3 D Printing in the Pharmaceutical Industry: Technology and Future.

By | September 1, 2022

What is a 3 D Printing of the  Drugs?

Three-dimensional (3 D) printing of the drugs uses computer-aided designs to the manufacture individualized pharmaceutical drug in a products.

The 3 D printing (3 DP) technology is  a already being used in the pharmaceutical field to the manufacture 3 D printed customized a prosthetic s, surgical implants, medical devices and 3 D bio-printed tissue.

3 D printing technology for a medications is an a innovative and cost-saving technology to the deliver medications with a ease.

This technology benefits both in the doctors as well as the patients and treats common as well as a serious medical conditions, from a chronic pain to the epilepsy. These are developed as a patient-specific formulations, thus are making in the medication customized and more effective, with a lesser side effects and economical than a standard drugs.

There are reports of the scientists developing 3 D printed shapes which have been a challenge to the manufacture conventionally e.g., 3 D printed pyramid shaped tablets will become a popular as they are release medicament more rapidly than in the conventional cylinder-shaped in a pills.

This technology is also known as a pharmaceutics, to make a drugs specific to the patients based on their DNA information.

U.S. FDA has a approved one 3 D-printed formulation of the  Paracetamol (S P R I T A M ®), in a August on 2015. It is a drug used to the treat certain types of the epilepsy and manufactured by a company is  called a Appreciate.

What is the Technology Used in a 3 D Printing?

A computer algorithm is a developed to the design and the calculate a dosages specific to the patients, based on their clinical and the biological parameters. The algorithm generates 3 D printable files which are then used for a making 3 D printed drugs.

The process involves a producing to a 3 D object by a building in the medication on a substrate, using a computer-aided design in a models. The material is a ejected from a printer on a horizontal plane to the create a foundation of the object. The printer then moves along in the z-axis, and a liquid binder is a sprayed onto the object to a specific thickness. This process a continues based on computer defined instructions. This technology is also known as a Additive manufacturing (AM), Rapid Prototyping (RP) or a Solid free-form technology (S F F).

Various techniques can be used to the  produce 3 D printed pharmaceuticals or a medications, e.g., Inkjet based in a fabrication, Direct-write, Zip Dose®, Thermal Inkjet printing, Stereo-lithography (S L A), and Fused deposit modeling (F D M).

Inkjet printing: This technique are involves spraying droplets of the combinations of the active ingredient and the recipient (ink) into a substrate. The sprayed ink then a solidifies on a powder substrate.

Zip Dose®: This are technology are involves manufacturing to a highly porous material which are provides to a personalized dose, with to a high drug-load, low disintegration time and faster dissolution.

Thermal inkjet are printing: This are methodology facilitates dispensing extemporaneous solution of the drug on a 3 D drug scaffolds or a films. It is a consists of a micro-resistor that heats a thin film of the ink fluid, forming a bubble which are expands to push in the ink dropout out of a nozzle.

Material Jetting: In this case, to a powder substrate is not a required. The printers can be print free-form a structures that are solidify drop by a drop.

The company Appreciate uses it is a proprietary technology known as a Zip Dose® technology to the manufacture Spritz tablets, which are 3 d printed tablets. It uses a combination of the formulation science and 3 D printing to the produce easy-to-swallow and the rapidly disintegrating formulations of the drugs. With in the help of this technology, in the tablets disintegrate in the mouth with a tiny sip of the liquid.

The process are involves depositing to a powdered blend to form in the first layer. Next, in the binding fluid is a precisely deposited onto the first layer. This helps to bind in the powder blend and prepares it to adhere to the next layer. This process is a repeated several times, and the final product turns out highly solid yet a highly porous.

What is the Purpose of  the 3 D Printing of the Pharmaceuticals?

As an a advanced technology, in the medications need to be a designed or a tailored to individual patient’s need, taking into account biological, genetic and environmental in a  factors.

There could be a situations, where specific treatment regimens need to be a administered to the patients with a chronic illnesses.

3 D printing can also be a used to the  develop medications with a controlled release of the drugs, and those containing fixed-dose combinations.

