Bioequivalence & Bioavailability International Journal最新文献

{"title":"Comparative Bioequivalence Studies of Two Metformin Extended- Release Formulations in Healthy Thai Volunteers","authors":"K. V","doi":"10.23880/beba-16000151","DOIUrl":"https://doi.org/10.23880/beba-16000151","url":null,"abstract":"Metformin is a first-line treatment for type 2 diabetic mellitus commonly used as a monotherapy or in a combination with other antidiabetic drugs. To control blood glucose levels, patients should be able to access to the treatment continuously. Thus, the Government Pharmaceutical Organization (GPO) had developed a generic metformin extended-release formulation as a low-cost alternative for patients and physicians. Two bioequivalence studies were conducted under fasting and fed conditions to compare the rate and extent of absorption between the test (Metformin XR 1000 mg) and reference (Glucophage XR 1000 mg) formulations. The study design for both studies was comparative randomized, open-label, single-dose, two-way crossover. Twenty-four subjects and fourteen eligible subjects were enrolled in the single-dose fasting and fed studies, respectively. Plasma concentrations of metformin were determined using a validated liquid chromatography tandem mass spectrometry method. The primary pharmacokinetics parameters including AUC 0-tlast , AUC 0−∞ and C max were statistically compared. The 90% confidence intervals of the geometric least squares mean ratio of log-transformed AUC 0-tlast , AUC 0−∞ and C max between the formulations were within 80.00-125.00% of bioequivalence criteria for both fasting and fed studies. The pharmacokinetic parameters following oral administration under fasting and fed conditions were comparable suggesting insignificant food effect on the absorption. The safety of metformin extended-release formulations was evaluated in healthy Thai subject. The test and reference products were well tolerated by the study subjects and no serious adverse events were reported in both studies. Based on the statistical indices, it was concluded that two metformin extended-release formulations were bioequivalent.","PeriodicalId":8995,"journal":{"name":"Bioequivalence & Bioavailability International Journal","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79585034","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}

{"title":"Brief Review on Some Neurological Diseases Which Have Association with Trinucleotide Repeat Sequences","authors":"Saberi B","doi":"10.23880/beba-16000152","DOIUrl":"https://doi.org/10.23880/beba-16000152","url":null,"abstract":"Trinucleotide repeat sequences can be seen in some neurological diseases. This study will briefly review some of these neurological diseases and the associated trinucleotide repeat sequences.","PeriodicalId":8995,"journal":{"name":"Bioequivalence & Bioavailability International Journal","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"73198009","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}

{"title":"Anti-Inflammation Effects of Rosmarinus Officinalis Extract Against Covid19 Virus ( In Silico Study)","authors":"Nazari Vm","doi":"10.23880/beba-16000154","DOIUrl":"https://doi.org/10.23880/beba-16000154","url":null,"abstract":"The critical condition of acute respiratory covid19 syndrome appeared to be the current health concern worldwide. It appeared at the beginning in Wuhan, China by end of 2019, soon after it spread to almost most of the global countries because of its high contagious properties. Precautionary procedures were the only helpful method to control the transmissions of person to person until any proper method of treatment or vaccine is established. Rosmarinus officinalis (RM) has strong anti-inflammation, anticancer and antibacterial effect. It is one of the probable choices of study against the outbreak of covid19 disease. In present article, we study in silico (molecular docking) characteristics of active compounds available in RM that is usually consumed as food additives and compare its biological effect with remdesivir and favipiravir as positive compounds based on docking properties. The actual active compounds in RM were selected based on their major roles in RM with desirable pharmacologic effects. The obtained results showed that both selected compounds were much stronger in inhibition of the studied proteins compared with remdesivir and favipiravir. Based on the combined scores in binding affinity, the drug-likeness properties of the ligands, showed to be better possible covid19 inhibitor compared with selected positive controls. The analysis of active site also showed that RM active compounds probably have the therapeutic efficacy against covid19 virus.","PeriodicalId":8995,"journal":{"name":"Bioequivalence & Bioavailability International Journal","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"84983358","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}

