Journal of Pharmaceutical Innovation最新文献

{"title":"Development and Evaluation of Carvedilol Nanosuspension by Acid Base Neutralization Method","authors":"Chandrashekhar D. Nayak,&nbsp;Preethi Sudheer,&nbsp;Arshad Bashir Khan,&nbsp;Bhargav Muthanna","doi":"10.1007/s12247-025-09991-6","DOIUrl":"10.1007/s12247-025-09991-6","url":null,"abstract":"<div><p>This study aimed to improve the solubility and dissolution rate of the biopharmaceutics classification system (BCS) 2 candidate carvedilol through nanoformulation using the design of experiments (DoE) approach. Nanosuspensions were prepared via acid-base neutralization using sodium hydroxide and hydrochloric acid at various molar ratios, with poloxamer 407 as a stabilizer, followed by ultrasonication. The drug content, solubility, particle size distribution, and zeta potential of the formulations were evaluated. The optimized formula was determined using a custom experimental design with JMP version 11 software. The formula was freeze-dried and characterized using X-ray, differential scanning calorimetry (DSC), scanning electron microscopy (SEM), and stability measurements. The nanosuspensions had particle sizes ranging from 292.0 nm to 622.5 nm and a polydispersity index (PDI) of 0.147-1.6. Drug release ranged from 72.46 ± 1.3% to 95.83 ± 1.2% after 5 h. The optimized formulation had a maximum desirability of 76.13, remained discrete without aggregation, and had a particle size of 292 nm, PDI of 0.615, and zeta potential of 45 mV. Comparative drug release profiles indicated that the plain drug suspension released 12.3% ± 0.12, the marketed formulation released 60.26% ± 0.56%, and the optimized formula released 95.83 ± 1.3% of the drug at 5 h respectively. X-ray analyzis revealed more evident peaks in the pure drug pattern, whereas the optimized formula displayed more randomized peaks. A shift in the endotherm from 124.68 °C to 80 °C suggests the amorphization of the drug in the nanosuspension. Pharmacokinetic studies in Wistar rats showed a 48-fold increase in the bioavailability of nanosuspensions compared to that of carvedilol. Carvedilol formulated as a nanosuspension via acid-base neutralization demonstrated enhanced solubility, dissolution, stability, and bioavailability.</p></div>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"20 3","pages":""},"PeriodicalIF":2.7,"publicationDate":"2025-05-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143949590","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Sustainable RP-HPLC Method for Simultaneous Quantification of Lysozyme and Dequalinium: A Novel Analytical Approach","authors":"Samar M. Mahgoub,&nbsp;Abdelatty M. Radalla,&nbsp;Ahmed A. Allam,&nbsp;Haifa E. Alfassam,&nbsp;Rehab Mahmoud","doi":"10.1007/s12247-025-09978-3","DOIUrl":"10.1007/s12247-025-09978-3","url":null,"abstract":"<div><h3>Purpose</h3><p>This study aims to develop and validate a novel reversed-phase high-performance liquid chromatography (RP-HPLC) method for the simultaneous quantification of lysozyme and dequalinium, two compounds with antimicrobial and anti-inflammatory properties. The research seeks to address the need for a reliable analytical tool for combination therapies targeting infections and inflammation, the study design is summarized in the Graphical Abstract.</p><h3>Methods</h3><p>The RP-HPLC method was optimized using a Zorbax 300 SB-C18 column at 60 °C, with a gradient mobile phase of trifluoroacetic acid and acetonitrile. The method was validated for linearity, detection limits, accuracy, precision, and robustness following ICH guidelines. Analytical performance was assessed in pharmaceutical formulations containing lysozyme and dequalinium.</p><h3>Results</h3><p>The method demonstrated excellent linearity (r2 &gt; 0.999) in the concentration range of 3–50 µg/mL for both compounds. Detection limits were 2.60 µg/mL for lysozyme and 2.06 µg/mL for dequalinium. Recovery rates were close to 100%, indicating high accuracy and precision. The method also displayed robust performance with minimal variation in results.</p><h3>Conclusions</h3><p>The developed RP-HPLC method is efficient, reliable, and suitable for the simultaneous quantification of lysozyme and dequalinium in pharmaceutical formulations. It offers a promising analytical tool for quality control in combination therapies and demonstrates exceptional sustainability, as indicated by high greenness, blueness, and whiteness scores.