scholarly journals Additive Manufacturing of Personalized Pharmaceutical Dosage Forms via Stereolithography

Pharmaceutics ◽  
2019 ◽  
Vol 11 (12) ◽  
pp. 645 ◽  
Author(s):  
Andrew V. Healy ◽  
Evert Fuenmayor ◽  
Patrick Doran ◽  
Luke M. Geever ◽  
Clement L. Higginbotham ◽  
...  

The introduction of three-dimensional printing (3DP) has created exciting possibilities for the fabrication of dosage forms, paving the way for personalized medicine. In this study, oral dosage forms of two drug concentrations, namely 2.50% and 5.00%, were fabricated via stereolithography (SLA) using a novel photopolymerizable resin formulation based on a monomer mixture that, to date, has not been reported in the literature, with paracetamol and aspirin selected as model drugs. In order to produce the dosage forms, the ratio of poly(ethylene glycol) diacrylate (PEGDA) to poly(caprolactone) triol was varied with diphenyl(2,4,6-trimethylbenzoyl)phosphine oxide (Irgacure TPO) utilized as the photoinitiator. The fabrication of 28 dosages in one print process was possible and the printed dosage forms were characterized for their drug release properties. It was established that both drugs displayed a sustained release over a 24-h period. The physical properties were also investigated, illustrating that SLA affords accurate printing of dosages with some statistically significant differences observed from the targeted dimensional range, indicating an area for future process improvement. The work presented in this paper demonstrates that SLA has the ability to produce small, individualized batches which may be tailored to meet patients’ specific needs or provide for the localized production of pharmaceutical dosage forms.

2009 ◽  
Vol 23 (3-4) ◽  
pp. 201-208 ◽  
Author(s):  
D. Córdoba-Díaz ◽  
M. Córdoba-Díaz ◽  
B. Elorza

Isoniazid, one of the most important drugs for the chempublisher-idapy of tuberculosis, can react with some widely used pharmaceutical excipients, like lactose, leading to the formation of hydrazones. This interaction can dramatically modify the oral bioavailability of the drug, what could lead to a failure of the treatment. Some analytical methods, including techniques like HPLC, can be used to quantify this type of products, but all of them are tedious and time-consuming. In this sense, the aim of the present work is to develop a sensitive, rapid and cheap alternative to publisher-id published methods. For this reason, two spectrophotometric methods were developed and validated. In the first one, isoniazid and its lactosyl-hydrazone were measured together. The second one involved a reaction between not bound to lactose isoniazid and 2,3-dichloro-1,4-naphthoquinone. Lactosyl-hydrazone is quantified by comparison of the results obtained from both methods. The linearity is confirmed to be within a range of 1.5–30.0 μg/ml of total isoniazid and 0.5–30.0 μg/ml of “free” isoniazid. Limits of quantification of 1.2 μg/ml and 0.3 μg/ml were obtained for bound and free isoniazid respectively. These results indicated that the here described methods are at least, as sensitive and accurate as the vast majority of the previously published chromatographic methods. This methodology shows a good repeatability (RSD below 2.0%) as well as good accuracy (average recoveries of 100.83% and 99.96% for total and free isoniazid respectively). The results obtained from the assay of isoniazid tablets demonstrated that the proposed method constitutes a clear alternative to chromatographic methods and also to the official titration method. It would be of interest for the routine quality control of oral dosage forms containing isoniazid and lactose and for stability studies.


Author(s):  
Giulia Pitzanti ◽  
Essyrose Mathew ◽  
Gavin P Andrews ◽  
David S Jones ◽  
Dimitrios A Lamprou

Abstract Objectives The traditional manufacturing methods of solid oral dosage forms (SODFs) are reported to be time-consuming, highly expensive and not tailored to the patient’s needs. Three-dimensional printing (3DP) is an innovative emerging technology that can help to overcome these issues. The aim of this review is to describe the most employed 3DP technologies, materials and the state of the art on 3DP SODFs. Characterization techniques of 3DP SODFs, challenges and regulatory issues are also discussed. Key findings The interest in the investigation of the suitability of 3DP as an alternative strategy for the fabrication of SODFs is growing. Different 3DP technologies and starting materials have been investigated for the development of SODFs. Numerous SODFs with complex geometries and composition, and with different release patterns, have been successfully manufactured via 3DP. Despite that, just one 3DP SODF has reached the market. Summary 3DP can be a promising alternative to the classical SODFs manufacturing methods. However, numerous technically and regulatory challenges still need to be addressed in order 3DP to be extensively used in the pharmaceutical sector.


