Approvals and Timing of New Formulations of Novel Drugs Approved by the US Food and Drug Administration Between 1995 and 2010 and Followed Through 2021

New formulations of prescription drugs can improve convenience and tolerability for patients, but they also constitute manufacturer strategies to extend brand-name drug market exclusivity periods. We examined whether new formulations of brand-name novel drugs were associated with novel drugs’ sales and/or therapeutic value, as well as characterized first new formulations’ approval timing relative to the novel drug’s generic approval. We found that manufacturers are several times more likely to secure Food and Drug Administration approval for a new formulation for existing drugs that have reached blockbuster status. (Blockbuster drugs are the most profitable drugs with more than $1 billion in annual sales, but are not necessarily the most innovative or clinically meaningful drugs.) Manufacturers also dramatically reduced pursuing approval for new formulations once their drugs began to face generic competition. In contrast, companies did not develop new formulations for drugs that were considered the most therapeutically valuable, innovative, or clinically useful. Thus, while the modified formulations may not be innovative or clinically meaningful themselves, drug manufacturers frequently do not alter drugs that are particularly valuable and innovative to begin with. Our study shows that drugs’ revenue, as opposed to patient benefit, is the clear driver for reformulating drugs

Hydrolytic and enzymatic degradation of a poly(å-caprolactone) network

“NOTICE: this is the author’s version of a work that was accepted for publication in Polymer Degradation and Stability. Changes resulting from the publishing process, such as peer review, editing, corrections, structural formatting, and other quality control mechanisms may not be reflected in this document. Changes may have been made to this work since it was submitted for publication. A definitive version was subsequently published in Polymer Degradation and Stability, [Volume 97, Issue 8, August 2012, Pages 1241–1248] DOI 10.1016/j.polymdegradstab.2012.05.038Long-term hydrolytic and enzymatic degradation profiles of poly(å-caprolactone) (PCL) networks were obtained. The hydrolytic degradation studies were performed in water and phosphate buffer solution (PBS) for 65 weeks. In this case, the degradation rate of PCL networks was faster than previous results in the literature on linear PCL, reaching a weight loss of around 20% in 60 weeks after immersing the samples either in water or in PBS conditions. The enzymatic degradation rate in Pseudomonas Lipase for 14 weeks was also studied, with the conclusion that the degradation profile of PCL networks is lower than for linear PCL, also reaching a 20% weight loss. The weight lost, degree of swelling, and calorimetric and mechanical properties were obtained as a function of degradation time. Furthermore, the morphological changes in the samples were studied carefully through electron microscopy and crystal size through X-ray diffraction. The changes in some properties over the degradation period such as crystallinity, crystal size and Young¿s modulus were smaller in the case of enzymatic studies, highlighting differences in the degradation mechanism in the two studies, hydrolytic and enzymatic.The authors would like to acknowledge the support of the Spanish Ministry of Science and Education through the DPI2010-20399-004-03 project. JM Meseguer-Duenas and A Vidaurre also would like to acknowledge the support of the CIBER-BBN, an initiative funded by the VI National R&D&i Plan 2008-2011, Iniciativa Ingenio 2010, Consolider Program, CIBER Actions and financed by the Instituto de Salud Carlos III with assistance from the European Regional Development Fund. The translation of this paper was funded by the Universidad Politecnica de Valencia, SpainCastilla Cortázar, MIC.; Más Estellés, J.; Meseguer Dueñas, JM.; Escobar Ivirico, JL.; Marí Soucase, B.; Vidaurre, A. (2012). Hydrolytic and enzymatic degradation of a poly(å-caprolactone) network. Polymer Degradation and Stability. 97(8):1241-1248. https://doi.org/10.1016/j.polymdegradstab.2012.05.038S1241124897