Generic Comparisons
May 2025
Comparative Study of Metronidazole Tablets Marketed in Saudi Arabia
Introduction: Metronidazole is usually used as an oral antiprotozoal and antibacterial agent to treat skin and mouth infections, bacterial vaginosis, and pelvic inflammatory diseases as well as some sexually transmitted infections... Full article
1Department of Pharmaceutics, College of Pharmacy, Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia.
Quality Evaluation of Azithromycin Oral Solid Dosage Forms in Nigeria: In Vivo-In Vitro Correlation Study
Background: Azithromycin is used for bacterial infections, such as respiratory tract and genitourinary tract infections, and has also been effective for preventing maternal sepsis during vaginal birth in some settings. The availability of low-cost azithromycin... Full article
1Department of Pharmaceutics and Pharmaceutical Technology, Faculty of Pharmacy, University of Lagos, Lagos, Nigeria.
2MEDAFRICA GMP Laboratory, Faculty of Pharmacy, University of Lagos, Lagos, Nigeria.
3Department of Pharmaceutical Chemistry, Faculty of Pharmacy, University of Lagos, Lagos, Nigeria.
4Department of Obstetrics and Gynecology, College of Medicine, University of Lagos, Lagos, Nigeria.
5Centre for Clinical Trials, Research & Implementation Science, College of Medicine, University of Lagos, Lagos, Nigeria.
In Vitro Pharmaceutical Quality Evaluation of Loratadine Tablets in Saudi Arabia
Introduction: Loratadine (LOR) is a widely used second-generation antihistamine that blocks histamine H1 receptors and relieves allergic symptoms. A variety of LOR brands are marketed in Saudi Arabia. The objective of this study was to compare the... Full article
1Department of Pharmaceutics, College of Pharmacy, King Saud University, Riyadh, Saudi Arabia
February 2025
Biopharmaceutical and Quality Evaluation of Immediate-Release Metformin Hydrochloride Tablets in Brazil
Metformin hydrochloride (MET) is considered the first drug of choice for the treatment of type 2 diabetes mellitus. Adverse events (AEs) related to the use of MET are mainly gastrointestinal-related. The speed of drug release and its... Full article
1Federal University of São João del-Rei, Divinópolis - MG, Brazil.
2Santa Mônica Divinópolis Hospital Hapvida NotreDame Intermédica, Divinópolis - MG, Brazil.
Consistency Evaluation of Dissolution of Granisetron Hydrochloride Tablets in China
A method for checking the dissolution of granisetron hydrochloride tablets was established to evaluate its consistency with the in vitro dissolution of the... Full article
1Hangzhou Chenning PharmLabs Co., Ltd., Hangzhou, China.
2Fuan Pharmaceutical Group, Ningbo Team Pharmaceutical Co., Ltd., Ningbo, China.
November 2024
In Vitro Performance of Commercially Available Glimepiride Tablets in Indonesia
Glimepiride is a commonly prescribed medication for diabetes mellitus that is available in both generic and innovator products. Although the performance of individual products varies, generics should meet quality standards of bioequivalence with the innovator. This study aimed to evaluate... Full article
1Department of Pharmaceutic and Pharmaceutical Technology, Faculty of Pharmacy, Universitas Wahid Hasyim, Semarang, Central Java, Indonesia.
2Department of Pharmacology and Clinical Pharmacy, Faculty of Pharmacy, Universitas Wahid Hasyim, Semarang, Central Java, Indonesia.
3Undergraduate Program, Faculty of Pharmacy, Universitas Wahid Hasyim, Semarang, Central Java, Indonesia.
August 2024
Comparative Study of Metformin Hydrochloride Tablets in Argentina
Metformin, a class III drug in the Biopharmaceutics Classification System, is an orally administered drug used to lower blood glucose concentrations in patients with non-insulin-dependent diabetes mellitus. Critical quality attributes were evaluated and compared for... Full article
1Departamento de Biología, Bioquímica y Farmacia, Universidad Nacional del Sur, Bahía Blanca, Argentina.
