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Model predictive in vitro dissolution testing in pharmaceutical continuous manufacturing: An equivalence study
| Contributor(s):: Atul Dubey, Su Qinglin, Paul Hermant, Federica Casati, Bhakti Halkude, Wei Wu, Anjana Ramnath, Stephen Born, Salvatore Mascia, Bayan Takizawa
A predictive mathematical model for tablet dissolution was developed and implemented in an end-to-end integrated continuous manufacturing pilot plant. The tablets were produced for immediate release with a proprietary extrusion-molding-coating (EMC) unit operation. Besides the mass balance of...
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Tablet coating by injection molding technology - Optimization of coating formulation attributes and coating process parameters
| Contributor(s):: Desai, Parind M., Puri, Vibha, Brancazio, David, Halkude, Bhakti S., Hartman, Jeremy E., Wahane, Aniket V., Martinez, Alexander R., Jensen, Keith D., Harinath, Eranda, Braatz, Richard D., Chun, Jung-Hoon, Trout, Bernhardt L.
We developed and evaluated a solvent-free injection molding (IM) coating technology that could be suitable for continuous manufacturing via incorporation with IM tableting. Coating formulations (coating polymers and plasticizers) were prepared using hot-melt extrusion and screened via...
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Material Properties and Compressibility Using Heckel and Kawakita Equation with Commonly Used Pharmaceutical Excipients
| Contributor(s):: Choi, Du-Hyung, Kim, Nam-Ah Chu, Kyung-Rok Jung, Youn-Jung, Yoon, Jeong-Hyun, Jeong, Seong-Hoon
This study investigated basic material properties and compressibility of commonly used pharmaceutical excipients. Five classes of excipients are selected including starch, lactose, calcium phosphate, microcrystalline cellulose (MCC), and povidone. The compressibility was evaluated using...
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Low Energy Nanoemulsions as Templates for the Formulation of Hydrophobic Drugs
| Contributor(s):: Badruddoza, AM, Gupta, AMyerson, AS, Trout, BL, Doyle, PS
Most small molecule active pharmaceutical ingredients (APIs) are hydrophobic which poses formulation challenges due to their poor water solubility. Current approaches are energy intensive and involve presenting the API in a nanoparticle form that is then combined with other additives into a...
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In Vitro Performance Tests for Continuous Manufacturing: The Impact on the Current Compendial Framework from the Viewpoint of the USP New Advancements in Product Performance Testing Expert
| Contributor(s):: Li, Hanlin Li, Nir, Ishai, Hermans, Andre, Fahmy, Raafat, Lu, Xujin, Biba, Edmond, Coutant, Carrie A.
As continuous manufacturing (CM) evolves from an emerging to widely adopted technology by industry in drug productmanufacturing, the compendiaI framework in product performance testing is also being evaluated for its applicability inCM. As such, the CM Working Group of the New Advancements in...
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Effects of Coating Materials and Processing Conditions on Flow Enhancement of Cohesive Acetaminophen Powders by High-Shear Processing With Pharmaceutical Lubricants
| Contributor(s):: Wei, GG, Mangal, S, Denman, J, Gengenbach, T, Bonar, KL, Khan, RI, Qu, L, Li, TL, Zhou, Q
This study has investigated the surface coating efficiency and powder flow improvement of a model cohesive acetaminophen powder by high-shear processing with pharmaceutical lubricants through 2 common equipment, conical comil and high-shear mixer. Effects of coating materials and processing...
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Continuous direct tablet compression: effects of impeller rotation rate, total feed rate and drug content on the tablet properties and drug release
| Contributor(s):: Jarvinen, Maiju A., Paaso, Janne, Paavola, Marko, Leiviska, Kauko, Juuti, Mikko, Muzzio, Fernando, Jarvinen, Kristiina
Context: Continuous processing is becoming popular in the pharmaceutical industry for its cost and quality advantages. Objective: This study evaluated the mechanical properties, uniformity of dosage units and drug release from the tablets prepared by continuous direct compression process....
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Continuous and Scalable Process for the Production of Hollow Crystals of a Poorly Water-Soluble Active Pharmaceutical Ingredient for Dissolution Enhancement and Inhaled Delivery
| Contributor(s):: Sheng, F, Chow, PSDong, YC, Heng, D, Lee, SH, Tan, RBH
This study reports a new technique for the manufacture of micron-sized, hollow crystals of a poorly water-soluble pharmaceutical compound, spironolactone, by a continuous and scalable antisolvent precipitation platform called a static mixer. Additives (polyvinylpyrrolidone (PVP) and Tween 80)...
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Comparative investigation of supersaturation and automated direct nucleation control of crystal size distributions using ATR-UV/vis spectroscopy and FBRM
| Contributor(s):: Saleemi, Ali N., Rielly, Chris D., Nagy, Zoltan K.
The paper presents a thorough evaluation of different control strategies used in cooling crystallization, namely, unseeded linear cooling, seeded linear cooling, supersaturation control, and automated direct nucleation control. The sensitivity and robustness of supersaturation and automated...
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Application of Model-Free and Model-Based Quality-by-Control (QbC) for the Efficient Design of Pharmaceutical Crystallization Processes
| Contributor(s):: Szilagyi, Botond, Eren, Ayse Quon, Justin L. Papageorgiou, Charles D., Nagy, Zoltan K.
The design of pharmaceutical crystallization processes is a challenging engineering problem because of the specific and versatile quality requirements of the end-product, amplified by the tight regulatory standards. The current industrial standard for crystallization process design is based on...