Ultra-portable fast-dispersal buccal naloxone tablets for constant carriage: Can they be manufactured? Are they acceptable and valued by users and family members?
Background: Naloxone nasal spray has been an important development, opening pathways for the introduction of take-home naloxone (THN) to new countries (e.g. Sweden) and to the wider workforce (e.g. police). However, it has limitations. It assumes healthy nasal mucosa (consider colds, hayfever, drug-related scarring, overdose-induced vomitus). It is also moderately bulky, contributing to reported poor naloxone carriage rates.
With university pharmaceutical sciences partners, we have produced rapid-dispersal wafer formulations (Alqurshi et al, Molecular Therapeutics, 2016). But this is of little value whilst languishing on a university laboratory bench.
Funding approval has been secured to task manufacturers to test feasibility to produce rapid-dispersal tablets in a credit-card-sized format to achieve high carriage rates, to liaise with the Medicines and Healthcare products Regulatory Agency (MHRA), and to investigate end-user acceptability.
Method: A major element of work is tasking the manufacturing industry (Catalent) to establish if they can adapt ‘Zydis’ technology to produce stable rapid-dispersal tablets in the desired format at a range of naloxone doses. A second element is consultation with MHRA (through pharmaceutical company Accord) to advise on the next-step healthy-volunteer study of safety, pharmacokinetics and optimal dose, including special attention to the speed of onset and duration of action. The third element involves focus group and individual consultations with individuals with relevant lived and living experience, family members and commissioners to establish the acceptability of different formats and implementation strategies.
Conclusions: We must always look for improvements to our current valued interventions. We need partnerships to contribute different skills. Buccal rapid-dispersal naloxone could transform portability and constant availability if results are positive.