Determination of feed forces to improve process understanding of Fused Deposition Modeling 3D printing and to ensure mass conformity of printed solid oral dosage forms

2021 ◽  
pp. 121416
Author(s):  
Nadine Gottschalk ◽  
Julian Quodbach ◽  
Alessandro-Giuseppe Elia ◽  
Florian Hess ◽  
Malte Bogdahn
Keyword(s):  
3D Printing ◽  
Fused Deposition Modeling ◽  
Dosage Forms ◽  
Oral Dosage ◽  
Fused Deposition ◽  
Process Understanding ◽  
Deposition Modeling ◽  
Solid Oral Dosage Forms ◽  
Oral Dosage Forms

scholarly journals 3D Printing of Mini Tablets for Pediatric Use

2021 ◽  
Vol 14 (2) ◽  
pp. 143
Author(s):  
Julius Krause ◽  
Laura Müller ◽  
Dorota Sarwinska ◽  
Anne Seidlitz ◽  
Malgorzata Sznitowska ◽  
...  
Keyword(s):  
3D Printing ◽  
Fused Deposition Modeling ◽  
Dosage Forms ◽  
Small Scale ◽  
Fused Deposition ◽  
On Demand ◽  
Pediatric Diseases ◽  
Deposition Modeling ◽  
Manufacturing Techniques ◽  
Pediatric Use

In the treatment of pediatric diseases, suitable dosages and dosage forms are often not available for an adequate therapy. The use of innovative additive manufacturing techniques offers the possibility of producing pediatric dosage forms. In this study, the production of mini tablets using fused deposition modeling (FDM)-based 3D printing was investigated. Two pediatric drugs, caffeine and propranolol hydrochloride, were successfully processed into filaments using hyprolose and hypromellose as polymers. Subsequently, mini tablets with diameters between 1.5 and 4.0 mm were printed and characterized using optical and thermal analysis methods. By varying the number of mini tablets applied and by varying the diameter, we were able to achieve different release behaviors. This work highlights the potential value of FDM 3D printing for the on-demand production of patient individualized, small-scale batches of pediatric dosage forms.

scholarly journals 3D Printing of Solid Oral Dosage Forms: Numerous Challenges With Unique Opportunities

2020 ◽  
Vol 109 (12) ◽  
pp. 3535-3550
Author(s):  
Ogochukwu Lilian Okafor-Muo ◽  
Hany Hassanin ◽  
Reem Kayyali ◽  
Amr ElShaer
Keyword(s):  
3D Printing ◽  
Dosage Forms ◽  
Oral Dosage ◽  
Solid Oral Dosage Forms ◽  
Oral Dosage Forms

scholarly journals Fully-automated system for dissolution rate of solid oral dosage forms according to the paddle method

1993 ◽  
Vol 15 (5) ◽  
pp. 171-176
Author(s):  
Erich Lamparter ◽  
Dieter Riedl
Keyword(s):  
Active Ingredient ◽  
Dosage Forms ◽  
Automated System ◽  
Oral Dosage ◽  
Simulated Gastric Fluid ◽  
Measuring Instruments ◽  
Solid Oral Dosage Forms ◽  
Oral Dosage Forms ◽  
Fully Automated System

This paper describes a fully-automated system (AUTO DISS®) for the determination of active ingredient release of solid oral dosage forms according to the paddle method of the US Pharmacopoeia (USP) and European Pharmacopoeia.Twenty batches can be tested continuously, with the six individuals (tablets, capsules etc.) of one batch being examined synchronous. The components of the AUTO DISS®system are presented and the operating steps of automatic filling with dissolution medium, dropping in of tablets, sampling and cleaning of vessels are described. Suitability for testing controlled-release drugs by means of automated buffer change from simulated gastric fluid to simulated intestinal fluid according to USP is also demonstrated. On-line determination of active ingredient concentration, as well as evaluation and documentation of measured values, is possible using an integrated automatic sampler in combination with various measuring instruments.The AUTO DISS®system is shown to be both rugged and accurate.

