Bioequivalence & Bioavailability International Journal最新文献

{"title":"Review on Various Aspects of 3-D Printing in Pharmacy","authors":"B. A","doi":"10.23880/beba-16000191","DOIUrl":"https://doi.org/10.23880/beba-16000191","url":null,"abstract":"3D printing also known as additive manufacturing which involves manufacturing of three dimensional objects by layering.3D printing includes layering materials, like plastics, composites or bio-materials to create objects that variety in shape, length, tension and color. This 3D printing generation has intense flexibility in what may be published. 3D printing has the capability to revolutionize the pharmaceutical manufacturing enterprise. Technologies currently being evaluated for use within the 3D printing of prescribed drugs, and the paintings of key market gamers to increase and increase their programs from studies to commercial. Close up of a 3D printing head approximately to begin a print at the printing mattress. The healthcare desires of the populace, and the therapeutics we use to deal with them, are changing. Though generics are undeniably critical, there’s a significant shift towards personalization and customization of remedy – inspired by using the adoption and enhancement of omics technology in healthcare. 3D Printing makes use of software that slices the 3D version into layers (0.01mm thick or less in most cases). Each layer is then traced onto the build plate by the printer, as soon as the pattern is finished, the construct plate is diminished and the subsequent layer is introduced on pinnacle of the previous one. 3D printing generation will revolutionize the pharmaceutical production style and system strategies. However, there's still a enormous barrier to make sure that 3D printed medicines have the same efficacy, protection, and balance as the pharmaceuticals conventionally manufactured by the Pharmaceutical Industry. Regarding the established order of recommendations, laws, first-class systems and protection of use and intake of 3D published drug treatments, it’s miles a top notch assignment for the regulatory authorities entailing great barriers, given the traditional requirements by way of the pharmaceutical sector.","PeriodicalId":8995,"journal":{"name":"Bioequivalence & Bioavailability International Journal","volume":"116 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-01-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"77275011","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":"Toxicity Interactions of Nanomaterials in Biological System: A Pressing Priority","authors":"L. S.","doi":"10.23880/beba-16000173","DOIUrl":"https://doi.org/10.23880/beba-16000173","url":null,"abstract":"Nanomaterials have made a rebellion in biomedical application especially treating several diseases due to its distinctive compositions. However, increased utilization of nanomaterials in biomedical applications has made an initiative to understand the possible interaction between the nanomaterials with the biological systems. These tiny particles enter into the body very easily and affect vulnerable systems which raise the interrogation of their potential effects on the susceptible organs. It is very crucial to comprehend the various exposure pathways, their movement, behavior and ultimate outcome. Specific and unique physicochemical properties, such as particle size and distribution, surface area, charge and coatings, particle shape/ structure, dissolution and aggregation, influence the nanomaterial interactions with cells. Toxicities in biological systems occurs as a result of a result of a variety of reasons including the production of ROS reactive oxygen species, degradation of the integrity of membrane and release of toxic metal ions thus preventing normal cell function. Various researchers have provided promising evidence that nanomaterial’s actively encompass and mediate chemical processes of cell, in addition to their passive interactions with cells. Certainly, it is very much essential to understand the possible toxic interactions of nanomaterial’s with the biological system as Nano toxicology. In this review, we emphasize the toxicological effects on different organs pertaining to nanomaterial-biological system interaction","PeriodicalId":8995,"journal":{"name":"Bioequivalence & Bioavailability International Journal","volume":"15 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-07-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"75364437","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":"Phytochemical Screening by FTIR Spectroscopic Analysis in the Methanolic Extracts Coffee (C. Arabica. L) to Seeds and Peels (Unroasted and Roasted) Cultivars Grown in Yemen","authors":"Ali Sa","doi":"10.23880/beba-16000179","DOIUrl":"https://doi.org/10.23880/beba-16000179","url":null,"abstract":"In this study methanolic extract of one plant namely Arabic coffee, were screened for the presence of analysis Constituents