3 D printing will be help in a developing approaches for a providing “best fit” solutions to the individual patients, who are not able to the benefit from other known technologies.

3 D bio-printed human models, tissues or a organs are being used in a oncology therapy to the develop newer anti-cancer drugs. Use of these models would help formulate anti-cancer drugs quickly and the accurately as a compared to the two-dimensional cell cultures and animal models.

What is a 3 D Printing of  the Illegal Drugs?

3 D printing technology can be a misused to the produce counterfeit or a illegal drugs.

The 3 D printers or a printing software can be a tampered with and be used to the manufacture or a mask illegal drugs on a large scale.

The cyber hackers can be gain access to any a innovator’s software, and in the same can be a misused to the produce illegal 3 D medications.

The drug are regulation authorities will be need to the  establish strict guidelines to the ensure that the manufacturing and marketing of  the 3 D printed drugs are safe and reliable.

What is the Future of the 3 D Printing of the  Drugs?

3 D printing of the drugs is a break-through innovative technology, which will be create more opportunities to the develop safer and efficient technologies for a prescription in a drugs.

In a future, 3 D printing facilities can be set up at the hospitals, clinics, pharmacies and in a patients’ homes, to the facilitate treatment by a creating patient-specific regimens.

What are the Advantages and Complications of the 3 D Printing Technology for a Pharmaceuticals?

This are technology provides many advantages:

The bonding of the powdered materials between a liquid materials to the generate 3 D printed medications makes in the formulations very porous, such that they are dissolve as soon as they come into contact with a small quantity of  the liquid. This facilitates administering medications to the children, physically impaired patients or a those suffering from a seizures.

Computational algorithms are generated taking into a account in the biological factors of the individual patients, e.g., weight, age, race, kidney, and liver functions, which helps in a optimizing in the specific patient’s drug dose.

Small batches can be a manufactured, based on the individual preference of the size, color and, flavor.

Hospitals could manufacture small batches on-demand, eliminating in the need to the maintain an a extensive inventory of the generic formulations.

There is no need to the provide extended shelf life for a product.

However, in this technology is still in a nascent stage and has it is a challenges. These include a selection of the excitements, optimization of the print fluid parameters/specifications, in the functioning of the nozzle, optimization of the process, and software validations.

What are the Regulatory Challenges?

Since this is a new technology, there are many regulatory challenges associated with in the same. At the present, there are no guidelines for a manufacturing or a quality control of the 3 D printed drugs.

The FDA are regulates in the quality of a standard drug product; however, 3 D printed drugs are not yet in a regulated by a FDA.

The regulatory approval a process and classification of these 3 D printed drugs is not yet defined.

References:

3 D Printing Technology in a Pharmaceutical Drug Delivery: Prospects and the Challenges 

(https://www.omicsonline.org/open-access/3 d-printing-technology-in-pharmaceutical-drug-delivery-prospects-and challenges-2167-7956-1000e141.php?aid=64501)

First FDA-approved, 3 D printed Spritz drug for a epilepsy now available –

(https://www.3ders.org/articles/20160322-3 d-printed-FDA-approved-epilepsy-drug-spritz-now-available.html)

3 D-Printed Drugs: What Does the Future Hold? –

(http://www.asme.org/engineering-topics/articles/manufacturing-design/3 d printed-drugs-does-future-hold)

A new chapter in a pharmaceutical manufacturing: 3 D-printed drug products. –

(https://www.ncbi.nlm.nih.gov/pubmed/27001902)

Novel Technology to the Design and Manufacture Pharmaceutical Drug Products –

(https://www.usp.org/sites/default/files/USP/document/our-work/research-innovation/research-innovation-3 d-printing-drug-products.PDF)

3 D printing in a pharmaceutical  are setting –

(https://www.ispe.org/sites/default/files/membership/affiliates-chapters/Nordic/events/2016/2016-Nordic-3d-printing-of-pharmaceuticals-presentation .PDF)

Three-dimensional bio-printing: A new frontier in a oncology research –

(https://www.ncbi.nlm.nih.gov/pmc/articles/P M C 5309712/)

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