Journal of Pharmaceutical Innovation最新文献

{"title":"Development and Optimization of Eudragit® EPO Coated Solid Dispersion-Based Immediate-Release Pellets of Drotaverine Hydrochloride for Pediatric use","authors":"Hitarthi Patel,&nbsp;Mitali Upadhyay,&nbsp;Meenakshi Patel","doi":"10.1007/s12247-025-10080-x","DOIUrl":"10.1007/s12247-025-10080-x","url":null,"abstract":"<div><h3>Purpose</h3><p>The study aimed to develop a pediatric-friendly, immediate-release pellet formulation of Drotaverine Hydrochloride (DHC) to address issues related to poor aqueous solubility, bitter taste, and dosing flexibility in children. The objective was to enhance solubility and ensure rapid drug release while masking the bitter taste of drug.</p><h3>Method</h3><p>Solid dispersions of DHC were prepared using Polyethylene Glycol (PEG) 4000 and PEG 6000 via the solvent evaporation technique. These were converted into pellets using extrusion–spheronization, with MCC (Microcrystalline Cellulose), as the pelletizing agent and Eudragit^® EPO coating for taste masking. A 2³ factorial design was employed to optimize critical variables: spheronization speed, PEG type, and superdisintegrant concentration. The optimized batch was evaluated for physicochemical properties, disintegration, drug content, in vitro drug release in both gastric and oral pH, and kinetic modeling.</p><h3>Results</h3><p>The optimized formulation (DHP6) comprised a solid dispersion of DHC with PEG 4000 (1:2 ratio), 10% superdisintegrant, and a spheronization speed of 7000 rpm. It exhibited a pellet size of 0.78 ± 0.02 mm, t₈₅ of 15 ± 3.25 min, and disintegration time of 0.83 ± 0.04 min. The pellets showed excellent flowability (angle of repose: 12.04°; Hausner ratio: 1.01), friability (0.12 ± 0.004%), and acceptable hardness (0.55 ± 0.25 g/cm²). In vitro release studies demonstrated &gt; 85% drug release within 15 min in 0.1 N HCl and negligible release in simulated salivary fluid, confirming effective taste masking. Release kinetics followed the Korsmeyer-Peppas model (R² = 0.9862), indicating diffusion-controlled release.</p><h3>Conclusion</h3><p>The developed immediate-release pellets of DHC offer improved solubility, rapid gastric release, and effective taste masking, making them a promising pediatric dosage form for abdominal pain management. The optimized formulation (DHP6) demonstrated robust physicochemical and performance characteristics, supporting its potential for pediatric use.</p></div>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"20 5","pages":""},"PeriodicalIF":2.7,"publicationDate":"2025-09-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145062080","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":"Development and Evaluation of Luliconazole-Loaded Microsponge Gel for Improved Topical Retention and Reduced Irritation","authors":"Ashwini Potulwar,&nbsp;Sailesh Wadher,&nbsp;Shradha Tiwari","doi":"10.1007/s12247-025-10076-7","DOIUrl":"10.1007/s12247-025-10076-7","url":null,"abstract":"<div><h3>Purpose</h3><p>Traditional topical therapies often require high drug concentrations, leading to irritation and poor patient compliance. The aim of this study is to develop a microsponge-based gel formulation of Luliconazole that enables controlled drug release, enhances retention within the skin layers, and reduces the irritation.</p><h3>Methods</h3><p>Luliconazole microsponge were formulated using solvent diffusion method using a quasi-emulsion system and optimized through a 3² factorial design to study the effects of Eudragit S-100 and Dichloromethane. The microsponges were evaluated for their particle size, drug entrapment efficiency, and in vitro release profile. The optimized formulation was then incorporated into a Carbopol-based gel, which was subsequently assessed for its physicochemical characteristics, in vitro drug release, antifungal efficacy against <i>Candida albicans</i>, and for skin irritation.</p><h3>Results</h3><p>The optimized microsponge had a particle size of 30–70 µm, entrapment efficiency of 91.35 ± 1.06 %, and controlled drug release (83.67 ± 2.11 % of LCZ over 12 h). The gel showed suitable pH (6.8–7.4), viscosity (2160 cPs), and higher drug content in LCZMG3 compared to other formulations. The antifungal study demonstrated a clear zone of inhibition, and skin irritation tests showed minimal irritation with controlled release and prolonged drug retention in skin layers.