Uncertainty in dissolution test of drug release

Paakkunainen, Maaret; Matero, Sanni; Ketolainen, Jarkko; Lahtela‐Kakkonen, Maija; Poso, Antti; Рейникайнен, Сату-Пиа

doi:10.1016/j.chemolab.2008.12.004

Cited by 12 publications

(8 citation statements)

References 8 publications

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“…They identified kinetic and stoichiometric factors, matrix interference and mass of sample as potential sources of uncertainty [11] . Paakkunainen and collaborators [37] studied the uncertainties associated with dissolution test of drug release. According to their results, uncertainties associated with sampling error, total analytical error and the error arising from the heterogeneous samples were the main sources of uncertainty.…”

Section: Uncertainty In Pharmaceutical Analysismentioning

confidence: 99%

Measurement uncertainty in pharmaceutical analysis and its application

Traple

Saviano

Francisco

et al. 2014

Journal of Pharmaceutical Analysis

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The measurement uncertainty provides complete information about an analytical result. This is very important because several decisions of compliance or non-compliance are based on analytical results in pharmaceutical industries. The aim of this work was to evaluate and discuss the estimation of uncertainty in pharmaceutical analysis. The uncertainty is a useful tool in the assessment of compliance or non-compliance of in-process and final pharmaceutical products as well as in the assessment of pharmaceutical equivalence and stability study of drug products.

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Section: Uncertainty In Pharmaceutical Analysismentioning

confidence: 99%

Measurement uncertainty in pharmaceutical analysis and its application

Traple

Saviano

Francisco

et al. 2014

Journal of Pharmaceutical Analysis

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show abstract

“…Typical quality defects of tablets are related to weight variation between tablets for example because of poor flowability of powders,67 uneven filling of dies,178 and the tablet sticking to the die wall in the ejection phase (which can affect the texture and composition). During die filling, segregation between larger and smaller particles may occur and cause uneven distribution of mixture components in the tablet.…”

Section: Tablet Productionmentioning

confidence: 99%

“…In dissolution testing, an important quality criterion to check the consistency of manufactured batches, multivariate methods have been applied in comparison of dissolution profiles25,178,219,220 and in the prediction of dissolution profiles and behavior 200,215,, 221,222,223,224. There is a firm belief that non‐destructive methods, for example NIR, can replace the destructive dissolution test 225.…”

Section: Tablet Productionmentioning

confidence: 99%

Towards Better Process Understanding: Chemometrics and Multivariate Measurements in Manufacturing of Solid Dosage Forms

Matero

Berg

Poutiainen

et al. 2013

Journal of Pharmaceutical Sciences

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“…In these assays, the amount of drug dissolved under standardized conditions of temperature, liquid/solid interface and medium composition is quantified as a function of time. 1,5 For this purpose, the analytical procedures should consume low sample volumes, present a high sampling rate and allow sample processing under rigorously controlled experimental conditions. 6,7 In general, dissolution assays are performed with Apparatus 1 or 2, as recommended by the United States Pharmacopoeia (USP) under controlled experimental conditions (e.g., dissolution medium, total testing time and sampling time).…”

Section: Introductionmentioning

confidence: 99%

“…1 During the manufacturing process, tests must be carried out to ensure the quality of tablets, their administration safety and the bioavailability of the pharmaceutical compounds. 2,3 For this reason, assays should mimic in vivo conditions for the dissolution and absorption of drugs.…”

Section: Introductionmentioning

confidence: 99%

A multicommuted flow system for dissolution studies of Captopril in pharmaceutical preparations

Sanchez

Rocha

Melchert

et al. 2011

J. Braz. Chem. Soc.

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Um procedimento analítico em sistema de análises em fluxo com multicomutação é proposto para a determinação de captopril e construção de curvas de dissolução de medicamentos. O método é baseado na reação do fármaco com Cu(II), com posterior complexação de Cu(I) com 4,4'-dicarboxi-2,2'-biquinolina (BQA) e detecção espectrofotométrica. Foi observada resposta linear entre 25 e 300 μmol L -1 captopril, com limite de detecção de 7 μmol L -1 (99,7% de confiança). O coeficiente de variação (n = 20) e a frequência de amostragem foram 2,2% e 47 determinações por hora, respectivamente, com consumo de 290 μg de BQA e geração de 3,6 mL de resíduo por determinação. Os resultados para 7 amostras de preparações farmacêuticas concordaram com os obtidos pelo procedimento volumétrico de referência com 95% de confiança. Perfis de dissolução obtidos com um aparato construído no laboratório foram concordantes com os relatados na literatura, com coeficiente de variação de 1,8% para três replicatas do produto de referência.A flow-based analytical procedure exploiting multicommutation is proposed for captopril determination and the construction of dissolution curves. The procedure is based on the redox reaction between Cu(II) and the drug with the subsequent complexation of Cu(I) with 4,4'-dicarboxy-2,2'-bichinoline (BCA) and spectrophotometric detection. A linear response was observed between 25 and 300 μmol L -1 captopril and the detection limit was estimated as 7 μmol L -1 (99.7% confidence level). The coefficient of variation (n = 20) and sampling rate were 2.2% and 47 determinations per hour, respectively, consuming 290 μg of BCA and generating 3.6 mL of waste per determination. The results for seven pharmaceutical samples agreed with those obtained by the reference volumetric procedure at the 95% confidence level. The dissolution profiles attained with a lab-made dissolution apparatus agreed with those reported in the literature, with a coefficient of variation of 1.8% for three replicates of the reference product.

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Uncertainty in dissolution test of drug release

Cited by 12 publications

References 8 publications

Measurement uncertainty in pharmaceutical analysis and its application

Measurement uncertainty in pharmaceutical analysis and its application

Towards Better Process Understanding: Chemometrics and Multivariate Measurements in Manufacturing of Solid Dosage Forms

A multicommuted flow system for dissolution studies of Captopril in pharmaceutical preparations

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