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Journal articles on the topic 'Physicochemical Equivalence'

Author: Grafiati

Published: 3 June 2025

Last updated: 31 July 2025

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1

Kecman, Sanja, Svetlana Goločorbin-Kon, and Momir Mikov. "Physicochemical Equivalence Studies of Two Amlodipine Tablet Formulations." Scripta Medica 49, no. 1 (2018): 18–24. http://dx.doi.org/10.18575/msrs.sm.e.18.03.

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G.Q., Othman. "Comparative Analysis of Five Brands of Lisinopril Tablets in Yemeni Market." Yemeni Journal for Medical Sciences 8, no. 1 (2014): 25–30. http://dx.doi.org/10.20428/yjms.v8i1.780.

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Background: In poor countries such as Yemen, the cost of drugs is a factor affecting the patient’s decision to buy it and generic medicines are introduced as cheaper alternatives to the high cost brands. However, it has been believed that generic medicines are inferior in quality compared to the branded medicines. Thus, the aim of the present study is to investigate the physicochemical equivalence of five brands of tablets containing Lisinopril (antihypertensive) sourced from different retail pharmacy outlets in the Yemeni market. Methods: The quality and physicochemical equivalence of five di

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Sánchez-Nava, Luis Alberto, Urias Bautista-Sánchez, and Ana Luisa Robles-Piedras. "Pharmaceutical equivalence and similarity studies of glibenclamide tablets." GSC Biological and Pharmaceutical Sciences 7, no. 1 (2019): 096–101. https://doi.org/10.5281/zenodo.4295724.

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The <em>in vitro</em> dissolution is the physicochemical test most used to estimate the release of the drug from the pharmaceutical form. Due to the close relationship between the dissolution rate of the drug <em>in vitro</em> and the absorption in vivo, the dissolution study is considered as the necessary and sufficient criterion to allow the commercialization of a pharmaceutical product. In this study, the similarity of the dissolution profiles of different products containing glibenclamide used in the Mexican Health Sector was compared. The dissolution profiles of 7 gene

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Balser, S., B. Freudensprung, K. Huebner, et al. "P0879 The totality of evidence for FYB202 – an EU-approved and US-licensed biosimilar to reference ustekinumab." Journal of Crohn's and Colitis 19, Supplement_1 (2025): i1674—i1675. https://doi.org/10.1093/ecco-jcc/jjae190.1053.

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Abstract Background Ustekinumab is a fully human IgG1/kappa monoclonal antibody to interleukin (IL)-12/23. It is authorized for the treatment of moderate to severe plaque psoriasis, active psoriatic arthritis, and active inflammatory bowel disorder. FYB202 has been approved by both EMA and FDA in September 2024 as a biosimilar to reference ustekinumab based on extensive comparative analytical characterization data and the proof of equivalence in clinical performance. Methods A full set of critical quality attributes was investigated with a comprehensive set of analytical methods. Functional co

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Okoye, I. E, Iwuagwu, and A. M. "Physicochemical equivalence of some brands of Nifedipine retard tablets available in Nigeria." African Journal of Biotechnology 9, no. 8 (2010): 1274–79. http://dx.doi.org/10.5897/ajb09.1466.

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Maiti, Kuntal, Subhas Bhowmick, Pankaj Jain, Murlidhar Zope, Keyur Doshi, and Thennati Rajamannar. "Comparison of Physicochemical Properties of Generic Doxorubicin HCl Liposome Injection with the Reference Listed Drug." Anti-Cancer Agents in Medicinal Chemistry 18, no. 4 (2018): 597–609. http://dx.doi.org/10.2174/1871520617666171121124610.

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Background: Liposomal doxorubicin is widely used for treating ovarian cancer and Kaposi’s sarcoma. Encapsulation of doxorubicin in highly complex polyethylene glycol–coated (stealth) liposomes prolongs residence time and avoids the systemic toxicity associated with administration of the free drug. Small variations in physicochemical properties introduced during manufacture of liposomes can influence the payload of encapsulated drug, stability of liposomes under physiological conditions, and release of drug at the target tissue. Accordingly, the US Food and Drug Administration and the European

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ASTAWAN, Made, Tutik WRESDIYATI, Eko Hari PURNOMO, and Anthony PURWANTO. "Equivalence Test between the Physicochemical Properties of Transgenic and Non-Transgenic Soy Flour." Journal of Nutritional Science and Vitaminology 66, Supplement (2020): S286—S294. http://dx.doi.org/10.3177/jnsv.66.s286.

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K. Lakshmi, V. Abishek, S. Ankit Kumar, A. Devipriya,, S. Devadharshini, and X. Ashlin. "COMPARATIVE IN VITRO BIOAVAILABILITY TESTING FOR DIFFERENT BRANDS OF FLUCONAZOLE UNCOATED TABLETS." RASAYAN Journal of Chemistry 17, no. 01 (2024): 215–20. http://dx.doi.org/10.31788/rjc.2024.1718561.

