Acute and subchronic oral toxicity studies of hydrogenated curcuminoid formulation ‘CuroWhite’ in rats

Gopi, Sreeraj; Jacob, Joby; Mathur, Kotrappa Y.

doi:10.1016/j.toxrep.2016.10.007

Cited by 20 publications

(19 citation statements)

References 16 publications

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“…Similarly, LA administration did not alter kidney tissue, which showed organised pyramidal structure without any tubular necrosis and inflammation in the cortex and inner portion of the medulla region. However, the toxic effect of any compound on the kidney is demonstrated by changes in the serum creatinine or urea level (Gopi, Jacob & Mathur, 2016). Finding from this study reveals the harmless nature of LA on renal function by establishing the outcomes from histopathological analysis, which did not notice lesion or necrotic marks upon LA administration.…”

Section: Discussionmentioning

confidence: 65%

Food additive “lauric acid” possess non-toxic profile on biochemical, haematological and histopathological studies in female Sprague Dawley (SD) rats

Khan

Aamir

Sisinthy

et al. 2020

PeerJ

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Background Lauric acid (LA), a common constituent of coconut oil, is used as food additives and supplements in various formulations. Despite various potential pharmacological properties, no scientific evidence on its dose-related toxicity and safety is available till date. Objective The current study was conducted to evaluate acute oral toxicity of LA on normal rats. Methods The study was conducted in accordance with the Organization for Economic Co-operation and Development guidelines (OECD 423) with slight modifications. LA was administered orally to female Sprague Dawley (SD) rats (n = 6/group) at a single dose of 300 and 2,000 mg/kg body weight, respectively, while normal control received vehicle only. Animals from all the three groups were monitored for any behavioural and toxicological changes and mortality for two weeks. Food and fluid consumption, body weight was monitored on daily basis. At the end (on day 15th) of the experimental period, blood was collected for haematological and biochemical analysis. Further, all the animals were euthanized, and internal organs were harvested for histopathological investigation using four different stainings; haematoxylin and eosin, Masson trichrome, Periodic Acid Schiff and Picro Sirius Red for gross pathology through microscopical observation. Results The study results showed no LA treatment-related mortality and morbidity at two different dosages. Daily food and water consumption, body weight, relative organ weight, haematological, and biochemical analysis were observed to be normal with no severe alterations to the internal tissues. Conclusion The current finding suggests that single oral administration of LA, even up to 2,000 mg/kg body weight, did not exhibit any signs of toxicity in SD rats; thus, it was safe to be used on disease models in animals.

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Section: Discussionmentioning

confidence: 65%

Food additive “lauric acid” possess non-toxic profile on biochemical, haematological and histopathological studies in female Sprague Dawley (SD) rats

Khan

Aamir

Sisinthy

et al. 2020

PeerJ

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“…No differences were found in growth between the control group and the test animals. The food consumption of male and female rats of control and experimental groups was similar, indicating that the feed intake and utilization was not affected (Gopi et al, 2016).…”

Section: Discussionmentioning

confidence: 85%

Preclinical 28 days sub-chronic toxicity study of novel formulation of metoprolol tartrate on albino rats using statistical tool

Siddique¹,

Das²,

Abdul³

et al. 2018

Afr. J. Pharm. Pharmacol.

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The experimental study mainly focused on evaluation of sub-chronic oral toxicity of sustained formulation of metoprolol succinate. After the formulation development of multiparticulate sustained release capsules, there was an urgent need to analyze their in vivo bioavailability in healthy normal human volunteers. Prior to use in human population, a subchronic oral toxicity study was performed on Swiss Albino rats, of the final formulated product to assess the possible therapeutic outcome and related toxicity. The final objective of the study is to find out the pharmacological interaction between the drugs and the excipients that may lead to toxicity to human volunteers. The sustained release formulation of Metoprolol tartrateat was administered in different dose according to the 28 days of study dosing schedule in 48 albino Wistar rats of either sex (24 males and 24 females); periodical safety and efficacy observation were done followed by blood chemistry, hematology and histopathological examination at the end of the study. All the animals were found alive after the study period. No behavioral abnormalities were found in the study animals. Statistical analysis of the results including various parameters like body weight, blood chemistry, hematology and histopathological evaluation did not produce any major differences between control and treated groups. The reformulated sustained release hydroxy propyl methyl cellulose based granules of metoprolol tartrate did not cause any subchronic toxicity to the study animals under experimental conditions.

