Inhalation

INH0820

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Drug developers can use bottom-up or top-down particle engineering approaches or a combination. Selecting the best approach depends on characteristics of the active pharmaceutical ingredient and the target product profile, including the inhaled biopharmaceutical classification system of the drug in development. 22 August 2020 Inhalation Particle engineering approaches for dry powder inhalers Considerations of API properties and target product profile to determine an appropriate particle engineering technology for inhaled drug products Cameron Kadleck, BSE; Joseph Churchman, BSc and Herbert Chiou, PhD Lonza Pharma Biotech and Nutrition It is not always obvious which particle engineering approach is best suited to a particular API. Choosing the right particle engineering technology requires first: establishing the requirements of the formulation and delivery device of the end product, second: evaluating material properties and conducting feasibility experi- ments, and third: evaluating risks associated with the most suitable engineering approaches. By understand- ing the ways different particle engineering approaches influence the end product, developers can be in the best position to accelerate clinical testing, commer- cialization and patient treatment. Ultimately, select- ing a particle engineering technology may depend on the target product profile (TPP) such as API stability, delivered dose and device type. Furthermore, there have been discussions about the TPP for inhaled drug products, which includes views of a consortium sponsored by the Product Quality Research Institute (PQRI) on the relevance of a Pul- monary Biopharmaceutical Classification System (BCS) 2 in defining a TPP. In addition to presenting a BCS classification for inhaled drug products, the fate of inhaled particles and regional deposition in central vs. peripheral airways was reviewed by the group. 3 Bottom-up approaches: Bulk solution to droplet formation to dried particles Bottom-up particle engineering techniques share a high-level process path that goes from bulk solution to droplet formation to dried particles. Bottom-up approaches include spray drying, spray freeze drying, thin film freezing and supercritical fluid technologies. Pulmonary illness rates are increasing and respira- tory diseases continue to be a leading cause of death and disability worldwide. 1 Although often treatable, diseases such as chronic obstructive pulmonary dis- ease (COPD), asthma and pulmonary infections continue to increase in number. Medications to treat respiratory disease are increasingly accessible but the clinical need for options that are affordable, robust and efficacious remains. Inhalation drug products are a unique field of pharma- ceutics in that they combine the physical attributes of the active pharmaceutical product ingredient (API), carrier and device into a single drug product. As the pharmaceutical industry continues to expand the breadth of small molecule and biologics compounds requiring lung delivery, it is expected there will continue to be an outstanding need to develop technologies capa- ble of delivering these compounds through inhalation. At the same time, there is a growing patient need for innovative inhaled drug products and therapies. Whether solid, liquid, crystalline or amorphous, there are many possible particle engineering technologies available to manufacture formulations with the appro- priate product quality attributes for pulmonary deliv- ery, and each has advantages and limitations. Particle engineering approaches can be divided among "bot- tom-up" (e.g., form change from solution to solid), "top-down" (e.g., milling), or a combination of both (e.g., milled then coated with a second component from solution) and each has its own characteristics and benefits for drug product delivery. Some particle engi- neering approaches may change the crystallinity of the active compound and potentially change the solubility.

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