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Autor:
Raj Suryanarayanan, Navpreet Kaur
Publikováno v:
Journal of Pharmaceutical Sciences. 110:3743-3756
Even though levothyroxine sodium pentahydrate tablets have been in the market since 1955, there continue to be recalls due to sub potency. We have comprehensively reviewed the factors affecting its stability in solid oral dosage forms. A compilation
Autor:
Renuka Thirumangalathu, Vineet Kumar, Sandeep Somani, Danika Rodrigues, Laura M. Tanenbaum, Kai Zhang, Santosh V. Thakkar, Ketan Amin
Publikováno v:
Journal of Pharmaceutical Sciences. 110:1077-1082
Developing ultra-high concentration biotherapeutics drug products can be challenging due to increased viscosity, processing, and stability issues. Excipients used to alleviate these concerns are traditionally evaluated at lower protein concentrations
Autor:
Alla Verlinsky, Nathan H. Joh, Shawn Cao, Nancy Jiao, Vibha Jawa, Lisa Thomas, Marisa K. Joubert, Twinkle R. Christian, Linda O. Narhi, Nilo Allotta
Publikováno v:
Journal of Pharmaceutical Sciences. 109:845-853
Silicone oil is a lubricant for prefilled syringes (PFS), a common primary container for biotherapeutics. Silicone oil particles (SiOP) shed from PFS are a concern for patients due to their potential for increased immunogenicity and therefore also of
Autor:
Nivedita Shetty, Jonathan Hou, Jag Shur, Evelyn Yanez, Karthik Nagapudi, Ajit S. Narang, Changquan Calvin Sun, Joan Cheng
Publikováno v:
Journal of pharmaceutical sciences. 111(4)
High drug load inhalable particles were prepared by co-spray drying a hydrophobic, crystalline, small molecule drug with various lipid or phospholipid excipients at a 9:1 molar ratio to understand the primary drivers of aerosol performance. The effec
Autor:
Alan F. Parr, Yan Shu, James E. Polli, Vinod P. Shah, D.W. Groot, Bertil Abrahamsson, Peter Langguth, Rodrigo Cristofoletti, Melissa Metry, Mehul Mehta, Jennifer B. Dressman, Tomokazu Tajiri
Publikováno v:
Journal of pharmaceutical sciences. 110(4)
Data are examined regarding possible waiver of in vivo bioequivalence testing (i.e. biowaiver) for approval of metformin hydrochloride (metformin) immediate-release solid oral dosage forms. Data include metformin's Biopharmaceutics Classification Sys
Publikováno v:
Journal of Pharmaceutical Sciences. 107:75-83
Drug solubility could affect the therapeutic use of a drug because the biological activity of a drug is only possible if some fraction of a dissolved drug can permeate and overcome biological membranes to reach its site of action. The solubility-perm
Publikováno v:
Journal of Pharmaceutical Sciences. 106:1944-1951
The storage of drug substance at subzero temperatures mitigates potential risks associated with liquid storage, such as degradation and shipping stress, making it the best solution for long-term storage. However, slower (generally uncontrolled) rates
Autor:
Bertil Abrahamsson, Paul M. Quizon, Gerlinde F. Plöger, Rodrigo Cristofoletti, Alan F. Parr, D.W. Groot, Tomokazu Tajiri, Vinod P. Shah, Jennifer B. Dressman, Mehul Mehta, James E. Polli, Peter Langguth
Publikováno v:
Journal of pharmaceutical sciences. 109(6)
Literature data and results of experimental studies relevant to the decision to allow waiver of bioequivalence studies in humans for the approval of immediate release solid oral dosage forms containing cephalexin monohydrate are presented. Solubility
Publikováno v:
Journal of pharmaceutical sciences. 108(5)
Degradation rates of solid-state drug products generally increase as the drug load decreases. A model for quantifying this effect based on surface area ratios is proposed here. This model relates the degradation rate to an estimate of the proportion
Publikováno v:
Journal of pharmaceutical sciences. 108(3)
Overencapsulation is a technique used to conceal tablet products for blinding in randomized controlled trials. A tablet is inserted in an opaque capsule shell with backfill excipient to prevent rattling. Regulatory authorities require evidence that s