</p><h3>Graphical Abstract</h3>\u0000<div><figure><div><div><picture><source><img></source></picture></div></div></figure></div></div>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"20 3","pages":""},"PeriodicalIF":2.7,"publicationDate":"2025-05-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144073849","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Novel pH-Responsive Folic Acid-Conjugated Zein-Carboxymethyl Cellulose Nanoparticles for Enhanced and Controlled Curcumin Release","authors":"Merve Öztekin,&nbsp;Yeşim Sağ Açıkel","doi":"10.1007/s12247-025-09992-5","DOIUrl":"10.1007/s12247-025-09992-5","url":null,"abstract":"<div><h3>Purpose</h3><p>The aim of this study is to develop a novel pH-sensitive drug delivery system by encapsulating curcumin (CR) in carboxymethyl cellulose (CMC)-coated zein (ZN) nanoparticles (NPs). In addition, this study aims to improve a tumour-specific drug delivery system by targeting NPs with folic acid.</p><h3>Methods</h3><p>ZN-NPs were prepared by an antisolvent precipitation technique. Zetasizer, TGA, FT-IR, XRD, SEM and DSC analyses were used in the characterisation studies of the NPs. The dialysis method was used to study the release of CR from CR-ZN-NPs and CR-ZN-CMC-NPs.</p><h3>Results</h3><p>The smallest average ZN-NPs size, 117.2 nm, was obtained with a ultrapure water/ethanol ratio of 10/90 and 0.2 g of ZN. The ZN-NPs size loaded with 1.5 mg of CR was found to be 184 nm. The optimum average ZN-CMC-NPs size was obtained as 277.5 nm with an ideal polydispersity index (0.230) and zeta potential value (-48.1 mV) at a ZN to CMC mass ratio of 1:3. The maximum CR encapsulation efficiency and loading capacity of CR-ZN-NPs containing 2.5 mg of CR were 51% and 0.64%, respectively. For CR-ZN-CMC-NPs, the maximum CR encapsulation efficiency and loading capacity were 70% and 0.58%, respectively. The cumulative release percentages of CR from CR-ZN-NPs and CR-ZN-CMC-NPs loaded with 1.5 mg of CR were 63.6% and 82.5%, respectively, after 72 h in pH 5.6 PBS buffer. Under pH 7.4 conditions, the cumulative CR release percentages from CR-ZN-NPs and CR-ZN-CMC-NPs were 90.6% and 92.1%, respectively, after 72 h. A more controlled, sustained, slower but slightly lower release of CR was obtained at pH 5.6 than at pH 7.4. CR release was slightly retarded by folic acid (FA) conjugation to CR-ZN-CMC-NPs. The release kinetics of CR from both CR-ZN-CMC-NPs and CR-ZN-NPs were best represented by the Higuchi and Korsmeyer-Peppas models, which suggests an \"anomalous transport\" mechanism.</p><h3>Conclusion</h3><p>The study demonstrates that CMC-coated ZN-NPs were used as an effective CR delivery system by providing optimal CR encapsulation efficiency and controlled release. The study suggests that this pH-responsive, biocompatible drug delivery system could be optimized for dual-drug combinations or synergistic effects in cancer therapy, providing a promising foundation for further research.</p><h3>Graphical Abstract</h3>\u0000<div><figure><div><div><picture><source><img></source></picture></div></div></figure></div></div>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"20 3","pages":""},"PeriodicalIF":2.7,"publicationDate":"2025-05-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1007/s12247-025-09992-5.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143908734","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Securing Drug Traceability: Blockchain-Enhanced Privacy Protection and Anti-Counterfeit Measures in Pharmaceutical Supply Chains","authors":"R. Kalpana,&nbsp;S. Sridevi","doi":"10.1007/s12247-025-09964-9","DOIUrl":"10.1007/s12247-025-09964-9","url":null,"abstract":"<div><h3>\u0000 <b>Background</b>\u0000 </h3><p>The pharmaceutical sector is under severe threat in ensuring the genuineness of drugs and securing sensitive information throughout the supply chain. Conventional security measures tend to be ineffective in addressing these issues comprehensively, resulting in weaknesses like counterfeit medicines and illegitimate access to data.</p><h3>\u0000 <b>Objective</b>\u0000 </h3><p>This research suggests an integrated, state-of-the-art security system to provide improved data protection, encryption effectiveness, and supply chain integrity in the pharmaceutical industry.