2Consejo Nacional de Investigaciones Científicas y Técnicas (CONICET), Bahía Blanca, Argentina.
Comparative Dissolution Study of Enzalutamide Capsules in India
Introduction: The objective was to conduct a comparative dissolution study of several brands of enzalutamide capsules available in the Indian market using a model-independent approach. Enzalutamide is classified as a Biopharmaceutical Classification System class 2 medicine due to its limited... Full article
1Hovione, East Windsor, NJ, USA.
2Graduate School of Pharmacy, Gujarat Technological University, Gandhinagar, Gujarat, India.
3Shree SK Patel College of Pharmaceutical Education and Research, Ganpat University, Mehsana, Gujarat, India.
4Exemplify Biopharma Inc., Cranbury, NJ, USA.
5Department of Pharmaceutical Chemistry and Analysis, Ramanbhai Patel College of Pharmacy, Charusat University, Changa, Gujarat, India.
6National Institute of Pharmaceutical Education and Research (NIPER) Ahmedabad, Gandhinagar, Gujarat, India.
May 2024
Dissolution Test of Patent and Generic Drugs of Metformin Hydrochloride
Type 2 diabetes is a chronic, multifactorial disease with a genetic predisposition caused by a deficit in the action or secretion of insulin, resulting in hyperglycemia, which is characterized by increased blood glucose levels. Metformin hydrochloride is the most frequently used medication. There is a wide.. Full article
1Basic Sciences Laboratory, Faculty of Dentistry, Universidad Autónoma de Sinaloa, Sinaloa, Mexico.
2Faculty of Medicine, Universidad Autónoma de Sinaloa, Sinaloa, Mexico.
3Laboratory of Biopharmacy Research, Escuela Nacional de Ciencias Biológicas, Instituto Politécnico Nacional, Unidad Profesional Adolfo López Mateos, Mexico City, Mexico.
Quality Control Parameters of Antihypertensive Medications Marketed in Eastern Ethiopia: Amlodipine Besylate and Enalapril Maleate Tablets
Substandard medications have a negative impact on treatment outcomes. To get the desired therapeutic effect, drugs need to have the required pharmaceutical properties and the right amount of the active pharmaceutical ingredient. Thus, this study aimed to.. Full article
1Department of Pharmaceutics, School of Pharmacy, College of Health and Medical Sciences, Haramaya University, Harar, Ethiopia.
2Department of Pharmacy, College of Medicine and Health Sciences, Debre Markos University, Debre Markos, Ethiopia.
3School of Environmental Health, College of Health and Medical Sciences, Haramaya University, Harar, Ethiopia.
February 2024
In Vitro Characterization of Multi-Source Omeprazole Capsule Dissolution Performance Under Biorelevant Conditions
Regulatory requirements for drugs approval in several countries allow pharmaceutical companies to market drug products after providing evidence of compliance with pharmacopeial quality requirements and good manufacturing practices, a policy that reduces drug treatment cost and increases... Full article
1Department of Pharmaceutical Sciences, Universidad de la República, Montevideo, Uruguay
Therapeutic Equivalence of Multisource Drugs Assessed by In Vitro Dissolution Studies: Amoxicillin/Clavulanic Acid Tablets
The objective of this study was to determine the in vitro therapeutic equivalence of multisource amoxicillin/clavulanic acid (875 mg/125 mg) tablets to establish their interchangeability with the reference product. Six multisource products manufactured in Peru, Colombia, Argentina, Mexico, and India were... Full article
1Investigación en Ciencias Básicas Estomatológicas (ICBEST) Group, Universidad Nacional Mayor de San Marcos, Lima, Perú
2Centro Nacional de Control de Calidad, Instituto Nacional de Salud, Lima, Perú
Comparative Dissolution Study of Atorvastatin Calcium Tablets in Indonesia
Atorvastatin calcium is a prescribed medication for hyperlipidemia that is widely used in Indonesia, both the innovator and its generic products. The performance of each product may vary, but generic products must meet quality standards of bioequivalence with the innovator. This study aimed to... Full article
