Development and validation of dissolution test for ritonavir soft gelatin capsules based on in vivo data

Rossi, Rochele Cassanta; Dias, Carolina Lupi; Donato, Eliane Maria; Martins, Laura Alegria; Bergold, Ana María; Fröehlich, Pedro Eduardo

doi:10.1016/j.ijpharm.2007.01.036

Cited by 35 publications

(19 citation statements)

References 10 publications

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“…Percentage recoveries of 100 ± 5 % have been previously recommended for the accuracy test [15]. As mean recoveries ranged from 100.1% to 103.5%, this showed that the dissolution method was accurate.…”

Section: Repeatabilitymentioning

confidence: 70%

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Development and Validation of a Dissolution Test for 6 mg Deflazacort Tablets

Sperandeo

Kassuha

2009

Sci. Pharm.

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The aim of this study was to develop and validate a dissolution test for the quality control of deflazacort (DEF) tablets, a drug mainly used for the prevention of organ transplantation rejection, labeled as containing 6 mg of active pharmaceutical ingredient (API), using an RP-HPLC method. After testing sink conditions and stability at 37°C, DEF was found to be unstable, and decomposed as a function of the dissolution media. However, in water the decomposition was not significant enough to interfere with the determination of dissolution for DEF. The best conditions to carry out the dissolution test were paddle at 50 rpm, with 500 mL of deaerated water at 37°C. Under these conditions, the in vitro release profiles of 6 mg DEF tablets produced by two different laboratories, representing all approved products in the national market, shown to be dissimilar. A correlation between disintegration and in vitro dissolution was found for the two investigated formulations. The developed dissolution test was adequate for its purpose and can be applied for the quality control of 6 mg DEF tablets.

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Section: Repeatabilitymentioning

confidence: 70%

“…The dissolution test and the HPLC method were validated through the determination of stability, specificity, linearity, accuracy/precision and ruggedness [15,17,27,28].…”

Section: Iid Dissolution Test and Hplc Validationmentioning

confidence: 99%

Development and Validation of a Dissolution Test for 6 mg Deflazacort Tablets

Sperandeo

Kassuha

2009

Sci. Pharm.

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“…It is well established that maintaining the sink condition is a crucial requirement for in vitro drug release studies in the pharmaceutical field (25,26). The sink condition means that drug concentration in the dissolution or release medium may not exceed 10 to 33% of drug solubility in these fluids (27,28). Aiming to maintain this condition to assess the in vitro drug release profiles, several approaches have been adopted, like the use of surfactants, solvents, and co-solvents in release medium as well as the use of the USP apparatus IV (26).…”

Section: Discussionmentioning

confidence: 99%

Assessing the In Vitro Drug Release from Lipid-Core Nanocapsules: a New Strategy Combining Dialysis Sac and a Continuous-Flow System

et al. 2015

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Abstract. The in vitro assessment of drug release from polymeric nanocapsules suspensions is one of the most studied parameters in the development of drug-loaded nanoparticles. Nevertheless, official methods for the evaluation of drug release from submicrometric carriers are not available. In this work, a new approach to assess the in vitro drug release profile from drug-loaded lipid-core nanocapsules (LNC) was proposed. A continuous-flow system (open system) was designed to evaluate the in vitro drug release profiles from different LNC formulations containing prednisolone or clobetasol propionate (LNC-CP) as drug model (LNC-PD) using a homemade apparatus. The release medium was constantly renewed throughout the experiment. A dialysis bag containing 5 mL of formulation (0.5 mg mL −1 ) was maintained inside the apparatus, under magnetic stirring and controlled temperature (37°C). In parallel, studies based on the conventional dialysis sac technique (closed system) were performed. It was possible to discriminate the in vitro drug release profile of different formulations using the open system. The proposed strategy improved the sink condition, by constantly renewing the release medium, thus maintaining the drug concentration farther from the saturated concentration in the release medium. Moreover, problems due to sampling errors can be easily overcome using this semi-automated system, since the collection is done automatically without interference from the analyst. The system proposed in this paper brings important methodological and analytical advantages, becoming a promising prototype semi-automated apparatus for performing in vitro drug release studies from drug-loaded lipid-core nanocapsules and other related nanoparticle drug delivery systems.

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“…IV-IVC has been defined as a predictive mathematical model describing the relationship between an in vitro property of a dosage form and its in vivo response [5]. In Rossi et al [6], it is shown how IV-IVC data is used to develop and validate a dissolution test for immediate release ritonavir soft gel capsules (Norvir ®). With ritonavir being a poorly soluble drug, dissolution is regarded as a predictor of in vivo performance, hence may be classified as a CQA.…”

Section: Cqamentioning

confidence: 99%