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Our current study aimed to evaluate and compare the five different brands of Fluconazole tablets that are commercially available in Chennai. The physicochemical equivalence of five brands of Fluconazole tablets was determined through the evaluation of various standard parameters such as weight variation, friability, hardness, disintegration, dissolution rate, and amount of drug present. All the brands were found to be bioequivalent and comply with the official tests for weight variation, friability, disintegration, and dissolution tests. The tested brands showed identical drug release profiles

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Sunte, Bramhadev Tukaram, Aditya Navnath Shinde, and Vaibhav Ravindra Vaidya. "Screening of Marketed Formulations of Shatavari Tablets to Establish Pharmaceutical Equivalence." Journal of Drug Delivery and Therapeutics 13, no. 8 (2023): 56–59. http://dx.doi.org/10.22270/jddt.v13i8.6173.

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Using an in vitro dissolving research, compare the pharmacological equivalent of three brands of Shatavari tablets sold in India. According to IP rules, the dissolution was performed using apparatus I (the paddle device). According to the Indian Pharmacopoeia, evaluation of physicochemical characteristics including weight variation test, content uniformity test, hardness test, friability test, disintegration test, and dissolution test was conducted. For weight fluctuation, content homogeneity, hardness, friability, disintegration time, and dissolving study, all brands complied with official sp

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*Farhana Israt, Jahan, and Chisty Md. Mainuddin. "PHYSICOCHEMICAL EVALUATION OF SOME COMMERCIALLY AVAILABLE BRANDS OF ATENOLOL TABLETS OF BANGLADESH." DIU Journal of Health and Life Sciences 5, no. 1 & 2 (2018): 9–16. http://dx.doi.org/10.36481/diuhls.v05i1-2.fdhpam71.

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Atenolol, a cardiovascular drug, is mainly used to reduce blood pressure and available worldwide under various trade names. The purpose of the current study is to ascertain physicochemical equivalence among the five different brands of atenolol 100 mg tablets commercially obtainable in Bangladesh. The sample tablets were examined for their weight variation, hardness, thickness, friability and disintegration time as well as dissolution time were evaluated spectrophotometrically conferring to the official (BP/USP) methods. The results showed that all brands of tablets showed satisfied results wh

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Jahan, Farhana Israt, and Md Mainuddin Chisty. "Physicochemical Evaluation Of Some Commercially Available Brands Of Atenolol Tablets Of Bangladesh." DIU Journal of Allied Health Sciences 5, no. 1 & 2 (2018): 9–16. https://doi.org/10.36481/diujahs.v05i1-2.fdhpam71.

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Atenolol, a cardiovascular drug, is mainly used to reduce blood pressure and available worldwide under various trade names. The purpose of the current study is to ascertain physicochemical equivalence among the five different brands of atenolol 100 mg tablets commercially obtainable in Bangladesh. The sample tablets were examined for their weight variation, hardness, thickness, friability and disintegration time as well as dissolution time were evaluated spectrophotometrically conferring to the official (BP/USP) methods. The results showed that all brands of tablets showed satisfied results wh

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Farhana, Israt Jahan, and Mainuddin Chisty Md. "Physicochemical Evaluation of Some Commercially Available Brands of Atenolol Tablets of Bangladesh." Journal of Allied Health and Life Sciences 5, no. 1&2 (2018): 9–16. https://doi.org/10.5281/zenodo.11000647.

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Abstract: Atenolol, a cardiovascular drug, is mainly used to reduce blood pressure and available worldwide under various trade names. The purpose of the current study is to ascertain physicochemical equivalence among the five different brands of atenolol 100 mg tablets commercially obtainable in Bangladesh. The sample tablets were examined for their weight variation, hardness, thickness, friability and disintegration time as well as dissolution time were evaluated spectrophotometrically conferring to the official (BP/USP) methods. The results showed that all brands of tablets showed satisfied

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13

Redfern, Julie, Rufus Adesoji Adedoyin, Sandra Ofori, et al. "Physicochemical equivalence of generic antihypertensive medicines (EQUIMEDS): protocol for a quality of medicines assessment." BMJ Global Health 1, no. 2 (2016): e000086. http://dx.doi.org/10.1136/bmjgh-2016-000086.

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hii, Jocelyn, Xavier Pivot, Lisa Soyeon Park, et al. "HD201: Analytical biocomparability and clinical trial progression of trastuzumab." Journal of Clinical Oncology 37, no. 15_suppl (2019): e12505-e12505. http://dx.doi.org/10.1200/jco.2019.37.15_suppl.e12505.

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e12505 Background: Trastuzumab, an approved prescription drug by EMA and FDA under the name Herceptin has become the key treatment in patients with HER2 positive breast cancer. HD201, developed and owned by Prestige Biopharma Pte Ltd is a biosimilar product to Herceptin (Trastuzumab). The development of HD201 from analytical biocomparability to clinical trial progression are demonstrated. Methods: Analytical biocomparability in terms of physicochemical (primary, higher order structure, glycan profiles, molecular and charge variants) and biological properties (inclusive of binding to Fcγ recept

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Balachandar, Kannan Gajendran, and Arumugam Thangamani. "Studies on Some of the Improvised Energetic Materials (IEMs): Detonation, Blast Impulse and TNT Equivalence Parameters." Oriental Journal of Chemistry 35, no. 6 (2019): 1813–23. http://dx.doi.org/10.13005/ojc/350626.