1Department of Pharmaceutical Technology, Faculty of Pharmacy, Universitas Wahid Hasyim, Indonesia
2Department of Pharmaceutical Chemistry, Faculty of Pharmacy, Universitas Wahid Hasyim, Indonesiea-.m ail: yninik@unwahas.ac.id
Evaluation of Different Methods for Dissolution Profile Similarity Comparison of Montelukast Tablets in Türkiye
This study aimed to evaluate the highly variable in vitro dissolution profiles of generics and innovator montelukast products in the Turkish drug market by comparing model-dependent and model-independent analysis methods. Seven generic montelukast sodium products were tested, labeled G1-G7, and... Full article
1Department of Pharmaceutical Technology, Karadeniz Technical University, Trabzon, Türkiye
2Department of Pharmaceutical Technology, Gazi University, Ankara, Türkiye
3Department of Pharmaceutical Technology, Suleyman Demirel University, Isparta, Türkiye
November 2023
Comparison of Rosuvastatin Calcium Tablets Marketed in Saudi Arabia Under Biowaiver Conditions: In Vitro Quality Control Dissolution Study
Rosuvastatin (RST) calcium is used to treat hyperlipidemia, and several generic brands of RST calcium are available in Saudi Arabia along with the innovator. The current study aimed to compare two generic brands of RST with the innovator with respect to physicochemical parameters and... Full article
1Department of Pharmaceutical Chemistry, College of Pharmacy, Jazan University, Jazan, Saudi Arabia.
2Substance Abuse and Toxicology Research Centre, Jazan University, Jazan, Saudi Arabia.
3Medical Research Center, Jazan University, Jazan, Saudi Arabia
4Department of Pharmaceutics, College of Pharmacy, Jazan University, Jazan, Saudi Arabia.
5College of Pharmacy, Jazan University, Jazan, Saudi Arabia.
Comparative Dissolution of Budesonide from Four Commercially Available Products for Oral Administration: Implications for Interchangeablity
Budesonide is a corticosteroid regularly used in oral formulations to treat various inflammatory diseases in the gastrointestinal tract, such as Crohn’s disease and ulcerative colitis. Budesonide has also been formulated to be effective against immunoglobulin A (IgA)-related nephropathy. This study aimed to... Full article
1Fraunhofer Institute of Translational Medicine and Pharmacology, Frankfurt, Germany
August 2023
Comparative Dissolution Study of Various Brands of Valsartan Tablets Marketed in Pakistan
The purpose of this study was to perform a comparative dissolution study of various brands of valsartan tablets marketed in Pakistan. This drug belongs to BCS class II, which has high permeability and low solubility. Four different brands of valsartan tablets (80 mg) were collected from the local market of... Full article
1Riphah Institute of Pharmaceutical Sciences, Riphah International University, Islamabad, Pakistan
Release Profile of Branded Atorvastatin Calcium Tablet Relative to Commercially Available Counterpart Generics
Atorvastatin, a hypolipidemic medication, is commonly used as oral anti-atherosclerotic and cardiovascular protectant, with multiple marketed tablet brands available. This study aimed to assess critical quality attributes, including in-vitro dissolution characteristics, for five atorvastatin calcium tablet brands... Full article
1Department of Pharmaceutical Sciences, College of Pharmacy, Alfaisal University, Riyadh, Saudi Arabia
May 2023
Influence of Storage Conditions on the Pantoprazole Dissolution Profile for Gastro-Resistant Tablet Formulations
Generic formulations share the same active pharmaceutical ingredient (API), but differences in excipients can impact the quality and efficacy of formulations. In this study, four gastro-resistant pantoprazole tablet formulations were selected from the Serbian drug market to compare... Full article
1Department of Pharmacy, Faculty of Medicine, University of Novi Sad, Novi Sad, Serbia.
2Centre for Medical and Pharmaceutical Investigations and Quality Control (CEMPhIC), Faculty of Medicine, University of Novi Sad, Novi Sad, Serbia.
