Pub Date : 2017-03-27DOI: 10.4172/2167-065X.1000169
Makoto Kantah, Birbal Singh, H. Sweed, G. B. Neto, N. Kumar, Fern, O. B. Chueire, F. Marotta, A. Lorenzetti, R. Bellow, U. Solimene
The aim of the present study was to assess the efficacy of a poly-phytocompound in a model of experimental BPH. Adult 8 weeks male Wistar rats were subjected to complete orchiectomy under anesthesia (i.p. injection of 100 mg/kg body weight of sodium pentobarbital). After castration, experimental BPH was reproduced by subcutaneous injection of testosterone (20 mg/kg) for 4 weeks and, at the same time, rats randomly divided in 3 groups (15 rats each): (A) untreated BPH model; (B) BPH plus TR10/P3795 orally and (C) BPH plus finasteride (10 mg/kg body weight) administered orally as positive control group. A third group (D) of sham-operated rats served as control. Both TR10/P3795- and finasteride-treated groups showed a significant (p<0.05) and comparable reduction of all morphometric parameters (volume, weight and weight/body weight ration) which were grossly abnormal in untreated BPH model (p<0.01 vs. sham-op.). Moreover, both treatment schedule maintained a near-to-normal 3 h urinary output (p<0.01 vs. untreated BPH). Untreated BPH showed a significant increase of epithelial size and thickness and these features were equally decreased by TR10/P3795 and finasteride (p<0.05). Either TR10/P3795 or finasteride brought about a significant decrease of serum level of DHT and PAP (p<0.05 vs. sham). There was no difference among the two treatments. Prostatic tissue concentration of MDA, IL-6, TNFα and TGFβ1 significantly increased in untreated BPH model (p<0.001). All these parameters significantly decreased, although not normalised, in TR10/P3795-treated group (p<0.05 vs. sham and vs. finasteride). Finasteride determined only a not significant trend decrease of IL-6 and TNFα. Given the multifactorial aetiology of BPH, the data from this experimental model show the promising larger spectrum of mechanisms of action of the tested poly-phytocompound.
{"title":"Beneficial Effect of a Multifunctional Polyphytocompound in Experimental Prostatic Hyperplasia in Rats","authors":"Makoto Kantah, Birbal Singh, H. Sweed, G. B. Neto, N. Kumar, Fern, O. B. Chueire, F. Marotta, A. Lorenzetti, R. Bellow, U. Solimene","doi":"10.4172/2167-065X.1000169","DOIUrl":"https://doi.org/10.4172/2167-065X.1000169","url":null,"abstract":"The aim of the present study was to assess the efficacy of a poly-phytocompound in a model of experimental BPH. Adult 8 weeks male Wistar rats were subjected to complete orchiectomy under anesthesia (i.p. injection of 100 mg/kg body weight of sodium pentobarbital). After castration, experimental BPH was reproduced by subcutaneous injection of testosterone (20 mg/kg) for 4 weeks and, at the same time, rats randomly divided in 3 groups (15 rats each): (A) untreated BPH model; (B) BPH plus TR10/P3795 orally and (C) BPH plus finasteride (10 mg/kg body weight) administered orally as positive control group. A third group (D) of sham-operated rats served as control. Both TR10/P3795- and finasteride-treated groups showed a significant (p<0.05) and comparable reduction of all morphometric parameters (volume, weight and weight/body weight ration) which were grossly abnormal in untreated BPH model (p<0.01 vs. sham-op.). Moreover, both treatment schedule maintained a near-to-normal 3 h urinary output (p<0.01 vs. untreated BPH). Untreated BPH showed a significant increase of epithelial size and thickness and these features were equally decreased by TR10/P3795 and finasteride (p<0.05). Either TR10/P3795 or finasteride brought about a significant decrease of serum level of DHT and PAP (p<0.05 vs. sham). There was no difference among the two treatments. Prostatic tissue concentration of MDA, IL-6, TNFα and TGFβ1 significantly increased in untreated BPH model (p<0.001). All these parameters significantly decreased, although not normalised, in TR10/P3795-treated group (p<0.05 vs. sham and vs. finasteride). Finasteride determined only a not significant trend decrease of IL-6 and TNFα. Given the multifactorial aetiology of BPH, the data from this experimental model show the promising larger spectrum of mechanisms of action of the tested poly-phytocompound.","PeriodicalId":10410,"journal":{"name":"Clinical Pharmacology & Biopharmaceutics","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2017-03-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"84126779","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2017-03-16DOI: 10.4172/2167-065X.1000168
S. Bellah, Tahasina Jahan Adity, R. Karim, Billah Sms, Alireza Sm, Obaidullah