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“…Done with single oral dose of 2000 mg/kg for 3 extract groups of 6 albino rats (3 males and 3 females in each group) weighing 155-215 gm. 16 Similarly, one control group of 6 rats administered orally distilled water (1 ml/100 g)…”

Section: Preliminary Acute Toxicity Studymentioning

confidence: 99%

Correlation between the in-vitro and in-vivo Antihyperglycemic Effect of Ocimum Sanctum, Trigonella Foenum Graecum and Curcuma Longa

Sd¹,

Muniappan²

2020

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This study is carried out to investigate the correlation between the in-vitro and in-vivo studies which demonstrates the antihyperglycemic effect of Trigonella foenum graecum, Ocimum sanctum and Curcuma longa extracts. Methanolic seed extract of Trigonella foenum graecum, methanolic leaf extract of Ocimum sanctum, ethyl acetate rhizomes extract of Curcumina longa are prepared and supplied by Sami labs, Bangalore, India on request. In-vitro studies such as alpha glucosidase inhibitory and DPP-IV inhibitory activity were done for all the three extracts as per previous studies. After Institutional animal ethical committee clearance male albino rats (155-215 g) were divided into 5 groups. Each group consists of randomly assigned 6 albino rats. The placebo (Normal saline) control group, Standard (Vildagliptin) group and 3 above mentioned extract groups. Oral glucose tolerance test (OGTT) was done. Blood samples were collected for blood sugar estimation at-30 (before extract),0, 15, 45 minutes and blood sugar levels were done by enzymatic assay. Results: The maximum alpha-glucosidase inhibitory activity at 100 μg/ml by Trigonella foenum graecum extract was 68% with IC 50 value of 57.25, Ocimum sanctum leaf extract was 65% with IC 50 value of 59.55, Curcuma longa was 72% with IC 50 value of 56.79 when compared to the Acarbose (STD) of 94% with IC 50 values of 42.78. The maximum % of DPP IV inhibition at 320 μg/ml of Trigonella foenum graecum extract was 77.84% with IC 50 value of 52.26, Ocimum sanctum extract was 86.98% with IC 50 value of 46.08 and Curcuma longa was 76.47% with IC 50 value of 55.06 when compared to the Vildagliptin (STD) was 80.15% with IC 50 value of 22.98. The OGTT results of Ocimum sanctum (200 mg/kg) shows reduction in blood glucose (p=<0.05) at 15 minutes and significant reduction (p=<0.001) at 45 minutes and Trigonella foenum graecum (2 gm/kg) showed significant reduction in blood glucose (p=<0.001) at 15 minutes when compared to control. Further clinical studies are necessary to establish the therapeutic potential of these extracts in the treatment of type 2 diabetes mellitus. Conclusion: Ocimum sanctum leaf extract, Trigonella foenum graecum seed extract shows significant alpha-glucosidase and DPP-IV inhibitory activity which correlates with the antihyperglycemic effects by in-vivo oral glucose tolerance test. Further clinical studies are necessary to establish the therapeutic potential of these extracts in the treatment of type 2 diabetes mellitus.

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Acute and subchronic oral toxicity studies of hydrogenated curcuminoid formulation ‘CuroWhite’ in rats

Cited by 20 publications

References 16 publications

Food additive “lauric acid” possess non-toxic profile on biochemical, haematological and histopathological studies in female Sprague Dawley (SD) rats

Food additive “lauric acid” possess non-toxic profile on biochemical, haematological and histopathological studies in female Sprague Dawley (SD) rats

Preclinical 28 days sub-chronic toxicity study of novel formulation of metoprolol tartrate on albino rats using statistical tool

Correlation between the in-vitro and in-vivo Antihyperglycemic Effect of Ocimum Sanctum, Trigonella Foenum Graecum and Curcuma Longa

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