J. Pharm. BioTech Ind., Volume 2, Issue 2 (June 2025) – 4 articles

Aims: To describe and analyze trends in the utilization, spending, and average per prescription price of disease-modifying antirheumatic drugs (DMARDs) in the US Medicaid population. Methods: Using the publicly available national outpatient Medicaid State Drug Utilization Data, a retrospective, descriptive trend analysis was conducted on DMARDs from 1991 to 2022. Annual prescription counts and reimbursement amounts were calculated for nonbiologic and biologic DMARDs. Average per prescription price and Market share competition were calculated and analyzed for DMARDs. Results: Medicaid utilization of nonbiologic peaked in 2021 with 884,000 while biologic DMARDs with 688,000 prescriptions. In 2022, biologic utilization took the lead and exceed nonbiologic with 1.5 million prescriptions. Over the last 32 years, biologics captured 94% of Medicaid expenditures toward DMARDs, of which, 56% was toward adalimumab alone. On the other hand, spending on conventional DMARDs accounted for 33% while 67% accounted toward Janus Kinase Inhibitors. Biologic DMARDs average prices increased from around $800 to around $6000. However, the average adalimumab price increased 12-fold from around $1200 in 2003 to over $15,000 in 2021. Medicaid spending toward adalimumab increased by 179%. Conclusions: The substantial increase of DMARDs utilization and expenditure contributed significant burden to Medicaid budget. Introducing biosimilars into the market in the past few years is eroding the market share for several established biologics. Further cost-containment policies may be necessary for costly DMARD pharmacotherapy. Full article

This study investigates the comparative impact of fermentation versus conventional extraction methods on the bioactive potency of “FERMENZA”, a patented, affordable, natural fermented cider-based topical formulation. Through comprehensive in vitro analysis, the fermented extract demonstrated superior antioxidant efficacy, with an IC₅₀ value of 0.77 ± 0.03 mg/mL, significantly outperforming solvent and steam-distilled extracts, which showed IC₅₀ values of 2.49 ± 0.01 mg/mL and 4.11 ± 0.03 mg/mL, respectively. Notably, the nitric oxide scavenging activity of the fermented extracts was markedly higher than that of conventional extracts, with IC₅₀ values ranging from 1.12 ± 0.03 to 2.29 ± 0.03 mg/mL. Fermentation also enhanced total phenolic content (TPC), with mixed fruit extracts (pomegranate-beetroot, banana-papaya) reaching TPC levels of 2.43 ± 0.03 mg gallic acid equivalent/g, surpassing individual and conventionally processed samples. The study employed a Quality by Design approach to optimize fermentation conditions, achieving peak yields of gallic acid and TPC at 35 °C and 72 h, which further validates the process affordability. Under these conditions, the fermented extracts from pomegranate and beetroot demonstrated exceptional antimicrobial properties against E. coli, S. aureus, P. aeruginosa, P. acne, and M. furfur, with minimum inhibitory concentration values ranging from 0.25 mg/mL to 0.60 mg/mL, superior to those observed in conventionally extracted samples from pomegranate and beetroot. These findings highlight the efficacy of fermentation in enhancing bioactive compound availability, positioning FERMENZA as a potent fermented formulation for probable skin and hair-related cosmeceutical applications. Full article

The main objective of this research was to correlate the equilibrium solubility of sodium sulfadiazine in several {ethanol (EtOH, 1) + water (2)} mixtures reported in mass/volume and mass/mass percentages at different temperatures. Aqueous solubility of sodium sulfadiazine decreases almost linearly with decreasing temperature, but it decreases non-linearly with the addition of EtOH to water. Logarithmic solubility was adequately correlated with a bivariate model involving temperature and mixture composition. These solubility results were also well correlated with the Jouyban–Acree-based models. Moreover, an adapted version of the Jouyban–Acree model was used to represent the density of the saturated solvent mixtures at different temperatures. Furthermore, the apparent specific volumes of this drug at saturation were also calculated from densities of saturated solutions and cosolvent mixtures free of drug as well as from the respective mixture compositions. These findings provide valuable insights into the solubility and volumetric behavior of sodium sulfadiazine, which could be useful for pharmaceutical formulation and process optimization. Full article

A selective inhibitor of cyclooxygenase-2 (COX-2), Celecoxib (CEB), known for its anti-inflammatory properties, can exhibit polymorphism, with Form III often emerging as an undesired crystalline impurity during the green manufacturing process of the preferred Form I. Controlling the Form III content in the drug product is crucial, as different crystalline forms can impact drug bioavailability and therapeutic efficacy. This study presents a method to quantify the weight percentage of Form III in the bulk of CEB Form I by employing powder X-ray diffraction (PXRD). Initially, pure Form I and III of CEB were characterized using DSC, FTIR, and PXRD, supporting the method’s development. Binary mixtures, with varying ratios of CEB polymorphs Form I and Form III, were prepared and analyzed using continuous scans over an angular (2θ) range of 2–40. The calibration curve was constructed using 2θ unique peaks for Form I and Form III, respectively. Linear regression analysis exhibited a strong linear relationship within the weight ratio range of 1–20%. The developed method was validated to assess recovery, precision, ruggedness, limits of detection, and quantitation. These findings indicate that the method exhibits repeatability, sensitivity, and accuracy. The newly developed and validated PXRD method is applicable for quality control of CEB Form I produced through the green melt crystallization process by detecting low levels of Form III polymorphic impurity. This research significantly contributes to ensuring the clinical efficacy and manufacturing quality of Celecoxib by providing a reliable method for controlling polymorphic impurities. Full article