BIOMAT Database Logo BIOMAT Database Logo

Quality of amoxicillin/clavulanic acid oral formulations for intended veterinary use in the UK, Malaysia, Serbia and Thailand. 2023

L Pelligand, and D Baker, and A Sivagurunathan, and Z Kovačević, and N Suemanotham, and J L Stair, and M Scott, and F Liu, and S W Page, and L Guardabassi, and P V Steagall, and
Department of Clinical Services and Sciences and Department of Comparative Biomedical Sciences, Royal Veterinary College, Hatfield, UK.

Amoxicillin/clavulanate is the most commonly used oral antimicrobial drug in companion animals. The objective of the study was to detect types and frequency of deficits in the quality of veterinary oral formulations of amoxicillin/clavulanate in various countries. In a prospective study with purposive sampling, amoxicillin/clavulanate tablet formulations for canine use were collected in four countries (wholesalers or veterinary practice) and shipped to a central bioanalytical laboratory. Twenty-four samples were collected from the UK (nine), Malaysia (nine), Serbia (four) and Thailand (two), yielding 18 different formulations (10 veterinary). Packaging inspection, tablet disintegration and content assay were conducted (validated high-performance liquid chromatography with ultra-violet detection); content was acceptable when within the 90% to 120% pre-specified range (US Pharmacopeia). Secondary packaging was present for 13 of 24 samples and primary packaging integrity was verified for all but one sample. Amoxicillin trihydrate/potassium clavulanate label ratio was 4:1, except for three formulations (2:1). Tablet dose strength ranged from 250 to 625 mg. All formulations contained both analytes. For amoxicillin, two of 24 samples were out of specification with 72.8% (Malaysia) and 82.3% (Thailand) of labelled content. For clavulanate, four of 24 samples were out of specification with 46.9% (Serbia), 79.0% (UK), 84.3% (Serbia) and 86.5% (Thailand) of labelled content. One formulation (Thailand) failed for both analytes. Antimicrobial formulations of substandard quality have negative consequences for efficacy in patients and potentially promote antimicrobial resistance. There was evidence of substandard formulations in all countries, not only for amoxicillin but especially for clavulanate; this could compromise equitable access to acceptable quality essential veterinary medicines worldwide.

UI MeSH Term Description Entries
D008296 Malaysia A parliamentary democracy with a constitutional monarch in southeast Asia, consisting of 11 states (West Malaysia) on the Malay Peninsula and two states (East Malaysia) on the island of BORNEO. It is also called the Federation of Malaysia. Its capital is Kuala Lumpur. Before 1963 it was the Union of Malaya. It reorganized in 1948 as the Federation of Malaya, becoming independent from British Malaya in 1957 and becoming Malaysia in 1963 as a federation of Malaya, Sabah, Sarawak, and Singapore (which seceded in 1965). The form Malay- probably derives from the Tamil malay, mountain, with reference to its geography. (From Webster's New Geographical Dictionary, 1988, p715 & Room, Brewer's Dictionary of Names, 1992, p329) Federation of Malaya,Malay Federation,Malay Peninsula,Malaya,Malaya Federation,Sabah,Sarawak
D011446 Prospective Studies Observation of a population for a sufficient number of persons over a sufficient number of years to generate incidence or mortality rates subsequent to the selection of the study group. Prospective Study,Studies, Prospective,Study, Prospective
D004285 Dogs The domestic dog, Canis familiaris, comprising about 400 breeds, of the carnivore family CANIDAE. They are worldwide in distribution and live in association with people. (Walker's Mammals of the World, 5th ed, p1065) Canis familiaris,Dog
D006113 United Kingdom Country in northwestern Europe including Great Britain and the northern one-sixth of the island of Ireland, located between the North Sea and north Atlantic Ocean. The capital is London. Great Britain,Isle of Man
D000658 Amoxicillin A broad-spectrum semisynthetic antibiotic similar to AMPICILLIN except that its resistance to gastric acid permits higher serum levels with oral administration. Hydroxyampicillin,Actimoxi,Amoxicillin Anhydrous,Amoxicillin Monopotassium Salt,Amoxicillin Monosodium Salt,Amoxicillin Sodium,Amoxicillin Trihydrate,Amoxicillin, (R*)-Isomer,Amoxicilline,Amoxil,Amoxycillin,BRL-2333,Clamoxyl,Clamoxyl G.A.,Clamoxyl Parenteral,Penamox,Polymox,Trimox,Wymox,BRL 2333,BRL2333
D000818 Animals Unicellular or multicellular, heterotrophic organisms, that have sensation and the power of voluntary movement. Under the older five kingdom paradigm, Animalia was one of the kingdoms. Under the modern three domain model, Animalia represents one of the many groups in the domain EUKARYOTA. Animal,Metazoa,Animalia
D000890 Anti-Infective Agents Substances that prevent infectious agents or organisms from spreading or kill infectious agents in order to prevent the spread of infection. Anti-Infective Agent,Anti-Microbial Agent,Antimicrobial Agent,Microbicide,Microbicides,Anti-Microbial Agents,Antiinfective Agents,Antimicrobial Agents,Agent, Anti-Infective,Agent, Anti-Microbial,Agent, Antimicrobial,Agents, Anti-Infective,Agents, Anti-Microbial,Agents, Antiinfective,Agents, Antimicrobial,Anti Infective Agent,Anti Infective Agents,Anti Microbial Agent,Anti Microbial Agents
D000900 Anti-Bacterial Agents Substances that inhibit the growth or reproduction of BACTERIA. Anti-Bacterial Agent,Anti-Bacterial Compound,Anti-Mycobacterial Agent,Antibacterial Agent,Antibiotics,Antimycobacterial Agent,Bacteriocidal Agent,Bacteriocide,Anti-Bacterial Compounds,Anti-Mycobacterial Agents,Antibacterial Agents,Antibiotic,Antimycobacterial Agents,Bacteriocidal Agents,Bacteriocides,Agent, Anti-Bacterial,Agent, Anti-Mycobacterial,Agent, Antibacterial,Agent, Antimycobacterial,Agent, Bacteriocidal,Agents, Anti-Bacterial,Agents, Anti-Mycobacterial,Agents, Antibacterial,Agents, Antimycobacterial,Agents, Bacteriocidal,Anti Bacterial Agent,Anti Bacterial Agents,Anti Bacterial Compound,Anti Bacterial Compounds,Anti Mycobacterial Agent,Anti Mycobacterial Agents,Compound, Anti-Bacterial,Compounds, Anti-Bacterial
D013607 Tablets Solid dosage forms, of varying weight, size, and shape, which may be molded or compressed, and which contain a medicinal substance in pure or diluted form. (Dorland, 28th ed) Tablet
D013785 Thailand Formerly known as Siam, this is a Southeast Asian nation at the center of the Indochina peninsula. Bangkok is the capital city. Kingdom of Thailand,Siam

