By Tony Pidgeon, Process Technology Director Pharma Services, Patheon, part of Thermo Fisher Scientific
There are many parenteral dosage forms from which the pharmaceutical scientist can choose to develop their drug product. For primary pack choices, there are traditional vials, ampoules, cartridges, pre-filled syringes and complex containers such as the various types of dual chamber syringes. Additionally, there are newer dosage forms such as wearable injection devices or pump patches. Each have their own merits and advantages, but these advantages may not be realized until the product is marketed. Consideration must also be made on the form of the product within the container and the environment in which it will be used and needs to be (or is able to be) stored. The most desired form is normally an aqueous liquid which can be stored at room temperature; however, there are many perfectly acceptable products which are supplied in solid form such as lyophilized powder for reconstitution which need to be stored in refrigerated or even frozen conditions.
To make the right choices which can, and arguably should, change during the development life cycle of the product, the pharmaceutical scientist needs to employ a sound development strategy. In this article, the author discusses the choices available and strategies which can be employed at the different stages of development.