and tested for their of Fourier Transform infrared (FTIR) spectra. Infrared measurement techniques of methanolic extracts of Coffee (C. arabica. L) Seeds and peels (unroasted and roasted) include the following functional groups: Phenolic (O-H), Aliphatic- (CH), nitro compounds (CN), Aromatics (C = C) and Aliphatic (C-O). The FTIR method was performed on a spectrophotometer system, which was used to detect the characteristic peak values and their functional groups. The results of the present study generated the FTIR spectrum profile for the medicinally important plants of Arabic coffee can be used in the industry","PeriodicalId":8995,"journal":{"name":"Bioequivalence & Bioavailability International Journal","volume":"49 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-07-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"74594463","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":"Exploring Efficacy of Bauhinia Variegata as Medicinal Herb in Combating Different Clinical Conditions: A Systematic Review","authors":"K. S.","doi":"10.23880/beba-16000175","DOIUrl":"https://doi.org/10.23880/beba-16000175","url":null,"abstract":"Nowadays, the use of herbal therapy has reached its maximum hike. Lesser adverse events make this approach more prominent among the population. Bauhinia variegata, which is one of the medicinal plants employed in various indications like antibacterial, and various cancers, is practiced in the Indian traditional health system of Ayurveda. This plant natively belongs to the tropical Indian subcontinent. The phytoconstituents like glucokinins, inorganic ions sulphur compounds, coumarins, phenolic compounds (polyphenols, flavonoids), steroids, amines, peptides, terpenes, glycopeptides, and polysaccharides are associated with hypoglycemic effects. Glucokinins possess functional similarity with insulin. Its literature showed its expected indications in wide range i.e. cancer, diabetes, oxidative stress, depression. Therapeutic activities of this plant are based on chemical constituents present in it. Despite using the raw plant, using the extract is more prominent and suitable for treatment. The method of extraction of chemical constituents is very important. The extraction should be done without altering the therapeutic constituents. This review gives a thorough insight into the plant's chemical constituents, extraction methodologies, and different clinical conditions in which different parts of this plant are used. As a conclusion, this plant has shown great potential due to its plethora of chemical constituents which could also be explored in other indications with same mechanism of action is required.","PeriodicalId":8995,"journal":{"name":"Bioequivalence & Bioavailability International Journal","volume":"52 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-07-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"87852453","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":"Bioequivalence Study of Two Etoricoxib 90 mg Film-Coated Tablet Formulations","authors":"Dewi Ou","doi":"10.23880/beba-16000174","DOIUrl":"https://doi.org/10.23880/beba-16000174","url":null,"abstract":"The present study was conducted to compare the bioavailability of two etoricoxib 90 mg film-coated tablet formulations (test formulation and reference formulation). This study was an open-label, randomized, single-dose, two-periods, twotreatments, and crossover study which included 24 healthy adult male and female subjects under fasting conditions. Each of the two study periods was separated by a 7 days washout. A single dose of test or reference drug was administered to the subject in each period based on the randomization scheme. Plasma concentrations of the drug were determined by LC-MS/MS method. The pharmacokinetic parameters assessed in this study were the area under the plasma concentration-time curve from time zero to 96 h (AUC0-96h), area under the plasma concentration-time curve from time zero to infinity (AUC0-∞), the peak plasma concentration of the drug (Cmax), time needed to achieve the peak plasma concentration (Tmax), and the elimination half-life (T1/2). The geometric mean ratios (90% CI) of the test drug/reference drug for etoricoxib were 102.39% (97.63% – 107.38%) for AUC0-96h and 93.23% (86.54% – 100.43%) for Cmax. The 90% Confidence Intervals (CI) calculated for AUC0-96h and Cmax of etoricoxib were within the standard bioequivalence range (80.00– 125.00% for AUC0-t and Cmax). It was concluded that the two etoricoxib film-coated tablets (test and reference drug) were bioequivalent in terms of the rate and extent of absorption","PeriodicalId":8995,"journal":{"name":"Bioequivalence & Bioavailability International Journal","volume":"11 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-07-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"91523126","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":"Nano based Drug Delivery System for Cancer Therapy: A