</p><h3>Conclusion</h3><p>The luliconazole microsponge gel exhibited superior antifungal activity, reduced irritation, and improved local drug retention compared to marketed preparations. This novel formulation holds promise for effective, patient-friendly treatment of fungal infections with enhanced compliance.</p></div>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"20 5","pages":""},"PeriodicalIF":2.7,"publicationDate":"2025-09-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145037484","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":"Development of Sertaconazole Loaded Nanoemulgel Using Quality by Design Approach for Enhanced Antifungal Drug Delivery","authors":"Shalini Pandey,&nbsp;Sourav Paul,&nbsp;Krishna Kant Jangde,&nbsp;Dinesh Kumar Mishra","doi":"10.1007/s12247-025-10075-8","DOIUrl":"10.1007/s12247-025-10075-8","url":null,"abstract":"<div><h3>Purpose</h3><p>This study focuses on the development and optimization of a sertaconazole-loaded nanoemulgel (SER-NEG) using a quality by design (QbD) approach for improved topical antifungal therapy. The goal was to formulate a stable nanoemulsion (NE) using the low Energy spontaneous emulsification method, followed by its incorporation into a gel matrix for enhanced drug retention and efficacy.</p><h3>Methods</h3><p>A pseudoternary phase diagram was constructed to determine the optimal ratio of oleic acid (oil), S_mix (surfactant-co-surfactant), and aqueous phase for a stable NE. Box-Behnken Design (BBD) was applied to optimize critical material attributes (CMAs) affecting critical quality attributes (CQAs) like globule size (GS) and entrapment efficiency (EE). The optimized NE was incorporated into an HPMC-Carbopol gel to form a NEG. The formulation was evaluated for in vitro drug release, release kinetics, morphology, stability, antifungal efficacy, and rheological properties.</p><h3>Results</h3><p>The optimized SER-NEG were evaluated for GS (111 nm), EE (99.7%), viscosity (2682 ± 96.77 cP), and spreadability (7.03 ± 0.98 cm). In vitro release studies showed sustained release (77.00% ± 4.28% over 8 h), following the Higuchi diffusion model (R² = 0.977). SEM analysis confirmed a uniform, spherical morphology, while stability studies showed excellent physical stability. Antifungal efficacy demonstrated a superior zone of inhibition against <i>Candida albicans</i> (1.1 ± 0.1 cm) and <i>Aspergillus niger</i> (0.6 ± 0.1 cm) compared to marketed formulations.</p><h3>Conclusion</h3><p>The QbD-optimized SER-NEG displayed enhanced stability, controlled drug release, and better antifungal activity. It ensures smooth application thereby could improve patient compliance. With these many advantages, this carrier system becomes a promising candidate for topical antifungal therapy.</p></div>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"20 5","pages":""},"PeriodicalIF":2.7,"publicationDate":"2025-09-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145011506","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":"Robust RP-HPLC Method for the Analysis of Domiphen Bromide in Pharmaceuticals with Comprehensive Sustainability Assessment","authors":"Samar M. Mahgoub,&nbsp;Abdullah S. Alawam,&nbsp;Ahmed A. Allam,&nbsp;Abdelaty Mohamed,&nbsp;Rehab Mahmoud","doi":"10.1007/s12247-025-10074-9","DOIUrl":"10.1007/s12247-025-10074-9","url":null,"abstract":"<div><h3>Purpose</h3><p>Domiphen bromide (DB), a quaternary ammonium compound, is widely used as an antimicrobial preservative in pharmaceutical formulations. This study aimed to develop and validate a simple, sensitive, and reliable reversed-phase HPLC method for the quantitative determination of DB in pure and commercial preparations, evaluating its stability-indicating capacity and environmental sustainability.