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teriparatide (Xinfutai)

✓ Approved

Shenzhen Salubris Pharmaceuticals Co., Ltd. · PTH1R · 重组蛋白

什么是 teriparatide？

teriparatide 是一种重组蛋白，由Shenzhen Salubris Pharmaceuticals Co., Ltd.研发。该药已获批，用于治疗相关适应症，给药途径：Injectable (Others)、Subcutaneous Injection。

药物档案

商品名Xinfutai
公司Shenzhen Salubris Pharmaceuticals Co., Ltd.
药物类别重组蛋白
分子靶点PTH1R
给药途径Injectable (Others), Subcutaneous Injection
状态Approved
来源： ClinicalTrials.gov, Shenzhen Salubris Pharmaceuticals Co., Ltd.

作用机制

分子靶点

teriparatide 作用于 1 个分子靶点：

PTH1Rparathyroid hormone 1 receptor (PTHR, EKNS)
需要更深入的分析？Noah AI 可解释复杂机制并与同类药物比较。

治疗适应症

teriparatide 针对 1 个适应症，涉及 1 个治疗领域。

治疗领域疾病/病症分期
Musculoskeletal and connective tissue disordersOsteoporosis✓ Approved

相关研究文献

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Process Analytical Technology Integration in 3D Printing Processes: Benefits and Challenges.

Pansare Swaroop J SJ, Iqubal Mohammad Kashif MK, Kayalar Canberk C, Dongala Bhanu Prakash BP et al.

Three-dimensional printing (3DP) manufacturing technologies will transform pharmaceutical industry, offering the ability to produce personalized medicine and complex dosage forms with diverse geometries, with the advantage of on-demand dispensing. Maintaining consistent product quality and regulatory compliance pose major challenges in the current landscape due to the inherent variability and multivariate complexity of 3DP. Employing Process Analytical Technology (PAT) with Quality by Design (QbD) and continuous manufacturing (CM) principles provides the necessary framework for real-time monitoring (RTM), control, and understanding of critical process parameters and quality attributes. As a result, key PAT tools are now applied to various 3DP processes such as extrusion-based printing, powder bed fusion, and inkjet printing, utilizing spectroscopic, thermal, imaging, and emerging sensing technologies. Data generated from these tools are further processed using chemometric models, machine learning (ML), and multivariate data analysis for real-time decision-making and closed-loop control, thus enabling smart manufacturing. Although progress has been made, certain challenges remain regarding PAT, model transferability, validation, scalability, data management, and regulatory issues. This promotes a continuously evolving landscape for implementing PAT in 3DP that supports standardization, real-time release testing (RTRT), and lifecycle management. Emerging technologies focus on combining PAT with artificial intelligence (AI), digital twins, and automated feedback systems to develop self-regulating, adaptive 3DP platforms. This review highlights PAT's role as a key element in advancing pharmaceutical 3DP from experimental applications to robust, scalable, and regulatory-compliant manufacturing, offering a comprehensive overview of current technologies, data analytics, regulatory issues, challenges, and future directions in the field.

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Bacillus subtilis DES-59 Modulates Microbial Community Structure and Aroma Formation in Cigar Fermentation to Improve the Quality of Heat-Not-Burn (HnB) Tobacco.

Liang Lu-Xin LX, Zhu Ming-Jun MJ, Zhao Lu L

Cigar tobacco is characterized by high protein and low sugar contents, which limits the sensory performance of cigar-flavored heat-not-burn (HnB) products. In this study, Yunxue 6 cigar tobacco powder was fermented with Bacillus subtilis DES-59 for 7 days under solid-state culture at 25oC and 65% relative humidity. Compared with the control group, fermented tobacco exhibited a 10.55% reduction in protein, alongside 30.10% and 47.86% increases in total free amino acids and reducing sugars, respectively. Py-GC/MS analysis at 350°C showed increased release of pyrolytic aroma compounds, with the relative abundances of esters, aldehydes / ketones, and phenols increasing by 86.95%, 58.53%, and 35.69%, respectively. Sensory evaluation of HnB cigarettes manufactured from the fermented tobacco powder showed an overall sensory score improvement from 79.00 to 83.00, mainly driven by enhanced aroma and flavor. High-throughput sequencing demonstrated that inoculation reshaped the bacterial community, increasing the relative abundance of Bacillus from 12.20% to 52.40%. PICRUSt functional prediction suggested an increased functional potential for amino acid and carbohydrate metabolism in the treated group. Overall, inoculation with B. subtilis DES-59 was associated with changes in the chemical composition, bacterial community structure, pyrolysis-derived aroma profile, and sensory characteristics of cigar tobacco powder. These findings provide preliminary evidence supporting the potential application of B. subtilis DES-59 in the fermentation of cigar tobacco powder for the development of cigar-flavored raw materials for HnB products.