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This work reports the computational analysis of the physicochemical, detonation, blast peak over pressure, blast impulse and TNT equivalence parameters of some of the Improvised Energetic Materials (IEMs) such as ammonium nitrate, urea nitrate, C4, hexamethylene triperoxide diamine (HMTD) and triacetone triperoxide (TATP), which are used in bombing incidents all over the world in the form of Vehicle-Borne Improvised Explosive Devices (VBIEDs) or Person-Borne Improvised Explosive Devices (PBIEDs). The blast impulse, peak over pressure, TNT equivalence and detonation parameters reported in this

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Zuheir, Osman Alaa Elmardi Osman Aminah M. Abedelghayoum. "COMPARATIVE EVALUATION OF PHYSICOCHEMICAL PROPERTIES OF SOME COMMERCIALLY AVAILABLE BRANDS OF METFORMIN HCL TABLETS MARKETED IN SUDAN." INDO AMERICAN JOURNAL OF PHARMACEUTICAL RESEARCH 07, no. 01 (2017): 7471–77. https://doi.org/10.5281/zenodo.1007055.

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The pharmaceutical equivalence of five different brands of metformin hydrochloride 500 mg tablets available in the Sudanese market was evaluated using a number of official and non-official pharmacopoeial tests; which included determination of assay of content, evaluation of uniformity of weight, friability, hardness, thickness, disintegration time and dissolution tests. The dissolution profiles of the generic brands and innovator were studies and compared using similarity factor f2 and difference factor f1. The results showed that all the five tested brands complied with the requirements of we

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Coaguila-Llerena, Hernán, Victor Manuel Ochoa-Rodriguez, Gabriela Mariana Castro-Núñez, Gisele Faria, Juliane Maria Guerreiro-Tanomaru, and Mario Tanomaru-Filho. "Physicochemical Properties of a Bioceramic Repair Material - BioMTA." Brazilian Dental Journal 31, no. 5 (2020): 511–15. http://dx.doi.org/10.1590/0103-6440202003163.

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Abstract This study aimed to assess the physicochemical properties of a repair material in the Brazilian market, BioMTA, in comparison to other two materials currently in use (Biodentine and MTA Angelus). The initial setting time was evaluated using Gillmore needle. The pH was measured with a pH-meter after 24 h, 3, 7, 14 and 21 days. The radiopacity was determined using the equivalence in millimeters of aluminum (mm Al) from digitized occlusal radiographs. Solubility was determined after immersion in water for 7 days. The data were analyzed by one-way ANOVA and Tukey tests (a=0.05). The BioMT

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18

Osei, Yaa Asantewaa, Elvis Oppong Boakye, Marcel T. Bayor, and Frederick William Akuffo Owusu. "Physicochemical Equivalence and Quality Assessment of Various Brands of Gastro-Resistant Omeprazole Capsules in the Kumasi Metropolis." Scientific World Journal 2022 (November 9, 2022): 1–9. http://dx.doi.org/10.1155/2022/7924600.

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The proliferation of counterfeit and poor-quality drugs is a major public health problem, especially in developing countries such as Ghana where there are inadequate resources to effectively monitor their prevalence. Most of these drugs, which are counterfeited, are drugs, which are in high demand and will reap huge profits for the unscrupulous people who engage in such activities. The introduction of Omeprazole as one of the first-line therapies in the management of peptic and duodenal ulcers in the treatment guidelines of Ghana has resulted in many generics being introduced onto the market.

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Nahar, Saimun, Most Salma Khatun, and Md Shahidul Kabir. "Application of microbiological assay to determine the potency of intravenous antibiotics." Stamford Journal of Microbiology 10, no. 1 (2020): 25–29. http://dx.doi.org/10.3329/sjm.v10i1.50729.

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Demonstration of equivalent amounts of active pharmaceutical ingredient is a basic requirement for intravenous generic drugs prior to administration. Physicochemical methods are often used to determine concentration of antibiotics in biological fluids. However, it does not permit direct quantification of potency of a desired antibiotic. This study demonstrates the application of a microbiological assay to determine the potency and concentration of commercially available pharmaceutical-grade antibiotics used for injections. Concentration-dependent variation of inhibitory effect of four commerci

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20

Anyanwu-Ndulewe, C. A., L. E. Mogbolu, M. A. Oladunni, and A. A. Adepoju-Bello. "Physicochemical Evaluation of Brands of Amlodipine Besylate Tablets." Journal of Basic and Social Pharmacy Research 1, no. 5 (2020): 24–33. http://dx.doi.org/10.52968/27459534.

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Background: Hypertension is a chronic condition, and the cost of filling prescriptions has a potential of putting a financial strain on patients, hence the need for lower priced but bioequivalent generics. The Nigerian drug market is awash with generics of Amlodipine besylate, a first line drug in the treatment of hypertension, therefore, any prescribed alternative must be bioequivalent to the originator. Objectives: This study assessed the physicochemical properties of some brands in order to predict pharmaceutical and bioequivalence and invariably, the interchangeability with the innovator b

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A, Kolawole Jacob, and Bana DJ. "Comparative Evaluation of the Physicochemical and In Vitro Dissolution Properties of Some Expired and Unexpired Brands of Metformin Tablets." Der Pharma Chemica 15, no. 1 (2023): 9. https://doi.org/10.5281/zenodo.13318759.

