Dear All,
Time for me to tap into the wisdom of this group on two subjects:
1) In trying to describe a drug dosage form that uses pump technology to deliver a precise drop(s) to an inhaler for aerosolizing and subsequent inhalation by the user, the company wants to use the term "drop dispenser" when describing the dosage form more specifically. Yes this is a combination product where the dosage form and the inhaler will be labeled for use together. Please comment on the use of drop dispenser.
2) This same dosage form (not a nasal spray or dropper for direct delivery of medicine to a patient) when evaluating container closure integrity (microbial ingress) of the container closure system could use a variety of tests; what test(s) would be appropriate to consider based on the intended use to deliver a precise drop to an inhaler not a subject. The dosage form is re-usable and will have a limited in-use life.
I really look forward to all your input,
Dar
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Darlene Rosario RAC
Principal Consultant RA, Quality and Compliance
Velocity Consulting
Ventura CA
United States
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