Alstonia scholaris (Family: Apocynaceae) has been investigated for the assessment of the biological activities. The bark of Alstonia Scholaris were extracted with pet ether, chloroform, carbon tetrachloride and methanol extract to afford 0.9 g, 0.8 g, 0.7 g, 3 g respectively for the test. We used crude pet ether, chloroform and carbon tetrachloride extract of the plant for the screening of antimicrobial activity against some selected organisms as bacteria and fungi by disc diffusion method. Out of all samples, chloroform and carbon tetrachloride extract showed strongest zone of inhibition and spectrum of activity. In vitro antioxidant activity of the extract of Alstonia scholaris was estimated by using DPPH free radical scavenging assay method. In DPPH free radical scavenging assay IC50 value of methanolic extract of Alstonia scholaris was found to be 39 g/ml which indicates mild to moderate antioxidant activity while Ascorbic acid was the standard drug. In the bioassay of brine shrimp lethality, the methanol extract showed an average of LC50 0.91 μg/ml. This indicated that the cytotoxicity exhibited by methanolic extract was very significant.
{"title":"Evaluation of Antioxidant, Antimicrobial and Cytotoxic Activity of the Bark of Alstonia scholaris","authors":"S. Bellah, Tahasina Jahan Adity, R. Karim, Billah Sms, Alireza Sm, Obaidullah","doi":"10.4172/2167-065X.1000168","DOIUrl":"https://doi.org/10.4172/2167-065X.1000168","url":null,"abstract":"Alstonia scholaris (Family: Apocynaceae) has been investigated for the assessment of the biological activities. The bark of Alstonia Scholaris were extracted with pet ether, chloroform, carbon tetrachloride and methanol extract to afford 0.9 g, 0.8 g, 0.7 g, 3 g respectively for the test. We used crude pet ether, chloroform and carbon tetrachloride extract of the plant for the screening of antimicrobial activity against some selected organisms as bacteria and fungi by disc diffusion method. Out of all samples, chloroform and carbon tetrachloride extract showed strongest zone of inhibition and spectrum of activity. In vitro antioxidant activity of the extract of Alstonia scholaris was estimated by using DPPH free radical scavenging assay method. In DPPH free radical scavenging assay IC50 value of methanolic extract of Alstonia scholaris was found to be 39 g/ml which indicates mild to moderate antioxidant activity while Ascorbic acid was the standard drug. In the bioassay of brine shrimp lethality, the methanol extract showed an average of LC50 0.91 μg/ml. This indicated that the cytotoxicity exhibited by methanolic extract was very significant.","PeriodicalId":10410,"journal":{"name":"Clinical Pharmacology & Biopharmaceutics","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2017-03-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"90870060","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2017-02-25DOI: 10.4172/2167-065X.1000167
F. He, N. Kumar, F. Marotta, Birbal Singh, A. Khokhlov, Manoj Kumar, A. Italia, A. Lorenzetti, Makoto Kantah, R. Catanzaro
About one fourth of all American adults and a bit less than one sixth of Europeans are reported to be affected by metabolic syndrome. Aging seem associated to a consistent increase of this phenomenon which is now clear to be associated with a low-grade pro-inflammatory cascade. Dyslipidemia is a characteristic factor involved in this multifaceted metabolic setting and this provides new avenues to non-chemical biopharmaceutical interventions. Eighty-two patients (66 males and 16 females, 38-69 as age range) with metabolic syndrome were selected randomly. Patients meeting inclusion criteria were advised to adhere to a standard balanced diet but no specific dietary calorie-restriction or life-style modifications. Two matched patients groups were assigned either to 1 tab/ dinner of drug A and another group received 1 tab/dinner of drug B, both for 3 months. Physicians and patients were blinded as for the content of the tablets except being aware that one being P3/GB-2016 while the other a looking alike placebo. A third group of 25 healthy, normal-weight subjects without any biochemical abnormalities served as control. The mean HbA1c level showed a trend decrease in group I at 3-month observation but this group showed a significant decrease of total and LDL cholesterol, non-HDL aliquot and triglycerides throughout the study period (p<0.05). Serum concentration of either MIP1α or MIF were significantly higher in dysmetabolic patients as compared to healthy control (p<0.01). Treatment with P3/GB-2016 proved to significantly decrease both parameters at 3-month observation (p<0.01). Whereas circulating levels of MCP-1 appeared showed a wide dispersion of data and appearing to be higher in those subjects with highest (n.s.). Overall, P3/GB-2016 seems to be an effective oral agent in controlling dyslipidemia and key regulatory modulator within the management of metabolic syndrome.