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The comparative evaluation of the physicochemical properties and in vitro dissolution of some expired and unexpired brands of metformin tablets, six brands of expired (serial 1)and also unexpired (serial 2) of the same brand were used. The samples were determined using thin layer chromatography (TLC). Pharmacopoeia tests such as uniformity of weight, hardness, friability and assay were used to assess the physicochemical equivalence of the expired and unexpired metformin tablet brands. In vitro dissolution testing was conducted for both the expired and the unexpired tablets. All the brands (exp

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Jacob, A. Kolawole, and DJ Bana. "Comparative Evaluation of the Physicochemical and In Vitro Dissolution Properties of Some Expired and Unexpired Brands of Metformin Tablets." DER PHARMA CHEMICA 15, no. 1 (2023): 9. https://doi.org/10.4172/0975-413X.15.1.21-29.

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The comparative evaluation of the physicochemical properties and in vitro dissolution of some expired and unexpired brands of metformin tablets, six brands of expired (serial 1)and also unexpired (serial 2) of the same brand were used. The samples were determined using thin layer chromatography (TLC). Pharmacopoeia tests such as uniformity of weight, hardness, friability and assay were used to assess the physicochemical equivalence of the expired and unexpired metformin tablet brands. In vitro dissolution testing was conducted for both the expired and the unexpired tablets. All the brands (exp

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Kolawole, Jacob A., and DJ Bana. "Comparative Evaluation of the Physicochemical and In Vitro Dissolution Properties of Some Expired and Unexpired Brands of Metformin Tablets." Der Pharma Chemica 15, no. 1 (2023): 9. https://doi.org/10.5281/zenodo.10934596.

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The comparative evaluation of the physicochemical properties and in vitro dissolution of some expired and unexpired brands of metformin tablets, six brands of expired (serial 1)and also unexpired (serial 2) of the same brand were used. The samples were determined using thin layer chromatography (TLC). Pharmacopoeia tests such as uniformity of weight, hardness, friability and assay were used to assess the physicochemical equivalence of the expired and unexpired metformin tablet brands. In vitro dissolution testing was conducted for both the expired and the unexpired tablets. All the brands (exp

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Voskresenskaya, A. A., M. B. Sarkizova, N. S. Khodzhaev, et al. "Biosimilars of ranibizumab in retinal diseases: new possibilities in ophthalmology." Russian Annals of Ophthalmology 141, no. 2 (2025): 106. https://doi.org/10.17116/oftalma2025141021106.

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The development of biological therapeutic agents has provided new opportunities for treating neovascular age-related macular degeneration (nAMD) using humanized monoclonal antibodies (mAbs) targeting vascular endothelial growth factor A (VEGF-A). The emergence of biosimilars of anti-VEGF agents can significantly improve treatment accessibility and its effectiveness by increasing patient adherence. The development of biosimilars involves comparative studies with the original drug to establish equivalence in physicochemical and biological properties, efficacy, and safety. Biosimilar development

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Coderch, Luisa, Ilaria Collini, Victor Carrer, Clara Barba, and Cristina Alonso. "Assessment of Finite and Infinite Dose In Vitro Experiments in Transdermal Drug Delivery." Pharmaceutics 13, no. 3 (2021): 364. http://dx.doi.org/10.3390/pharmaceutics13030364.

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Penetration, usually with finite dosing, provides data about the total active amount in the skin and permeation, being the most used methodology, usually with infinite dosing, leads to data about pharmacokinetic parameters. The main objective of this work is to assess if results from permeation, most of them at finite dose, may be equivalent to those from penetration usually at infinite dose. The transdermal behavior of four drugs with different physicochemical properties (diclofenac sodium, ibuprofen, lidocaine, and caffeine) was studied using penetration/finite and kinetic permeation/infinit

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F Badulla, Wafa, Dua’a H Al-Maqdi, and Ebtesam S Bamahmood. "In Vitro Biopharmaceutical and Physicochemical Evaluation of Different Brands of Ciprofloxacin Marketed in Aden-Yemen." Malaysian Journal of Pharmaceutical Sciences 19, no. 2 (2021): 73–86. http://dx.doi.org/10.21315/mjps2021.19.2.5.

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The current study conducted to evaluate the biopharmaceutical and physicochemical equivalence of the three available pharmaceutical dosage forms of ciprofloxacin (CIP) in the local markets (tablets, infusion and eye drops). Three brands for each dosage form were selected and coded as Tablets I, II, III; CIP infusion (Infusion I, II, III) and CIP eye drops (Eye drops I, II, III). Different in vitro quality control tests, physiochemical and determination of active ingredients contents were performed. All brands of tablets have a satisfactory result that complies with the pharmacopeia specificati

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Inoue, Yutaka, Akiho Mitsumori, Itsuka Shinohara, Sachie Narumi, Isamu Murata, and Ikuo Kanamoto. "Evaluation between the Usability and Physicochemical Property of Acyclovir Ointments." Journal of Pharmaceutics 2018 (August 1, 2018): 1–8. http://dx.doi.org/10.1155/2018/8761394.

