Current Issue : January-March Volume : 2026 Issue Number : 1 Articles : 5 Articles
Dexamethasone (Dexa) is widely used for the prophylaxis of chemotherapy-induced nausea and vomiting. In pediatric patients, individual dosing often requires the manipulation of commercial tablets, leading to dose inaccuracies, higher treatment complexity and poor acceptance due to Dexa’s intensely bitter taste. This study aimed to develop 3D-printed chewable Dexa tablets with effective taste masking for pediatric oncology. Tablets were produced using semi-solid extrusion (SSE). The impact of excipients on printability and taste masking was evaluated, and the thermal stability of Dexa was assessed using DSC and TGA. Further assessments included disintegration, in vitro dissolution, content and mass uniformity, short-term stability and a sensory evaluation in healthy adult volunteers. The tablets demonstrated excellent uniformity of mass (average RSD 0.75 %) and API content (99.35 % ± 2.92 %). Disintegration times ranged from 96 s (2 mg) to 733 s (12 mg). Complete drug release was achieved within 2 h. Thermal analysis showed no degradation of Dexa, and storage stability was confirmed for at least 5 weeks. A substantial reduction in bitterness was observed. In conclusion, SSE enabled the reproducible production of child-appropriate, individually dosed Dexa chewable tablets with effective taste masking, supporting their clinical application in pediatric oncology....
Background/Objectives: Neuropathic pain, resulting from damage or pathology affecting the somatosensory nervous system, is a prevalent form of chronic pain that significantly impacts quality of life. Combined therapies are often utilised to manage this condition. Three-dimensional printing (3DP) offers a promising approach for personalising medication doses and dosage forms to meet individual patient needs. Methods: In this study, a formulation suitable for 3D printing was developed using magnesium citrate, uridine monophosphate, vitamins B3 (niacin), B6 (pyridoxine), B12 (cobalamin), B9 (folic acid), and spermidine to create a novel gel-based oral tablet for the targeted treatment of neurological pain. The antioxidant potential of the active pharmaceutical ingredients (APIs) was assessed using the 2,2-diphenyl-1-picrylhydrazyl (DPPH) and 2,2-azino-bis(3-ethylbenzothiazoline- 6-sulfonic acid) (ABTS) methods. The physical properties of the tablets were evaluated using a texture analyser, while the in vitro release profiles were determined by high-performance liquid chromatography (HPLC). Results: Results demonstrated that pectin–gelatin tablets hardened over time, with higher citric acid concentrations further enhancing this effect. Formulation AVII exhibited good hardness and low stickiness. Formulation AV, however, showed poor performance across all physical parameters and lacked sufficient structural integrity for practical application. While uridine monophosphate, B12, and B9 showed no significant differences in the release profiles of the tablets, spermidine, B6, and B3 displayed statistically significant variations. Specifically, AVII outperformed AV in terms of spermidine and B6 release, and AV showed a higher release of B3 compared to AV. Conclusions: The AVII tablet demonstrates potential for use in combined therapy targeting neurological pain disorders....
Background/Objectives: Controlled release systems, such as polymeric microparticles (MPs), have emerged as a promising solution to extend the bioavailability and reduce dosing frequency for biologic drugs; however, the formulation of these systems to encapsulate highly sensitive, hydrophilic biologic drugs within hydrophobic polymers remains a nontrivial task. Although scalable manufacturing and FDA approval of single emulsion processes encapsulating small molecules has been achieved, scaling more complex double emulsion processes to encapsulate hydrophilic biologics remains more challenging. Methods: Here, we demonstrate that two hydrophilic, low-molecular-weight, recombinant chemokines, CCL22 and CCL2, can be encapsulated in poly(lactic-co-glycolic acid) (PLGA) MPs using a single emulsion method where the proteins are dissolved in an organic solvent during formulation. Results: As expected, we observed some differences in release kinetics from single emulsion MPs compared to double emulsion MPs, which traditionally have been used to encapsulate proteins. Single emulsion MPs exhibited a substantially reduced initial burst. Importantly, protein released from single emulsion CCL22-MPs also retained biological activity, as determined by a cell-based functional assay. Decreasing particle size or changing the polymer end group from PLGA-COOH to PLGA-OH increased the initial burst from single emulsion MPs, demonstrating tunability of release kinetics for proteinloaded, single emulsion MPs. Finally, to improve scalability and enable more precise control over MP formulations, the single emulsion process was adapted to a microfluidic, continuous manufacturing system, and the resulting MPs were evaluated similarly. Conclusions: Altogether, this study demonstrates the feasibility of using a single emulsion encapsulation method for at least some protein biologics....
Ketoconazole (KZ) is a useful antifungal drug belonging to the imidazole group. its clinical use has been limited due to poor absorption, as it is primarily absorbed in the stomach and upper small intestine. Once the drug passes through the stomach via gastric emptying, its absorption significantly decreases, leading to reduced bioavailability. This study aimed to develop gastro-retentive mucoadhesive tablets by testing different drugpolymer ratios and assessing their physical and functional characteristics. Nine formulations (F1- F9) were created as gastro-retentive mucoadhesive tablets using sodium alginate (Na Alg) and Carbopol 934 (Carb 934). The powder blend was tested for flow properties, and the resulting tablets were assessed for thickness, hardness, weight variation, friability, mucoadhesion time, swelling index, mucoadhesive strength, and in vitro drug release. Results revealed that Carb 934's high molecular weight and cross-linking promote prolonged mucoadhesion, leading to extended drug release. Formulations with higher Na Alg contents demonstrated more swelling but less mucoadhesion time than those containing Carb 934. Together, Carb 934 and Na Alg provided controlled drug release due to the balanced properties of the polymers. This study explored mucoadhesive gastro-retentive tablets of ketoconazole, which showed enhanced gastric retention and extended release. These properties are expected to improve the drug’s absorption and bioavailability, potentially offering a more effective therapeutic option....
Background/Objectives: Visual inspection of parenteral drug products is a mandatory and critical unit operation, typically followed by an Acceptable Quality Level (AQL) check, as required by current Good Manufacturing Practices (cGMP) and regulatory authorities worldwide. Visual inspection and AQL checks need to ensure—probabilistically and statistically—that sterile product units with critical, major, or minor defects are excluded from the acceptable portion of a batch, thereby preventing such defective units from reaching distribution and eventually patients. Despite clearly defined batch defect categories, classifying individual defects and assigning them to the correct category remains challenging and has historically lacked standardization and scientific rationale. This paper presents a science-based risk assessment methodology for categorizing defects in sterile dosage forms, incorporating considerations of severity (with emphasis on patient safety), probability of occurrence, and probability of detection. Methods: The methodology is based on a modified Failure Mode and Effects Analysis (FMEA), tailored specifically for visual inspection defect classification. Results: Three examples demonstrate the practical application of this risk-based approach across different container formats: vials, pre-filled syringes, and cartridges. Conclusions: This standardized methodology offers a clear, consistent, and scientifically justified framework for defect classification. Its use enables pharmaceutical manufacturers to establish robust, risk-based defect categorization for the visual inspection of clinical and commercial sterile products....
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