Application of the SeDeM Expert System in Studies for Direct Compression Suitability on Mixture of Rhodiola Extract and an Excipient

Wan, Shulin; Yang, Rui; Zhang, Han; Li, Xuelian; Gu, Mingxian; Guan, Tianbing; Ren, Jianbing; Sun, Hai; Dai, Chuanyun

doi:10.1208/s12249-019-1320-4

Cited by 15 publications

(3 citation statements)

References 19 publications

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“…The developed DROT-FDGs were evaluated in terms of particle size distribution, relative homogeneity index, particles <160 µm, DROT-HCl content, and dissolution behavior. The particle size distribution and relative homogeneity index tests are described extensively in studies where the SeDeM/SeDeM-ODT expert systems are used to develop conventional or orodispersible tablets [ 26 , 27 , 28 , 29 , 30 , 31 , 32 ].…”

Section: Methodsmentioning

confidence: 99%

The Influence of the Intergranular Superdisintegrant Performance on New Drotaverine Orodispersible Tablet Formulations

Vlad,

Pintea,

Chirteș

et al. 2023

Pharmaceutics

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The main objective of this study consists in establishing the influence of the intergranular superdisintegrant on the specific properties of drotaverine hydrochloride fast-dissolving granules (DROT-FDGs) and orodispersible tablets (DROT-ODTs). The orodispersible tablets were obtained by the compression of the FDGs and excipient mixture with an eccentric tableting machine. To develop DROT-ODTs, two types of superdisintegrant excipients in different concentrations (water-soluble soy polysaccharides (SSP) (1%, 5%) and water-insoluble soy polysaccharides—Emcosoy® STS IP (EMCS) (1%, 3%, 5%)) were used, resulting in five formulations (D1–D5). The DROT-FDGs and the DROT-ODTs were subjected to pharmacotechnical and analytical evaluation. All the orodispersible tablets obtained respect the quality requirements in terms of friability (less than 1%), crushing strength (ranging between 52 N for D2 and 125.5 N for D3), and disintegration time (<180 s). The in vitro release of drotaverine from ODTs showed that all formulations presented amounts of active substance released greater than 85% at 10 min. The main objective, developing 30 mg DROT-ODTs for children aged between 6 and 12 years by incorporating the API in FDGs, was successfully achieved.

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Section: Methodsmentioning

confidence: 99%

The Influence of the Intergranular Superdisintegrant Performance on New Drotaverine Orodispersible Tablet Formulations

Vlad,

Pintea,

Chirteș

et al. 2023

Pharmaceutics

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“…Recently Wan et al corrected the DC properties of rhodiola extract with a certain dose and variety of excipients. [17] Different materials have different properties of DC. In order to know more intuitively the range of direct pressure of all kinds of materials, Su-Negre et al have characterized 51 kinds of DC excipients through the sSe-DeM Expert System.…”

Section: Research On Different Types Of Materialsmentioning

confidence: 99%

SeDeM Expert System：A review and new perspectives

Sun

Guan

et al. 2019

J Pharm Biopharm Res

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The SeDeM Expert System was first known as a galenic pre-formulation system, which was based on the experimental research and quantitative determination of powdered substances. And the mathematical formula provided by the SeDeM Expert System has plays an important role in the study of powder properties. The system can be used not only to evaluate the powder direct compression (DC) of excipients and active pharmaceutical ingredients (API's), but also to predict the possible formulations, so it can reduce unnecessary research and trials, and shorten the time of development. In this paper, the research development and application of SeDeM Expert System in DC was summarized, and the results showed that with a few exceptions, the system was skilled in predicting acceptable tablet formulations. Finally, the new application prospect of the system is presented, including the application of the Internet traffic and content management (iTCM) database and the new co-processed excipients.

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“…This method enables the characterisation of medicine formulations in solid pharmaceutical forms, by providing information on the physical and galenic profile of powdered substances (API and excipients) (Suñé-Negre et al, 2008. The SeDeM method has been successfully applied (as reported), in various studies (Aguilar-Díaz et al 2013;Wan et al 2019;Ahmed et al 2019).…”

Section: Introductionmentioning

confidence: 98%

Formulation and development of paediatric orally disintegrating carbamazepine tablets

Canadell-Heredia

Suñé-Pou

Nardi-Ricart

et al. 2022

Saudi Pharmaceutical Journal

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Application of the SeDeM Expert System in Studies for Direct Compression Suitability on Mixture of Rhodiola Extract and an Excipient

Cited by 15 publications

References 19 publications

The Influence of the Intergranular Superdisintegrant Performance on New Drotaverine Orodispersible Tablet Formulations

The Influence of the Intergranular Superdisintegrant Performance on New Drotaverine Orodispersible Tablet Formulations

SeDeM Expert System：A review and new perspectives

Formulation and development of paediatric orally disintegrating carbamazepine tablets

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