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Correlative Spectroscopic and Structural Imaging for Resin-Embedded Extended-Release Morphine Sulfate Pellets.

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Correlative spectroscopic and structural imaging provides a powerful approach for characterizing the microstructure of complex pharmaceutical formulations. Laser direct infrared (LDIR) spectroscopy is an emerging, rapid spectroscopic imaging technique that complements traditional approaches by enabling non-destructive chemical and morphological analysis over large sample surfaces within minutes. In this study, the capabilities of LDIR imaging were evaluated alongside Raman mapping, SEM-EDS, laser microscopy, and micro-CT as part of a correlative workflow to characterize the microstructure and chemical composition of pharmaceutical pellets. Resin embedding enabled consistent handling and structural preservation of extended-release pharmaceutical pellets across all imaging modalities. Two commercially available morphine sulfate ER pellets (ER-1 and ER-2) with different excipient compositions were used as model systems. Laser microscopy revealed distinct differences in surface topography, while micro-CT performed before milling confirmed inherent structural features. ER-1 displayed a smooth, intact core, whereas ER-2 exhibited internal cracks and cavities. Hyperspectral LDIR imaging successfully identified major components in both formulations (hit-quality index, HQI ≥ 0.83) with strong concordance to Raman mapping (HQI ≥ 0.85). The spatial distribution of the active pharmaceutical ingredient (API) revealed a layered structure in ER-1 and a homogeneous core in ER-2. This correlative workflow, combining resin embedding with multiple imaging modalities, underscores the value of LDIR and complementary techniques for comprehensive physicochemical characterization of complex drug products. These findings highlight the utility of correlative imaging for regulatory assessment and quality control of complex extended-release formulations.

PMID 42717169
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Enhanced Solubility of Famotidine through Salification.

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Famotidine (FMT) is an active pharmaceutical ingredient that exhibits poor aqueous solubility and poor permeability. Molecular electrostatic potential and pK a calculations were used to guide a salification strategy for FMT and afforded five salts featuring carboxylic acid-containing coformers. All solids feature charge-assisted hydrogen bonds between the guanidinium group of FMT and carboxylate of the coformer. All salts exhibited good thermal and benchtop stability, and a six- to 20-fold increase in aqueous solubility was achieved, depending on the coformer used. The best performing salts include coformers on the FDA's generally recognized as safe list, making the solids promising for pharmaceutical applications.

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PubMedAAPS PharmSciTech2026-09-10

Solid Lipid Nanoparticles Based Dry Powder Inhalers for Enhanced Drug Delivery Against Lung Diseases.

Onel Cagla C, Pirincci Tok Yagmur Y, Ozsoy Yildiz Y

The global incidence of lung diseases associated with high mortality and morbidity rates is projected to rise in the coming years. Conventional therapies face limitations such as low bioavailability and systemic side effects with oral administration, as well as poor patient compliance and frequent dosing with traditional inhalers. These shortcomings have created an urgent need for novel pulmonary drug delivery systems. In recent years, nanoparticulate drug carriers have gained significance for their potential to enable targeted lung delivery and reduced dosing frequency. Among them, solid lipid nanoparticles (SLNs) have attracted considerable attention due to their biocompatible and biodegradable structures, controlled release capabilities, organic solvent-free production processes and favorable aerodynamic behavior. This review provides a comprehensive perspective to guide the rational design of SLN-based dry powder inhaler (DPI) systems by integrating formulation strategies, production techniques, surface functionalization, and DPI development, with the goal of enhancing therapeutic outcomes in respiratory diseases such as cancer, infections, chronic obstructive pulmonary disease, and cystic fibrosis.

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Spray Freeze Drying for Solid Formulations of RNA Lipid Nanoparticles.

Arte Kinnari Santosh KS, Sapkota Rachana R, Patil Chanakya D CD, Huang Yijing Y et al.

Spray-freeze drying (SFD) is a promising drying technique for stabilizing RNA lipid nanoparticles (RNA-LNPs) by converting them into solid-state formulations. This study examined the impact of the SFD process and the widely utilized stabilizing disaccharides, such as sucrose and trehalose, on the major properties (e.g. particle size, encapsulation efficiency) of RNA-LNPs post drying. Various process parameters, such as atomization, freezing, and drying temperature, were systematically evaluated, along with the impact of incorporating annealing post freezing step. Surface area measurements, solid-state particle size analysis, scanning electron microscopy, powder X-ray diffraction and solid-state NMR spectroscopy were employed to gain deeper insights into powder characteristics and matrix mobility. Our findings demonstrated that sucrose provided superior stabilization as compared to trehalose in our tested formulations and processes. Moreover, incorporation of the annealing process enhanced LNP stability. Results from the stability study revealed that the annealed 10% and 20% sucrose formulations maintained their stability, highlighting the potential of optimized SFD processing for producing solid formulations of RNA-LNPs.

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