Author: Fischer, Dagmar ; Enke, Marcel ; Seyferth, Stefan ; Schneeberger, Achim ; Jescheck, Lisa ; Schwarz, Nicolle ; Gruschwitz, Franka ; Hanf, Felix ; Winkler, Daniela

3D printing offers new opportunities to customize oral dosage forms of pharmaceuticals for different patient populations, improving patient safety, care, and compliance. Although several notable 3D print technologies have been developed, such as inkjet printing, powder-based printing, selective laser sintering (SLS) printing, and fused deposition modelling (FDM), among others, their capacity is often limited by the number of printing heads. 3D screen-printing (3DSP) is based on a classic flatbed screen printing that is widely used in industrial applications for technical applications. 3DSP can build up thousands of units per screen simultaneously, enabling mass customization of pharmaceuticals. Here, we use 3DSP to investigate two novel paste formulations: immediate-release (IR) and extended-release (ER) using Paracetamol (acetaminophen) as the active pharmaceutical ingredient (API). Both disk-shaped and donut-shaped tablets were fabricated using one or both pastes to design drug delivery systems (DDS) with tailored API release profiles. The size and mass of the produced tablets demonstrated high uniformity. Characterization of the tablets physical properties, such as breaking force (25-39 N) and friability (0.002-0.237%), adhering to Ph. Eur (10th edition). Finally, drug release tests with a phosphate buffer at pH 5.8 showed Paracetamol release depended on the IR- and ER paste materials and their respective compartment size of the composite DDS, which can be readily varied using 3DSP. This work further demonstrates the potential of 3DSP to manufacture complex oral dosage forms exhibiting custom release functionalities for mass production.

01 Jan 2021·International Journal of PharmaceuticsQ2 · MEDICINE

3D screen printing – An innovative technology for large-scale manufacturing of pharmaceutical dosage forms

Q2 · MEDICINE

Article

Author: Jescheck, Lisa ; Fischer, Dagmar ; Hack, Franz ; Nguyen, Doan Chau Yen ; Schneeberger, Achim ; Moldenhauer, Daniel

Three-dimensional (3D) screen printing was used to fabricate oral dosage forms of different geometry and size. The paste required as starting material for the 3D screen printing process was designed for delayed release and contained the model drug paracetamol (acetaminophen). A prototype screen printing unit was used to fabricate different tablets in a single production process. The resulting tablets were produced with three different sizes and designed geometries (disk, donut, cuboid, oval and grid). Investigation of size and mass of the individual tablets demonstrated high uniformity within the various groups of tablets. Further characterization of their physical properties, such as breaking force and friability, yielded results comparing favorably to conventionally produced tablets. Finally, drug release tests in artificial gastric media showed paracetamol release to depend on the surface-area-to-volume ratio. In conclusion, the study shows the potential of 3D screen printing to fabricate more complex oral dosage forms in the setting of mass production with high reproducibility.

Pharmaceutics

3D Screen Printing Offers Unprecedented Anticounterfeiting Strategies for Oral Solid Dosage Forms Feasible for Large Scale Production

Article

Author: Franzmann, Susanne ; Hanf, Felix ; Jescheck, Lisa ; Gruschwitz, Franka V ; Schneeberger, Achim ; Enke, Marcel ; Schwarz, Nicolle ; Winkler, Daniela

A threat to human health in developed and, in particular, in developing countries, counterfeit medicines represent the largest identified fraud market worldwide. 3D screen printing (3DSP), an additive manufacturing technology that enables large-scale production, offers unique opportunities to combat counterfeit drugs. One such possibility is the generation of oral dosage forms with a distinct colored inner structure that becomes visible upon breakage and cannot be copied with conventional manufacturing methods. To illustrate this, we designed tablets containing a blue cross. Owing to paste properties and the limited dimensions of the cross, the production process was chosen to be continuous, involving two screen and paste changes. The two pastes (tablet body, cross) were identical except for the blue color of the latter. This ensured the build-up and mechanical stability of the resulting tablets in a mass production environment. The ensuing tablets were found to be uniform in weight and size and to comply with regulatory requirements for hardness, friability, and disintegration time (immediate release). Moreover, all tablets exhibited the covert anticounterfeit feature. The study delivers a proof-of-concept for incorporating complex structures into tablets using 3DSP and showcases the power of the technology offering new avenues for combating counterfeit drugs.

