Generic Comparisons

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.