Jove
Visualize
Contact Us
JoVE
x logofacebook logolinkedin logoyoutube logo
ABOUT JoVE
OverviewLeadershipBlogJoVE Help Center
AUTHORS
Publishing ProcessEditorial BoardScope & PoliciesPeer ReviewFAQSubmit
LIBRARIANS
TestimonialsSubscriptionsAccessResourcesLibrary Advisory BoardFAQ
RESEARCH
JoVE JournalMethods CollectionsJoVE Encyclopedia of ExperimentsArchive
EDUCATION
JoVE CoreJoVE BusinessJoVE Science EducationJoVE Lab ManualFaculty Resource CenterFaculty Site
Terms & Conditions of Use
Privacy Policy
Policies

Related Concept Videos

Pharmaceutical Equivalents01:26

Pharmaceutical Equivalents

238
As defined by regulatory standards, pharmaceutical equivalents require generic drug products to have identical dosage forms and chemically identical active pharmaceutical ingredients (APIs). They must adhere to compendial or applicable standards for potency, content uniformity, disintegration times, and dissolution rates. In the case of modified-release dosage forms, variations in drug content are permissible as long as the delivered amount remains consistent with the innovator drug product.
238
Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence01:27

Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence

209
Changes in polymorphic forms can significantly influence the bioavailability of poorly soluble drugs. Although the FDA defines pharmaceutical equivalence based on having the same active ingredient, dosage form, and route of administration, it does not automatically disqualify products with different polymorphic forms. This means two products with different polymorphs can still be deemed pharmaceutically equivalent. However, polymorphic differences can affect properties like wettability,...
209
Pharmaceutical Alternatives: Stability-Related Therapeutic Nonequivalence01:22

Pharmaceutical Alternatives: Stability-Related Therapeutic Nonequivalence

235
Generic intravenous (IV) drugs are considered bioequivalent to their branded counterparts due to their 100% bioavailability upon administration. However, variations in stability among different drug products can significantly influence their therapeutic performance, even if they are pharmaceutically equivalent.Cefuroxime, a prophylactic antimicrobial, is often used as a single-dose IV injection for patients undergoing coronary artery bypass grafting surgery. A 3 g dose typically provides...
235
Formulation and Manufacturing Process: Physical Attributes of Generic Tablets and Capsules01:18

Formulation and Manufacturing Process: Physical Attributes of Generic Tablets and Capsules

390
Bioequivalence in generic drugs, such as tablets and capsules, refers to their pharmaceutical equivalence to the brand-name counterparts. However, for therapeutic equivalence, manufacturers must also consider physical attributes like size, shape, and weight (FDA Guidance for Industry, December 2003). Discrepancies in these aspects could impact patient compliance and cause medication errors. For instance, swallowing difficulties, often experienced with larger tablets or capsules, can lead to...
390
Bioequivalence: Overview01:16

Bioequivalence: Overview

2.1K
Pharmaceutical equivalents, by definition, are drug products with the same active ingredient in the same quantities, encapsulated in identical dosage forms, and intended for the same administration routes. These pharmaceutical equivalents are deemed bioequivalent if the bioavailability of the active entity in the drug preparations is similar. Moreover, pharmaceutical equivalents demonstrating bioequivalence are also regarded as therapeutically equivalent. This means that when used as directed,...
2.1K
Factors Influencing Drug Absorption: Pharmaceutical Parameters01:28

Factors Influencing Drug Absorption: Pharmaceutical Parameters

683
Solid dosage forms such as tablets and capsules undergo rigorous manufacturing processes to ensure stability and effectiveness. Their dissolution and absorption properties are influenced significantly by the choice of excipients (inactive ingredients that serve various roles in the formulation), and the methodology applied during production. The manufacturing parameters, such as compression force and granulation techniques, significantly affect dissolution rates. Elevated compression forces...
683

You might also read

Related Articles

Articles linked to this work by shared authors, journal, and citation graph.

Sort by
Same author

Association of Glucose-Lowering Therapy with Myocardial Work Recovery and Reverse Remodeling After STEMI.

Journal of clinical medicine·2026
Same author

Insights into the Thermal Degradation Kinetics of β-Lactam Antibiotics: A Comparative Study of Cefazolin, Ceftriaxone, and Meropenem.

Antibiotics (Basel, Switzerland)·2026
Same author

The Complexity of Drug Development: Translational Value and Limitations of Computational ADMET Assays Applied to Approved Anticancer Drugs.

Pharmaceuticals (Basel, Switzerland)·2026
Same author

Polypharmacy and Drug-Drug Interactions in Chronic Obstructive Pulmonary Disease: A Narrative Clinical Review.

