3D Printing or additive manufacturing, as many of us think, was not invented 5 years ago. In fact, it is already a production technology as it has been around for 3 decades. It first began in 1980s. It is a digital process that creates three dimensional objects, layer upon layer, using variety of polymers, metals and ceramics. Three dimensional printing technology (3DPT) relies on computer aided designs to achieve utmost flexibility, time saving, and exceptional manufacturing capability of pharmaceutical medicines. 3DP is gaining increasing attention in pharmaceutical formulation development as an effective strategy to overcome some challenges of conventional pharmaceutical unit operations. For instance, the conventional manufacturing unit operation involving milling, mixing, granulation and compression can result in disparate qualities of the final products with respect to drug loading , drug release, drug stability and pharmaceutical dosage form stability.

The efforts in developing 3DP in pharmaceutical product development resulted in a

landmark FDA approval (August, 2015) of SPRITAM (Levetiracetam) tablets by Aprecia Pharmaceutical, USA. It is the only 3D printed drug which has FDA approval. They are used to treat epilepsy. SPRITAM is a porous tablet that rapidly dissolves with a single sip of liquid, which makes it easier for patients to swallow large doses and adhere to their prescribed regimen. On the manufacturing side, 3-D printing enables precise control of dose uniformity and density, allowing Aprecia to consistently fit a maximum-strength 1,000 mg dose inside of a single, easy-to-ingest pill. The process involves 3d prototyping of layer by layer fabrication to drug excipients to formulate into desired dosage form. It begins with making a virtual design using 3D modeling applications on computers. This soft copy of the design is sent to the 3D printer. The printer then with additional information of formulation formula and dosage form, 'prints' the dosage form.

Some advantages of 3D printing in pharmaceutical industry as well as health care:

• Compared to conventional pharmaceutical product manufacturing process, 3DP offers a lot of attractive qualities, such as,
• high production rates due to its fast operating systems,
• ability to achieve high drug-loading with much desired precision and accuracy especially for potent drugs that are applied in small doses,
• reduction of material wastage which can save in the cost of production and
• amenability to broad types of pharmaceutical active ingredients including poorly water-soluble, peptides and proteins, as well as drug with narrow therapeutic
• Drugs can be tailor made/personalized according to one's Factors like Size, Shape, Dose, appearance and the rate of delivery can be customized according to requirement. For example, the tablet can be 'printed' in the shape of a cartoon, making it easy to administer to kids. Meanwhile, the tablet can be 'printed' having suitable sizes and doses which will make drug administration easier in aged patients as well as in infants.
• 3D printed tissue models are used for pharmacological studies and new surgical techniques, leading to lesser surgical times and increasing surgery success
• Industry scale manufacture of hearing aids, dentures, personalized prosthetics, Jawbones,

Amey Revdekar

T.Y.B. Pharm

Tags: MET Institute of Pharmacy