Related Publications

L Pelligand, and D Baker, and A Sivagurunathan, and Z Kovačević, and N Suemanotham, and J L Stair, and M Scott, and F Liu, and S W Page, and L Guardabassi, and P V Steagall, and
Oral amoxicillin and amoxicillin-clavulanic acid: properties, indications and usage.
July 2020, Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases,
L Pelligand, and D Baker, and A Sivagurunathan, and Z Kovačević, and N Suemanotham, and J L Stair, and M Scott, and F Liu, and S W Page, and L Guardabassi, and P V Steagall, and
Relative Oral Bioavailability of Two Amoxicillin-Clavulanic Acid Formulations in Healthy Dogs: A Pilot Study.
January 2019, Journal of the American Animal Hospital Association,
L Pelligand, and D Baker, and A Sivagurunathan, and Z Kovačević, and N Suemanotham, and J L Stair, and M Scott, and F Liu, and S W Page, and L Guardabassi, and P V Steagall, and
New formulations of amoxicillin/clavulanic acid: a pharmacokinetic and pharmacodynamic review.
January 2005, Clinical pharmacokinetics,
L Pelligand, and D Baker, and A Sivagurunathan, and Z Kovačević, and N Suemanotham, and J L Stair, and M Scott, and F Liu, and S W Page, and L Guardabassi, and P V Steagall, and
Use of amoxicillin and amoxicillin-clavulanic acid and hospitalization for acute liver injury.
January 1999, Annali dell'Istituto superiore di sanita,
L Pelligand, and D Baker, and A Sivagurunathan, and Z Kovačević, and N Suemanotham, and J L Stair, and M Scott, and F Liu, and S W Page, and L Guardabassi, and P V Steagall, and
Quality control parameters for broth microdilution susceptibility testing of amoxicillin and amoxicillin-clavulanic acid.
February 1994, European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology,
L Pelligand, and D Baker, and A Sivagurunathan, and Z Kovačević, and N Suemanotham, and J L Stair, and M Scott, and F Liu, and S W Page, and L Guardabassi, and P V Steagall, and
Disposition and oral bioavailability of amoxicillin and clavulanic acid in pigs.
December 2007, Journal of veterinary pharmacology and therapeutics,
L Pelligand, and D Baker, and A Sivagurunathan, and Z Kovačević, and N Suemanotham, and J L Stair, and M Scott, and F Liu, and S W Page, and L Guardabassi, and P V Steagall, and
Ventricular fibrillation after oral administration of amoxicillin and clavulanic acid.
December 2013, Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology,
L Pelligand, and D Baker, and A Sivagurunathan, and Z Kovačević, and N Suemanotham, and J L Stair, and M Scott, and F Liu, and S W Page, and L Guardabassi, and P V Steagall, and
Kounis syndrome secondary to amoxicillin/clavulanic acid use.
February 2008, International journal of cardiology,
L Pelligand, and D Baker, and A Sivagurunathan, and Z Kovačević, and N Suemanotham, and J L Stair, and M Scott, and F Liu, and S W Page, and L Guardabassi, and P V Steagall, and
[Amoxicillin-clavulanic acid and oral anticoagulants: a possible dangerous association].
January 2004, Annali italiani di medicina interna : organo ufficiale della Societa italiana di medicina interna,
L Pelligand, and D Baker, and A Sivagurunathan, and Z Kovačević, and N Suemanotham, and J L Stair, and M Scott, and F Liu, and S W Page, and L Guardabassi, and P V Steagall, and
Impact of amoxicillin and oral amoxicillin-clavulanic acid defined daily doses on consumption indicators.
May 2019, Medecine et maladies infectieuses,
Copied contents to your clipboard!