Long-Acting Injectables (LAIs) are rapidly growing across the pharmaceutical industry for the treatment of chronic conditions, infectious diseases (HIV, Malaria, TB, Hepatitis C, etc.), antipsychotic drugs, hormonal contraceptives, bone health, cancer, etc., because they offer the opportunity to reduce administration frequency, improve patience adherence and experience, and reduce healthcare costs. A recent example on the impact of LAI regimens to patients comes from the FDA approval of Cabenuva, an extended-release dosage of Cabotegravir and Rilpivirine for the treatment of HIV. Other key cross-pharma collaborations highlight the intense activity in the area.
However, the path for design and development of LAIs is not as defined as it is for other dosage forms (e.g. oral solid dosage forms). At this stage, there is a need for experts in the field across the pharmaceutical, regulatory, and academic landscape to work together to identify gaps and defining strategies to accelerate the development of this game-changing class of drug products.
The LAI Drug Product Design and Development space should be brought to the same level as the oral solid dosage forms space, with clear regulatory guidelines (e.g. BCS classification, ICH M9), defined mechanistic understanding, predictive simulation tools (e.g., PBPK modeling), and biorelevant dissolution methods.
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