{"title":"Effect of an Integrated Nutraceutical Formula on Key Inflammatory Regulators in Subjects with Metabolic Syndrome Features: A Randomized, Double-Blind Study","authors":"F. He, N. Kumar, F. Marotta, Birbal Singh, A. Khokhlov, Manoj Kumar, A. Italia, A. Lorenzetti, Makoto Kantah, R. Catanzaro","doi":"10.4172/2167-065X.1000167","DOIUrl":"https://doi.org/10.4172/2167-065X.1000167","url":null,"abstract":"About one fourth of all American adults and a bit less than one sixth of Europeans are reported to be affected by metabolic syndrome. Aging seem associated to a consistent increase of this phenomenon which is now clear to be associated with a low-grade pro-inflammatory cascade. Dyslipidemia is a characteristic factor involved in this multifaceted metabolic setting and this provides new avenues to non-chemical biopharmaceutical interventions. Eighty-two patients (66 males and 16 females, 38-69 as age range) with metabolic syndrome were selected randomly. Patients meeting inclusion criteria were advised to adhere to a standard balanced diet but no specific dietary calorie-restriction or life-style modifications. Two matched patients groups were assigned either to 1 tab/ dinner of drug A and another group received 1 tab/dinner of drug B, both for 3 months. Physicians and patients were blinded as for the content of the tablets except being aware that one being P3/GB-2016 while the other a looking alike placebo. A third group of 25 healthy, normal-weight subjects without any biochemical abnormalities served as control. The mean HbA1c level showed a trend decrease in group I at 3-month observation but this group showed a significant decrease of total and LDL cholesterol, non-HDL aliquot and triglycerides throughout the study period (p<0.05). Serum concentration of either MIP1α or MIF were significantly higher in dysmetabolic patients as compared to healthy control (p<0.01). Treatment with P3/GB-2016 proved to significantly decrease both parameters at 3-month observation (p<0.01). Whereas circulating levels of MCP-1 appeared showed a wide dispersion of data and appearing to be higher in those subjects with highest (n.s.). Overall, P3/GB-2016 seems to be an effective oral agent in controlling dyslipidemia and key regulatory modulator within the management of metabolic syndrome.","PeriodicalId":10410,"journal":{"name":"Clinical Pharmacology & Biopharmaceutics","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2017-02-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"78562060","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2017-01-21DOI: 10.4172/2167-065X.1000166
Tangudu Nk, M. Vujic-Spasic
Tight regulation of systemic and cellular iron levels is required for good health. This control is ensured by hepcidin, a small peptide hormone produced predominantly by the liver. Lack of hepcidin expression or mutations affecting regulators of hepcidin expression, cause common genetic iron disorders. Hepcidin is also expressed in myeloid cells and its expression is increased after infections and in response to lipopolysaccharide. Our study uncovers that macrophages rapidly increase hepcidin expression in response to excess of heme. Moreover, we demonstrate that the underlying mechanism by which heme triggers hepcidin activation in macrophages depends on the Toll Like Receptor (TLR)-4 and the contribution of Extracellular Signal-Regulated Kinases (ERK) pathway. Our data propose the contribution of hepcidin, locally produced by macrophages, to the pathology of disorders characterized by excess of free heme, such as certain bacterial infections and hemolytic disorders. Finally, using macrophages from Hfe-deficient mice, we demonstrate that the lack of Hfe is not critical for the hepcidin induction by heme but is required to maintain basal hepcidin expression in macrophages. The findings that the levels of hepcidin in macrophages are directly controlled by the actions of Hfe in these cells expand our view on Hfe beyond the liver and as mere regulator of iron levels.
