Challenges of Pharmaceutical Industry Related to Solid Form Selection

3 Challenges of Pharmaceutical Industry Related to Solid Form Selection 

A likely dependence of drug performance, processing, and safety on the sohd form selection imposes a series of challenges on the pharmaceutical industry. Here three challenges are outlined—solubility improvement, physical stabihty, and unfavorable 

1999-Open letter in the South African Medical Journal asking that regulatory or quality control authorities ensure that analytical tests are performed to confirm the intended polymorphic form (Form Q of Veimox (anthelmintic mebendazole) raw material and tablets. Solid-state evidence revealed that in KMted raw material contained an inactive or less efficacious polymorph (Form A) or mixtures of undesired solid phases (Forms A and B). 

1998-Product withdrawal of Norvir (ritonavir) due to dissolution failure of oral capsules as a result of the appearance of a more thermodynamically stable form. 

2010-Recall of 1.5 million tablets of the popular blood thinner Coumadin (warfarin sodium 2-propanol solvate), due to concerns with variability in the 2-propanol levels, which in turn might affect the crystallinity of warfarin sodium. Complete loss of 2-propanol content would result in amorphous formation. 

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