Key Takeaways & Executive Findings
- •• • Three-stage rhGH release at 1, 4, and 6 h post-administration replicates the endogenous overnight GH pulses, achieving stabilized IGF-1 secretion; this temporal precision is critical because conventional daily subcutaneous injections fail to synchronize rhGH levels with natural rhythms, leading to suppressed endogenous GH production and suboptimal therapeutic indexes. • • The burst-release module incorporates anhydrous citric acid and sodium bicarbonate as an effervescent agent, while delayed-release modules use a water-insoluble poriferous shell and swellable core with 10 mg mL−1 (Module 2) and 1 mg mL−1 (Module 3) hydroxypropyl methylcellulose (HPMC); these formulation parameters directly govern the release kinetics and are essential for scalable manufacturing. • • In GH gene knockout mice and healthy rats, the BRIGHT patch increased body length, bone length, and bone quality without increases in weight or body fat, demonstrating a therapeutic index superior to subcutaneous rhGH injection and effervescent-agent-doped microneedles; this addresses the clinical need for growth-promoting effects without metabolic side effects. • • Transcriptome analysis revealed that the BRIGHT patch affects more differentially expressed growth-associated genes than subcutaneous rhGH solution or effervescent-agent-doped microneedles, providing mechanistic evidence that biorhythm-mimicking delivery enhances growth-related biological processes at the transcriptional level.
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Abstract
Recombinant human growth hormone (rhGH) therapy for paediatric short stature relies on daily subcutaneous injections that fail to replicate the endogenous circadian rhythm of growth hormone (GH) secretion, resulting in suboptimal insulin-like growth factor-1 (IGF-1) induction and poor bone growth outcomes. Gu and co-workers reported a biorhythm-inspired growth hormone transdermal (BRIGHT) patch integrating microneedles with three distinct release modules: one burst-release module employing an effervescent agent (anhydrous citric acid and sodium bicarbonate) and two delayed-release modules comprising a water-insoluble poriferous shell and swellable core with 10 mg mL−1 (Module 2) and 1 mg mL−1 (Module 3) hydroxypropyl methylcellulose (HPMC). The patch achieved three-stage rhGH release at 1, 4, and 6 h, mimicking the three overnight pulses of endogenous hGH, and stabilized IGF-1 secretion. In healthy rats and GH gene knockout mice, the BRIGHT patch improved body length, bone length, and bone quality without increasing weight or body fat. Transcriptome analysis revealed broader differential expression of growth-associated genes compared with subcutaneous rhGH injection and effervescent-agent-doped microneedles. This platform offers a neotype intelligent microneedle system for biorhythm-synchronized drug release across circadian rhythm-related diseases.
1. Introduction
Conventional recombinant human growth hormone (rhGH) therapy for paediatric short stature requires daily subcutaneous injections that fail to replicate the endogenous circadian rhythm of growth hormone secretion, resulting in poor synchronization with natural physiological pulses and suboptimal therapeutic outcomes. Repeated injections also disrupt sleep, which can suppress endogenous growth hormone production, creating a clinical bottleneck that demands alternative delivery strategies.
Gu and co-workers developed a biorhythm-inspired growth hormone transdermal (BRIGHT) patch featuring microneedles with three distinct release modules: one burst-release module using an effervescent agent and two delayed-release modules with hydroxypropyl methylcellulose (HPMC) at 10 mg mL−1 and 1 mg mL−1. This design achieves three-stage rhGH release at 1, 4, and 6 h, mimicking the three overnight pulses of endogenous hGH, and stabilizes IGF-1 secretion. The patch improved bone growth and quality in healthy rats and GH gene knockout mice without increasing weight or body fat, and transcriptome analysis showed broader differential expression of growth-associated genes compared with subcutaneous rhGH injection and effervescent-agent-doped microneedles.