{"title":"Heme Activates Macrophage Hepcidin Expression via Toll like Receptor 4 and Extracellular Signal-Regulated Kinases Signaling Pathway","authors":"Tangudu Nk, M. Vujic-Spasic","doi":"10.4172/2167-065X.1000166","DOIUrl":"https://doi.org/10.4172/2167-065X.1000166","url":null,"abstract":"Tight regulation of systemic and cellular iron levels is required for good health. This control is ensured by hepcidin, a small peptide hormone produced predominantly by the liver. Lack of hepcidin expression or mutations affecting regulators of hepcidin expression, cause common genetic iron disorders. Hepcidin is also expressed in myeloid cells and its expression is increased after infections and in response to lipopolysaccharide. Our study uncovers that macrophages rapidly increase hepcidin expression in response to excess of heme. Moreover, we demonstrate that the underlying mechanism by which heme triggers hepcidin activation in macrophages depends on the Toll Like Receptor (TLR)-4 and the contribution of Extracellular Signal-Regulated Kinases (ERK) pathway. Our data propose the contribution of hepcidin, locally produced by macrophages, to the pathology of disorders characterized by excess of free heme, such as certain bacterial infections and hemolytic disorders. Finally, using macrophages from Hfe-deficient mice, we demonstrate that the lack of Hfe is not critical for the hepcidin induction by heme but is required to maintain basal hepcidin expression in macrophages. The findings that the levels of hepcidin in macrophages are directly controlled by the actions of Hfe in these cells expand our view on Hfe beyond the liver and as mere regulator of iron levels.","PeriodicalId":10410,"journal":{"name":"Clinical Pharmacology & Biopharmaceutics","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2017-01-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"86852440","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2017-01-01DOI: 10.4172/2167-065X.1000E128
Antoine Al Achi
According to the U.S. Centres for Disease Control and Prevention (CDC), the prevalence of essential hypertension (adults, 20 years of age or older) in the U.S.A. was estimated to be 33.5% (2013-2014 data), with an estimated death rate of 9.5 per 100,000 due to this illness [1]. The CDC reports also state that the occurrence of this disease in the population varies by age, gender, and ethnicity. Older persons, males (up to the age of 45 years), and African-Americans suffer from this condition the most [2]. Treating hypertension with antihypertensive drugs has been the mainstay for managing individuals with this condition. Surveys in the U.S.A. have shown that clinician’s choice for selecting a particular antihypertensive medication was not correlated with age, gender, ethnicity, or the medical insurance the patient had [3]. Moreover, the most prescribed medications were (in descending order) angiotensin-converting enzyme inhibitors, thiazide diuretics, angiotensin receptor blockers, calcium-channel blockers, and betablockers [3]. It is interesting to note that hypertension and osteoporosis, both are frequently encountered in older patients, share similar risk factors of genetic predisposition and environmental conditions. Moreover, antihypertensive medications can influence, positively or negatively, the bone mineral density in patients with osteoporosis [4]. In this editorial, the use of some nutraceuticals by patients suffering from essential hypertension is briefly discussed.
{"title":"Are Nutraceuticals Effective in Controlling Essential Hypertension","authors":"Antoine Al Achi","doi":"10.4172/2167-065X.1000E128","DOIUrl":"https://doi.org/10.4172/2167-065X.1000E128","url":null,"abstract":"According to the U.S. Centres for Disease Control and Prevention (CDC), the prevalence of essential hypertension (adults, 20 years of age or older) in the U.S.A. was estimated to be 33.5% (2013-2014 data), with an estimated death rate of 9.5 per 100,000 due to this illness [1]. The CDC reports also state that the occurrence of this disease in the population varies by age, gender, and ethnicity. Older persons, males (up to the age of 45 years), and African-Americans suffer from this condition the most [2]. Treating hypertension with antihypertensive drugs has been the mainstay for managing individuals with this condition. Surveys in the U.S.A. have shown that clinician’s choice for selecting a particular antihypertensive medication was not correlated with age, gender, ethnicity, or the medical insurance the patient had [3]. Moreover, the most prescribed medications were (in descending order) angiotensin-converting enzyme inhibitors, thiazide diuretics, angiotensin receptor blockers, calcium-channel blockers, and betablockers [3]. It is interesting to note that