2000 ◽  
Vol 66 (1) ◽  
pp. 11-17 ◽  
Author(s):  
C.W Rowe ◽  
W.E Katstra ◽  
R.D Palazzolo ◽  
B Giritlioglu ◽  
P Teung ◽  
...  

2007 ◽  
Vol 96 (2) ◽  
pp. 330-340 ◽  
Author(s):  
J.Axel Zeitler ◽  
Yaochun Shen ◽  
Colin Baker ◽  
Philip F. Taday ◽  
Michael Pepper ◽  
...  

Pharmaceutics ◽  
2021 ◽  
Vol 13 (9) ◽  
pp. 1401
Author(s):  
Danae Karalia ◽  
Angeliki Siamidi ◽  
Vangelis Karalis ◽  
Marilena Vlachou

The aim of this review is to present the factors influencing the mechanical properties of 3D-printed oral dosage forms. It also explores how it is possible to use specific excipients and printing parameters to maintain the structural integrity of printed drug products while meeting the needs of patients. Three-dimensional (3D) printing is an emerging manufacturing technology that is gaining acceptance in the pharmaceutical industry to overcome traditional mass production and move toward personalized pharmacotherapy. After continuous research over the last thirty years, 3D printing now offers numerous opportunities to personalize oral dosage forms in terms of size, shape, release profile, or dose modification. However, there is still a long way to go before 3D printing is integrated into clinical practice. 3D printing techniques follow a different process than traditional oral dosage from manufacturing methods. Currently, there are no specific guidelines for the hardness and friability of 3D printed solid oral dosage forms. Therefore, new regulatory frameworks for 3D-printed oral dosage forms should be established to ensure that they meet all appropriate quality standards. The evaluation of mechanical properties of solid dosage forms is an integral part of quality control, as tablets must withstand mechanical stresses during manufacturing processes, transportation, and drug distribution as well as rough handling by the end user. Until now, this has been achieved through extensive pre- and post-processing testing, which is often time-consuming. However, computational methods combined with 3D printing technology can open up a new avenue for the design and construction of 3D tablets, enabling the fabrication of structures with complex microstructures and desired mechanical properties. In this context, the emerging role of computational methods and artificial intelligence techniques is highlighted.


Pharmaceutics ◽  
2021 ◽  
Vol 13 (7) ◽  
pp. 1096
Author(s):  
Christos S. Katsiotis ◽  
Michelle Åhlén ◽  
Maria Strømme ◽  
Ken Welch

Fused deposition modelling (FDM) is the most extensively employed 3D-printing technique used in pharmaceutical applications, and offers fast and facile formulation development of personalized dosage forms. In the present study, mesoporous materials were incorporated into a thermoplastic filament produced via hot-melt extrusion and used to produce oral dosage forms via FDM. Mesoporous materials are known to be highly effective for the amorphization and stabilization of poorly soluble drugs, and were therefore studied in order to determine their ability to enhance the drug-release properties in 3D-printed tablets. Celecoxib was selected as the model poorly soluble drug, and was loaded into mesoporous silica (MCM-41) or mesoporous magnesium carbonate. In vitro drug release tests showed that the printed tablets produced up to 3.6 and 1.5 times higher drug concentrations, and up to 4.4 and 1.9 times higher release percentages, compared to the crystalline drug or the corresponding plain drug-loaded mesoporous materials, respectively. This novel approach utilizing drug-loaded mesoporous materials in a printed tablet via FDM shows great promise in achieving personalized oral dosage forms for poorly soluble drugs.


2000 ◽  
Vol 66 (1) ◽  
pp. 1-9 ◽  
Author(s):  
W.E Katstra ◽  
R.D Palazzolo ◽  
C.W Rowe ◽  
B Giritlioglu ◽  
P Teung ◽  
...  

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