Comparative Study of Brand and Generics Ciprofloxacin Tablets Available in the Saudi Market
Introduction: Ciprofloxacin is a fluoroquinolone class of antibiotics with broad-spectrum antibacterial activity. Biowaiver studies of generic ciprofloxacin products can be used to establish bioequivalence with the reference product. Methods: The experiments are carried out using the... Full article
1Department of Pharmaceutics, College of Clinical Pharmacy, Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia.
February 2023
Physicochemical Quality and In Vitro Bioequivalence of Amoxicillin Capsules Marketed in Burkina Faso, Africa
Amoxicillin is a penicillin antibiotic widely prescribed to treat many infections. Several brands of oral forms of amoxicillin are available on the local market. The aim of this study was to evaluate the physicochemical quality and in vitro bioequivalence of several brands of amoxicillin capsules (500 mg) marketed in...
Full article
1Laboratoire du Développement du Médicament, Centre de Formation, de Recherche et d’Expertises en Sciences du Médicament (CEA-CFOREM), Ecole Doctorale Sciences et Santé, Université Joseph Ki-Zerbo, Ouagadougou, Burkina Faso, Africa.
2Laboratoire National de Santé Publique, Ministère de la Santé, Ouagadougou, Burkina Faso, Africa.
November 2022
Influence of Storage Conditions on Pharmaceutical Equivalence and Similarity of Hydrochlorothiazide Tablets in Argentina
Similarity studies are used with the intention to establish interchangeability of certain formulations in vitro, without the need to carry out in vivo studies. This interchangeability between formulations should be conserved during the product shelf life, as an integral part of the pharmaceutical stability...
Full article
1Control de Calidad de Medicamentos, Departamento de Biología, Bioquímica y Farmacia, Universidad Nacional del Sur, San Juan 670, 8000 Bahía Blanca, Argentina.
2CONICET-UNS, Bahía Blanca, Argentina.
Comparative Evaluation of Amlodipine Besylate Generic Tablet and Capsule Brands in Riyadh, Saudi Arabia
The objective of this study was to evaluate the physicochemical quality control parameters and pharmaceutical equivalence of amlodipine besylate generic tablets and capsules with the innovator brands (Norvasc and Amlor, respectively) available in Riyadh, Saudi Arabia. Five brands of amlodipine besylate tablets...
Full article
1Al Faisal University, College of Pharmacy, Riyadh, Saudi Arabia.
2King Saud University, College of Medicine, Riyadh, Saudi Arabia.
3Department of Pharmaceutics and Industrial Pharmacy, University of Ilorin, Ilorin Nigeria.
August 2022
In Vitro Bioequivalence of Acetylsalicylic Acid and Implications in Public Health
Acetylsalicylic acid is one of the most prescribed medications in the world. It is used for prevention of acute myocardial infarction, colorectal cancer, antipyretic, and as an analgesic. This study aimed to investigate the in vitro bioequivalence of three formulations of acetylsalicylic acid, simulating physiological conditions...
Full article
1Faculty of Pharmacy and Biochemistry, San Luis Gonzaga National University of Ica, Ica, Peru.
2Institute of Food Science and Nutrition, ICAN, San Ignacio de Loyola University, Lima, Peru.
3Environmental Engineering, San Ignacio de Loyola University, Lima, Peru.
4International Network for Research in Pharmacology and Precision Medicine (REDIFMEP), School of Human Medicine, San Ignacio de Loyola University, Lima, Peru.
Comparative Analysis of Commercially Available Acetaminophen Tablets in Saudi Arabia
Acetaminophen is a widely used oral analgesic and antipyretic medication; however, quality control parameters may differ across various brands. The aim of the present study was to evaluate and compare critical quality attributes, including in-vitro dissolution characteristics, of five acetaminophen tablet brands...
Full article
1Department of Pharmaceutical Sciences, College of Pharmacy, Alfaisal University, Riyadh, Saudi Arabia.
2Department of Pharmaceutics, College of Pharmacy, Qassim University, Buraidah, Saudi Arabia.