</p><h3>Methods</h3><p>Chromatographic separation was performed via an Inertsil ODS-3 column with acetonitrile and perchloric acid solution (70:30, v/v) as the mobile phase. Detection was performed at 275 nm with a column temperature of 25 °C. Method validation followed ICH guidelines, assessing linearity, precision, accuracy, robustness, and specificity. A quality by design (QbD) approach was employed with a 2³ full factorial design of experiments (DoE) to optimize critical parameters, including the acetonitrile ratio, flow rate, and column temperature, with statistical analysis (ANOVA) confirming their influence on retention, resolution, and peak shape. Forced degradation studies under acidic, basic, oxidative, thermal, photolytic, and neutral conditions were conducted. The method’s greenness was evaluated via multiple analytical effectiveness and eco-balance metrics. Statistical analysis included one-way ANOVA for batch comparisons.</p><h3>Results</h3><p>The method exhibited excellent linearity (1.132–1000 µg/mL, r² &gt;0.999) with exceptional sensitivity (LOD: 0.373 µg/mL, LOQ: 1.132 µg/mL). The RSD values were less than 2% for the intraday and interday analyses. The accuracy ranged from 98.8 to 99.76% across the three concentration levels. Degradation studies revealed the highest susceptibility to basic hydrolysis (26.72%), followed by acid hydrolysis (18.45%) and oxidative stress (15.23%). The method successfully separated DB from all the degradation products, confirming its stability-indicating capacity. ANOVA confirmed that there was no significant batch-to-batch variation in commercial products (F = 0.82, <i>p</i> &gt; 0.05). Solution stability studies confirmed standard/sample integrity for 24 h at 25 °C and 48 h at 4 °C.</p><h3>Conclusions</h3><p>The developed RP-HPLC method is robust, accurate, and precise for routine determination and stability assessment of DB in pharmaceutical formulations. This method was further applied to the analysis of a commercial formulation (Maalox^® oral suspension) with no observed interference from excipients. The method aligns with green chemistry principles and is suitable for quality control and regulatory applications.</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 5","pages":""},"PeriodicalIF":2.7,"publicationDate":"2025-09-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1007/s12247-025-10074-9.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145007954","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":"Enhancing Flowability and Compactibility of Glutinous Rice Starch Through Co-Precipitation: A Central Composite Design Approach","authors":"Jomjai Peerapattana,&nbsp;Chonticha Amornrojvaravut","doi":"10.1007/s12247-025-10077-6","DOIUrl":"10.1007/s12247-025-10077-6","url":null,"abstract":"<div><h3>Purpose</h3><p>Flowability and compactibility are essential properties for excipients in direct compression tablet formulations. Native starches often exhibit limitations in these aspects. They exhibit poor flow characteristics due to their small particle size and high moisture sensitivity, and their limited plastic deformation leads to low compactibility. This study aimed to optimize a co-precipitation method to enhance the flow and compaction properties of glutinous rice starch (GRS), providing an alternative excipient for direct compression. The influence of key formulation parameters on the physicomechanical properties of modified starch was investigated, and optimal conditions for achieving superior performance were established.</p><h3>Methods</h3><p>Co-precipitated GRS (cpGRS) was prepared by swelling native starch in an alkaline sodium hydroxide solution, followed by incorporation of excipients (polyvinylpyrrolidone K30 (PVP K30) and calcium carbonate), and subsequent acid neutralization to precipitate modified starch granules. A Central Composite Design (CCD) was employed to systematically evaluate the effects of sodium hydroxide concentration, mixing time, endpoint pH, PVP K30, and calcium carbonate concentration on the flowability and compactibility of cpGRS. The modified starch was characterized in terms of yield, Carr’s Index, Hausner Ratio, tensile strength, and disintegration time.</p><h3>Results</h3><p>Higher sodium hydroxide concentrations and calcium carbonate levels significantly improved flowability and compactibility, while endpoint pH influenced particle size distribution. The optimized conditions (0.43 M sodium hydroxide, 95 min of mixing, endpoint pH 6.97, 7.09% w/w PVP K30, and 14.02% w/w calcium carbonate) produced cpGRS with a tensile strength of 3.05 MPa, a disintegration time of 222.95 s, a yield of 68.80%, and improved flow properties (Carr’s Index 17.16, Hausner Ratio 1.21).