Urgency
Personalization of treatment is an inevitable trend of modern medical care to optimize drug response and reduce harmful effects of drugs on each patient, in which the foundation is appropriate monitoring, dose adjustment and drug release kinetics. Three-dimensional printing (3D printing) has emerged as a new technology platform that meets the requirements of personalized drug production, allowing flexible customization of size, dose unit, drug release kinetics, or combine multiple active ingredients in one preparation unit. Furthermore, the 3D printing drug preparation process is completely automatic, fully controlled by computer, has high accuracy and repeatability, especially suitable for the electronic medical care model. Levodopa is the first-line drug, the gold standard in the treatment of Parkinson’s disease. However, the patient’s response to the drug is very different and depends on the stage of the disease. Therefore, in the early stages of treatment, the doctor must find the appropriate dose and the dose must also be adjusted during treatment. In addition, the bioavailability of drugs is often very low (only about 30%), fluctuates widely between individuals, and is not even stable within the same individual. The drug has a short half-life (< 1 hour), is quickly hydrolyzed in the periphery, and is the cause of serious side effects of the drug. Controlling the drug’s sustained release in the stomach, combining it with carbidopa (a hydrolysis inhibitor) in a formulation unit and optimizing appropriate release kinetics is a potential solution to overcome the inherent pharmacological disadvantages of the active ingredient. This dosage form has the potential to replace the surgical method of injecting levodopa gel into the duodenum through a transabdominal tube, which has many potential risks of infection, stray tubes, difficulty in complying with treatment, and especially very high cost. The new oral drug delivery system containing levodopa/carbidopa is estimated to have a much lower cost and will create opportunities to access modern therapy for many patients, reducing the medical burden on families and society, while improving the quality of life for patients.
Novelty
Personalization of treatment is being applied and gradually expanded in developed countries and is an inevitable trend of modern medical care. This project research drug production using 3D printing technology, which is an indispensable new technology platform in personalized drug preparation, allowing the creation of new structures and dosage forms that current pharmaceutical manufacturing platforms cannot achieve. The success of the project will open up solutions to overcome the pharmacological shortcomings of active ingredients, to optimize treatment effectiveness and overcome adverse drug reactions. Currently, no research on the preparation of a controlled gastric drug delivery system containing levodopa/carbidopa using 3D printing technology has been published. In Vietnam, we have not seen any research on the application of 3D printing technology in personalized medicine preparation being implemented.
Objectives
– Develop printing filament formula and manufacturing process parameters. The printing filaments must have suitable chemical and physical properties for 3D FDM printing.
– Design the model, perform the printing process and evaluate the quality characteristics of the dosage form. Develop mathematical models to describe the relationship between formulation and process parameters to dosage form properties, supporting the individualization of printed drugs.
– Monitor the movement of the dosage form in the digestive tract of experimental animals. Evaluate the bioavailability and pharmacokinetics of the dosage form in experimental animals.
Tasks
– Develop formulas and manufacturing processes for printing filaments suitable for 3D FDM printing techniques; Build printing models, perform drug printing and evaluate the characteristics of the dosage form. Build mathematical models that demonstrate the correlation between input variables and the properties of the dosage form.
– Monitor the movement of the dosage form in the gastrointestinal tract of experimental animals. Evaluate bioavailability and pharmacokinetics of the developed dosage form in experimental animals.
