Development of Discriminating Method for Dissolution of Aceclofenac Marketed Formulations

Soni, Tejal; Nagda, Chirag D.; Gandhi, Tejal; Chotai, Narendra P.

doi:10.14227/dt150208p31

Cited by 48 publications

(32 citation statements)

References 19 publications

(9 reference statements)

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“…That is why the dissolution test for this product was developed as well as verified for other medicines available in the world-wide market. 22 Apparatus 2 (paddle) was used for pharmaceutical form tablet and 50 or 75 rpm as stirring speed, following the guideline for dissolution tests. 14 The influence of stirring speed can be observed in Figure 2.…”

Section: Development Of Dissolution Methodsmentioning

confidence: 99%

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Development of dissolution method for benznidazole tablets

Lima¹,

Sobrinho²,

Silva³

et al. 2009

Quím. Nova

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Recebido em 8/9/08; aceito em 14/4/09; publicado na web em 17/9/09The aim of this work was the development of a dissolution method for benznidazole (BNZ) tablets. Three different types of dissolution media, two stirring speeds and apparatus 2 (paddle) were used. The accomplishment of the drug dissolution profiles was compared through the dissolution efficiency. The assay was performed by spectrophotometry at 324 nm. The better conditions were: sodium chloride\ hydrochloride acid buffer pH 1.2 with stirring speed of 75 rpm, volume of 900 mL and paddle as apparatus. Ahead of the results it can be concluded that the method developed consists in an efficient alternative for assays of dissolution for benznidazole tablets.

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Section: Development Of Dissolution Methodsmentioning

confidence: 99%

“…A way also used for comparing dissolution is the dissolution efficiency (DE), 22 according to Table 3 differences between the tested conditions can be verified, showing condition IV as the one with …”

Section: Development Of Dissolution Methodsmentioning

confidence: 99%

Development of dissolution method for benznidazole tablets

Lima¹,

Sobrinho²,

Silva³

et al. 2009

Quím. Nova

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“…Drugs with limited water solubility are usually lipophilic, and drug release is usually the rate-limiting process for oral drug absorption of these substances 1 .…”

Section: Introductionmentioning

confidence: 99%

Dissolution Method Development and Enhancement of Solubility of Clopidogrel Bisulfate

Jassim¹,

Hussein²

2017

Int. Res. J. Pharm.

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Dissolution of drug is the rate determining step for oral absorption of the poorly water soluble drugs and solubility is the basic requirement for the absorption of the drug from GIT. The development of a soulful dissolution procedure for drug products with lower water solubility has been a provocation to both the pharmaceutical industry and the agencies that regulate them. This study demonstrates the systematic development o f a discriminatory dissolution method for clopidogrel bisulfate, a BCS class II drug exhibiting highly pH-dependent solubility. The method was developed by testing solubility of clopidogrel bisulfate in different concentrations of sodium lauryl sulfate. The results showed 900 ml of 0.1 N HCl and phosphate buffer pH 6.8 containing 1% SLS with a paddle speed of 50 rpm was selected as discriminative dissolution test conditions for clopidogrel bisulfate tablets. In conclusion surfactants and pH changes are very effective ways to increase solubility. The in vitro dissolution must serve as both a quality control tool and a potential surrogate marker of drug bioavailability and bioequivalence.

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“…The strategy to determine the solubility and permeability properties of drugs uses a biopharmaceutical classification system to classify drugs into four basic groups (Amidon et al, 1995). The development of a dissolution method for a drug product with limited water solubility and combinations of drugs has been a challenge for both the pharmaceutical industry and regulatory agencies (Soni et al, 2008;Dressman et al, 1998;Oliveira et al, 2009). Currently, there is increased demand for biorelevant dissolution media, which have the ability to discriminate changes in the formulation and manufacturing process (He et al, 2004;Panikumar et al, 2012;Menegola et al, 2007).…”

Section: Introductionmentioning

confidence: 99%

Development of dissolution test method for a telmisartan/amlodipine besylate combination using synchronous derivative spectrofluorimetry

Anumolu

Neeli

Anuganti

et al. 2014

Braz. J. Pharm. Sci.

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The dissolution process is considered an important in vitro tool to evaluate product quality and drug release behavior. Single dissolution methods for the analysis of combined dosage forms are preferred to simplify quality control testing. The objective of the present work was to develop and validate a single dissolution test for a telmisartan (TEL) and amlodipine besylate (AML) combined tablet dosage form. The sink conditions, stability and specificity of both drugs in different dissolution media were tested to choose a discriminatory dissolution method, which uses an USP type-II apparatus with a paddle rotating at 75 rpm, with 900 mL of simulated gastric fluid (SGF without enzymes) as the dissolution medium. This dissolution methodology provided good dissolution profiles for both TEL and AML and was able to discriminate changes in the composition and manufacturing process. To quantify both drugs simultaneously, a synchronous first derivative spectrofluorimetric method was developed and validated. Drug release was analyzed by a fluorimetric method at 458 nm and 675 nm for AML and TEL, respectively. The dissolution method was validated as per ICH guidance.Uniterms: Combined dosage forms/quality control. Dissolution test/combined dosage forms. Telmisartan. Amlodipine besylate. Spectrofluorimetry/quantification analysis.O processo de dissolução é considerado como uma importante ferramenta in vitro para avaliar a qualidade do produto e o comportamento de liberação do fármaco. Prefere-se um ensaio único de dissolução para formas farmacêuticas contendo associação de fármacos pela simplificação dos testes de controle de qualidade. O objetivo do presente trabalho foi desenvolver e validar um teste de dissolução único para forma farmacêutica comprimidos contendo telmisartana (TEL) e besilato de anlodipino (AML) associados. Condições "sink", estabilidade e especificidade de ambos os fármacos nos diferentes meios de dissolução foram avaliadas para selecionar um método de dissolução discriminatório, que utiliza um aparato do tipo II da USP, com pás girando a 75 rpm e 900 mL de fluido gástrico simulado (SGF sem enzima) como o meio de dissolução. Estas condições proporcionaram bons perfis de dissolução para ambos, TEL e AML, sendo capaz de discriminar as mudanças na composição e processo de fabricação. Para quantificar os dois fármacos simultaneamente, um método de fluorescência derivada sincronizado foi desenvolvido e validado. A quantidade de fármaco liberado foi analisada pelo método fluorimétrico em 458 e 675 nm para a AML e TEL, respectivamente. O método de dissolução foi validado de acordo com a orientação da ICH.Unitermos: Forma farmacêutica com associação/controle de qualidade. Teste de dissolução/forma farmacêutica com associação. Telmisartana. Besilato de anlodipino. Espectrofluorimetria/análise quantitativa.

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Development of Discriminating Method for Dissolution of Aceclofenac Marketed Formulations

Cited by 48 publications

References 19 publications

Development of dissolution method for benznidazole tablets

Development of dissolution method for benznidazole tablets

Dissolution Method Development and Enhancement of Solubility of Clopidogrel Bisulfate

Development of dissolution test method for a telmisartan/amlodipine besylate combination using synchronous derivative spectrofluorimetry

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