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A lot of prescription medicines have become switch over-the-counter (OTC) medicines. However, additives in brand-name drugs, generic drugs, and switch OTC drugs differ; therefore, the feelings associated with the use of these medicines vary for patients. The aim of this study was to compare the physicochemical properties and the feeling of use (assuming skin as an index of usability) of acyclovir (ACV) ointments. Five ACV ointments were used: ACV-A, a brand-name drug, ACV-B and ACV-C, generic drugs, and ACV-D and ACV-E, switch OTC drugs. The physicochemical properties were evaluated by determi

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Rugo, Hope S., Abhijit Barve, Cornelius F. Waller, et al. "Heritage: A phase III safety and efficacy trial of the proposed trastuzumab biosimilar Myl-1401O versus Herceptin." Journal of Clinical Oncology 34, no. 18_suppl (2016): LBA503. http://dx.doi.org/10.1200/jco.2016.34.18_suppl.lba503.

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LBA503 Background: Trastuzumab has revolutionized treatment of HER2+ breast cancer. Globally accessible alternatives are a critical need. We evaluated Myl-1401O, a proposed trastuzumab biosimilar, as treatment for HER2+ metastatic breast cancer (MBC), based on physicochemical analyses, nonclinical, pharmacokinetic and pharmacodynamic studies*. Methods: Heritage is a double-blind, randomized clinical trial designed to evaluate comparative efficacy and safety of Myl-1401O vs Herceptin. Eligible patients (pts) had centrally confirmed, measurable HER2+ MBC without prior chemotherapy or trastuzumab

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Zhao, Yuxuan, Enhua Wang, and Zhicheng Shi. "Numerical Investigation of the Ignition Delay Time of Kerosene Premixed Combustion in an SI Engine." Energies 15, no. 5 (2022): 1744. http://dx.doi.org/10.3390/en15051744.

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SI engines are installed widely in small aircrafts as they have good fuel economy. Currently, these SI engines are fueled with gasoline, although their safety can be improved if kerosene is used. However, the combustion performance of kerosene cannot fulfil the requirements due to the differences in physicochemical properties. This study investigates the ignition delay time of kerosene at a pressure range of 15–35 bar and a temperature range of 600–1000 K. A detailed chemical reaction mechanism is employed for the premixed combustion process. Under the initial conditions of 1000 K and 35 bar,

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Oliveira, Hiago, Isabela Pinheiro, Ana Ramos, Osvaldo Venturini, Adriano Mariano, and York Santiago. "Influence of Physicochemical Properties of Oil Sludge on Syngas Production for Energy Applications." Resources 14, no. 1 (2024): 8. https://doi.org/10.3390/resources14010008.

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Oil sludge (OS) is a hazardous waste generated in the refinery and platform production chain. Its recovery is globally limited by methods like incineration, landfilling, and stabilization, which are costly and environmentally harmful. In Brazil, advanced techniques such as gasification are still underdeveloped compared to established practices elsewhere. This study aims to characterize the chemical and physical properties of OS to enable its recovery through energy methods, reducing environmental impacts. OS samples from oil storage tanks were analyzed using mass spectrometry, thermogravimetry

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Widiyasari, Een, and Teuku Nanda Saifullah Sulaiman. "Assessment of physicochemical properties and comparison of the dissolution profile of amoxicillin caplets." Jurnal Ilmiah Farmasi 16, no. 2 (2020): 118–29. http://dx.doi.org/10.20885/jif.vol16.iss2.art4.

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Background: Marketed drugs must meet the required standards to guarantee product quality. Amoxicillin is a generic compound marketed under various trademarks as copy drugs. Amoxicillin caplets are an immediate release dosage form of BCS class I. An essential aspect of evaluating copy drugs is to assess the equivalence for their treatment to the innovator drugs to ensure the safety and effectiveness of the circulating copy drugs. Objective: The study aims to evaluate the physicochemical properties and compare the dissolution profile of amoxicillin caplets available in the market. Methods: Five

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Dhiman, Yogita, Deepika Pandey, Sumedh Joshi, Shivani Ghildiyal, and Tanuja Manoj Nesari. "Comprehensive Comparative Study of Five Medicinal Vitex Species Using Physicochemical, Phytochemical, HPTLC and FTIR Analyses." Journal of Ayurveda and Holistic Medicine (JAHM) 13, no. 5 (2025): 62–71. https://doi.org/10.70066/jahm.v13i5.1758.

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Background: This study aims to perform a comparative analytical evaluation of five Vitex species—Vitex agnus-castus, V. cannabifolia, V. negundo, V. ovata, and V. trifolia—to identify their similarities and differences. While V. negundo is the accepted source of Nirgundi, a key Ayurvedic herb for inflammation management, other species are also used under this name. The findings will aid in assessing their therapeutic equivalence and support the rational use of Vitex species in Ayurvedic formulations. Materials and Methods: Leaves of five Vitex species were collected, authenticated, and subject

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Bandaliyeva, A., S. Muslumzade, A. Huseynova, and M. Aslanov. "THE EFFECT OF THE PHYSICAL STATE OF THE SUBSTANCE ON THE THERAPEUTİC EFFİCACY OF DRUGS." Scientific heritage, no. 157 (March 25, 2025): 74–76. https://doi.org/10.5281/zenodo.15085530.