{"title":"Effect of Dietary Inclusion of Ginger ( Zingiber officinale ) and Garlic ( Allium sativum ) Oil Mixture on the Growth Performance and Caecal Microbial Population of Broiler Chickens","authors":"Alagbe Jo","doi":"10.23880/beba-16000153","DOIUrl":"https://doi.org/10.23880/beba-16000153","url":null,"abstract":"The objective of the present study was to determine effect of dietary inclusion of ( Zingiber officinale ) and garlic ( Allium sativum ) oil mixture (GIGM) on the growth performance and caecal microbial population of broiler chickens. One hundred and fifty one-day-old broiler chicks (Ross 308) were randomly allocated into 5 treatments with three replicates consisting of 10 birds each in a completely randomized design. Birds in treatment 1 (T1) was fed basal diet with 0 % inclusion of GIGM while T2, T3, T4 and T5 were given 0.1 %, 0.2 %, 0.3 % and 0.4 % respectively. Clean feed and water were offered ad libitum and all other management practices were strictly observed throughout the experiment which lasted for 56 days. Results obtained were used to determine weight gain (WG), average daily weight gain (ADWG), total feed intake (TFI), average daily feed intake (ADFI), feed conversion ratio (FCR) and microbial population of E.coli , Salmonella spp and Lactobacillus spp. ADWG, ADFI and FCR were significantly (P ˂ 0.05) influenced by the dietary inclusion of GIGM. ADWG were highest in T5 (47.80 g), T4 (45.75 g) and T3 (45.09 g), intermediate in T2 (39.59 g) and lowest in T1 (30.72 g). Lactobacillus spp increased as the level of dietary inclusion of GIGM increases (P ˂ 0.05). E.coli and Salmonella spp counts were significantly (P ˂ 0.05) different among the treatments. It was concluded that GIGM could be included in the diet of broilers up to 0.4 % without causing any deleterious effect on the performance and health of birds.","PeriodicalId":8995,"journal":{"name":"Bioequivalence & Bioavailability International Journal","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"90232881","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}

{"title":"Overview of 3D Printing Technology","authors":"Hussain S","doi":"10.23880/beba-16000149","DOIUrl":"https://doi.org/10.23880/beba-16000149","url":null,"abstract":"The pharmaceutical industry is advancing at an incredible rate. Novel drug formulations for targeted therapy have been developed all thanks to advances in modern sciences. Even so, the manufacturing sector of novel dosage forms is minimal, and the industry continues to rely on traditional drug delivery systems, particularly modified tablets. The use of 3D printing technologies in pharma companies has opened up new possibilities for printed products and device research and production. 3D Printing has slowly progressed from its original use as pre-surgical imaging templates and tooling molds to produce one-of-a-kind instruments, implants, tissue engineering scaffolds, testing platforms, and drug delivery systems. The most significant advantages of 3D printing technologies include the ability to produce small batches of drugs with custom dosages, forms, weights, and drug release profiles. The production of medicines in this manner could eventually contribute to the realization of the principle of personalized medicine. The biomedical industry and academia have also embraced 3D printing in recent years. It offers commercially available medical devices as well as a forum for cutting-edge studies in fields such as tissue and organ printing. This mini-review provides an overview of 3D printed technology in medicines.","PeriodicalId":8995,"journal":{"name":"Bioequivalence & Bioavailability International Journal","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"86237822","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}

{"title":"Improvement of Vitamin D 3 Metabolites Level after Oral Administration of the Biofield Energy Treated Proprietary Test Formulation in Vitamin D 3 Deficiency Diet (VDD) Induced Rat Model","authors":"Jana S","doi":"10.23880/beba-16000138","DOIUrl":"https://doi.org/10.23880/beba-16000138","url":null,"abstract":"The present experiment was evaluated to study of the effect of Consciousness Energy Healing Treatment (the Trivedi Effect ® ) on novel proprietary test formulation in male Sprague Dawley (SD) rats, fed with vitamin D3 deficiency diet (VDD) for the estimation of vitamin D3 metabolites in kidney tissue. A novel proprietary test formulation was formulated with a few minerals (magnesium, zinc, copper, calcium, selenium, and iron), vitamins (ascorbic acid, pyridoxine HCl, alpha tocopherol, cyanocobalamin, and cholecalciferol), Panax ginseng extract, β-carotene, and cannabidiol isolate. The novel test formulation was divided into two parts; one part was defined as the untreated test formulation, while the other part of the test formulation and the animals received Biofield Energy Healing Treatment by a renowned Biofield Energy Healer, Mr. Mahendra Kumar Trivedi. 25-OH vitamin D 3 level was significantly increased in the Biofield Energy Treated test formulation group (G5), Biofield Energy Treatment per se (G6), and 15-days pre-treatment of the Biofield Energy Treated test formulation (G7) groups by 21%, 22.9%, and 11.5%, respectively as compared with the disease control group (G2). Additionally, the level of 1,25-(OH) 2 D 3 was increased by 55% in the G6 group as compared with the G2. Further, the expression of CYP24A in kidney was increased by 13.9% in the G6 group, while CYP27B expression in kidney was significantly increased by 17.6%, 18.6%, 10.1%, and 15.6% in the G5, G6, G7 (Biofield Energy Treated test formulation from day -15), and G8 (Biofield Energy Treatment per se plus Biofield Energy Treated test formulation from day -15) groups, respectively as compared with the G4 group. Vitamin D receptor (VDR) expression was significantly increased by 69.5% and 31% in the G6 and G7 groups, respectively as compared with the G2 group. Overall, the results showed significant improvement of the availability of vitamin D 3 metabolites, that could be helpful for the vitamin D 3 deficiency persons to maintain good bone health and immunity. Therefore, the results suggest that there was significant slowdown in the disease progression and disease related all other complications/symptoms in the Biofield Energy Treatment group per se and/or Biofield Energy Treated Test formulation groups ( viz . G6, G7, G8, and G9) comparatively with the disease group.","PeriodicalId":8995,"journal":{"name":"Bioequivalence & Bioavailability International Journal","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"87684152","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}

