teriparatide (Xinfutai Pro)

Primary Packaging Hydrophilicity/Hydrophobicity: A Critical Factor Governing Visible-Bubbles during Reconstitution Process of Lyophilized High-Concentration Monoclonal Antibody Formulations.

Gao Han H, Ding Zhao-Lin ZL, Ouyang Jun J, Fang Wei-Jie WJ

Driven by the evolving demands of modern pharmaceutical industry, high-concentration monoclonal antibody formulations (HCMFs) have emerged as a central research hotspot in biopharmaceutical development, attributable to their merits such as low administration volume and reduced medical expenditure. For lyophilized HCMFs, reconstitution performance serves as a critical quality attribute of equivalent importance to long-term storage stability. As components in direct contact with lyophilized drug products, primary packaging containers are indispensable critical excipients for pharmaceutical preparation. This work systematically investigated the effects of inner surface characteristics of glass vials on the long-term stability and reconstitution behaviors of lyophilized HCMFs. The results demonstrated that the surface hydrophilicity/hydrophobicity of vial walls exerted no remarkable influence on the physicochemical stability of mAb-X during prolonged storage. Nevertheless, in the reconstitution process, the intrinsically high viscosity of concentrated mAb solutions, combined with the ultralow surface free energy, intense hydrophobicity and weakened contact line pinning effect of such vials, triggered massive visible-bubbles to adhere beneath the liquid-solid interface. These trapped bubbles failed to ascend and dissipate along the inner walls and bottom of vials. Collectively, this study verifies that hydrophobic primary packaging materials, when adopted as storage containers for lyophilized HCMFs, will induce severe reconstitution defects, which may further lead to inaccurate dosing and compromised clinical operability.

Qualitative and quantitative analysis of pharmaceutical content by terahertz spectroscopy and machine learning algorithms.

Wang Xiaoning X, Zhang Chunyi C, Qu Qiuhong Q, Wang Pengfei P

Process analytical technology (PAT) plays an essential role in pharmaceutical manufacturing by enabling effective quality control and improving production efficiency. Terahertz (THz) spectroscopy has attracted considerable attention due to its advantages of high biosafety, distinctive spectral fingerprints, and excellent quantitative performance. However, achieving rapid classification and accurate quantification of pharmaceutical content remains challenging. Therefore, the combination of THz spectroscopy and machine learning algorithms is introduced to address this challenge. Three active pharmaceutical ingredients (APIs), namely isoniazid, 4-aminobenzoic acid, and diflunisal, were selected, and principal component analysis (PCA) was first employed for dimensionality reduction of the THz spectral data. Subsequently, the prediction accuracy and computational efficiency were optimized using four machine learning algorithms, including support vector regression (SVR), multilayer perceptron (MLP), convolutional neural networks (CNNs) and backpropagation artificial neural network (BP-ANN). Among all models, the PCA-SVR model achieved the best prediction performance, with a coefficient of determination of 0.9990 and a root mean square error of 1.2%. In addition, the prediction time is reduced by up to 90%, which greatly improves the efficiency of data processing. The robustness of the proposed framework was further validated using a multi-component pharmaceutical system to simulate practical tablet formulations. This work demonstrates the potential of THz spectroscopy for component identification and content prediction of active pharmaceutical ingredients and sheds light on the nondestructive application for monitoring pharmaceutical quality and improving production efficiency in an online manner.

Pharmaceutical Waste Management and Awareness at Household Level: A Cross-Sectional Survey of Katlehong and Lambton in Ekurhuleni Municipality.

Tshomela Sithembile Mduduzi SM, Rampedi Isaac Tebogo IT, Kwenda Phyllis Rumbidzai PR

With the growing human population, improved access to healthcare, and the increasing burden of disease, the consumption and subsequent disposal of pharmaceuticals is rising. This study assessed and compared household pharmaceutical waste (HPW) storage and disposal, and environmental awareness among residents of Katlehong Township and Lambton Suburb within the Ekurhuleni Metropolitan Municipality. A stratified random sampling technique was used to identify and administer a semi-structured questionnaire to 303 respondents (Katlehong = 221; Lambton = 82). Microsoft Excel and IBM SPSS ver.30 were used to generate descriptive statistics and χ 2 tests. The results revealed limited knowledge of what pharmaceutical waste is in Katlehong (39.4%, n = 87) and Lambton (42.7%, n = 35). Despite this, 77% (n = 233) of respondents expressed willingness to adopt proper disposal practices if adequate education and disposal alternatives are provided. Concerning storage, the most frequently adopted method in Katlehong (43.0%, n = 95) and Lambton (53.7%, n = 44) was inside a medicine box. Residents of Katlehong (61.5%, n = 136) and Lambton (72.0%, n = 59) mostly threw away HPW together with household general waste. Generally, higher‑income households (> R300,000/year) significantly adopted safe HPW disposal methods (χ 2 (5, 303) = 20.989, p < 0.001, Φ = 0.118, RR( = 0.245 (95% CI: 0.934-24.341)), when compared to lower-income households (< R500,000/year). Moreso, regardless of comparatively lower socio-economic conditions prevailing in the township of Katlehong, the data revealed statistically significant safer pharmaceutical storage practices (χ 2 (5, 303) = 20.989, p < 0.001, Φ = 0.121, RR(Kahlehong) = 0.442 (95% CI: 0.204-0.957), as compared to Lambton. Overall findings revealed poor pharmaceutical storage and HPW disposal, as well as limited awareness in both study areas. However, annual household income and the socio-economic status of the suburb did significantly influence HPW disposal and pharmaceutical storage practices, respectively. This highlights the urgent need for public education and accessible take-back systems to promote safe HPW management across both socioeconomic communities while also incorporating targeted interventions to effect change.

Pharmaceutical industry payments to Australian anaesthetists and pain medicine specialists: 2015-2024.

Cai Steven C SC, Dempster Anne-Marie Amie W AAW, Forbes Malcolm M