In a randomised clinical trial led by a team from Oxford University, a total of 2104 severe Covid-19 hospital patients received therapy of a once-daily 6mg dose of dexamethasone, either by orally or by intravenous injection, for ten days.
These were compared with 4321 patients who received usual care alone. For those on ventilators, it cut death risk from 41% to 28%. For patients needing oxygen, it cut death risk from 25% to 20%.
These initial trials illustrated such a positive outcome that the UK has already licensed its use for the treatment of Covd-19. Dexamethasone’s status as a relatively low-cost generic drug means that it is already readily available to hospitals. However, it is likely that manufacturers will need to ramp up production to meet the demand for what may become a highly sought after drug in both the UK and across the world for the treatment of Covid-19.
In support of this increased production, it is anticipated that the need for QC testing of raw materials, API’s and finished products will also increase along with the dependence on approved testing laboratories. With many in-house laboratories having to cope with reduced capacity due to Coronavirus restrictions, the use of contract laboratories could become an important factor in getting the products released to the market in the timeframes required.
Butterworth Laboratories has reacted very swiftly to each development in the Coronavirus crisis and the implementation of innovative working practices have allowed it to maintain its usual capacity throughout. This has led to new customers adding Butterworth to their approved list of contract laboratories which in itself has created an additional challenge – how to audit a laboratory in lockdown. The Butterworth QA team worked closely with clients and were able to complete a first remote audit within weeks. The audit process was so successful that they feel that this may become a cost and time-saving alternative to some on-site audits in the future.
Established over 45 years ago, Butterworth’s MHRA and FDA approved laboratory has gained experience in a broad range of GMP testing of, raw materials, APIs and finished products, including corticosteroid drugs, such as Dexamethasone, to pharmacopoeial standards.
Butterworth Laboratories Ltd is available to support companies who are manufacturing Dexamethasone based products with QC testing to pharmacopoeia, in-house and client methodologies.
If you have such requirements, please contact us by filling out the enquiry form attached to this page.