A new principal component analysis-based approach for testing “similarity” of drug dissolution profiles

Maggio, Rubén M.; Castellano, Patricia M.; Kaufman, Teodoro S.

doi:10.1016/j.ejps.2008.02.009

Cited by 55 publications

(35 citation statements)

References 32 publications

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“…These methods allow the use of one arbitrarily chosen value for the diff erence allowed between the test and reference products (17). Our present results as well as some literature data (11,14) suggest that diff erences both in the level and the shape of dissolution curves are important when comparing profi les.…”

Section: Comparison Of Dissolution Profi Lessupporting

confidence: 56%

“…The f 2 factor is a logarithmic transformation of the sum-squared error of diff erences between the test and the reference products over all time points. It is known from the literature that these factors are sensitive to the measurements beyond 85 % dissolution (11,13,14). In the present work, the values of f 1 and f 2 were calculated twice, once for the dissolution results up to 40 min (the time at which the dissolution profi les nearly reached the fi nal plateau) and up to 60 min (the time at which the dissolution process was completed).…”

Section: Comparison Of Dissolution Profi Lesmentioning

confidence: 99%

“…A wide range of methods are available for comparison of dissolution profi le data (11)(12)(13)(14). There are also offi cial recommendations in this area (15,16 …”

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confidence: 99%

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Dissolution profiles of perindopril and indapamide in their fixed-dose formulations by a new HPLC method and different mathematical approaches

et al. 2015

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A new HPLC method was introduced and validated for simultaneous determination of perindopril and indapamide. Validation procedure included specifi city, sensitivity, robustness, stability, linearity, precision and accuracy. The method was used for the dissolution test of perindopril and indapamide in three fi xed-dose formulations. The dissolution procedure was optimized using diff erent media, different pH of the buff er, surfactants, paddle speed and temperature. Similarity of dissolution profi les was estimated using diff erent model-independent and model-dependent methods and, additionally, by principal component analysis (PCA). Also, some kinetic models were checked for dissolved amounts of drugs as a function of time.Keywords: perindopril, indapamide, dissolution profi les, model-independent methods, model-dependent methods, PCA One example in the area of anti-hypertensive polytherapy is the use of an angiotensin converting enzyme inhibitor, e.g., perindopril, and a diuretic, e.g., indapamide (Fig. 1) in one fi xed-dose formulation (1).Bearing in mind previous reports concerning simultaneous determination of perindopril and indapamide, some spectrophotometric methods were developed (2-5). Also, a few HPLC methods were elaborated and validated in the range of offi cial requirements (5-9). However, none of the above methods was applied to the dissolution study of perindopril and indapamide in their fi xed-dose combinations.A dissolution test is necessary to control the product properties within a batch and between batches. It is also needed in bioequivalence studies where similarity of dissolution profi les between a test product and a reference product should be demonstrated (10).A wide range of methods are available for comparison of dissolution profi le data (11)(12)(13)(14). There are also offi cial recommendations in this area (15,16

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Section: Comparison Of Dissolution Profi Lessupporting

confidence: 56%

Section: Comparison Of Dissolution Profi Lesmentioning

confidence: 99%

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Dissolution profiles of perindopril and indapamide in their fixed-dose formulations by a new HPLC method and different mathematical approaches

et al. 2015

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“…Dissolution testing is used to determine long-term stability and drug product shelf life. Dissolution results can be used as a quality control tool for predicting in vivo performance of a drug product (11)(12)(13). Several guidelines on dissolution testing of solid dosage forms have been introduced by regulatory authorities like FDA.…”

Section: Introductionmentioning

confidence: 99%

Effect of Polymorphism and Application of Kinetic Models for the Evaluation of In Vitro Dissolution Profiles of an Eletriptan Hydrobromide Formulation

Kommavarapu¹,

Maruthapillai²,

Kamaraj³

et al. 2015

Dissolution Technol.

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The intent of this work was to study the effect of polymorphism on dissolution properties and to apply several methods to evaluate the dissolution profiles of immediate-release tablets containing alpha (α) and beta (β) forms of eletriptan hydrobromide (EH). The polymorphs were characterized by X-ray diffraction (XRD), differential scanning calorimetry (DSC), and diffuse reflectance infrared Fourier transform spectroscopy (DRIFTS). The dissolution conditions were USP Apparatus 2 (paddle) with 900 mL of 0.1 N HCl medium at a rotation speed of 100 rpm. The dissolution profiles were compared using model-independent, model-dependent, and statistical methods. In the model-independent approaches, dissolution efficiency (DE), mean dissolution time (MDT), difference factor (f 1 ), and similarity factor (f 2 ) were evaluated. A statistical assessment of DE data was performed using ANOVA and the t-test. Dissolution kinetics was determined using model-dependent approaches in which nine drug release mathematical models were evaluated. The dissolution profile of the α formulation was best represented by the Weibull model, and the β formulation by the Korsmeyer-Peppas model. The calculated fit factors infer that the two tablet formulations are similar with minor differences. Statistical and model-dependent approaches demonstrate that there may be a difference in the drug release mechanism.

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“…Limited studies describe the effects of different methods of analysis on the similarity outcome using a small number of dissolution profiles and/or simulated ones. [8][9][10] However, it is unclear whether the data used for evaluations represent the dissolution profiles of many formulations on the market.…”

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confidence: 99%

Comparison of Dissolution Similarity Assessment Methods for Products with Large Variations: <i>f</i><sub>2</sub> Statistics and Model-Independent Multivariate Confidence Region Procedure for Dissolution Profiles of Multiple Oral Products

Yoshida¹,

Shibata²,

Izutsu³

et al. 2017

Biological & Pharmaceutical Bulletin

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2 statistics defined in the MHLW guidelines (MHLW f 2 method) and two different Method B procedures, including a bootstrap method applied with f 2 statistics (BS method) and a multivariate analysis method using the Mahalanobis distance (MV method). The MHLW f 2 and BS methods provided similar dissolution similarities between reference and generic products. Although a small difference in the similarity assessment may be due to the decrease in the lower confidence interval for expected f 2 values derived from the large variation in individual dissolution rates, the MV method provided results different from those obtained through MHLW f 2 and BS methods. Analysis of actual dissolution data for products with large individual variations would provide valuable information towards an enhanced understanding of these methods and their possible incorporation in the MHLW guidelines.

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A new principal component analysis-based approach for testing “similarity” of drug dissolution profiles

Cited by 55 publications

References 32 publications

Dissolution profiles of perindopril and indapamide in their fixed-dose formulations by a new HPLC method and different mathematical approaches

Dissolution profiles of perindopril and indapamide in their fixed-dose formulations by a new HPLC method and different mathematical approaches

Effect of Polymorphism and Application of Kinetic Models for the Evaluation of In Vitro Dissolution Profiles of an Eletriptan Hydrobromide Formulation

Comparison of Dissolution Similarity Assessment Methods for Products with Large Variations: <i>f</i><sub>2</sub> Statistics and Model-Independent Multivariate Confidence Region Procedure for Dissolution Profiles of Multiple Oral Products

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