hypertension and osteoporosis, both are frequently encountered in older patients, share similar risk factors of genetic predisposition and environmental conditions. Moreover, antihypertensive medications can influence, positively or negatively, the bone mineral density in patients with osteoporosis [4]. In this editorial, the use of some nutraceuticals by patients suffering from essential hypertension is briefly discussed.","PeriodicalId":10410,"journal":{"name":"Clinical Pharmacology & Biopharmaceutics","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2017-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"86772571","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2017-01-01DOI: 10.4172/2167-065X.1000178
K. Islam, D. Sohel, Redwan Hossain, T. Sultana, H. Kawsar
Background: This study deals with the comparative in vitro dissolution and in vitro disintegration characteristics of different brands of ranitidine hydrochloride film coated tablets most commonly available in Bangladesh which reflects the in vivo study. The objective of this present study was to evaluate the in vitro kinetic studies of ranitidine hydrochloride film coated tablets available in Bangladesh. Ranitidine hydrochloride is a potent H2 blocker recommended for hyperacidity related disorders and most common OTC drugs that frequently used by the common people in the world. Methods: Twenty one brands of ranitidine hydrochloride film coated tablets available in Bangladesh drug market were assayed spectrophotometrically and their various kinetics (Zero Order, First Order, Higuchi and Hixson-Crowell) studies were performed to predict in vivo analysis. Results: In Bangladesh, commercially available twenty one brands of ranitidine hydrochloride film coated tablets were studied. The media of the study was distilled water (pH 7.5) due to identify complete organoleptic properties of Ranitidine Hydrochloride. Nine brands (RH-3, RH-5, RH-6, RH-10, RH-11, RH-12, RH-13, RH-14 and RH-17) showed delayed disintegration time instead of quick release formulation, which often claimed by those manufacturer. Other twelve brands (RH-1, RH-2, RH-4, RH-7, RH-8, RH-9, RH-15, RH-16, RH-18, RH-19, RH-20 and RH-21) showed the moderate disintegration time. The tablets were studied for in vitro dissolution behavior for 1 h in distilled water using USP reference dissolution apparatus. The in vitro dissolution profiles of the thirteen brands (RH-1, RH-2, RH-4, RH- 7, RH-8, RH-9, RH-13, RH-15, RH-16, RH-18, RH-19, RH-20 and RH-21) were fulfilled the USP in vitro dissolution specification of 80% drug release within 45 min. On the other hand, five of the total selected brands (RH-3, RH-5, RH-10, RH-12 and RH-17) were failed to fulfill the USP in vitro dissolution specification. Rest three brands (RH-6, RH-11 and RH-14) exhibited very poor release pattern among the selected brands and their drug release rate were 23%, 11% and 19% respectively after one hour study. The drug potency, multiple coefficient (from zero order, first order, Higuchi and Hixson-Crowell cube root law), similarity and dissimilarity factors were determined in this study. The predicted steady state plasma concentration determined by comparing the in vivo pharmacokinetic data of reference brand (Zantac) using superposition principle of steady state plasma levels determination. Conclusion: Most of the brands meet the official requirements, which are very essential parameters for the prediction of in vivo drug release by oral route. As a result the patients will get the proper therapeutic effect to combat against hyperacidity problems while they use those brands of ranitidine hydrochloride film coated tablets.
{"title":"Kinetic Studies of Ranitidine Hydrochloride Film Coated Tablets Available in Bangladesh: In vitro Study Reflection on in vivo","authors":"K. Islam, D. Sohel, Redwan Hossain, T. Sultana, H. Kawsar","doi":"10.4172/2167-065X.1000178","DOIUrl":"https://doi.org/10.4172/2167-065X.1000178","url":null,"abstract":"Background: This study deals with the comparative in vitro dissolution and in vitro disintegration characteristics of different brands of ranitidine hydrochloride film coated tablets most commonly available in Bangladesh which reflects the in vivo study. The objective of this present study was to evaluate the in vitro kinetic studies of ranitidine hydrochloride film coated tablets available in Bangladesh. Ranitidine hydrochloride is a potent H2 blocker recommended for hyperacidity related disorders and most common OTC drugs that frequently used by the common people in the world. Methods: Twenty one brands of ranitidine hydrochloride film coated tablets available in Bangladesh drug market were assayed spectrophotometrically and their various kinetics (Zero Order, First Order, Higuchi