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ZHANG Qi, CHEN Zhong, WU Di (2025). Neotype Intelligent Drug Delivery Device: Biorhythm-Mimicking Growth Hormone Patch. SCIENCE CHINA Materials. https://doi.org/10.1007/s40843-025-3413-3
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Frequently Asked Questions
What are the exact release kinetics and temporal thresholds of the BRIGHT patch, and how do they compare with physiological GH pulses?
The BRIGHT patch achieves three-stage rhGH release at 1, 4, and 6 h post-administration, corresponding to a burst release followed by two delayed releases. This temporal profile mimics the three overnight pulses of endogenous human growth hormone (hGH) secretion, which are critical for body growth. The burst-release module uses an effervescent agent (anhydrous citric acid and sodium bicarbonate), while the delayed modules employ a water-insoluble poriferous shell and swellable core with 10 mg mL−1 (Module 2) and 1 mg mL−1 (Module 3) hydroxypropyl methylcellulose (HPMC). These release times are within the 2–3 h time frame required for short-time pulsatile release, as proposed by Gu and co-workers.
What is the quantitative therapeutic benefit of the BRIGHT patch compared with subcutaneous rhGH injection in terms of bone growth and body composition?
In healthy rats and GH gene knockout mice, the BRIGHT patch improved body length, bone length, and bone quality without increases in weight or body fat. In contrast, subcutaneous rhGH injection (SC) and rhGH-loaded effervescent-agent-doped microneedles (EF-MN) did not achieve the same therapeutic index. Transcriptome analysis further revealed that the BRIGHT patch affects more differentially expressed growth-associated genes than the SC and EF-MN groups, indicating a broader mechanistic impact on growth-related biological processes. These results demonstrate superior efficacy in promoting skeletal growth while avoiding metabolic side effects such as weight gain and adiposity.
What are the manufacturing and scalability challenges associated with the three-module microneedle design, particularly regarding the effervescent agent and HPMC concentrations?
The BRIGHT patch integrates three distinct modules using a UV-curable base material, which requires precise control over the effervescent agent (anhydrous citric acid and sodium bicarbonate) in Module 1 and the hydroxypropyl methylcellulose (HPMC) concentrations in Modules 2 and 3 (10 mg mL−1 and 1 mg mL−1, respectively). The water-insoluble poriferous shell and swellable core of the delayed-release modules demand uniform porosity and swelling behavior to achieve the 4 h and 6 h release times. Scalability bottlenecks include maintaining module integrity during UV curing, preventing premature effervescence, and ensuring batch-to-batch reproducibility of release kinetics. These factors directly affect cost parity against legacy subcutaneous injection devices.
How does the BRIGHT patch address the failure mechanisms of conventional rhGH therapy, specifically regarding sleep disruption and endogenous GH suppression?
Conventional daily subcutaneous rhGH injections fail to synchronize rhGH levels with natural circadian rhythms, and repeated injections disrupt sleep, which can lead to abnormal secretion of endogenous hGH. The BRIGHT patch achieves biorhythm-paralleled rhGH release without disturbing slumber, as it autonomously delivers three pulses at 1, 4, and 6 h. This time-programmed delivery mimics the endogenous overnight GH pulses, thereby avoiding the suppression of endogenous GH production and improving therapeutic efficiency. The patch also stabilizes IGF-1 secretion, which is a key mediator of growth hormone effects.
What is the clinical relevance of the BRIGHT patch for paediatric short stature compared with PEG-rhGH, and what are the remaining translational barriers?
PEG-rhGH is widely used for children’s slow growth caused by endogenous GH deficiency, but it requires frequent injections and does not replicate circadian rhythm. The BRIGHT patch offers a neotype intelligent microneedle platform for biorhythm-synchronized drug release, potentially improving therapeutic indexes while reducing injection pain and sleep disruption. However, translational barriers include long-term safety and immunogenicity of the microneedle materials, scale-up manufacturing costs, and regulatory approval for a novel combination product. Clinical trials in paediatric populations are needed to establish non-inferiority or superiority versus PEG-rhGH in terms of adult height and bone quality.
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