</p><h3>Conclusion</h3><p>This optimized co-precipitation approach effectively enhances the functional properties of GRS, making it a viable excipient for direct compression tablet formulations. This study provides a novel starch modification strategy that broadens the application of rice-derived excipients in pharmaceutical sciences.</p></div>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"20 5","pages":""},"PeriodicalIF":2.7,"publicationDate":"2025-09-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144998580","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":"Design and Evaluation of Compritol®-Based Mesalazine Pellets and Tablets for Sustained Release Throughout the Gastrointestinal Tract","authors":"Amirhossein Lulu,&nbsp;Abbas Akhgari,&nbsp;Sara Feizollahi,&nbsp;Mohammadreza Abbaspour,&nbsp;Hossein Shahdadi Sardou","doi":"10.1007/s12247-025-10072-x","DOIUrl":"10.1007/s12247-025-10072-x","url":null,"abstract":"<div><h3>Background/Objective</h3><p>Drug delivery to the gastrointestinal tract (GIT) has become very important for the local treatment of digestive diseases such as inflammatory bowel disease (IBD). Mesalazine is an anti-inflammatory drug used as the first-line treatment for IBD. The current study aims to prepare mesalazine controlled-release pellets/tablets based on Compritol^® 888 ATO for the gradual release of the drug throughout the intestine.</p><h3>Methods</h3><p>Formulations were designed using Design Expert software based on Central Composite Design (CCD). The independent variables were the ratio of Compritol^® 888 ATO to Microcrystalline cellulose (MCC) in the pellet/tablet formulations and the curing temperature. The dependent variables were the drug release percentages in media simulating the stomach and various sections of the intestine. Pellets were manufactured using the extrusion-spheronization method and tablets were prepared using the wet granulation method. The optimal pellet formulation was evaluated by image analysis, SEM, FTIR, and DSC, as well as the drug release was continuously evaluated in simulated gastric media (pH 1.2), simulated intestinal media (duodenum, jejunum and terminal ileum with pHs of 6.5, 6.8, 7.2, respectively), and colon with pH 6.8.</p><h3>Results</h3><p>Increasing the amount of Compritol^® 888 ATO and the curing temperature in the formulation significantly controlled the drug release. The optimal pellet formulation, consisting of 40% mesalazine, 58% Compritol^® 888 ATO, and 2% PVP K30, cured at 75 °C for 24 h, successfully achieved the desired results. In contrast, the tablet formulations failed to deliver the expected outcomes. Image analysis of the pellets showed that the aspect ratio and sphericity of the optimal pellets were 1.12 ± 0.04 and 0.88 ± 0.03, respectively, indicating a spherical shape. The evaluation of SEM images also confirmed the results obtained from the image analysis software. According to the DSC and FTIR results, there was no interference between the drug and excipients. The dissolution test results demonstrated that incorporating Compritol^® 888 ATO in the tablet structure resulted in minimal drug release, whereas the optimal pellet gradually released the entire drug content over approximately 15 h.</p><h3>Conclusion</h3><p>The optimal pellet formulation controlled the drug release in the simulated media of different parts of the GIT. Its release profile was similar to Pentasa^®’s, suggesting that it could be considered for extended drug delivery throughout the GIT.