Drop-on-Demand System for Manufacturing of Melt-based Solid Oral Dosage: Effect of Critical Process Parameters on Product Quality.

The features of a drop-on-demand-based system developed for the manufacture of melt-based pharmaceuticals have been previously reported. In this paper, a supervisory control system, which is designed to ensure reproducible production of high quality of melt-based solid oral dosages, is presented. This control system enables the production of individual dosage forms with the desired critical quality attributes: amount of active ingredient and drug morphology by monitoring and controlling critical process parameters, such as drop size and product and process temperatures. The effects of these process parameters on the final product quality are investigated, and the properties of the produced dosage forms characterized using various techniques, such as Raman spectroscopy, optical microscopy, and dissolution testing. A crystallization temperature control strategy, including controlled temperature cycles, is presented to tailor the crystallization behavior of drug deposits and to achieve consistent drug morphology. This control strategy can be used to achieve the desired bioavailability of the drug by mitigating variations in the dissolution profiles. The supervisor control strategy enables the application of the drop-on-demand system to the production of individualized dosage required for personalized drug regimens.

A Review of the Benefits 3D Printing Brings to Patients with Neurological Diseases.

This interdisciplinary review focuses on how flexible three-dimensional printing (3DP) technology can aid patients with neurological diseases. It covers a wide variety of current and possible applications ranging from neurosurgery to customizable polypill along with a brief description of the various 3DP techniques. The article goes into detail about how 3DP technology can aid delicate neurosurgical planning and its consequent outcome for patients. It also covers areas such as how the 3DP model can be utilized in patient counseling along with designing specific implants involved in cranioplasty and customization of a specialized instrument such as 3DP optogenetic probes. Furthermore, the review includes how a 3DP nasal cast can contribute to the development of nose-to-brain drug delivery along with looking into how bioprinting could be used for regenerating nerves and how 3D-printed drugs could offer practical benefits to patients suffering from neurological diseases via polypill.

A comprehensive overview of extended release oral dosage forms manufactured through hot melt extrusion and its combination with 3D printing.

Oral dosage formulations are considered to be the most convenient pharmaceutical dosage forms for almost all ages because of their simplicity and non-invasive administration compared to other dosage forms. To improve therapeutic efficacy and avoid frequent daily doses, extending drug release profile is of great interest in pharmaceutical industry. Hot-Melt Extrusion (HME) has gained great attention in pharmaceutical industry since it is one of the continuous manufacturing processes, which can cut down production steps and human errors as opposed to batch to batch process. This controlled and continuous process can improve product quality and reproducibility. HME is a versatile technology, where controlled/sustained oral dosage forms have been one of its important production lines. With the emergence of 3D printing, the future of personalized medicine has become more applicable. Recently, there is a great orientation towards the combination of HME and Fused Deposition Modelling (FDM), in an aim to be a continuous process for personalized and telemedicine. Several extended-release formulations have been manufactured successfully through HME coupled with FDM. This review will shed light on pharmaceutical approaches used to control and sustain drug release in oral formulations by HME and its combination with FDM 3D printing. Quality by design approaches and critical process- and formulation-related factors that affect the release profiles in both HME and FDM will be also discussed clearly in this review.

Trends in the production methods of orodispersible films.

Interest in orodispersible films (ODF) is growing day-by-day, since this dosage form overcomes some therapeutic obstacles, such as impaired swallowing, and offers several benefits, such as the possibility to adapt the dosing requirements for a subset of patients. As a consequence, technologies to produce ODF have risen attention for possible applications in the development of patient-centric formulations. This review critically discusses current trends in the technology platforms proposed to manufacture ODF, including the innovation and opportunities to produce very small batches in a pharmacy setting. Although the main Pharmacopoeias recommend testing customized dosage forms for quality assurance, pharmaceutical assays are a matter of debate due to the complexity and high cost of conventional methods. Alternatively, non-disruptive online analytic methods can be proposed to assay ODF properties, above all to assure the uniformity of drug content.

Aspects of 3D printed drugs.

Three-dimensional (3D) printing is an additive manufacturing technique where objects are created under computer control. Apart from opening many avenues of manufacturing, 3D printing of medicine has become a lucrative area in research. The technology can deliver customised and effectively on-demand treatments for individuals with unique needs; drug delivery system capable of dispensing spatially accurate and low volumes of medicine; preparation of medicine comprised of complex composition and geometric shape. Advent of 3D printed drugs like Spritam® has been FDA approved which have heightened the hopes. Pharmaceutical industry at present is shifting from mass production to personalised medicine as it promises future production of on-demand printed drugs with customised doses, increased productivity and cost-effectiveness. The goal of this article is to outline and explore the various approaches, along with the key aspects of drug printing, and also allow space for exploration of the main areas of 3D printing to be tackled in the future in order to make it an effective manufacturing route for the pharmaceutical industry.

Dropwise additive manufacturing of pharmaceutical products for amorphous and self emulsifying drug delivery systems.

The improvements in healthcare systems and the advent of the precision medicine initiative have created the need to develop more innovative manufacturing methods for the delivery and production of individualized dosing and personalized treatments. In accordance with the changes observed in healthcare systems towards more innovative therapies, this paper presents dropwise additive manufacturing of pharmaceutical products (DAMPP) for small scale, distributed manufacturing of individualized dosing as an alternative to conventional manufacturing methods A dropwise additive manufacturing process for amorphous and self-emulsifying drug delivery systems is reported, which utilizes drop-on-demand printing technology for automated and controlled deposition of melt-based formulations onto inert tablets. The advantages of drop on demand technology include reproducible production of droplets with adjustable sizing and high placement accuracy, which enable production of individualized dosing even for low dose and high potency drugs. Flexible use of different formulations, such as lipid-based formulations, allows enhancement of the solubility of poorly water soluble and highly lipophilic drugs with DAMPP. Here, DAMPP is used to produce solid oral dosage forms from melts of an active pharmaceutical ingredient and a surfactant. The dosage forms are analyzed to show the amorphous nature, self-emulsifying drug delivery system characteristics and dissolution behavior of these formulations.