Title
Aligning Species Conservation with Animal Welfare: Formulation of Vulture-Safe Meloxicam Manufactured in South Asia and the Reaction of Goats to its Administration
Author(s)
Richard J. Cuthbert; Surya Paudel; Anand Chaudhary; Krishna Kaphle; Jeewan Thapa; Tulsi Ram Subedi; Mark A. Taggart
Published
2014
Abstract
1. Resident vulture populations in South Asia have undergone catastrophic declines due to their toxicity to the non-steroidal anti-inflammatory drug (NSAID) diclofenac, which was widely used as a painkiller in treating domestic ungulates, the principal food source for vultures. As a result of the critically endangered status of resident vultures, the manufacture of veterinary products of diclofenac was banned in India, Nepal and Pakistan in 2006.
2. Preparations of the NSAID meloxicam are promoted as an alternative to diclofenac, due to its safety to vultures and the wide-scale use of meloxicam in Europe where it is the main NSAID of choice for treating livestock. However, veterinarians in South Asia have raised concerns on the pain and irritation reaction that meloxicam products were causing when injected in goats and cattle.
3. We investigated the pH, osmolarity and formulation of a range of veterinary NSAIDs that were available for purchase in India and Nepal, and undertook an experiment to measure the pain reaction of domestic goats (Capra hircus) to South Asian meloxicam products and to Metacam®, the meloxicam product used in Europe.
4. NSAIDs purchased in South Asia exhibited a wide range of pH values and osmolarities, with many products having high pH (strongly alkaline) and high osmolarities (hypertonic), far in excess of those found in mammalian plasma. All products contained the labelled ingredients and concentrations of active ingredient were generally within the stated range. Only Metacam® was found to contain meglumine, an excipient used in many pharmaceutical products.
5. Treatment of goats, undertaken in a replicated and blind experiment, revealed that both meloxicam products manufactured in South Asia caused acute pain reactions following intra-muscular injection. In contrast, there was no difference in the reaction of goats to injections of Metacam® in comparison to injections with saline solution. The degree of pain of South Asian products was related to both high pH and high osmolarity. While short-term pain reactions were observed, no lasting pain or tissue damage occurred with any product.
6. The high pH and osmolarity of South Asian products of meloxicam are a result of the low solubility of meloxicam in water, with solubility increasing in more alkaline solutions. The addition of the excipient meglumine (as found in Metacam®) increases the solubility of meloxicam, without creating concomitant problems of high pH and osmolarity. Boehringer Ingelheim, the German pharmaceutical company that developed and markets Metacam®, has waived copyright to their formulation in India, allowing this to be used to manufacture meloxicam in South Asia. Promotion of a safe, effective and pain-free veterinary meloxicam formulation will benefit vulture conservation, animal welfare and the pharmaceutical industry in South Asia.
Full Citation
Cuthbert, R.J., Paudel, S., Chaudhary, A., Kaphle, K., Thapa, J., Subedi, T.R. and Taggart, M.A. (2014). Aligning species conservation with animal welfare: formulation of vulture-safe meloxicam manufactured in South Asia and the reaction of goats to its administration. RSPB Research Report No. 52. Royal Society for the Protection of Birds, Sandy, Bedfordshire, UK.
Access Full Text
Back
DMX4087200000