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In recent years, several directions of biopharmaceutical research have been identified in pharmacy: studying the role of pharmaceutical factors, absorption conditions, biotransformation, biological affinity and its determination methods, development of methods for identifying drugs in biological fluids, investigation of drug pharmacokinetics, and determination of clinical effects. One of the main objectives of biopharmaceutics is to study the physical state of substances, which plays a crucial role in the therapeutic significance of drugs. In the past, insufficient attention was given to the p

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JACH, Agnieszka, Ilona CIEŚLAK, and Andrzej TEODORCZYK. "Investigation of glycerol doping on ignition delay times and laminar burning velocities of gasoline and diesel fuel." Combustion Engines 169, no. 2 (2017): 167–75. http://dx.doi.org/10.19206/ce-2017-230.

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Glycerol is a major by-product of biodiesel production. Per one tone of produced biodiesel, one hundred kilograms of glycerol is produced. Production of glycerol is increasing due to increase of demand for biodiesel. One of methods of glycerol utilization is combustion. Recent experimental studies with use of a diesel engine and a constant volume combustion chamber show that utilization of glycerol as a fuel results in lower NOx emissions in exhaust gases. It combusts slower than light fuel oil, what is explained by higher viscosity and density of glycerol. Glycerol has low cetane number, so t

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González-Méndez, Israel, Kendra Sorroza-Martínez, Ignacio González-Sánchez та ін. "Exploring the Influence of Spacers in EDTA–β-Cyclodextrin Dendrimers: Physicochemical Properties and In Vitro Biological Behavior". International Journal of Molecular Sciences 24, № 19 (2023): 14422. http://dx.doi.org/10.3390/ijms241914422.

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The synthesis of a new family of ethylenediaminetetraacetic acid (EDTA) core dimers and G0 dendrimers end-capped with two and four β-cyclodextrin (βCD) moieties was performed by click-chemistry conjugation, varying the spacers attached to the core. The structure analyses were achieved in DMSO-d6 and the self-inclusion process was studied in D2O by 1H-NMR spectroscopy for all platforms. It was demonstrated that the interaction with adamantane carboxylic acid (AdCOOH) results in a guest-induced shift of the self-inclusion effect, demonstrating the full host ability of the βCD units in these new

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Al-Kubati, Sana Saleh, Olfat Saleh Ahmed, and Randa Mohammed Saif. "THE EVALUATION OF SOME BRANDS OF LEVOCETIRIZINE DIHYDROCHLORIDE FILM-COATED TABLETS FOR QUALITY AND EQUIVALENCE SOLD IN ADEN, YEMEN." Electronic Journal of University of Aden for Basic and Applied Sciences 3, no. 4 (2022): 313–21. http://dx.doi.org/10.47372/ejua-ba.2022.4.201.

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Generic drugs are less expensive than innovator drugs, and their proliferation has become a problem in low-income countries. They need to be therapeutically and pharmaceutically equivalent to the innovator. Levocetirizine dihydrochloride is an effective drug for relieving the signs of chronic urticaria, perennial allergic rhinitis, and seasonal allergic rhinitis. Our investigation into this drug in private pharmacies in Aden, Yemen, revealed that it is sold under the names of 28 brands from different countries of origin. Because of this, it is difficult for medical professionals and patients w

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Zhukova, L. G., E. V. Artamonova, S. A. Demidova, et al. "Results of an international, double-blind, randomized, phase III clinical trial to compare the efficacy and safety of a biosimilar pertuzumab (BCD-178) with reference pertuzumab in patients with HER2-positive breast cancer." Medical alphabet, no. 11 (July 3, 2025): 7–16. https://doi.org/10.33667/2078-5631-2025-11-7-16.

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Introduction. The increasing need for affordable treatment options for patients with HER2-positive breast cancer necessitates the development of pertuzumab biosimilars to expand access to effective therapies. BCD-178 is a pertuzumab biosimilar that has demonstrated equivalence to reference pertuzumab (RP) based on physicochemical characterization, preclinical in vitro and in vivo and clinical phase I study. The international, multicenter, Phase III clinical trial BCD-178–2/PREFER was conducted to comparatively evaluate the efficacy and safety of BCD-178 and RP in combination with TCHP regimen

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Alves, Teresa, Daniel Arranca, Ana Martins, Helena Ribeiro, Sara Raposo, and Joana Marto. "Complying with the Guideline for Quality and Equivalence for Topical Semisolid Products: The Case of Clotrimazole Cream." Pharmaceutics 13, no. 4 (2021): 555. http://dx.doi.org/10.3390/pharmaceutics13040555.