Next Generation Theranostics","authors":"Prabu Sl","doi":"10.23880/beba-16000178","DOIUrl":"https://doi.org/10.23880/beba-16000178","url":null,"abstract":"Cancer is considered as one of the foremost cause of illness and death with very complex pathophysiology even though prominent advancement has been made on innovative tumor treatments. Therapeutic properties and the global survival rate are still disappointing for the patients with cancer. There is a shortfall in the capabilities of these cancer therapies, some novel strategies are developed to provide better treatment therapies to improve their quality of life and also aids in reducing the number of deaths. Amongst the cardinal phases towards ensuring ideal cancer management is early diagnosis and targeted drug delivery of anti-tumor to decrease its toxicities. Recently the progress of nanotechnology as novel therapeutics, have advanced and trialed to overwhelm numerous limitations of previously available drug delivery systems for cancer treatment. Nanobased therapeutics has provided the chance to directly contact the tumorous cells selectively with improved drug localization, cellular application as well as providing targeted drug delivery eluding the interaction with the healthy cells. In this review, we summarize about various novel nanomaterials as anti-tumour drug delivery carriers for cancer treatment; also provide insight into the superlative necessities of nanotechnology in cancer therapy and its challenges in targeted drug delivery","PeriodicalId":8995,"journal":{"name":"Bioequivalence & Bioavailability International Journal","volume":"10 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-07-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"84730831","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":"Bioequivalence Study of Etoricoxib 120 mg in Healthy Subjects","authors":"Setiawati E","doi":"10.23880/beba-16000172","DOIUrl":"https://doi.org/10.23880/beba-16000172","url":null,"abstract":"Etoricoxib is an oral selective cyclo-oxygenase-2 (COX-2) inhibitor with anti-inflammatory and antirheumatic properties belonging to the group of NSAIDs. Study Objective: The objective of this study was to investigate the bioequivalence study of Etoricoxib, Tricox® 120 mg film coated caplet manufactured by PT Guardian Pharmatama for PT Nulab Pharmaceutical Indonesia in comparison with Etoricoxib 120 mg, Arcoxia® film coated tablet manufactured by Frosst Iberica, S.A., Spain, registered and packed by PT Merck Sharp Dohme Pharma Tbk Pasuruan, East Java. Indonesia. Methods: The study was conducted using an open-label, randomized, single-dose, two-periods, two-treatment, crossover study under fasting for 10 hours with 7 (seven) days washed-out period between each period. A single oral dose of the test drug or reference drug was administered to 16 healthy male subjects. The number of subjects who finished the study was fourteen (14) healthy male subjects. Serial plasma samples were obtained over a 72 hours period. Plasma concentrations of the drug were determined by LC-MS/MS method. From the Etoricoxib concentration vs. time curves, the following pharmacokinetic parameters were obtained: AUC0-72h, AUC0-∞, and Cmax, while the statistical interval proposed was 80.00 - 125.00% for AUC0-72h and Cmax with 90% Confidence Interval (CI) with α = 5.00%. The estimation of Tmax and T1/2 in the bioequivalence study was based on a nonparametric statistical procedure on the original data using Wilcoxon Sign Test. Results: The main pharmacokinetic parameters of the test drug Tricox® (BN: T200909) compared to reference drug, Arcoxia® (BN: T015857) were calculated based on geometric mean ratio and 90% confidence interval (CI). The results for AUC0-72h and Cmax were 91.97% (87.50% – 96.66%) and 96.98% (88.41% – 106.36%) respectively, with intra-subject variability (%CV) were 13.56% for AUC0-72h and 7.28% for Cmax. Hence, the number of 14 (fourteen) subjects has adequate number for required power of study. Conclusion: The study demonstrated that the test drug Tricox® (BN: T200909) manufactured by PT Guardian Pharmatama for PT Nulab Pharmaceutical Indonesia bioequivalence in term of both rate and extent of absorption to the reference drug Arcoxia® (BN: T015857) manufactured by Frosst Iberica, S.A., Spain, registered and packed by PT Merck Sharp Dohme Pharma Tbk Pasuruan, East Java. Indonesia.","PeriodicalId":8995,"journal":{"name":"Bioequivalence & Bioavailability International Journal","volume":"45 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-07-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"81756657","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":"Basic Aspects and the Overview on Pharmacokinetics and Studies on Drug Distribution- A Panoramic Review","authors":"Dudhat Kr","doi":"10.23880/beba-16000177","DOIUrl":"https://doi.org/10.23880/beba-16000177","url":null,"abstract":"Patients who are in critical condition display a