</p><h3>\u0000 <b>Methods</b>\u0000 </h3><p>The suggested framework utilizes Attribute-Based Encryption (ABE) in conjunction with QR code technology for secure, fine-grained data encryption. For the optimization of encryption key selection, a hybrid optimization method combining Red Panda Optimization (RPO) Algorithm and Group Teaching Optimization Algorithm (GTOA) is proposed. Additionally, Multi-Party Computation (MPC) protocols and Shamir’s Secret Sharing scheme are used to guarantee that only legitimate parties can reconstruct and view important data, maintaining confidentiality and integrity.</p><h3>\u0000 <b>Results</b>\u0000 </h3><p>Performance testing shows that the framework proposed performs better than traditional cryptos. Encryption time registered was at 0.21234 seconds, which was quicker than RSA (0.308372) and 3DES (0.36462). Decryption took 0.22112 seconds, which was faster than RSA’s 0.312773. Total turnaround time was cut to 0.431231 seconds, which was far superior to Blowfish at 0.52356 seconds. The system also attained a restoration efficiency level of 0.987453, ahead of RSA at 0.92133 and Blowfish at 0.94109.</p><h3>\u0000 <b>Conclusion</b>\u0000 </h3><p>The security model offers a secure and feasible solution for end-to-end data protection and prevention of tampering and unauthorized access in the pharma supply chain.</p></div>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"20 3","pages":""},"PeriodicalIF":2.7,"publicationDate":"2025-05-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143908735","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Oral Site-Specific Drug Delivery System: Functionalized Modified Hyaluronic Acid 5-Fluorouracil Microspheres for Colon Cancer","authors":"He Ying Mao,&nbsp;Jing Xu,&nbsp;Shuai Hong,&nbsp;Jing Shu Piao,&nbsp;Ming Guan Piao","doi":"10.1007/s12247-025-09967-6","DOIUrl":"10.1007/s12247-025-09967-6","url":null,"abstract":"<div><h3>Purpose</h3><p>The study aimed to create functionalized modified 5-fluorouracil hyaluronic acid microspheres (PAR-HA Mps/5-Fu) for localized drug delivery to colorectal cancer by targeting the CD44 receptor, with the ability to control release rate by different PH release environments.</p><h3>Methods</h3><p>PAR-HA Mps/5-Fu were prepared by emulsification cross-linking method. The optimal oral formulation was identified through a combination of single-factor examination and orthogonal experimental design. In vitro release experiments were performed in different media and drug release models were fitted. The in vivo pharmacokinetic profile, in vivo safety, and in vivo biodistribution of PAR-HA Mps/5-Fu were investigated in in vivo examinations.</p><h3>Results</h3><p>In this study, PAR-HA Mps/5-Fu was successfully prepared. While PAR-HA Mps/5-Fu was difficult to dissolve (16.17%) in artificial gastric fluid, it was constantly released (98.45%) in artificial colonic fluid, and its release pattern fit the Weibull equation. The results of the in vivo experiments showed that PAR-HA Mps/5-Fu had good drug localization in the pathological environment, the pharmacokinetic parameters of the formulation showed significant improvement compared to the 5-FU solution. Meanwhile, oral administration of PAR-HA Mps/5-Fu did not affect the organism, tissues, or blood system.</p><h3>Conclusion</h3><p>The study demonstrated that PAR-HA Mps/5-FU can facilitate the local delivery of 5-FU to the colon, thereby addressing the clinical limitations of 5-FU, including its short plasma half-life, low bioavailability, and high toxicity.</p><h3>Graphical Abstract</h3>\u0000<div><figure><div><div><picture><source><img></source></picture></div></div></figure></div></div>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"20 3","pages":""},"PeriodicalIF":2.7,"publicationDate":"2025-05-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143908733","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Salep Polysaccharide-Based Multi-Responsive Nanogel for Controlled Doxorubicin Release: Structural Characterization and Functional Evaluation for Targeted Breast Cancer Therapy","authors":"Ghasem Rezanejade Bardajee,&nbsp;Hossein Mahmoodian,&nbsp;Negin Shafiei,&nbsp;Mahnaz Rouhi,&nbsp;Golnaz Sang,&nbsp;Mohammad Amin Karimi","doi":"10.1007/s12247-025-09962-x","DOIUrl":"10.1007/s12247-025-09962-x","url":null,"abstract":"<div><h3>Purpose</h3><p>Effective drug delivery remains a significant challenge in breast cancer therapy. This study was designed to develop a salep polysaccharide-based multi-responsive nanogel (NG) for the controlled delivery of doxorubicin (DOX) to breast cancer cells, with the goal of enhancing targeted treatment and reducing systemic toxicity.