Generic Comparisons

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 Yaméogo^1,2, Wendpouiré Zoungrana-Somé^1,2, B. Charles Sombié¹, Hermine Zimé-Diawara¹, Bertrand Goumbri², Aïssata Sanfo-Diasso², Elie Kabré², and Rasmané Semdé^1
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 Vidal^1,2
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 Vidal^1,2
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. Alvarado^4
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. Ameer^1
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. Alhazmi^2,3 Mohammed Albratty¹ Asim Najmi¹ Muhammad Hadi Sultan^2
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 Vidal^1,2
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-Rimache^1
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. Alvarado^4
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 Bolarte^5
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. Alhazmi^1,2, Muhammad H. Sultan³, and Sadique A. Javed^1
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 Vidal^1,2
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-Perez^4,5
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 Murtaza^4
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.