Biodegradable 3D Printed Polymer Microneedles for Transdermal Drug Delivery

2018 ◽  
Author(s):  
Michael A. Luzuriaga ◽  
Danielle R. Berry ◽  
John C. Reagan ◽  
Ronald A. Smaldone ◽  
Jeremiah J. Gassensmith
Keyword(s):  
Drug Delivery ◽  
3D Printing ◽  
Transdermal Drug Delivery ◽  
Fused Deposition Modeling ◽  
Fused Deposition ◽  
Modeling Software ◽  
Deposition Modeling ◽  
3D Printed ◽  
Microfabrication Technique ◽  
Mechanical Strengths

Biodegradable polymer microneedle (MN) arrays are an emerging class of transdermal drug delivery devices that promise a painless and sanitary alternative to syringes; however, prototyping bespoke needle architectures is expensive and requires production of new master templates. Here, we present a new microfabrication technique for MNs using fused deposition modeling (FDM) 3D printing using polylactic acid, an FDA approved, renewable, biodegradable, thermoplastic material. We show how this natural degradability can be exploited to overcome a key challenge of FDM 3D printing, in particular the low resolution of these printers. We improved the feature size of the printed parts significantly by developing a post fabrication chemical etching protocol, which allowed us to access tip sizes as small as 1 μm. With 3D modeling software, various MN shapes were designed and printed rapidly with custom needle density, length, and shape. Scanning electron microscopy confirmed that our method resulted in needle tip sizes in the range of 1 – 55 µm, which could successfully penetrate and break off into porcine skin. We have also shown that these MNs have comparable mechanical strengths to currently fabricated MNs and we further demonstrated how the swellability of PLA can be exploited to load small molecule drugs and how its degradability in skin can release those small molecules over time.

scholarly journals Multi-Analytical Framework to Assess the In Vitro Swallowability of Solid Oral Dosage Forms Targeting Patient Acceptability and Adherence

Pharmaceutics ◽  
2021 ◽  
Vol 13 (3) ◽  
pp. 411
Author(s):  
Abdul Latif Ershad ◽  
Ali Rajabi-Siahboomi ◽  
Shahrzad Missaghi ◽  
Daniel Kirby ◽  
Afzal Rahman Mohammed
Keyword(s):  
Hydroxypropyl Methylcellulose ◽  
Analytical Framework ◽  
Dosage Forms ◽  
Oral Dosage ◽  
Surface Erosion ◽  
World Population ◽  
Swallowing Problems ◽  
Solid Oral Dosage Forms ◽  
Oral Dosage Forms

A lack of effective intervention in addressing patient non-adherence and the acceptability of solid oral dosage forms combined with the clinical consequences of swallowing problems in an ageing world population highlight the need for developing methods to study the swallowability of tablets. Due to the absence of suitable techniques, this study developed various in vitro analytical tools to assess physical properties governing the swallowing process of tablets by mimicking static and dynamic stages of time-independent oral transitioning events. Non-anatomical models with oral mucosa-mimicking surfaces were developed to assess the swallowability of tablets; an SLA 3D printed in vitro oral apparatus derived the coefficient of sliding friction and a friction sledge for a modified tensometer measured the shear adhesion profile. Film coat hydration and in vitro wettability was evaluated using a high-speed recording camera that provided quantitative measurements of micro-thickness changes, simulating static in vivo tablet–mucosa oral processing stages with artificial saliva. In order to ascertain the discriminatory power and validate the multianalytical framework, a range of commonly available tablet coating solutions and new compositions developed in our lab were comparatively evaluated according to a quantitative swallowability index that describes the mathematical relationship between the critical physical forces governing swallowability. This study showed that the absence of a film coat significantly impeded the ease of tablet gliding properties and formed chalky residues caused by immediate tablet surface erosion. Novel gelatin- and λ-carrageenan-based film coats exhibited an enhanced lubricity, lesser resistance to tangential motion, and reduced stickiness than polyvinyl alcohol (PVA)–PEG graft copolymer, hydroxypropyl methylcellulose (HPMC), and PVA-coated tablets; however, Opadry® EZ possessed the lowest friction–adhesion profile at 1.53 a.u., with the lowest work of adhesion profile at 1.28 J/mm2. For the first time, the in vitro analytical framework in this study provides a fast, cost-effective, and repeatable swallowability ranking method to screen the in vitro swallowability of solid oral medicines in an effort to aid formulators and the pharmaceutical industry to develop easy-to-swallow formulations.

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