</p><h3>Methods</h3><p>The NG was synthesized using radical precipitation/dispersion polymerization, incorporating magnetic graphene oxide (MGO), N-isopropylacrylamide (NIPAM), 2-dimethylaminoethyl acrylate (DMAEA), and a redox-responsive crosslinker, N,N’-Bis(acryloyl)cystamine (BAC). Structural characterization by DLS and TEM confirmed a semi-spherical morphology, with a mean hydrodynamic diameter of approximately 78 nm and a polydispersity index (PDI) of 0.335. FT-IR, EDAX, and XRD validated the successful incorporation of components while SEM and AFM provided detailed insights into the surface morphology.</p><h3>Results</h3><p>The NG demonstrated a high DOX loading capacity (92%) and an efficient drug release profile. Under acidic (pH 5) and reductive (10 mM glutathione) conditions, 96% of DOX was released, decreasing the drug release time from 10 hours to approximately 60 minutes. The release kinetics were consistent with the Korsmeyer-Peppas model, indicative of Fickian diffusion. Furthermore, cytotoxicity evaluations using the MTT assay revealed low toxicity in normal MCF-10A cells, supporting the potential of the NG to improve therapeutic efficacy while minimizing adverse effects.</p><h3>Conclusion</h3><p>The salep polysaccharide-based multi-responsive NG represents a promising targeted drug delivery system for breast cancer therapy. Its high DOX loading capacity, rapid and controlled drug release under tumor-like conditions, and minimal toxicity underscore its potential to advance the application of biopolymer-based nanogels in precision oncology.</p><h3>Graphical Abstract</h3>\u0000<div><figure><div><div><picture><source><img></source></picture></div></div></figure></div></div>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"20 3","pages":""},"PeriodicalIF":2.7,"publicationDate":"2025-05-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143900751","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Enhanced Zn-Co-Fe Layered Double Hydroxides for Effective Levofloxacin Removal: Innovation in Reuse of Waste Adsorbent","authors":"Ali M. Abdelkawy,&nbsp;Fatma M. Elantabli,&nbsp;Rehab Mahmoud,&nbsp;Samar M. Mahgoub,&nbsp;Fatma I. Abo El-Ela,&nbsp;Hassan A. Mohamed,&nbsp;S. A. Abdel Moaty","doi":"10.1007/s12247-025-09988-1","DOIUrl":"10.1007/s12247-025-09988-1","url":null,"abstract":"&lt;div&gt;&lt;h3&gt;Purpose&lt;/h3&gt;&lt;p&gt;Pharmaceutical waste, particularly antibiotics like levofloxacin, poses a significant threat to aquatic ecosystems and human health due to its persistence and potential to induce antibiotic resistance. This study focuses on the development of Zn-Co-Fe layered double hydroxide (LDH) and its modified form, Cu-Cyanoguanidine-ZnCoFe/LDH, as efficient adsorbents for levofloxacin removal from wastewater. The objective is to provide a sustainable solution for wastewater treatment and antimicrobial resistance management.&lt;/p&gt;&lt;h3&gt;Methods&lt;/h3&gt;&lt;p&gt;The catalysts were synthesized via co-precipitation and characterized using FTIR, XRD, SEM, TEM, PZC and BET analyses. Adsorption experiments were conducted to evaluate the effects of pH, adsorbent dose, and contact time, while kinetic and isotherm models were employed to elucidate the adsorption mechanisms.&lt;/p&gt;&lt;h3&gt;Results&lt;/h3&gt;&lt;p&gt;Cu-Cyanoguanidine-ZnCoFe/LDH achieved 90% levofloxacin removal efficiency at pH 9, driven by electrostatic interactions, hydrogen bonding, and π-π stacking. The point of zero charge (PZC) for the adsorbents was determined to be 7.00. The adsorption process followed a mixed 1st and 2nd order kinetic model, with rate constants of k1 = 473.39 min⁻&lt;sup&gt;1&lt;/sup&gt; and k2 = 3310.39 g/mg&lt;sub&gt;·&lt;/sub&gt;min, indicating both physical and chemical adsorption mechanisms. The Langmuir isotherm model revealed a maximum adsorption capacity (Qmax) of 390 mg/g for the modified LDH. Statistical analysis confirmed the significance of the results (p &lt; 0.05). Notably, the adsorbent retained significant antibacterial activity even after levofloxacin removal, as confirmed by antimicrobial assays. Furthermore, the material exhibited excellent recyclability, maintaining 93.9% of its adsorption capacity after four regeneration cycles using NaOH. Cu-Cyanoguanidine exhibited strong antibacterial and anti-biofilm activity, effectively degrading levofloxacin and reducing inflammation. In vitro tests confirmed efficient levofloxacin removal, with treated samples showing no antibacterial activity. In vivo studies on bacterial keratitis demonstrated that Cu-Cyanoguanidine LDH improved treatment efficacy and tissue integrity, even with reduced dosing.