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Semisolids constitute a significant proportion of topical pharmaceutical dosage forms available on the market, with creams being considered profitable systems for releasing active substances into the skin. This work aimed at the development of a generic Clotrimazole topical cream, based on the assumptions that assist the development of such formulations. First, the critical parameters to obtain a final formulation as similar as possible to the reference product were defined. Then, the percentages of cetyl palmitate and octyldodecanol were identified as critical variables and chosen for optimiz

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Салій, О. О., О. В. Лось, О. П. Баула, and В. Ю. Турчина. "Development of composition and evaluation of equivalence of diacerein hard gelatin capsules." Farmatsevtychnyi zhurnal, no. 6 (December 20, 2021): 62–72. http://dx.doi.org/10.32352/0367-3057.6.21.06.

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Diacerein is a new generation of symptomatic slow-acting agent for the treatment of osteoarthritis, when taken orally, it exhibits moderate anti-inflammatory and analgesic activity, slows down the decay of cartilage tissue and relieves pain and swelling, but its physicochemical properties it is practically insoluble in water, due to which only 35‒56% the drug reaches systemic circulation. Therefore, the search for approaches to increase the dissolution rate of a practically insoluble API using the formulation, type of excipients, degree of solubility and kinetics of the substance release from

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Kavle, Ruchita Rao, Patrick James Nolan, Alaa El-Din Ahmed Bekhit, Alan Carne, James David Morton, and Dominic Agyei. "Physicochemical Characteristics, Techno-Functionalities, and Amino Acid Profile of Prionoplus reticularis (Huhu) Larvae and Pupae Protein Extracts." Foods 12, no. 2 (2023): 417. http://dx.doi.org/10.3390/foods12020417.

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The amino acid profile, techno-functionalities (foaming stability/capacity, emulsion stability/capacity, solubility, and coagulation), and physicochemical characteristics (colour, particle size, surface hydrophobicity, Fourier-transform infrared spectroscopy, and differential scanning calorimetry) of protein extracts (PE) obtained from Prionoplus reticularis (Huhu grub) larvae (HLPE) and pupae (HPPE) were investigated. Total essential amino acid contents of 386.7 and 411.7 mg/g protein were observed in HLPE and HPPE, respectively. The essential amino acid index (EAAI) was 3.3 and 3.4 for HLPE

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Eto, Takashi, Yuji Karasuyama, Verónica González, and Ana Del Campo García. "A randomized, single-dose, pharmacokinetic equivalence study comparing MB02 (proposed biosimilar) and reference bevacizumab in healthy Japanese male volunteers." Cancer Chemotherapy and Pharmacology 88, no. 4 (2021): 713–22. http://dx.doi.org/10.1007/s00280-021-04324-z.

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Abstract Purpose MB02 is a biosimilar to bevacizumab that has demonstrated similar physicochemical and functional properties in in vitro studies to the reference bevacizumab (Avastin®). This study aims to assess the pharmacokinetic (PK) similarity of MB02 to the reference bevacizumab in Japanese population. Methods This double-blind, randomized, parallel-group, single-dose PK study, was performed in healthy Japanese male volunteers. Subjects were equally randomized (1:1) to receive a single (3 mg/kg) IV dose of MB02 or reference bevacizumab. PK assessments were done up to 70 days post-dose. No

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Baula, O. P., O. O. Saliy, V. I. Bessаrabov, and A. М. Gerasimchuk. "Comparative studies of the kinetics of dissolution of medicines on the basis of clopidogrel." Farmatsevtychnyi zhurnal, no. 1 (February 17, 2021): 26–34. http://dx.doi.org/10.32352/0367-3057.1.21.03.

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Generic medicines occupy dominant positions both in the pharmaceutical market of Ukraine and in industrial production by domestic pharmaceutical enterprises. The use of generic drugs in medical practice is of significant medical and social importance for expanding the accessibility of the general population to essential drugs. In Ukraine, more than twenty generic medicines based on clopidogrel, both foreign and domestic, are registered. All generic drugs containing clopidogrel bisulfate must comply with pharmaceutical bisulfate must comply with pharmaceutical equivalence, the kinetics of relea

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Demidova, T. Yu, and V. V. Titova. "Evolution of insulin therapy in the light of innovative technologies of the 21<sup>st</sup> century." Meditsinskiy sovet = Medical Council, no. 23 (January 20, 2024): 209–16. http://dx.doi.org/10.21518/ms2023-439.

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The advent of insulin biosimilars has ushered in a new era in the treatment of diabetes mellitus, promising increased accessibility and affordability of this life-saving medication. This comprehensive review explores the evolving landscape of insulin biosimilars, focusing on their therapeutic equivalence, regulatory considerations, and clinical implications. Biosimilars are biological drugs produced using innovative technologies that replicate the structure and action of the reference drug in a very close way and are not inferior in effectiveness and other characteristics to the original, but

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Kateregga Ismael and B Naga Shubha. "Regulatory challenges in complex generics: A focus on liposomal and nanoparticulate drug products." International Journal of Science and Research Archive 14, no. 3 (2025): 834–49. https://doi.org/10.30574/ijsra.2025.14.3.0730.

