3D printing of pediatric-centered drug formulations can provide suitable alternatives to current treatment options, though further research is still warranted for successful clinical implementation of these innovative drug products. Extensive research has been conducted on the compliance of 3D-printed drug products to a pediatric quality target product profile. The 3D-printed tablets were of particular interest in providing superior dosing and release profile similarity compared to conventional drug manipulation and compounding methods, such as oral liquids. In the future, acceptance of 3D-printed tablets in the pediatric patient population might be better than current treatments due to improved palatability. Further research should focus on expanding clinical knowledge, providing regulatory guidance and expansion of the product range, including dosage form possibilities. Moreover, it should enable the use of diverse good manufacturing practice (GMP)-ready 3D printing techniques for the production of various drug products for the pediatric patient population.

/pdf/3d-printing-of-pediatric-medication-the-end-of-bad-tasting-ssg69d4p.pdf

3D Printing of Pediatric Medication: The End of Bad Tasting Oral Liquids?—A Scoping Review

Background: Post-herpetic neuralgia (PHN) is usually a constant or intermittent burning, stabbing, or sharp shooting pain with hyperalgesia or allodynia, persisting beyond the healing of herpetic skin lesions. This review was carried out in concordance to the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines. We used PICOS (Population, Intervention, Control, and Outcome Study) design for inclusion of potential studies into this review. Online literature available in PubMed, Cochrane, and Embase was searched for studies from January 1995 till March 2020, which evaluated interventional treatments in PHN by an independent reviewer, using the relevant medical subject heading (MeSH) terms. We analyzed the following outcome parameters with regard to each intervention—pain status at predefined fixed intervals after the intervention, quality of sleep using any of the reported questionnaires, analgesic consumption, functional evaluation, and quality of life assessment after the intervention. Conclusion: Interventional pain management options provide effective and long-lasting pain relief to patients not responding to medical management. The choice of intervention will depend on the region involved, cost, and invasiveness. Simple procedures such as intercostal nerve blocks/neurolysis, stellate ganglion blocks, paravertebral neurolysis, epidural steroid injections, and dorsal root ganglion–radiofrequency ablation are effective interventions, and if they fail, spinal cord stimulators could be effective in the hands of experienced pain physicians.

Post-herpetic neuralgia: A systematic review of current interventional pain management strategies

Microneedle-mediated delivery of Ziconotide-loaded liposomes fused with exosomes for analgesia.

Development and characterization of Novel topical oil/PEG creams of voriconazole for the treatment of fungal infections

The study examined the advantages of semi-solid extrusion 3D printing technology in improving the quality and clinical efficacy of subdivide drugs. Levothyroxine sodium was used as a model drug, and its subdivision demand were investigated based on prescriptions from two 3A hospitals. Levothyroxine sodium tables were subdivided via 3D printing were compared with those subdivided via manual method (grinding and shearing) and then their weight variability, weight loss, drug content and content uniformity were compared to evaluate quality. Levothyroxine sodium tables subdivided by both methods were administered to low birth weight (LBW), very low birth weight (ELBW) and very low birth weight (VLBW) premature infants with transient hypothyroxinemia, and their thyroid hormone levels and weight changes were recorded to compare efficacy. Results showed that the quality of the manual subdivision drugs did not meet the requirements of the European Pharmacopoeia, U.S. Food and Drug Administration's Tablet Scoring industry guidelines and Chinese guidelines, while that of the 3D-printed drugs did. Thyroid level were elevated in all levothyroxine sodium-treated infant; however, the thyroid level of 3D-ELBW and 3D-VLBW infants showed significant elevation (p<0.05 versus manual groups). The 3D-VLBW infants began their first suckling faster, and needed the days of intravenous nutrition fewer (p<0.05 versus manual groups). The cumulative weight gain curves of 3D-ELBW and 3D-VLBW infants were higher than that of manual group and their maximum difference reached 132.31 g and 94.32 g, respectively. Conclusively, 3D printing technology is a superior method for subdividing drugs that can prepared precise dose to improve drug efficacy. 

Improving the quality and clinical efficacy of subdivided levothyroxine sodium tablets by 3D printing technology

Assessment of practices for suspended oral drugs by tablet crushing in pediatric units

Complications of the intrathecal route may cause potential toxicity related to the medical device and properties of the administered drug and/or excipient. A description of clinical and histological effects of polyethylene glycol and miripirium after Depo-Medrol injection, and the adverse reactions of particulate methylprednisolone acetate was conducted. The safety of the intrathecal route with excipients, label and off-label drugs is discussed. A bibliographic search in Medline, Google, and Cochrane database from 1940 to June 2016 was performed. The keywords included ‘intrathecal methylprednisolone acetate’, ‘miripirium’, ‘myristyl-gamma-picolinium’, ‘side effects’, ‘intrathecal Depo-Medrol’, ‘polyethylene glycol’, and ‘intrathecal devices’ used individually or in combination. Adverse reactions have been reported with this intrathecal administration route such as arachnoiditis, bladder dysfunction, headache, meningitis. Some pharmaceutical excipients have been associated with specific toxicity issues and with allergic and anaphylaxis reactions. Additives of methylprednisolone acetate formulations such as polyethylene glycol and miripirium chloride can be neurotoxic when injected intrathecally. Polyethylene glycol—an antimicrobial agent widely used in pharmaceutical drugs—has been associated with cardiovascular, hepatic, respiratory, and CNS toxicity. Intrathecal methylprednisolone acetate (Depo-Medrol) therapy seems not fully safe due to reported adverse events. The use of other forms of corticosteroid therapy free from excipients should be emphasized such as soluble methylprednisolone sodium succinate.

Safety of intrathecal route: focus to methylprednisolone acetate (Depo-Medrol) use.

Voriconazole topical cream formulation: evidence for stability and antifungal activity

Recent studies have highlighted the benefit of repurposing oral erlotinib (ERL) treatment in some rare skin diseases such as Olmsted syndrome. The use of a topical ERL skin treatment instead of the currently available ERL tablets may be appealing to treat skin disorders while reducing adverse systemic effects and exposure. A method to prepare 0.2% ERL cream, without resorting to a pure active pharmaceutical ingredient, was developed and the formulation was optimized to improve ERL stability over time. Erlotinib extraction from tablets was incomplete with Transcutol, whereas dimethyl sulfoxide (DMSO) allowed 100% erlotinib recovery. During preliminary studies, ERL was shown to be sensitive to oxidation and acidic pH in solution and when added to selected creams (i.e., Excipial, Nourivan Antiox, Pentravan, and Versatile). The results also showed that use of DMSO (5% v/w), neutral pH, as well as a topical agent containing antioxidant substances (Nourivan Antiox) were key factors to maintain the initial erlotinib concentration. The proposed ERL cream formulation at neutral pH contains a homogeneous amount of ERL and is stable for at least 42 days at room temperature in Nourivan cream with antioxidant properties.

/pdf/stability-and-formulation-of-erlotinib-in-skin-creams-2ac4ipcw.pdf

Stability and Formulation of Erlotinib in Skin Creams

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Assessment of practices for suspended oral drugs by tablet crushing in pediatric units

Safety of intrathecal route: focus to methylprednisolone acetate (Depo-Medrol) use.

Voriconazole topical cream formulation: evidence for stability and antifungal activity

Stability and Formulation of Erlotinib in Skin Creams