Morphology of the lectotype of Chelodina oblonga Gray 1841 (Testudines: Chelidae).

Uncertainty about taxonomy and nomenclature of the Australian long-necked turtle Chelodina oblonga has ensued since its description by Gray in 1841. This has been due to the general nature of information about provenance of the lectotype specimen and the ostensible morphological similarity of the specimen to another taxon from northern Australia that confused Gray and many subsequent workers. The south-western Australian provenance of the specimen has recently been confirmed by Shea et al. (2020). The present paper provides a detailed consideration of morphology of the specimen and compares it with other specimens available to Gray and to larger series that are now available. The study elucidates morphological aspects that have underlain the history of confusion and it highlights a number of characters that consistently differentiate adults of the relevant taxa. These demonstrate that morphology of the C. oblonga lectotype conforms with the taxon from the south-west of Western Australia, as has also been confirmed by recently published investigations of mitogenomics and historical information about provenance of the lectotype.

Towards integrated drug substance and drug product design for an active pharmaceutical ingredient using particle engineering.

A novel experimental approach describing the integration of drug substance and drug production design using particle engineering techniques such as sonocrystallization, high shear wet milling (HSWM) and dry impact (hammer) milling were used to manufacture samples of an active pharmaceutical ingredient (API) with diverse particle size and size distributions. The API instability was addressed using particle engineering and through judicious selection of excipients to reduce degradation reactions. API produced using a conventional batch cooling crystallization process resulted in content uniformity issues. Hammer milling increased fine particle formation resulting in reduced content uniformity and increased degradation compared to sonocrystallized and HSWM API in the formulation. To ensure at least a 2-year shelf life based on predictions using an Accelerated Stability Assessment Program, this API should have a D [v, 0.1] of 55 µm and a D [v, 0.5] of 140 µm. The particle size of the chief excipient in the drug product formulation needed to be close to that of the API to avoid content uniformity and stability issues but large enough to reduce lactam formation. The novel methodology described here has potential for application to other APIs.