French market) with respect to the reference products named Glucophage® 850 mg (R1, Egyptian market and R2, French market). In addition to a generic controlled-release (CR) product; Cidophage Retard® 850 mg (G3) versus the reference product; Glucophage XR® 1000 mg (R3) (both from Egyptian market). Dissolution efficiency (D. E.) and the similarity factor (f2) were calculated. Weight uniformity, hardness, tablet dimensions and MH content were measured. Results:Results of the three apparatuses showed that MH IR products studied (reference and generics) did not meet the 75% USP 30 specifications for MH dissolved at 30 min. For MH CR products, Glucophage XR® did not fulfill the USP release criteria, while Cidophage Retard® did. USP apparatus IV revealed the highest sensitivity and discriminative capability. Conclusion:Generally, MH IR generics (G1 and G2) might be interchangeable with the innovator product (Glucophage®). However, Cidophage Retard® might not be interchangeable with Glucophage XR®.

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Section: Usp Apparatus IVsupporting

confidence: 88%

Section: Comparative In Vitro Release Study Of Mh Cr Productsmentioning

confidence: 99%

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Comparative in Vitro Dissolution Study on Metformin Market Products Using Different Dissolution Apparatuses

Hashem

Abdou

Mursi

et al. 2019

Int J Pharm Pharm Sci

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“…Furthermore, the dissolution profile curve was prepared by plotting percentage release of drug versus time of sample withdrawal. As per USP, the tablets were considered to comply with the standards if at least 80% of the drug released in 30 min (14,24). The difference factor (f 1 ) and similarity factor (f 2 ) for all generic products were determined with reference to the innovator product.…”

Section: Dissolution Testmentioning

confidence: 99%

Assessment of Physicochemical Properties and Comparison of Dissolution Profiles of Metformin Hydrochloride Tablets in Saudi Arabia

Bratty¹,

Alhazmi²,

Alam³

et al. 2020

Dissolution Technol.

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Although prevalence of substandard or counterfeit drugs is a world-wide problem, poor and developing countries are affected the most. To be a quality product, drug formulation must comply with certain standards. Consequently, in this study, metformin hydrochloride (MH) tablets (500 mg) available in the Saudi Arabian market were assessed through various pharmacopeial quality control tests. Parameters including weight variation, hardness, friability, drug content, and disintegration time were evaluated. Results were within acceptable limits for all selected products (nine generic and an innovator). Fourier-transform infrared spectroscopy (FT-IR) spectra of MH for all tested products were completely superimposed with that of the pure drug, confirming the use of correct active ingredient in all tablet formulations. The products were also evaluated by comparing the dissolution profile of the generic products with the innovator brand in pH 6.8 phosphate buffer. The range of percent drug release in 30 min was 82.71-98.43%, in comparison to 91.86% for reference product, which complies with the USP-NF specification of at least 80% drug release in 30 min. The difference factor (f 1 ), similarity factor (f 2 , except product H), and dissolution efficiency revealed that the dissolution profiles of the tested products were comparable to that of the reference product. These results show that the tested generic products were biopharmaceutically similar (except product H) to the innovator formulation. Therefore, the consumer can select any one of these equivalent products as a substitute for innovator product in case of cost concern or unavailability.

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“…The similarity factor was calculated only if either the reference or test products released less than 85% of the active ingredient within 15 min with n = 12 (12).…”

Section: Statistical Analysesmentioning

confidence: 99%

In Vitro Dissolution Profiles of Two Diltiazem Tablet Formulations and a Compounded Capsule Formulation: A Comparative Study

Souza¹,

Pereira²,

Nogueira³

et al. 2017

Dissolution Technol.

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The dissolution test is usually employed to evaluate the performance of drug products. In this study, we compared the in vitro dissolution profiles of two diltiazem hydrochloride tablet formulations with that of a diltiazem hydrochloride compounded capsule formulation. Other characteristics investigated were average weight, drug content, disintegration, and uniformity of dosage units according to the USP monograph. The paddle apparatus was set at 75 rpm in 900 mL of water at 37.0 ± 0.1 °C. Samples of 10 mL were withdrawn at 15, 30, 60, 120, 180, and 210 min without replacement and immediately filtered with 0.45-µm PVDF syringe filters. The samples were then analyzed employing a spectrophotometer at 237 nm. The similarity (f 2 ) and difference (f 1 ) factors were calculated for dissolution profile comparison. The drug contents of the reference, generic, and compounded products were 100.01%, 93.17%, and 98.48%, respectively. All of the products showed suitable acceptance values for drug content uniformity (3.16, 8.37, and 4.76 for reference drug, generic drug, and compounded capsule, respectively). The generic drug formulation showed a calculated f 2 value between 50 and 100 and an f 1 value less than 15. It was not possible to calculate the f 1 and f 2 values for the compounded capsules because they showed a drug release greater than 85% in 15 min. The generic and reference drugs were similar in relation to all tests. Furthermore, the generic and reference drug dissolution profiles were similar. The compounded capsules, which readily released the active ingredient, were not adequate only in the dissolution test. Further studies are necessary to investigate if the quick release of diltiazem from the drug products may pose any risks for patients, especially in Brazil where the compounded capsules are prescribed interchangeably with the reference drug.

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Comparing the Dissolution Profiles of Seven Metformin Formulations in Simulated Intestinal Fluid

Cited by 14 publications

References 8 publications

Comparative in Vitro Dissolution Study on Metformin Market Products Using Different Dissolution Apparatuses

Comparative in Vitro Dissolution Study on Metformin Market Products Using Different Dissolution Apparatuses

Assessment of Physicochemical Properties and Comparison of Dissolution Profiles of Metformin Hydrochloride Tablets in Saudi Arabia

In Vitro Dissolution Profiles of Two Diltiazem Tablet Formulations and a Compounded Capsule Formulation: A Comparative Study

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