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Lyophilization modeling is well documented in academic circles but has not yet been widely adopted by pharmaceutical manufacturing companies. To facilitate wider adoption and implementation, an accessible ExcelTM-based tool is provided, presenting several fresh examples as a practical introduction to the process of modeling the primary drying phase. Case studies are presented of the tool's application during process development and scale up which highlight business benefits that have been realized by using the model. The authors and contributors are members of the BioPhorum's Lyophilization Workstream and represent several pharmaceutical companies. The current manuscript is intended to serve as a pathway to not only share the collective knowledge on the topic but also accelerate its adoption in the industry., (Copyright © 2020 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.)

Developing coatings on implant surface as drug carriers can reduce organ toxicity and effectively deliver drug locally to the target compared with the oral approach. Titanium dioxide (TiO2) nanotube has great potential for this application for widely used Ti implants because of its high surface area, ability to promote bone growth, and biocompatibility. However, there are two issues needed to be solved before further advancing TiO2 nanotubes technology as drug carriers: uncontrolled drug release and poor mechanical properties. In this study, a drug carrier using a composite of biodegradable polymer/TiO2 nanotubes is engineered. Ibuprofen is selected as a concept drug because it is a commonly used anti-inflammatory, fever, and pain-reducing drug. In addition, ibuprofen has a very short plasma half-life of only 1-3 h. A simple characterization method is developed to investigate the infiltration of polymer into TiO2 nanotubes. Good infiltration was observed of polymer into TiO2 nanotubes. The synthesized drug carrier demonstrated much better sustained drug release profiles for ibuprofen of 5 days (low-molecular-weight polymer) and 9 days (high-molecular-weight polymer) compared with 30 min of pure TiO2 nanotubes. The drug carrier also exhibited much improved mechanical strength and flexibility compared with pure TiO2 nanotubes., (Copyright © 2013 Wiley Periodicals, Inc.)

Medicines are most often oral solid dosage forms made into tablets or capsules, and there is little room for individualized doses. The drug substance and additives are processed through multiple production phases, including complex powder handling steps. In drug manufacturing, the control of the solid-state properties of active pharmaceutical ingredient (API) is essential and it offers opportunities for enhancement of drug delivery systems. In this context, inkjet printing technologies have emerged over the last decades in pharmaceutical and biological applications and offer solutions for controlling material and product characteristics with high precision. Here we report the concept of conventional inkjet printing technology to produce printable pharmaceutical dosage forms on porous substrates. Data are shown to demonstrate inkjet printing of APIs into paper substrates, and how the model drug substances (paracetamol, theophylline, and caffeine) are penetrating the porous substrates used. The method enables controlling not only the deposition but also the crystallization of the drug substances. We anticipate that the inkjet printing approach has immense potential in making sophisticated drug delivery systems by use of porous substrates in the future. For example, it may offer new perspectives for solving problems around poorly soluble drugs and dosing low-dose medicines accurately. Furthermore, with the advent of genetic mapping of humans, controlled inkjet dosing can bring solutions to fabricate on-demand individualized medicines for patients., (Copyright © 2011 Wiley-Liss, Inc.)