Hyprolose 5mg ophthalmic inserts

Twin-screw wet granulation (TSWG) is a method of continuous pharmaceutical manufacturing and a potential alternative method to batch granulation processes. It has attracted more and more interest nowadays due to its high efficiency, robustness, and applications. To improve both the product quality and process efficiency, the process understanding is critical. This article reviews the recent work in process understanding and optimization for TSWG. Various aspects of the progress in TSWG like process model construction, process monitoring method development, and the strategy of process control for TSWG have been thoroughly analyzed and discussed. The process modeling technique including the empirical model, the mechanistic model, and the hybrid model in the TSWG process are presented to increase the knowledge of the granulation process, and the influence of process parameters involved in granulation process on granule properties by experimental study are highlighted. The study analyzed several process monitoring tools and the associated technologies used to monitor granule attributes. In addition, control strategies based on process analytical technology (PAT) are presented as a reference to enhance product quality and ensure the applicability and capability of continuous manufacturing (CM) processes. Furthermore, this article aims to review the current research progress in an effort to make recommendations for further research in process understanding and development of TSWG.

Abstract licence: CC BY

Background/Objectives: Semi-solid extrusion (SSE) 3D printing is an innovative method utilized for preparation of various drug dosage forms, allowing for individualization by means of incorporation of one or multiple drugs in adjustable doses. SSE provides repeatable results and can be conveniently utilized in small batch production. This study aimed to develop a chewable formulation for pediatric patients which could be easily printed using SSE. Methods: Pectin and gelatin were utilized as gel-forming agents, polyvinylpyrrolidone as a thickener, glycerol as a plasticizer, citric acid as a pH modifier, and potassium sorbate as a conserving agent. Obtained tablets were evaluated for mass and content homogeneity and their mechanical properties compared to the long-time market standard for gummies. Results: Gummy formulation with texture properties comparable to the selected standard and mass homogeneity were prepared. The linear correlation between the model size and ondansetron content was proven. Conclusions: SSE 3D printing thus presents a suitable method of gummy formulation production with possible adjustment of dose by defining the object size.

Abstract licence: CC BY