J. Pharm. BioTech Ind., Volume 3, Issue 1 (March 2026) – 6 articles

Insulin injection remains the best therapy for diabetes mellitus, but subcutaneous injection continues to pose challenges, including patient discomfort, poor compliance and fluctuating plasma glucose profiles. Recently, transdermal insulin delivery has emerged as a non-invasive strategy that bypasses gastrointestinal degradation and first-pass hepatic metabolism, thereby increasing insulin bioavailability and enhancing patient acceptance. Recent developments in nanomedicine have facilitated the development of transdermal patches with enhanced drug encapsulation, uptake and controlled release. Nanostructured lipid carriers, polymeric nanocomposites, liposomes and SLNs have demonstrated a five-fold enhancement of transdermal flux and an extended insulin effect in preclinical models. The addition of ionic liquids and polymeric nanogels leads to an additional increase in insulin aqueous solubility and permeation, resulting from the temporary regulation of stratum corneum lipid organization. Bright and stimuli-responsive patches with glucose oxidase or phenylboronic acid functional groups enable regulated insulin delivery in response to changes in blood glucose, demonstrating near-normoglycemia for up to 48 h in animal testing. Nanocomposite systems assisted by microneedles have also been advanced to the early clinical phase, offering enhanced reproducibility of their pharmacokinetics and a low risk of dermal irritation. Despite these encouraging results, several translational challenges remain, such as biocompatibility, repeatability in the production of nanocarriers, long-term stability of formulations and regulatory standardization. This review examines the physicochemical design principles, materials innovations and permeation mechanism of nanomedicine-engineered insulin patches, the current state of preclinical and clinical advancements, challenges in production and future perspectives in viable patient-focused transdermal insulin delivery. Full article

Background: Fetuin (Ft) is the most abundant protein in fetal bovine serum (FBS) and is considered one of its essential components. This acidic glycoprotein plays a key role in cell adhesion and proliferation and is vital for maintaining in vitro cultures of animal and human cells, tissues, and organs. FBS is a natural source for Ft purification. However, the high demand for FBS as a standard reagent in cell culture severely limits its availability for use as a raw material for protein purification. Furthermore, the industrial production of FBS results in a significant amount of contaminated FBS. This contaminated fraction can thus be utilized for Ft recovery. Methods: In this work, we present a novel method for Ft recovery from FBS using a single chromatographic step based on anion exchange chromatography under acidic conditions. Results: Optimal adsorption conditions for Ft were studied using response surface methodology (RSM), which suggested a buffer pH of 4.2 and an FBS dilution of 40%. However, increasing the pH to 5 resulted in a 28% increase in Ft recovery, although with a slight reduction in Ft purity to 88%. A scale-up to half a liter of FBS was performed using a 400 mL column. A single-step elution with 0.3 M NaCl was employed, yielding an Ft recovery of 90% with a purity greater than 82%. Conclusions: The purified Ft demonstrated biological activity as a growth promoter in MDBK cell culture when utilized in a serum-free culture medium. Full article

Background/Objective: Effective topical delivery of 4-phenylbutyric acid (4-PBA) for arsenical vesicant-induced skin injury requires nanocarrier systems that maintain physicochemical and chemical stability during extended storage. This study systematically evaluated the six-month stability of five 4-PBA-loaded micro/nanoparticulate formulations—chitosan nanoparticles (N31, N35), emulsomes (E2), microsponges (MSs), and PLGA nanoparticles (P1)—to identify lead candidates suitable for field deployment and foam integration. Methods: Formulations were subjected to ICH-accelerated stability testing at 25 °C/60% RH and 40 °C/75% RH, with monthly evaluation of particle size, polydispersity index, zeta potential, drug content by HPLC, and chemical/thermal stability by FTIR and DSC. Results: N31 demonstrated superior colloidal stability, maintaining particle size within acceptable limits at both conditions despite progressive surface charge neutralization. E2 showed consistent drug content retention and preserved chemical integrity, though moderate vesicle fusion occurred. MS underwent complete physical degradation at 40 °C within the first month, while P1 exhibited hydrolytic degradation with substantial drug loss. N35 showed severe aggregation indicating colloidal instability. Conclusions: N31 and E2 emerged as lead candidates: N31 is recommended for field deployment where environmental control is limited, while E2 is suitable for controlled storage settings prioritizing drug loading capacity. Full article

There is a growing global demand for cost-effective alternatives to high-priced biologic therapies, which has significantly accelerated the development of biosimilars and positioned them as sustainable and affordable treatment options. Biosimilars include therapeutic products such as monoclonal antibodies, soluble receptors, growth factors, and hormones that demonstrate comparable efficacy, safety, and quality to their reference biologics. By providing lower-cost alternatives, biosimilars play a vital role in bridging the affordability gap and expanding patient access to essential, life-saving treatments, particularly in low- and middle-income countries. This review focuses on current Good Manufacturing Practices (cGMPs) in biosimilar development, highlighting critical processes such as cell line engineering, glycosylation optimization, and bioprocess refinement aimed at improving cell culture productivity and product yield while ensuring consistent safety, efficacy, and quality across production batches. Advances in biotechnology, especially in proteomics and advanced analytical characterization, have improved understanding of cellular mechanisms influencing product quality and strengthened comparability with reference biologics. These scientific innovations have enhanced regulatory and clinical confidence, supporting wider acceptance and use amongst patients. In addition, this review examines the evolving global regulatory landscape governing biosimilars and its role in reducing development timelines and costs. Together, scientific innovation, standardized manufacturing practices, and harmonized regulatory frameworks foster competition, accelerate market entry, and ultimately help bridge the gap between innovation and affordability, ensuring equitable and sustainable global access to advanced biologic therapies. Full article

Dry eye disease is a common condition in which tear production or quality is insufficient to lubricate the eyes properly. Standard treatment usually involves lubricating eye drops. In this study, we assessed the human health risks, including both non-carcinogenic and carcinogenic effects, associated with long-term exposure to the chemical elements arsenic (As), cadmium (Cd), cobalt (Co), iron (Fe), nickel (Ni), lead (Pb), and zinc (Zn) in eye drops used in Brazil. The results indicated that the Co concentration (1.1048 mg/kg) in the eye drops sample 5 exceeded the limit established by the ICH Q3D (R2) guideline for parenteral products (0.5000 mg/kg). Additionally, As levels in eye drop samples 2, 8–10, 12, 13, and 16, as well as Cd levels in samples 2, 3, 8–10, and 12, exceeded the limits established by the Brazilian Pharmacopoeia for parenteral administration (0.0500–0.0532 mg/kg). The main health risk appears to come from oral exposure, as the drug can drain into the nasal cavity via the nasolacrimal duct and then be absorbed through the gastrointestinal tract. While none of the tested eye drops posed non-carcinogenic risks, carcinogenic risks from oral exposure to As and Cd were identified, with overall risk levels exceeding acceptable thresholds. These findings emphasize the need for strict regulation and continuous monitoring of these products to reduce health risks and prevent long-term damage. Full article