News (Medical) associated with Laxxon Medical GmbH

22 May 2024

·www.biospace.com

Laxxon Medical Announces Development Program for Non-Invasive, 3D Printed Oral GLP-1 Asset, Offering an Alternative to GLP-1 Injections on Market

Using their SPID®-Technology, Laxxon Medical has manufactured a 3D printed oral tablet combining a GLP-1 receptor agonist and a permeation enhancer intended to increase bioavailability LXM.2 is being developed using the 505(b)2 pathway with an expected NDA submission in early 2027 Laxxon is seeking to partner or out-license LXM.2 NEW YORK, NY / ACCESSWIRE / May 22, 2024 / Laxxon Medical announced today the development program for LXM.2, a 3D printed oral glucagon-like peptide-1 (GLP-1) receptor agonist for the treatment of adults and pediatric patients 12 years and older with obesity. LXM.2 is an enterically coated oral solid tablet consisting of a GLP-1 receptor agonist combined with a permeation enhancer intended to increase bioavailability. The addition of the permeation enhancer was made possible using Laxxon Medical's SPID® (Screen Printed Innovative Drug) platform technology. "Polypeptides and proteins like GLP-1s are known to have low bioavailability due to the degradation in the GI tract and poor uptake, meaning they need protection from degradation and their absorption benefits from permeation enhancers. Traditionally, it has been difficult to manufacture products containing the permeation enhancer via conventional methods, such as direct compression or granulation, given its physicochemical properties. It has additionally been challenging for these traditional manufacturing methods to apply an enteric coating to the finished product." said Dr. Achim Schneeberger, Laxxon Medical's Chief Scientific Officer. "SPID®-Technology is not only characterized by precise and tailored dosing - its unique formulation allows manufacturing of oral solids containing clinically relevant doses of permeation enhancers at convincing hardness and low friability." The active pharmaceutical ingredient (API) in LXM.2 has already been approved by the FDA for use in adults and pediatric patients 12 years and older with obesity. LXM.2 is eligible to be developed using the 505(b)2 pathway. Laxxon has designed a streamlined development program and is targeting an NDA submission in early 2027. Laxxon Medical CEO Helmut Kerschbaumer said: "LXM.2 would be a game-changer for patients struggling with obesity. Injectable medications, while effective, can be inconvenient and pose a barrier for some people. An oral option would offer greater ease of use and potentially improve adherence to treatment. This could significantly increase the number of patients who can successfully manage their weight and achieve long-term health benefits. The ability to use the 505(b)2 pathway means we can potentially get LXM.2 to patients quickly." Laxxon is seeking to partner or out-license LXM.2. A team of Laxxon Medical representatives will be attending BIO in San Diego, June 3-8, 2024. Read more about LXM.2 here. About Laxxon Medical Laxxon Medical is a pharma-technology company pioneering a new generation of advanced pharmaceuticals with SPID®, a novel 3D screen printing platform technology. For new and common pharmaceutical drugs, SPID® unlocks innovative drug delivery advancements paired with fast-tracked market access and extensive IP protection to yield disruptive opportunities for partners and life-changing results for patients. Laxxon's pipeline includes ongoing working-projects with notable pharma players, biotech companies and research universities, in addition to 13 in-house Advanced Patented Generics products. Laxxon's IP is continuously growing and consists of 150 patents and patent applications with more than 3,000 patent claims. Investor Contact: Alexander Ruckdaeschel, Chief Strategy Directoralexander.ruckdaeschel@laxxonmedical.com Business Development Contact: Jessica McHargue, Director of Business Development jessica.mchargue@laxxonmedical.com Media Contact: Frances Hoggard, Communications Manager frances.hoggard@laxxonmedical.com SOURCE: Laxxon Medical View the original press release on accesswire.com

