Triple negative breast cancer (TNBC) with poor prognosis and aggressive nature accounts for 10–20% of all invasive breast cancer (BC) cases and is detected in as much as 15% of individuals diagnosed with BC. Currently, due to the absence of the estrogen receptor (ER), progesterone receptor (PR), and human epidermal growth factor 2 (HER2) receptor, there is no hormone-based therapy for TNBC. In addition, there are still no FDA-approved targeted therapies for patients with TNBC. TNBC treatment is challenging owing to poor prognosis, tumor heterogeneity, chemotherapeutic side effects, the chance of metastasis, and multiple drug-resistance. Therefore, various bio-inspired tumor-homing nano systems responding to intra- and extra- cellular stimuli are an urgent need to treat TNBC patients who do not respond to current chemotherapy. In this review, intensive efforts have been made for exploring cell-membrane coated nanoparticles and immune cell-targeted nanoparticles (immunotherapy) to modulate the tumor microenvironment and deliver accurate amounts of therapeutic agents to TNBC without stimulating the immune system.
Background
Most biopharmaceuticals are developed in liquid dosage forms that are less stable than solid forms. To ensure the stability of biopharmaceuticals, it is critical to use an effective drying technique in the presence of an appropriate stabilizing excipient. Various drying techniques are available for this purpose, such as freeze drying or lyophilization, spray drying, spray freeze-drying, supercritical fluid drying, particle replication in nonwetting templates, and fluidized bed drying.
Area covered
In this review, we discuss drying technologies and their applications in the production of stable solid-state biopharmaceuticals, providing examples of commercially available products or clinical trial formulations. Alongside this, we also review how different analytical methods may be utilized in the evaluation of aerosol performance and powder characteristics of dried protein powders. Finally, we assess the protein integrity in terms of conformational and physicochemical stability and biological activity.
Expert opinion
With the aim of treating either infectious respiratory diseases or systemic disorders, inhaled biopharmaceuticals reduce both therapeutic dose and cost of therapy. Drying methods in the presence of optimized protein/stabilizer combinations, produce solid dosage forms of proteins with greater stability. A suitable drying method was chosen, and the process parameters were optimized based on the route of protein administration. With the ongoing trend of addressing deficiencies in biopharmaceutical production, developing new methods to replace conventional drying methods, and investigating novel excipients for more efficient stabilizing effects, these products have the potential to dominate the pharmaceutical industry in the future.
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