May 2022
Study of Drug Release Kinetics of Rosuvastatin Calcium Immediate-Release Tablets Marketed in Saudi Arabia
Rosuvastatin (RST), a BCS class II drug, is a poorly water-soluble antihyperlipidemic agent. The aim of the present work was to determine and compare the drug release kinetics from the RST calcium innovator (Crestor) and generic products (Ivarin and Resova) marketed in Saudi Arabia by employing various... Full article
1Department of Pharmaceutical Chemistry, College of Pharmacy, Jazan University, Jazan, Saudi Arabia.
2Department of Pharmaceutics, College of Pharmacy, Jazan University, Jazan, Saudi Arabia.
3Substance Abuse and Toxicology Research Centre, Jazan University, Jazan, Saudi Arabia.
Pharmaceutical Equivalence of Losartan Potassium Tablets in Argentina
Losartan potassium (LOK) is an antihypertensive agent from the group of selective angiotensin AT1 receptor antagonists, widely used in the form of tablets for oral administration. The available data for BCS classification are confusing, though class III or IV are most likely. The quality attributes of... Full article
1Departamento de Biología, Bioquímica y Farmacia, Universidad Nacional del Sur, Bahía Blanca, Argentina.
2Consejo Nacional de Investigaciones Científicas y Técnicas (CONICET), Bahía Blanca, Argentina.
February 2022
Therapeutic Equivalence Evaluated Through In Vitro Studies of Multi-Source Drugs: A Moxifloxacin Case Study in Lima, Peru
This study aimed to determine the therapeutic equivalence of four multi-source drugs containing moxifloxacin (400 mg tablets) in vitro studies to establish their interchangeability with the reference product. Four multi-source products were acquired in pharmaceutical establishments in metropolitan Lima, each from different manufacturing sites...Full article
1Grupo “Investigación en Ciencias Básicas Estomatológicas” (ICBEST), Universidad Nacional Mayor de San Marcos, Lima, Perú.
2Centro Nacional de Control de Calidad, Instituto Nacional de Salud, Lima, Perú.
November 2021
Quality Attributes and In Vitro Bioequivalence of Amlodipine (5 mg) Tablets in Ica, Peru
Dissolution studies have evolved from quality control testing to being an indicator of biopharmaceutical performance and an alternative to in vivo bioequivalence and interchangeability studies in clinical practice...Full article
1Faculty of Pharmacy and Biochemistry, San Luis Gonzaga National University of Ica, Ica, Peru.
2Peruvian Association of Immunogenomics and Personalized Medicine, Lima, Peru.
3Research Unit in Nutrition, Health Functional Foods and Nutraceuticals, San Ignacio de Loyola University, Lima, Peru.
4International Network for Research in Pharmacology and Precision Medicine (REDIFMEP), San Ignacio de Loyola University, Lima, Peru.
May 2021
In Vitro Biopharmaceutical Equivalence of Carbamazepine Sodium Tablets Available in Lima, Peru
Carbamazepine is an antiepileptic iminostilbene that is dispensed from multiple sources in Peru without bioequivalence studies. The biopharmaceutical equivalence of two generic (A and B) and one commercial brand (C) of carbamazepine sodium as compared to the innovator drug was determined by...Full article
Angel T. Alvarado1, Ana María Muñoz2, María R. Bendezú3, Juan J. Palomino-Jhong3, Jorge A. García3, César André Alvarado4, Erick A. Alvarado4, Gaby Ochoa-Pachas5, Mario Pineda-Pérez5, and Mario Bolarte5
1International Network for Research in Pharmacology and Precision Medicine, School of Human Medicine, San Ignacio de Loyola University, Lima, Peru.
2Research Unit in Nutrition, Health, Functional Foods and Nutraceuticals, Universidad San Ignacio de Loyola, Lima Peru.
3Faculty of Pharmacy and Biochemistry, San Luis Gonzaga National University of Ica, Ica, Peru.
4Faculty of Human Medicine, University of San Martín de Porres, Lima, Peru.
5Peruvian Association of Immunogenomics and Personalized Medicine, Lima, Peru.