&lt;/p&gt;&lt;h3&gt;Conclusions&lt;/h3&gt;&lt;p&gt;This study highlights the potential of Cu-Cyanoguanidine-ZnCoFe/LDH as a sustainable and cost-effective adsorbent for pharmaceutical wastewater treatment, demonstrating high removal efficiency, robust adsorption mechanisms, and retained antibacterial properties. Its strong performance in eliminating pharmaceutical contaminants underscores its feasibility for large-scale wastewater treatment applications, offering a viable solution to mitigate both environmental pollution and antibiotic resistance. The study further emphasizes the potential integration of LDH-based materials into existing treatment infrastructures, providing an eco-friendly alternative to conventional remediation methods. By addressing critical challenges associate","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"20 3","pages":""},"PeriodicalIF":2.7,"publicationDate":"2025-05-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1007/s12247-025-09988-1.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143900717","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A Self-Nanoemulsifying Drug Delivery System for Vitamin D3: Design, Optimization and Pharmacokinetic Evaluation","authors":"Mariyambibi A. Mandarawala,&nbsp;Ashok N. Mahajan,&nbsp;Shaileshkumar K. Koradia,&nbsp;Moinuddin M. Soniwala","doi":"10.1007/s12247-025-09949-8","DOIUrl":"10.1007/s12247-025-09949-8","url":null,"abstract":"<p>Vitamin D3 (VTD3), a fat-soluble vitamin, is vital for various physiological functions but suffers from poor stability and solubility. Formulation strategies are essential to enhance its stability and bioavailability. This study aimed to develop an optimized Self-Nanoemulsifying Drug Delivery System (SNEDDS) for VTD3 to improve its dissolution efficiency and systemic availability via oral administration using a Design of Experiments (DoE) approach.</p><p>Solubility and emulsification studies identified suitable oils, surfactants, and cosurfactants. Ternary phase diagrams and a simplex lattice design were employed to optimize the formulation. Captex 300 (X1), Acrysol K 140 (X2), and Transcutol HP (X3) were the independent variables, while droplet size (Y1) and cumulative drug release (Y2) in pH 1.2 HCl were the dependent variables. The final formulation was selected based on desirability functions, and contour and surface plots were applied for detailed analysis. The SNEDDS was evaluated for visual inspection, globule size, zeta potential, emulsification time, PDI, cloud point, resistance to dilution, VTD3 content, drug release, stability, and pharmacokinetic properties.</p><p>The optimized SNEDDS (20% Captex 300, 50% Acrysol K140, 30% Transcutol HP) exhibited a globule size of 18.22 nm, &gt; 98% drug content, and &gt; 86% drug release within 60 min in both 0.1 N HCl and pH 6.8 buffer. A 3.95-fold bioavailability improvement was observed in vivo compared to plain VTD3 suspension. Stability studies confirmed no significant changes in the physicochemical properties.</p><p>The developed SNEDDS formulation, encapsulated in HPMC capsules, significantly improved VTD3's stability, dissolution, and bioavailability. This provides a promising approach to oral lipophilic compound delivery.</p>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"20 3","pages":""},"PeriodicalIF":2.7,"publicationDate":"2025-04-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143888797","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Formulation and Evaluation of Herbal Lipbalm for the Treatment of Cheilitis","authors":"Irin rose Paul,&nbsp;Anaswara Sankar,&nbsp;Mariya Sunny,&nbsp;Manju Maria Mathews,&nbsp;Dhanish Joseph","doi":"10.1007/s12247-025-09939-w","DOIUrl":"10.1007/s12247-025-09939-w","url":null,"abstract":"<div><h3>Purpose</h3><p>This study aimed to formulate and evaluate a herbal lip balm for the treatment of cheilitis. Angular cheilitis presents as a roughly triangular area of erythema and edema at one or, more commonly, both corners of the mouth. The most frequent cause of angular cheilitis in adults is a fungal infection caused by <i>Candida albicans,</i> and less frequently, <i>Staphylococcus aureus</i>.