Assistant Professor, Pharmaceutics & Drug Delivery, University of Texas at Austin
Feng Zhang is an associate professor at the Division of Molecular Pharmaceutics and DrugDelivery at College of Pharmacy at The University of Texas at Austin. He received his Ph.D. in pharmaceuticsfrom the University of Texas at Austin. He worked in the industry for 14 years prior... Read More →
Glatt Pharmaceutical Services develops and produces solid pharmaceutical dosage forms. Our focus lies on multiparticulate systems such as pellets, micropellets and granules. Whether you are looking for optimal bioavailablity or taste masking, improved solubility or stabilization of... Read More →
One of the many lessons that the SARS-CoV-2 pandemic has taught the world is the vulnerability of supply chains. When factoring in wars, tit-for-tat tariffs, and safety recalls, an actionable plan needs to be in place to swiftly adapt to rapidly changing supply demands. In response, a call for more flexible manufacturing is desired to address such challenging geographic, economical, and political climates. One aspect of flexible manufacturing is the ability to quickly transfer product between manufacturing locations. When production of a specific product cannot meet supply additional manufacturing lines, not previously utilized for said product, could be implemented to meet the additional supply demand. One such instance where this procedure would have been extremely useful during the recall and subsequential lack of supply of baby formula in the United States, which resulted in the import of product from foreign entities. In the current practice of transferring between one manufacturing route, or site, to another, the procedure is to perform multiple designed experiments and perform statistical analysis on the results. While scientifically beneficial, practically this leads to significant waste in material with little to no actionable items. This methodical approach is not suited to respond to a crisis. Therefore, an approach is needed to focus on critical quality attributes of the existing drug product and methods in which to reproduce the key attributes. One step that is universal in making tablets is the compaction step. Whether it is roller compaction, wet granulation, direct compaction, batch manufacturing, or continuous manufacturing, a tablet press is utilized to bring punches together and compress the final blend into a desired thickness, shape, and mass. Therefore, if the material entering the dies of the press has the same properties (bulk packing, flow, etc.) similar tablet properties should be obtained for both processes. With this understanding, the research presented here is focused on how shearing of powder that occurs in different manufacturing lines can be utilized to generate blend with similar properties. Utilizing three different blenders and two different tablet press feed frames, an IR shear sensitive formulation was blended in three different manufacturing routes, under different shearing profiles, number of rotations, throughput, and RPM, to prove that the final product can be manufactured on different lines.
Business and Technical Consultant, Evolve Consulting
Eduardo Jule earned his PhD in Materials Engineering from the University of Tokyo, where he specialized in designing polymer-based nanoparticles as cytotoxic payload carriers. He later transitioned to a Business Development role at NanoCarrier. Following that, he joined Capsugel and... Read More →
Melanie Marota is a director at Merck and has over 15 years of experience in oral drug product development. She has made substantial contributions to Merck’s pipeline culminating in multiple commercial products including Belsomra, Zepatier, Welireg, and Lagevrio. Melanie has successfully... Read More →
Dr. James DiNunzio has over 12 years of oral solid dosage drug product development experience and currently serves as an Associate Principal Scientist at Merck & Co. Dr. DiNunzio received his Ph.D. in Pharmacy (Pharmaceutics track) from The University of Texas at Austin, and holds... Read More →
Pharmaceutical salts are a commonly used strategy to improve the bioavailability of poorly water-soluble active pharmaceutical ingredients (APIs). The selected salt form is expected to have high solubility to obtain optimal supersaturation and sufficient physical stability for adequate shelf life. In this presentation, we aim to develop equations to describe critical parameters of salts, including pH-solubility profile and pHmax. The equations serve as a valuable tool to aid in the calculation of salt solubility at pH below the pHmax in the presence of common counter ions. This provides the knowledge to assess the risks of pre-selection of the salt formers without the necessity of salt synthesis. The solubilities calculated by this model demonstrate good agreement with experimental solubility results reported in the literature. Compared to the conventional approaches for salt solubility and pHmax calculation, our model stands out, especially for poorly water-soluble bases with low pKa values, which benefit the most from salt formation. Moreover, the equations are used to support the concept that salt selection should focus on finding salt forms with sufficient solubility, rather than the most soluble salt, as excessively high solubility could be detrimental to physical stability.