and Hixson-Crowell) studies were performed to predict in vivo analysis. Results: In Bangladesh, commercially available twenty one brands of ranitidine hydrochloride film coated tablets were studied. The media of the study was distilled water (pH 7.5) due to identify complete organoleptic properties of Ranitidine Hydrochloride. Nine brands (RH-3, RH-5, RH-6, RH-10, RH-11, RH-12, RH-13, RH-14 and RH-17) showed delayed disintegration time instead of quick release formulation, which often claimed by those manufacturer. Other twelve brands (RH-1, RH-2, RH-4, RH-7, RH-8, RH-9, RH-15, RH-16, RH-18, RH-19, RH-20 and RH-21) showed the moderate disintegration time. The tablets were studied for in vitro dissolution behavior for 1 h in distilled water using USP reference dissolution apparatus. The in vitro dissolution profiles of the thirteen brands (RH-1, RH-2, RH-4, RH- 7, RH-8, RH-9, RH-13, RH-15, RH-16, RH-18, RH-19, RH-20 and RH-21) were fulfilled the USP in vitro dissolution specification of 80% drug release within 45 min. On the other hand, five of the total selected brands (RH-3, RH-5, RH-10, RH-12 and RH-17) were failed to fulfill the USP in vitro dissolution specification. Rest three brands (RH-6, RH-11 and RH-14) exhibited very poor release pattern among the selected brands and their drug release rate were 23%, 11% and 19% respectively after one hour study. The drug potency, multiple coefficient (from zero order, first order, Higuchi and Hixson-Crowell cube root law), similarity and dissimilarity factors were determined in this study. The predicted steady state plasma concentration determined by comparing the in vivo pharmacokinetic data of reference brand (Zantac) using superposition principle of steady state plasma levels determination. Conclusion: Most of the brands meet the official requirements, which are very essential parameters for the prediction of in vivo drug release by oral route. As a result the patients will get the proper therapeutic effect to combat against hyperacidity problems while they use those brands of ranitidine hydrochloride film coated tablets.","PeriodicalId":10410,"journal":{"name":"Clinical Pharmacology & Biopharmaceutics","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2017-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"85185485","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2017-01-01Epub Date: 2017-05-18DOI: 10.4172/2167-065X.1000170
Francesco Marotta, Massimiliano Marcellino, Umberto Solimene, Biagio Cuffari, Hariom Yadav, Alexander N Khokhlov, Aldo Lorenzetti, Amelie Mantello, Joseph Cervi, Roberto Catanzaro
In recent years a number of studies have reported the significant relationship between metabolic syndrome and neurodegenerative disease. There is accumulating evidence that the interplay of combined genetic and environmental risk factors (from diet to life style to pollutants) to intrinsic age-related oxi-inflammatory changes may be advocated for to explain the pandemic of neurodegenerative diseases. In recent years a specific Fermented Papaya Preparation (FPP) has been shown to significantly affect a number of redox signalling abnormalities in a variety of chronic diseases and as well in aging mechanisms either on experimental and on clinical ground. The aim of the present study was to evaluate FPP use in impending metabolic disease patients with potentially neurodegenerative disease clustered risk factors. The study population consisted of 90 patients aged 45-65 years old, with impending metabolic syndrome and previously selected as to be ApoE4 genotype negative. By applying a RCT, double-blind method, one group received FPP 4.5 g twice a day (the most common dosage utilized in prior clinical studies) while the other received an oral antioxidant cocktail (trans-resveratrol, selenium, vitamin E, vitamin C). Then, after 21 month treatment period, a selected heavy metal chelator was added at the dosage of 3 g/nocte for the final 3 months study treatment. The parameters tested were: routine tests oxidized LDL-cholesterol, anti-oxidised LDL, Cyclophilin-A (CyPA), plasminogen activator inhibitor-1 and CyPA gene expression. From this study it would appear that FPP, unlike the control antioxidant, significantly decreased oxidized-LDL and near normalizing the anti-Ox-LDL/Ox-LDL ratio (p<0.001) although unaffecting the lipid profile per sè. Moreover, only FPP decreased cyclophilin-A plasma level and plasminogen activator-inhibitor (p<0.01) together with downregulating cyclophilin-A gene expression (p<0.01). Insulin resistance was only mildly improved. Heavy metals gut clearance proved to be effectively enhanced by the chelator (p<0.01) and this was not affected by any of the nutraceuticals, nor it added any further benefit to the biological action of FPP.