Pharmaceutics·2026
Same author

Decoding Cyclodextrins in Skin Applications: Structure, Mechanisms, and Safety in Cosmetic and Dermatologic Formulations (Part I).

International journal of molecular sciences·2026
Same author

Demographic, Geographic, and Temporal Patterns of Adult Dental Emergency Presentations in Arad County, Western Romania.

Healthcare (Basel, Switzerland)·2026

Related Experiment Video

Updated: Mar 8, 2026

A Package of Established Analytical Tools to Investigate the Solid-State Alteration of Lipid-Based Excipients
11:27

A Package of Established Analytical Tools to Investigate the Solid-State Alteration of Lipid-Based Excipients

Published on: August 9, 2022

2.6K

Comparative Solid-State Stability of Perindopril Active Substance vs. Pharmaceutical Formulation.

Valentina Buda1, Minodora Andor2, Adriana Ledeti3

  • 1Faculty of Pharmacy, Victor Babes University of Medicine and Pharmacy, 2 Eftimie Murgu, 300041 Timisoara, Romania. buda.valentina.oana@gmail.com.

International Journal of Molecular Sciences
|January 19, 2017
PubMed
Summary

This study investigated the thermal stability of perindopril erbumine, finding that common pharmaceutical excipients significantly enhance its stability. These excipients are recommended for developing new generic solid formulations of this antihypertensive drug.

Keywords:
ASTM E698comparative stabilitydecompositionisoconversional kinetic studyperindopril erbumineperindopril tert-butylaminepharmaceutical formulationthermal stability

More Related Videos

Self-Nanoemulsification of Healthy Oils to Enhance the Solubility of Lipophilic Drugs
08:18

Self-Nanoemulsification of Healthy Oils to Enhance the Solubility of Lipophilic Drugs

Published on: July 27, 2022

1.6K
Transport Properties of Ibuprofen Encapsulated in Cyclodextrin Nanosponge Hydrogels: A Proton HR-MAS NMR Spectroscopy Study
10:10

Transport Properties of Ibuprofen Encapsulated in Cyclodextrin Nanosponge Hydrogels: A Proton HR-MAS NMR Spectroscopy Study

Published on: August 15, 2016

10.8K

Related Experiment Videos

Last Updated: Mar 8, 2026

A Package of Established Analytical Tools to Investigate the Solid-State Alteration of Lipid-Based Excipients
11:27

A Package of Established Analytical Tools to Investigate the Solid-State Alteration of Lipid-Based Excipients

Published on: August 9, 2022

2.6K
Self-Nanoemulsification of Healthy Oils to Enhance the Solubility of Lipophilic Drugs
08:18

Self-Nanoemulsification of Healthy Oils to Enhance the Solubility of Lipophilic Drugs

Published on: July 27, 2022

1.6K
Transport Properties of Ibuprofen Encapsulated in Cyclodextrin Nanosponge Hydrogels: A Proton HR-MAS NMR Spectroscopy Study
10:10

Transport Properties of Ibuprofen Encapsulated in Cyclodextrin Nanosponge Hydrogels: A Proton HR-MAS NMR Spectroscopy Study

Published on: August 15, 2016

10.8K

Area of Science:

  • Pharmaceutical Sciences
  • Physical Chemistry
  • Materials Science

Background:

  • Limited literature exists on the thermal stability and decomposition kinetics of perindopril erbumine.
  • Understanding thermal behavior is crucial for pharmaceutical formulation and storage.

Purpose of the Study:

  • To evaluate the thermal stability and decomposition kinetics of perindopril erbumine (API) and its solid pharmaceutical formulation.
  • To assess the compatibility of perindopril erbumine with common pharmaceutical excipients.
  • To investigate the effect of thermal treatment on the stability of perindopril erbumine.

Main Methods:

  • Attenuated Total Reflectance Fourier Transform Infrared (ATR-FTIR) spectroscopy.
  • Thermal analysis including thermogravimetry (TG), derivative thermogravimetry (DTG), and heat flow (HF).
  • Model-free kinetic methods (Friedman, Kissinger-Akahira-Sunose, Flynn-Wall-Ozawa) and classical methods (Kissinger, ASTM E698).

Main Results:

  • Perindopril erbumine's main thermal degradation step showed activation energy between 59-69 kJ/mol.
  • The solid pharmaceutical formulation exhibited significantly higher thermal stability with activation energy around 170 kJ/mol.
  • Excipients like anhydrous colloidal silica, microcrystalline cellulose, lactose, and magnesium stearate improved perindopril erbumine's thermal stability.

Conclusions:

  • The studied excipients enhance the thermal stability of perindopril erbumine in solid formulations.
  • These excipients are suitable for developing new generic solid pharmaceutical formulations of perindopril erbumine.
  • The findings provide valuable data for the formulation and storage of perindopril erbumine-based medications.