variety of organ dysfunctions and frequently need to be treated with a range of medications, such as sedatives, analgesics, neuromuscular blockers, antibiotics, inotropes, and gastric acid suppressants. A crucial component of treatment for this patient population is comprehending how organ dysfunction might change the pharmacokinetics of medications. Due to gastrointestinal failure, many medications will need to be administered intravenously. When the oral route is an option, hypomotility, changes in gut pH, and enteral feeding may affect bioavailability. The main factors affecting medication clearance, and consequently steady-state drug concentrations, efficacy, and toxicity in a given patient, are hepatic and renal dysfunction. Many medications are cleared from the body primarily through oxidative metabolism, and it is becoming increasingly understood how important it is for critically ill patients to have diminished hepatic cytochrome P450 system activity. Both filtration and secretion clearance pathways are necessary for the elimination of parent medications and their active metabolites, making renal failure equally crucial. Renal failure is frequently a secondary cause of changes in the steady-state volume of distribution, which can lower the body's effective medication concentrations. Failure of the endocrine, endothelium, muscular, or central neurological systems may also have an impact on how a medication is metabolized. For some medications, there is strong evidence that changes in pharmacokinetic characteristics depend on time. To maximize the pharmacodynamic response and result, it is essential to understand the underlying pathophysiology in the critically sick and utilize pharmacokinetic principles in the selection of drug and dosing regimen.","PeriodicalId":8995,"journal":{"name":"Bioequivalence & Bioavailability International Journal","volume":"2 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-07-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"88259048","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":"The Potential of Biosurfactants in the Pharmaceutical Industry: A Review","authors":"S. V","doi":"10.23880/beba-16000176","DOIUrl":"https://doi.org/10.23880/beba-16000176","url":null,"abstract":"Surface-active substances known as \"bio-based surfactants\" come from a variety of sources, including plants, animals, microorganisms, marine life, synthetics, and semi-synthetics. Bio-based surfactants have a variety of uses, including in food, personal care, pharmaceutical, and industrial formulations as well as in agricultural and oil field chemicals and institutional and industrial cleaning. Nowadays, there is a significant demand for bio-based surfactants on the market as a result of the strict environmental rules that governments across the globe have placed on the use of toxins in detergents and growing environmental concerns among consumers. Due to their low toxicity and biodegradability, bio-based surfactants are acknowledged as a more environmentally friendly alternative to traditional petrochemical-based surfactants. Additional research going on for the creation of innovative biodegradable surfactants as a result, either by biological processes or from renewable resources (bio-catalysis or fermentation are included). Many such varieties, their properties, clinical assessment of surfactant formulations, use of bio-based surfactants, industrial state-of-the-art, and prospective markets for bio-based surfactants manufacturing are discussed in this paper.","PeriodicalId":8995,"journal":{"name":"Bioequivalence & Bioavailability International Journal","volume":"10 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-07-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89996632","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":"Novel Approaches in Green Extraction for Natural Medicines","authors":"Jani S","doi":"10.23880/beba-16000166","DOIUrl":"https://doi.org/10.23880/beba-16000166","url":null,"abstract":"Green extraction is based on discovery and design of extraction process which will reduce unit operation, reduce energy consumption, reduce time consumption, reduce organic solvent use, alternate solvent with water or agro-solvent and ensure safe and high-quality extract. In this study the conventional extraction methods and various green extraction methods were compared. Both these studies on extraction process were done in the past, in this review those studies were compared. From this we can know that which method is suitable for extraction which will not harmful for the environment, promote the health of patient, produce by-product or co-product instead of waste.","PeriodicalId":8995,"journal":{"name":"Bioequivalence & Bioavailability International Journal","volume":"45 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-02-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89848834","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}