{"title":"Bioavailability of Trans and Saturated Fatty Acids in Stuffed Cookies and Wafers Produced in Brazil","authors":"Montilla Tcl","doi":"10.23880/beba-16000143","DOIUrl":"https://doi.org/10.23880/beba-16000143","url":null,"abstract":"Several scientific studies highlight that trans fatty acids are harmful to health. The World Health Organization (WHO) considering the presence of trans fat in food recommends its total elimination by the year 2023. The Brazilian Health Surveillance Agency’s (ANVISA) Collegiate Board Resolution (RDC) No. 54, from November 2012, establishes that only foods with trans fat levels lower ≤ 0.1 g per portion can claim zero trans on the label. Stuffed cookies and wafers are important representatives of ultra-processed foods containing high levels of sugars and fats, being widely consumed for their low cost and accessibility. The objective of this study was to evaluate the levels of trans and saturated fat by gas chromatography (AOAC Official Method 996.06) in stuffed cookies and wafers, 31 stuffed cookies and 33 wafers were analyzed in the city of São Paulo, evaluating the amount of trans fats, between 0.01 to 1.56 g/serving and 0.01 and 2.56 g / serving in the filled wafers and cookies respectively. Therefore, it was found that some brands of stuffed wafers and wafers still present large amounts of trans fat in their composition causing risks to the consumer’s health","PeriodicalId":8995,"journal":{"name":"Bioequivalence & Bioavailability International Journal","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79322025","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}

{"title":"Toxic Effect of Methylation and Chlorpyrifos on Liver of Male Rabbits","authors":"Mohammed Saa","doi":"10.23880/beba-16000140","DOIUrl":"https://doi.org/10.23880/beba-16000140","url":null,"abstract":"The irrational use of organ phosphorus insecticides in Yemen play a crucial role in the occurrence of many diseases affecting plants, animals, and man. Methidathion (MD) and Chlorpyrifos (CF) are two of widely used organ phosphorus insecticides in agriculture. The purpose of the present study was to investigate the in vivo effect of (MD) and (CF) on lipid peroxidation (LPO), antioxidant defense system in the liver cells and liver function in male rabbits after orally administration a single dose of 1/8 of LD50 of (MD) and (CF) period of 20 days. Thirty healthy male rabbits weighting 1400-1600g., were divided into 3 groups with 10 animals in each, first group served as control animals, they received 3ml.of corn oil, while animals in second and third groups received 1/8 of LD50 of (MD) and (CF) respectively. The level of alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), lactate dehydrogenase (LDH), and gamma glutamyl transferase (γ-GT) in serum were analyzed, the level of (LPO), and methylglyoxal (MG), in liver homogenate were also studied. Results showed a significant (P<0.01) increase in all studied parameters in animals treated with (MD) and (CF) as compared to control animals. Our results indicated to the high toxicity of (MD) and (CF).","PeriodicalId":8995,"journal":{"name":"Bioequivalence &amp; Bioavailability International Journal","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89334456","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}

{"title":"Formulation and Evaluation of Polymeric Bilayer Matrix Tablet Containing Glipizide and Metformin Hydrochloride","authors":"Lakshmana Prabu S","doi":"10.23880/beba-16000139","DOIUrl":"https://doi.org/10.23880/beba-16000139","url":null,"abstract":"The objective of the present study was to develop Bilayer tablets of Glipizide and metformin hydrochloride from polymeric matrices of HPMC K4M and Eudragit L-100. Drugs Glipizide and metformin hydrochloride are frontline anti-diabetic drugs prescribed in combination. Tablets were prepared by wet granulation method using different ratios of HPMC K4M and Eudragit L-100 and evaluated for its physicochemical properties, in vitro release profile and stability studies. The prepared granules physiochemical property results were within the limits and the formulated tablets hardness, friability and content uniformity was found to be between 5.1±0.1 and 5.9±0.3; 0.21 ±0.02 and 0.49±0.02%; 98.99 ±1.06 and 100.45±0.52 %w/w respectively. The invitro release was found to be observed for 12 hours in phosphate buffer pH 6.8 and compared with market formulation. The dissolution release of formulation was comparable with market formulation and the difference factor and similarity factor f1 and f2 were found to be 3.75 and 79.46 for metformin hydrochloride; 8.74 and 65.78 for glipizide respectively. Stability studies were carried out as per ICH guidelines and tested for its physicochemical properties and in vitro release studies. The stability study result reveals that the prepared formulation was stable.","PeriodicalId":8995,"journal":{"name":"Bioequivalence &amp; Bioavailability International Journal","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79370618","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}

{"title":"Bioavailability of Phenolic Compounds in Food and their Properties in Cellular Protection","authors":"M. J.","doi":"10.23880/beba-16000145","DOIUrl":"https://doi.org/10.23880/beba-16000145","url":null,"abstract":"","PeriodicalId":8995,"journal":{"name":"Bioequivalence &amp; Bioavailability International Journal","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"81277800","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}