Statistical Comparison of Dissolution Profiles to Predict the Bioequivalence of Extended Release Formulations

Gómez-Mantilla, José-David; Schaefer, Ulrich F.; Casabó, V.G.; Lehr, Thorsten; Lehr, Claus‐Michael

doi:10.1208/s12248-014-9615-6

Cited by 11 publications

(4 citation statements)

References 47 publications

(51 reference statements)

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“…Model independent factors (f1 and f2) demonstrate the difference and similarity between reference and generic drugs by comparing percentage drug release curves. Similar drug release profiles have f1 values 0-15 and f2 values 50-100 (4,5). Differences in dissolution efficiency and 95% confidence intervals should lie within 10% of the mean for comparable dissolution profiles (6,7).…”

Section: Gc2mentioning

confidence: 92%

Comparative Dissolution Study of Various Brands of Valsartan Tablets Marketed in Pakistan

Ansari,

Amin,

Ashraf

et al. 2023

Dissolution Technol.

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The purpose of this study was to perform a comparative dissolution study of various brands of valsartan tablets marketed in Pakistan. This drug belongs to BCS class II, which has high permeability and low solubility. Four different brands of valsartan tablets (80 mg) were collected from the local market of Rawalpindi and Islamabad, labeled as A, B, C, and D. All brands were evaluated for weight variation, hardness, friability, disintegration, and dissolution. Brand A (multinational brand) was selected as a reference for having a good dissolution profile. A modelindependent approach, f1 (difference factor), f2 (similarity factor), and dissolution efficiency were used to compare the brands. Results of the dissolution study showed that f1 and f2 for all brands were within the specified limits of 0-15 for f1 and 50-100 for f2. Mean dissolution efficiency and 95% confidence intervals were within the acceptable range of ± 10% for all brands. All other quality control test results were within the acceptable ranges, except hardness of brand C. Dissolution profiles of brands B, C, and D were comparable with brand A (and have much lower prices). Therefore, brands B, C, and D can be prescribed in place of brand A, which will be more cost-effective for the patients.

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Section: Gc2mentioning

confidence: 92%

Comparative Dissolution Study of Various Brands of Valsartan Tablets Marketed in Pakistan

Ansari,

Amin,

Ashraf

et al. 2023

Dissolution Technol.

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“…The Weibull function is often used in the dissolution and release analysis of pharmaceutical preparations. 21 Because of the universal and flexible form of the Weibull function, it has been recently used to numerically describe complex plasma concentration-time curves for oral drug absorption. 22 Of the models mentioned, a onecompartment model with Weibull absorption displayed the best fit, and it was chosen as the structure model in this study.…”

Section: Ta B L Ementioning

confidence: 99%

Effects of food on the pharmacokinetics of ensartinib in healthy Chinese subjects

Shao

Ruan

Yang

et al. 2021

Clin Exp Pharma Physio

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Lung cancer is the most frequent cause of cancer-related deaths globally. According to the pathological classification of patients, >80% of all cases of lung cancer are non-small-cell lung cancer (NSCLC). Chromosomal rearrangement of the deformed lymphoma kinase (ALK) gene is detected in 3% to 8% of cases of NSCLC. 1 After the discovery of ALK rearrangement in NSCLC, it was recognized that these mutations confer sensitivity to ALK inhibition.The first-in-class ALK inhibitor crizotinib has proven more effective than first-line chemotherapy. However, the central nervous system (CNS) was the most common site of disease progression in patients receiving crizotinib because of its poor brain penetration. 2 Consequently, several second-(ceritinib, alectinib, and brigatinib) and third-generation (lorlatinib) ALK tyrosine kinase inhibitors (ALK-TKIs) have been developed to treat patients with drug-resistant mutations following treatment with first-and/or second-generation ALK-TKIs. 3

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“…8,9 For instance, firstly the basic criteria to declare similarity between the in vitro dissolution profiles (f 2 profile lacks the strong statistical justifications. 10,11 Secondly, statistical hypothesis cannot be formulated because it is impossible to evaluate the probability and rate of false positive or negative results. 12 Thirdly, the value of f 2 is sensitive to the number of time points selected for a particular dissolution profile and lastly, f 2 is insensitive to shape of dissolution curves as its results do not demonstrate the extent and degree of deviation between the in vitro dissolution profiles.…”

Section: Introductionmentioning

confidence: 99%

Application of Similarity Factor (f2) and Time Required to Drug Release (t%) Indicators for Dissolution Profiles Comparison of Paracetamol Tablets

Zeeshan¹,

Phang²,

Sheshala³

2020

IJPER

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Introduction: The comparison of in vitro dissolution profiles is an integral step during the development of any generic product. However, using merely similarity factor (f 2) as a dissolution parameter may not be adequate. Objectives: The present study was conducted to explore whether f 2 alone suffices to adequately compare the dissolution profiles of tablets or both f 2 and time required to percentage drug release (t %) generate closely similar results. Methods: The reference (R) and two generic paracetamol test products (T1 and T2), each containing 500 mg drug were subjected to dissolution studies under different pH conditions namely 1.2, 4.5 and 6.8. The amount of drug released was quantified using validated UV-Visible spectrophotometric method and results were analysed using bootstrap similarity factor approach and the time required to release 25% (t 25%), 50% (t 50%) and 75% (t 75%) of drug. The data were evaluated statistically using one-way multivariate analysis of variance (MANOVA) followed by post hoc Tukey's test. Results: T1 tablets demonstrated similarity in the drug release with R product at pH 1.2. Although T2 product did not show any similarity with R at all pH values used yet it depicted rapid release profiles pivotal for an immediate-release product. Both f 2 and t % exhibited closely similar results for all sets of data. Conclusion: Application of similarity factor alone may provide reliable results for comparison of dissolution profile. Nevertheless, the time required to release t 25% , t 50% and t 75% may be used along with similarity factor for better interpretation of in vitro dissolution results particularly for potent drugs.

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Statistical Comparison of Dissolution Profiles to Predict the Bioequivalence of Extended Release Formulations

Cited by 11 publications

References 47 publications

Comparative Dissolution Study of Various Brands of Valsartan Tablets Marketed in Pakistan

Comparative Dissolution Study of Various Brands of Valsartan Tablets Marketed in Pakistan

Effects of food on the pharmacokinetics of ensartinib in healthy Chinese subjects

Application of Similarity Factor (f2) and Time Required to Drug Release (t%) Indicators for Dissolution Profiles Comparison of Paracetamol Tablets

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