18 Dec 2023

·www.biospace.com

Laxxon Medical to Participate in 26th Annual Needham Growth Conference

NEW YORK, NY / ACCESSWIRE / December 18, 2023 / Laxxon Medical, a leading pharma-technology company pioneering a new generation of advanced pharmaceuticals, today announced that management is scheduled to participate in the 26th Annual Needham Growth Conference on January 17th and 18th, 2024 in New York City. Laxxon CEO/Chairman Helmut Kerschbaumer and Chief Strategy Officer Alexander Ruckdaeschel will participate in one-on-one meetings with institutional, private equity, and venture capital investors. The conference will be held onsite at the Lotte New York Palace in New York City on Wednesday, January 17th, and Thursday, January 18th, with virtual access on Tuesday, January 16th, and Friday, January 19th. For more information about the conference or to schedule a one-on-one meeting with Laxxon Medical, please get in touch with your Needham representative. About Laxxon Medical Laxxon Medical is a pharma-technology company pioneering a new generation of advanced pharmaceuticals with SPID®, a novel 3D screen printing platform technology. For new and common pharmaceutical drugs, SPID® unlocks innovative drug delivery advancements paired with fast-tracked market access and extensive IP protection to yield disruptive opportunities for partners and life-changing results for patients. Laxxon's pipeline includes ongoing working-projects with notable pharma players, biotech companies and research universities, in addition to 13 in-house Advanced Patented Generics products. Laxxon's IP is continuously growing and consists of 150 patents and patent applications with more than 3,000 patent claims. Laxxon is partnered with CDMO Hovione and is jointly establishing cGMP productions in Portugal and the United States. Company website: . Investor Contact: Alexander Ruckdaeschel Chief Strategy Director a.ruckdaeschel@laxxonmedical.com Media Contact: Frances Hoggard Communications Manager f.hoggard@laxxonmedical.com SOURCE: Laxxon Medical View the original press release on accesswire.com

06 Dec 2023

·www.biospace.com

Laxxon Medical to Attend 42nd Annual J.P. Morgan Healthcare Conference in San Francisco

NEW YORK, NY / ACCESSWIRE / December 6, 2023 / Laxxon Medical announced today its attendance at the 42nd Annual J.P. Morgan Healthcare Conference, taking place January 8-11, 2024, in San Francisco, California. The J.P. Morgan Healthcare Conference is the largest and most informative healthcare investment symposium in the industry, connecting global industry leaders, emerging fast-growth companies and innovative technologies of the investment community. Representing Laxxon Medical at the J.P.Morgan Healthcare Conference is CEO Helmut Kerschbaumer and Chief Strategy Officer Alexander Ruckdaeschel, who will meet with institutional investors. About Laxxon Medical Laxxon Medical is a pharma-technology company pioneering a new generation of advanced pharmaceuticals with SPID®, a novel 3D screen printing platform technology. For new and common pharmaceutical drugs, SPID® unlocks innovative drug delivery advancements paired with fast-tracked market access and extensive IP protection to yield disruptive opportunities for partners and life-changing results for patients. Laxxon's pipeline includes ongoing working-projects with notable pharma players, biotech companies and research universities, in addition to 13 in-house Advanced Patented Generics products. Laxxon's IP is continuously growing and consists of 150 patents and patent applications with more than 3,000 patent claims. Laxxon is partnered with CDMO Hovione and is jointly establishing cGMP productions in Portugal and the United States. Company website: . Company Contact Frances Hoggard | Communications Manager | f.hoggard@laxxonmedical.com SOURCE: Laxxon Medical View source version on accesswire.com:

100 Deals associated with Laxxon Medical GmbH

100 Translational Medicine associated with Laxxon Medical GmbH

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Pipeline

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The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

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Drug(Targets)	Indications	Global Highest Phase

LXM.3	Diabetes Mellitus More	Preclinical
LXM.16	Attention Deficit Disorder With Hyperactivity More	Preclinical
LXM.5	Parkinson Disease More	Unknown
LXM.11	Thrombosis More	Unknown
LXM.12	Prostatic Cancer More	Unknown

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