Evaluation of In Vitro Equivalence of Commonly Available Generic Brands of Amlodipine Tablets in Saudi Arabia Under Biowaiver Conditions
When a medicine is not able to treat the disease for which it was intended, as in case of substandard and falsified drug products, it may prolong the disease and in worst scenario, the patient may die because of the untreated illness or the product itself. To ensure the quality and safety of medicine, WHO recommends...Full article
Asim Najmi1, Mohammed Al Bratty1, Bassam Abdullah Al-Bassam1, Rami Ali Aseri1, Turki Suliman Wadani1, Abdulrahman Ibrahim Al-Muntashiri1, Hassan A. Alhazmi1,2, Muhammad H. Sultan3, and Sadique A. Javed1
1Department of Pharmaceutical Chemistry, College of Pharmacy, Jazan University, Jazan, Saudi Arabia.
2Substance Abuse and Toxicology Research Centre, Jazan University, Jazan, Saudi Arabia.
3Department of Pharmaceutics, College of Pharmacy, Jazan University, Jazan, Saudi Arabia.
February 2021
Comparative Assessment of Critical Quality Attributes of Sildenafil Tablets
Sildenafil citrate is a selective inhibitor of the enzyme phosphodiesterase type 5, used to treat erectile dysfunction in adults and pulmonary hypertension, mainly in children. This work aimed to perform a comparative study of sildenafil tablets marketed in Argentina and establish their pharmaceutical equivalence...Full article
Marta I.V. Brevedan1, María A. Varillas1, and Noelia L. Gonzalez Vidal1,2
1Departamento de Biología, Bioquímica y Farmacia, Universidad Nacional del Sur, Bahía Blanca, Argentina.
2Consejo Nacional de Investigaciones Científicas y Técnicas, Bahía Blanca, Argentina.
In Vitro Biopharmaceutical Equivalence of 5-mg Glibenclamide Tablets in Simulated Intestinal Fluid Without Enzymes
This research evaluated the biopharmaceutical equivalence in vitro of three brands of glibenclamide 5-mg tablets (reference, brand name, and generic drugs) from Lima, Peru following the guidelines of the Biopharmaceutical Classification System (BCS). Glibenclamide is a BCS class 2 drug. Quality control parameters were evaluated including hardness, weight, friability, and drug content...Full article
Angel T. Alvarado1, Ana Maria Muñoz2, Maria Bendezú3, Jorge A. García3, Juan J. Palomino-Jhong3, Gaby Ochoa-Pachas4, Andres Chonn-Chang4, Luis Sullon-Dextre4, Berta Loja-Herrera4, and Mario Pineda-Perez4,5
1International Research Network in Pharmacology and Precision Medicine, Human Medicine School, San Ignacio de Loyola University, Lima, Peru.
2Research Unit in Nutrition, Health, Functional Foods and Nutraceuticals, Universidad San Ignacio de Loyola (UNUSAN-USIL), Lima, Peru.
3Faculty of Pharmacy and Biochemistry, National University San Luis Gonzaga, Ica, Peru.
4Peruvian Association of Immunogenomics and Personalized Medicine, Lima, Peru.
5Departmental Pharmaceutical Chemical College of Lima, Peru.
November 2020
In Vitro Comparative Dissolution Assessment of Different Brands of Co-Amoxiclav Tablets in Pakistan
Dissolution test results are the principal indicator in estimating the in-vivo bioavailability of most oral solid dosage forms and are an important quality attribute to assess the generic formulation. This study was designed to assess the release of co-amoxiclav from finished pharmaceutical solid dosage formulations...Full article
Muhammad Khurram Waqas1 Rehan Ali1 Muhammad Usman1 Muhammad Nabeel Shahid1 Akhtar Rasul2 Barkat Ali Khan3 and Ghulam Murtaza4
1Institute of Pharmaceutical Sciences, University of Veterinary and Animal Sciences, Lahore, Pakistan.
2College of Pharmacy, Government College University, Faisalabad, Pakistan.
3Faculty of Pharmacy, Gomal University, Dera Ismail Khan, Pakistan.
4Department of Pharmacy, COMSATS University Islamabad, Lahore Campus, Pakistan.