Generic Comparisons

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

Yessica Imbriago1 Alejandra Schiavo1 Andrés Baptista1 Patricia Rega1 Marianela Lorier1 Pietro Fagiolino1 Cecilia Maldonado1 Marta Vázquez1 Manuel Ibarra1
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

Victor Chumpitaz-Cerrate1 Luis Moreno-Exebio1 Eliberto Ruiz-Ramirez1 César Franco-Quino1 María Flores-Rodríguez2 Lesly Chávez-Rimache1
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

Yulias Ninik Windriyati1 Ibrahim Arifin2 Lailatunnafiah1 Any Farikhah1
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

Özlem Çoban1 Duygu Yilmaz Usta2 Sıla Gulbag Pinar3
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

Md I. Alam1 Mohammed Albratty1 Hassan A. Alhazmi1,2,3 Asim Najmi1 Khalid Zoghebi1 Muhammad H. Sultan4 Waquar Ahsan1 Shamama Javed4 Md I. Alam4 Abdulelah M. Tawhari5 Abdulrhman A. B. Nasib5 Ali M. M. Fagiri5 Abdulrahman N. S. Alattas5 Waseem H. A. Mosayyikh5
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

Jennifer Dressman1
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

Muhammad Mohsin Ansari1 Muhammad Zain Amin1 Usman Ashraf1 Muhammad Noman Ehsan1 Muhammad Farhan1 Aasil1 Hina Ahsan1
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

Omar Z. Ameer1
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

Jelena Čanji Panić1 Nemanja Todorović1 Kristina Jonaš1 Ana Stjepanović1 Gordana ?vonja-Parezanović1 Milana Vuković1 Mladena Lalić-Popović1,2
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

Hassan M. Alsulais1 Ali K. Alqaisum1 Ahmed A. Aldoulah1 Ashfaq A. Mohsin1 Hassan M. Ghonaim1
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

B. Gérard Josias Yaméogo1,2, Wendpouiré Zoungrana-Somé1,2, B. Charles Sombié1, Hermine Zimé-Diawara1, Bertrand Goumbri2, Aïssata Sanfo-Diasso2, Elie Kabré2, and Rasmané Semdé1
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

Marta I.V. Brevedan1, María A. Varillas1, and Noelia L. Gonzalez Vidal1,2
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

Doaa R. Adam,1 Nuran Al Rayes,1 Raghad Fatoum,1 Ghosoun Arafeh,1 Tasneem Rashed Adam,2 and Adeola Kola-Mustapha1,3 Marta I.V. Brevedan1, María A. Varillas1, and Noelia L. Gonzalez Vidal1,2
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

María R. Bendezú1 Jorge A. García1 Haydee Chávez1 Ana María Muñoz2 John Jáuregui3 Miguel Mucha3 Ricardo Losno4 María Saravia4 and Angel T. Alvarado4
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

Aiman Y. Alwadi1 Ghosoun M. Arafeh1 Mohammad S. Almehlesi2 Hamzah M. Maswadeh2 Ibrahim M. Salman1 and Omar Z. Ameer1
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

Waquar Ahsan1 Md Shamsher Alam1 Shamama Javed2 Hassan A. Alhazmi2,3 Mohammed Albratty1 Asim Najmi1 Muhammad Hadi Sultan2
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

María A. Varillas1 Marta I.V. Brevedan1 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 (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

Victor Chumpitaz-Cerrate1 Luis Moreno-Exebio1 Eliberto Ruiz-Ramirez1 César Franco-Quino1 María Flores-Rodríguez2 and Lesly Chávez-Rimache1
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

Jorge A. García1, María R. Bendezú1, Mario Pineda-Pérez2, Ana María Muñoz3, María Saravia4, and Angel T. Alvarado4
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.