Forced degradation studies to assess the stability of drugs and products

Singh, Saranjit; Junwal, Mahendra; Modhe, Gajanan; Tiwari, Harsita; Kurmi, Moolchand; Parashar, Neha; Sidduri, Padmaja

doi:10.1016/j.trac.2013.05.006

Cited by 191 publications

(107 citation statements)

References 32 publications

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“…Stability of a product during its self-life is an important aspect in the successful development of dosage form (Singh et al, 2013). Hence, a well-designed stability-testing plan is essential for the development of NE.…”

Section: Stability Of Nesmentioning

confidence: 99%

Perspectives of nanoemulsion assisted oral delivery of docetaxel for improved chemotherapy of cancer

et al. 2014

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Context: Nanoemulsions (NE) are one of the robust delivery tools for drugs due to their higher stability and efficacy. Objectives: The purpose of present investigation is to develop stable, effective and safe NE of docetaxel (DTX). Methods: Soybean oil, lecithin, Pluronic F68, PEG 4000 and ethanol were employed as excipients and NEs were prepared by hot homogenization followed by ultra-sonication. NEs were optimized and investigated for different in vitro and in vivo parameters viz. droplet size, poly dispersity index, charge; zeta potential, drug content and in vitro drug release, in vitro cytotoxicity, in vitro cell uptake and acute toxicity. Transmission electron microscopy was performed to study morphology and structure of NEs. Stability studies of the optimized formulation were performed. Results: Droplet size, poly dispersity index, zeta potential, drug content and in vitro drug release were found to be 233.23 ± 4.3 nm, 0.24 ± 0.010, À43.66 ± 1.9 mV, 96.76 ± 1.5%, 96.25 ± 2.1%, respectively. NE F11 exhibited higher cell uptake (2.83 times than control) and strong cytotoxic activity against MCF-7 cancer cells (IC 50 ; 13.55 ± 0.21 mg/mL at 72 h) whereas no toxicity or necrosis was observed with liver and kidney tissues of mice at a dose of 20 mg/kg. Transmission electron microscopy ensured formation of poly-dispersed and spherical droplets in nanometer range. NE F11 (values indicated above) was selected as the optimized formulation based on the aforesaid parameters. Conclusion: Conclusively, stable, effective and safe NE was developed which might be used as an alternative DTX therapy.

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Section: Stability Of Nesmentioning

confidence: 99%

Perspectives of nanoemulsion assisted oral delivery of docetaxel for improved chemotherapy of cancer

et al. 2014

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“…Sometimes chemical interactions between the excipients and the drug can occur and lead to decrease in stability [13].…”

Section: Factors Influencing Drug Stabilitymentioning

confidence: 99%

Stability of a Dosage Form and Forced Degradation Studies

Sattar¹,

Basheer²,

Qamar³

2016

J Bioequiv Availab

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“…The book [33] and three other reviews [35][36][37] deal with forced (or stress) degradation studies. The identification and the structure elucidation of (potential) degradants formed in the course of these studies is an important step in the development of a new drug or a dosage form in order to see the degradation pathway of the drug substance under more severe conditions than the normal storage conditions.…”

Section: Identification Of Degradants In Drugs and Drug Productsmentioning

confidence: 99%

Identification in drug quality control and drug research

Gǒrög

2015

TrAC Trends in Analytical Chemistry

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Forced degradation studies to assess the stability of drugs and products

Cited by 191 publications

References 32 publications

Perspectives of nanoemulsion assisted oral delivery of docetaxel for improved chemotherapy of cancer

Perspectives of nanoemulsion assisted oral delivery of docetaxel for improved chemotherapy of cancer

Stability of a Dosage Form and Forced Degradation Studies

Identification in drug quality control and drug research

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