{"title":"A 2-year Double-Blind RCT Follow-up Study with Fermented Papaya Preparation (FPP) Modulating Key Markers in Middle-Age Subjects with Clustered Neurodegenerative Disease-Risk Factors.","authors":"Francesco Marotta, Massimiliano Marcellino, Umberto Solimene, Biagio Cuffari, Hariom Yadav, Alexander N Khokhlov, Aldo Lorenzetti, Amelie Mantello, Joseph Cervi, Roberto Catanzaro","doi":"10.4172/2167-065X.1000170","DOIUrl":"https://doi.org/10.4172/2167-065X.1000170","url":null,"abstract":"<p><p>In recent years a number of studies have reported the significant relationship between metabolic syndrome and neurodegenerative disease. There is accumulating evidence that the interplay of combined genetic and environmental risk factors (from diet to life style to pollutants) to intrinsic age-related oxi-inflammatory changes may be advocated for to explain the pandemic of neurodegenerative diseases. In recent years a specific Fermented Papaya Preparation (FPP) has been shown to significantly affect a number of redox signalling abnormalities in a variety of chronic diseases and as well in aging mechanisms either on experimental and on clinical ground. The aim of the present study was to evaluate FPP use in impending metabolic disease patients with potentially neurodegenerative disease clustered risk factors. The study population consisted of 90 patients aged 45-65 years old, with impending metabolic syndrome and previously selected as to be ApoE4 genotype negative. By applying a RCT, double-blind method, one group received FPP 4.5 g twice a day (the most common dosage utilized in prior clinical studies) while the other received an oral antioxidant cocktail (trans-resveratrol, selenium, vitamin E, vitamin C). Then, after 21 month treatment period, a selected heavy metal chelator was added at the dosage of 3 g/nocte for the final 3 months study treatment. The parameters tested were: routine tests oxidized LDL-cholesterol, anti-oxidised LDL, Cyclophilin-A (CyPA), plasminogen activator inhibitor-1 and CyPA gene expression. From this study it would appear that FPP, unlike the control antioxidant, significantly decreased oxidized-LDL and near normalizing the anti-Ox-LDL/Ox-LDL ratio (p<0.001) although unaffecting the lipid profile <i>per sè</i>. Moreover, only FPP decreased cyclophilin-A plasma level and plasminogen activator-inhibitor (p<0.01) together with downregulating cyclophilin-A gene expression (p<0.01). Insulin resistance was only mildly improved. Heavy metals gut clearance proved to be effectively enhanced by the chelator (p<0.01) and this was not affected by any of the nutraceuticals, nor it added any further benefit to the biological action of FPP.</p>","PeriodicalId":10410,"journal":{"name":"Clinical Pharmacology & Biopharmaceutics","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2017-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.4172/2167-065X.1000170","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"37170887","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2017-01-01DOI: 10.4172/2167-065X.1000E129
W. Elbossaty
Lymphoma is a cancer of the white blood cells; the body has two main types of lymphocytes: B lymphocytes, or B-cells, and T lymphocytes. T-cell lymphoma is a disease in which T lymphocyte cells become cancerous. One of the most common forms of T-cell lymphoma is cutaneous, or skin, lymphoma, because it starts in the lymphocytes in the skin. Cutaneous lymphoma actually describes many different disorders with various signs and symptoms, outcomes and treatment considerations. Sezary Syndrome (SS) is characterized by erythroderma, generalized lymphadenopathy, and the presence of circulating atypical lymphocytes, which are difficult to identify by morphologic data.
{"title":"Sezary Syndrome and T–Cell Lymphoma","authors":"W. Elbossaty","doi":"10.4172/2167-065X.1000E129","DOIUrl":"https://doi.org/10.4172/2167-065X.1000E129","url":null,"abstract":"Lymphoma is a cancer of the white blood cells; the body has two main types of lymphocytes: B lymphocytes, or B-cells, and T lymphocytes. T-cell lymphoma is a disease in which T lymphocyte cells become cancerous. One of the most common forms of T-cell lymphoma is cutaneous, or skin, lymphoma, because it starts in the lymphocytes in the skin. Cutaneous lymphoma actually describes many different disorders with various signs and symptoms, outcomes and treatment considerations. Sezary Syndrome (SS) is characterized by erythroderma, generalized lymphadenopathy, and the presence of circulating atypical lymphocytes, which are difficult to identify by morphologic data.","PeriodicalId":10410,"journal":{"name":"Clinical Pharmacology & Biopharmaceutics","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2017-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"83383473","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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