BHA confirms injectable omeprazole can be used within rules
Previously, traces of testosterone, at less than one millionth of the internationally accepted standard for impurities, had been found in a batch of the product last year.
Independent experts confirmed that there could be no adverse effects on equine health or equestrian sport, but BOVA immediately took steps to identify and completely eliminate the excipient ingredient that contained traces of testosterone.
The BOVA product was declared free of testosterone in September 2019 and the product has continued to be used in racehorses in Australia following guidance from Racing NSW, since this time.
Multiple samples of each batch of injectable omeprazole have since been demonstrated to be free of testosterone using a validated and highly sensitive method of analysis before the product is released for sale. “Long acting injectable omeprazole has become an important treatment option for horses with gastric disease, particularly those affected by glandular gastric disease,” said Dr Mike Hewetson BSc BVSc PhD FHEA DipECEIM MRCVS, the Royal Veterinary College.
In a recent prospective blinded clinical trial of Bova’s long-acting injectable omeprazole, rates of healing for both glandular and squamous gastric disease were four times higher with injectable omeprazole than with a registered oral product.
1,2 A published studies on injectable omeprazole can be found here and here .
1. Rendle, D. & Hallowell, G. Treatment of equine squamous gastric disease in elite endurance horses with oral and long-acting injectable omeprazole: a randomised, blinded clinical trial. Proceedings of the 12th ECEIM Congress, Valencia, November 2019.
2. Rendle, D. & Hallowell, G. Treatment of equine glandular gastric disease in elite endurance horses with oral and long-acting injectable omeprazole: a randomised, blinded clinical trial. Proceedings of the 12th ECEIM Congress, Valencia, November 2019 ENDS Note to editors Bova UK is a subsidiary of Bova Australia, a company founded by Nicholas Bova in 2008 as an extension of the family pharmacy business, founded in 1968.
It is now the largest veterinary compounder in Australia, has more than 70 employees and services thousands of vets.
The manufacture of specials medications in the UK is a tightly regulated process.
While some human healthcare companies are authorised to supply veterinary specials under licence in the UK, Bova is currently the only company in the UK to have specific veterinary authorisation to manufacture sterile specials.
Bova UK has been audited by the VMD to ensure it follows Good Manufacturing Principles when preparing its formulations.
This includes ensuring that raw materials are sourced from manufacturers recognised for their high standards and quality pharmaceutical materials.
All of the equipment at Bova has been validated and confirmed it is fit for purpose.
Staff must also be trained and validated before they are able to prepare any formulations for clients.
The company is meticulous with its adherence to strict quality assurance guidelines when preparing sterile medications and uses a bespoke positive pressure suite that has been certified for sterile compounding.
Further information from: Sarah Shephard, Bright Bay, +44(0) 1986 784562, 07768 958911, [email protected]