Cost-effective because of less manufacturing waste.Accurate and precise dosing of potent drugs.
Direct digital manufacturing “just in-time” in pharmacy or any healthcare facilities. With the simultaneous ascending trend in patient-centric drug product development found within the last decade, 3D printing is now one of the fastest developing branches of technology, art and science.Īdvantages of 3D printing over conventional manufacturing: Three-dimensional (3D) printing is a form of additive manufacturing (AM) programmed with a computer aided design (CAD) wherein a structure is built by depositing or binding materials in successive layers to produce a 3D object. The FDA Office of Orphan Products Development (OOPD) is constantly working to advance the evaluation and development of products (drugs, biologics, devices, or medical foods) that demonstrate promise for the diagnosis and/or treatment of rare diseases or conditions. As a result, Orphan drugs currently occupy a large part of personalized medicine. 3D printing holds tremendous promise for orphan drugs, designed to treat very small group of patients that are usually not developed by the pharmaceutical industry due to economic reasons. Orphan diseases and orphan drugs are most important contributing factors towards the development of personalized therapy and customized dosage forms. So proper treatment is a personalized encounter between doctor and patient. The orphan diseases are often so rare that a physician may observe only 1 case a year or less. Because many thousands of orphan diseases exist in the aggregate (about 20 to 30 million Americans have orphan diseases), these patients are disenfranchised from drug development by the pharmaceutical industries. But genomic research has changed that "one size fits all" approach and opened the door to more personalized approaches to using and developing drugs.ĭiseases that are very rare and found in less than 200,000 patients in the United States are known as orphan diseases, which is the cutoff point for the number of patients for a drug to be profitable. Until recently, drugs have been developed with the idea that each drug works pretty much the same way in every single patient. Pharmacogenomics uses information about a person's genetic makeup, to choose the drugs that are likely to work best for that particular person. Inter-personal variability is an increasingly global problem when treating patients from different socio-economic, cultural and genetic make-ups. This relatively new branch of therapy is also known as personalized medicine. Precision medicine is an approach that allows doctors to select treatments that are most likely to help patients based on a genetic understanding of their disease. Pharmaceutical formulation scientists are constantly motivated towards new concepts in drug design, better understanding of material properties, manufacturing technology and processes that assures the best quality drug products. In recent years, patient-centric dosage form design is a noticeable trend in pharmaceutical formulation. Precision medicine is one of the major areas where 3D printing technology can bring about a revolution. Smart manufacturers are constantly investing in 3D-printing research, while new entrepreneurs are also breaking into the pharmaceutical space. The first orally disintegrating 3D printed tablet, Spritam® (levetiracetam)-an anti-epileptic drug, was approved by U.S. A 3D printed human skull was successfully implanted in a 22-year-old woman in Netherlands in 2014 and 3D printer-created human ear, kidney, liver and heart are being used successfully for many years. The first 3D pill in Pharmaceutical has been reported in 1996. The first 3D printed object was a tiny cup for eye wash invented by Chuck Hill in 1984. Three-dimensional (3D) printing is a very recent innovation in pharmaceutical formulation that has emerged as one of the most revolutionary and powerful tools towards personalized medicine. The first 3D printer was developed by Charles Hull in 1984, and since then different applications of this technology have been applied to several industries. 3D printing can be used to print anything that is sketched in 3D as it requires a CAD file, or a 3D digital model. The oldest known pills can be traced back to 140 BC and the first compressed tablets were prepared by Dr. 
The use of three-dimensional objects is nothing new in human history such as in the areas of food, fashion, toys, automobiles, constructions and needless to mention in pharmaceuticals.
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