</p><h3>Methods</h3><p>Plant extracts were obtained through Soxhlet extraction, and the concentration for the final formulation was optimized using Design of Experiments (DOE). Organoleptic evaluation and antimicrobial studies were conducted. In vitro cytotoxicity studies were conducted using MTT assay. Skin irritancy was assessed using the HET-CAM test, while the wound healing potential was confirmed through a scratch wound healing assay.</p><h3>Results</h3><p>The formulated lip balm exhibited a pleasant appearance, uniform distribution, and was free from grittiness. Antimicrobial studies demonstrated significant antibacterial activity and promising antifungal properties against angular cheilitis-causing pathogens. The HET-CAM test confirmed that the lip balm was free from skin irritancy. Safety was further verified through in vitro cytotoxicity testing via the MTT assay, with an LC50 value of 299.957 µg/ml. High cell viability, even at 100 µg/ml, indicating no toxicity in cultured cell lines. The Scratch assay confirmed the lip balm's wound healing potential, reinforcing the formulation's efficacy.</p><h3>Conclusion</h3><p>The formulation was found to be safe and effective, suggesting its potential as a therapeutic option for angular cheilitis. This study offers a systematic approach to developing herbal lip balm using natural extracts known for their medicinal properties<b>.</b></p></div>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"20 3","pages":""},"PeriodicalIF":2.7,"publicationDate":"2025-04-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143879594","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Novel Effervescent Formulation Containing Butyric Acid Treated Egg Shell and Psoralen for Manamegent of Osteoporosis","authors":"Maithilee Mande,&nbsp;Mayuri Kale,&nbsp;Dyandevi Mathure,&nbsp;Ravindra Kulkarni,&nbsp;Deepa Mandlik,&nbsp;Vaibhav Shinde","doi":"10.1007/s12247-025-09993-4","DOIUrl":"10.1007/s12247-025-09993-4","url":null,"abstract":"<div><h3>Background</h3><p>Current treatments available for osteoporosis involve high risk and severe adverse effects hence, can’t be used in prolonged treatment.</p><h3>Purpose</h3><p>Development of effervescent granules containing a synergistic blend of psoralen and eggshell derived calcium butyrate (ECB) as a novel oral formulation for osteoporosis treatment.</p><h3>Methods</h3><p>Wet granulation method was used for preparation of effervescent granules, Psoralen dissolved in ethanol by vortex mixing was used as granulating agent. The eggshell powder was treated with butyric acid to get soluble calcium butyrate (ECB). Both psoralen and ECB were mixed with the effervescent base containing citric acid, sodium bicarbonate and mannitol. The formulation was optimized by using central composite design in design expert software version 7.1.6. Anti-osteoporotic activity of optimized formulation was studied by glucocorticoid induced osteoporosis model in female wistar rats.</p><h3>Results</h3><p>The optimized formulation demonstrated rapid dissolution, with over 90% of psoralen and calcium released within 30 min, indicating enhanced bioavailability. Results revealed that the effervescent granules significantly improved alkaline phosphatase activity and calcium levels in osteoporotic animals; histopathological analysis confirmed improved bone architecture. These findings underscore the potential of this dual-action formulation for enhancing bone health and warrant further investigation into its clinical applications in osteoporosis management.</p><h3>Conclusion</h3><p>Psoralen and ECB effervescent granules (PECB-EG) are an effective treatment option for long term treatment of osteoporosis.</p><h3>Graphical Abstract</h3><div><figure><div><div><picture><source><img></source></picture></div></div></figure></div></div>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"20 3","pages":""},"PeriodicalIF":2.7,"publicationDate":"2025-04-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143871325","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}