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Complex generics, particularly liposomal and nanoparticulate drug products, pose unique regulatory challenges due to their intricate formulations, specialized delivery mechanisms, and physicochemical properties. Unlike traditional generics, these formulations require rigorous characterization, bioequivalence assessments, and in-depth in vitro and in vivo studies to ensure therapeutic equivalence. Regulatory agencies such as the FDA, EMA, and ICH have developed specific guidelines, yet differences in global regulatory frameworks persist, adding complexity to the approval process. Key hurdles in

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Marin, Raul Payri, Sergio Falla Hoyos, Elena Silvestre Soriano, and Aritz Lekuona. "Evaluation of Operational Parameters in a Pulse Combustor for Industrial Applications." Energies 18, no. 5 (2025): 1172. https://doi.org/10.3390/en18051172.

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The scientific community is showing growing interest in pulsed combustion technology due to its superior efficiency, environmental advantages, and diverse applications. Nevertheless, despite its promise, this technology remains underexplored because of its intricate nature and the numerous physicochemical mechanisms involved. This article introduces a pulse combustor, analyzing various power levels as a fundamental component. Each adjustment to operating parameters is shown to profoundly influence overall system behavior. This study advances pulse combustion technologies by addressing challeng

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Das, Abhishek, and Gautam Sarkhel. "Effect of stoichiometric ratios for synthesized epoxy phenolic novolac (EPN) resins on their physicochemical, thermomechanical and morphological properties." Pigment & Resin Technology 45, no. 4 (2016): 265–79. http://dx.doi.org/10.1108/prt-08-2014-0060.

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Purpose The purpose of this paper is to study the effect of various stoichiometric ratios for synthesised epoxy phenolic novolac (EPN) resins on their physicochemical, thermomechanical and morphological properties. Design/methodology/approach In the present study, EPN (EPN-1, EPN-2, EPN-3, EPN-4 and EPN-5) resins were synthesised by varying five types of different stoichiometric ratios for phenol/formaldehyde along with the corresponding molar ratios for novolac/epichlorohydrin. Their different physicochemical properties of interest, thermomechanical properties as well as morphological propert

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Green, Kathryn J., Ivan L. Lawag, Cornelia Locher, and Katherine A. Hammer. "Correlation of the antibacterial activity of commercial manuka and Leptospermum honeys from Australia and New Zealand with methylglyoxal content and other physicochemical characteristics." PLOS ONE 17, no. 7 (2022): e0272376. http://dx.doi.org/10.1371/journal.pone.0272376.

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Variation in the antibacterial potency of manuka honey has been reported in several published studies. However, many of these studies examine only a few honey samples, or test activity against only a few bacterial isolates. To address this deficit, a collection of 29 manuka/Leptospermum honeys was obtained, comprising commercial manuka honeys from Australia and New Zealand and several Western Australian Leptospermum honeys obtained directly from beekeepers. The antibacterial activity of honeys was quantified using several methods, including the broth microdilution method to determine minimum i

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Sánchez-Pérez, Juan Francisco, Gonzalo García-Ros, Manuel Conesa, Enrique Castro, and Manuel Cánovas. "Methodology to Obtain Universal Solutions for Systems of Coupled Ordinary Differential Equations. Examples of a Continuous Flow Chemical Reactor and a Coupled Oscillator." Mathematics 11, no. 10 (2023): 2303. http://dx.doi.org/10.3390/math11102303.

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This paper presents a concise and orderly methodology to obtain universal solutions to different problems in science and engineering using the nondimensionalization of the governing equations of the physical–chemical problem posed. For its application, a deep knowledge of the problem is necessary since it will facilitate the adequate choice of the references necessary for its resolution. In addition, the application of the methodology to examples of coupled ordinary differential equations is shown, resulting in an interesting tool to teach postgraduate students in the branches of physics, math

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Suplotova, L. A., and A. Sh Tilkiyan. "Ultrafast-acting insulin: pharmacological properties and their impact on clinical aspects." Meditsinskiy sovet = Medical Council, no. 13 (September 2, 2024): 146–54. http://dx.doi.org/10.21518/ms2024-262.

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The goal of modern insulin therapy used in the treatment of diabetes mellitus is to mimic physiologic insulin secretion by pancreatic beta cells. The new ultrafast-acting insulin analog aspart (UFAiAsp) demonstrates a faster onset and shorter duration of action compared to the ultra-short-acting insulin analog aspart (USAIasp), which substantiates the possibility of insulin administration immediately before meals, which helps to improve glycemic control by regulating postprandial glucose levels, improving patients' quality of life. We conducted a literature search for the period from 2012 to 2

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Antova, Iva, Mario Ignjatovikj, Packa Antovska, et al. "A validated and discriminatory in vitro release test for evaluation of marketed Clotrimazole cream formulations." 68 68, no. 02 (2022): 35–46. http://dx.doi.org/10.33320/maced.pharm.bull.2022.68.02.004.

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In vitro surrogate tests are broadly used for evaluation of the critical release characteristics of semi-solid dosage forms. In general, these tests are limited to assess the effect of crucial manufacturing process related steps on the physicochemical characteristics and overall drug product performance. In vitro release tests (IVRT) do not directly anticipate in vivo performance, but may detect in vitro changes that may correlate with in vivo performance. The objective of this work was to develop a suitable in vitro release test for evaluation of the similarity between two marketed Clotrimazo

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