</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 5","pages":""},"PeriodicalIF":2.7,"publicationDate":"2025-09-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144990602","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":"Advancing Lamotrigine Therapy: Piezoelectric Atomized Cloud Drying-Developed Microparticles in Lyophilized Orally Disintegrating Tablets with Characterization and PBPK Simulation for Enhanced Dissolution, Rapid Absorption, and Faster Onset of Action","authors":"Swayamprakash Patel,&nbsp;Chelsi Patel,&nbsp;Mehul Patel,&nbsp;Ashish Patel,&nbsp;Jagruti Desai","doi":"10.1007/s12247-025-10067-8","DOIUrl":"10.1007/s12247-025-10067-8","url":null,"abstract":"<div><p>Epilepsy, a prevalent neurological disorder, is predominantly managed by antiepileptic drugs (AEDs) like lamotrigine. Despite its clinical efficacy, its slow dissolution rate delays therapeutic onset, necessitating improved formulation strategies. This study introduces a novel compression-free lamotrigine formulation using lyophilized orally disintegrating tablets (ODTs) containing microparticles developed through Piezoelectric Atomized Cloud Drying (PACD). The PACD-generated microparticles significantly enhanced lamotrigine’s aqueous solubility (from 0.17 mg/mL to 2.62 mg/mL with PVP K30) and demonstrated &gt; 90% drug release within 10 min, addressing lamotrigine’s dissolution limitations. DSC and PXRD studies confirm the amorphization of lamotrigine that contributed to improvement in the solubility and dissolution rate. Microparticles with significantly smaller size (D90 = 1.851 μm, Mean Size (SD) = 1.098 ± 0.563 μm and PDI = 0.262) are also responsible for this solubility improvement. The optimized lamotrigine microparticle-loaded lyophilized orally disintegrating tablet (LMP-LODT) evaluated for physicochemical properties, disintegration, and in-vitro dissolution, showing rapid drug release and excellent patient-friendly attributes. Furthermore, Physiology-Based Pharmacokinetic (PBPK) simulations using PK-Sim^® predicted a reduced Tmax (0.66 h) indicating faster absorption and earlier attainment of therapeutic levels. In conclusion, combining PACD-engineered amorphous microparticles with lyophilized ODT technology effectively improved lamotrigine’s solubility, dissolution, and pharmacokinetic profile. This formulation approach offers a promising alternative to conventional lamotrigine tablets by enabling faster therapeutic onset, improved patient compliance, and potentially reduced dose-dependent adverse effects.</p></div>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"20 5","pages":""},"PeriodicalIF":2.7,"publicationDate":"2025-09-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144998579","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":"Efficacy of Drug Delivery Systems in Breast Cancer: A Meta-Analysis of Preclinical Animal Studies","authors":"Arlinda Daka Grapci,&nbsp;Pranvera Breznica Selmani,&nbsp;Blerina Koshi,&nbsp;Ibadete Bytyçi,&nbsp;Rozafa Koliqi","doi":"10.1007/s12247-025-10069-6","DOIUrl":"10.1007/s12247-025-10069-6","url":null,"abstract":"<div><h3>Purpose</h3><p>Breast cancer remains a leading cause of cancer-related death in women, with conventional chemotherapy facing challenges like limited efficacy and high toxicity. Drug delivery systems (DDS) offer promising alternatives by enhancing drug targeting, increasing bioavailability, and minimizing adverse effects. This systematic review and meta-analysis evaluates the effectiveness of DDS in inhibiting tumor growth in preclinical breast cancer models, comparing targeted and non-targeted approaches, as well as the most common DDS platforms.</p><h3>Method</h3><p>A comprehensive literature search identified 62 preclinical studies on the efficacy of drug delivery systems (DDS) in breast cancer treatment. Key variables such as DDS type, chemotherapeutic agents, targeting strategies, and administration routes were analyzed, with subgroup analyses based on targeting approaches and administration methods. A risk of bias assessment was also performed to evaluate study quality.</p><h3>Results</h3><p>Drug delivery systems (DDS) significantly enhanced tumor growth inhibition compared to free drugs, with targeted DDS showing superior efficacy. Liposomes and epirubicin-loaded DDS exhibited the greatest tumor suppression, and aptamers were the most effective targeting ligands. Intraperitoneal administration showed a slight advantage over intravenous delivery. Methodological flaws, such as inadequate randomization and blinding, were noted in several studies.</p><h3>Conclusions</h3><p>DDS, particularly with targeted delivery strategies, significantly improve chemotherapeutic efficacy in preclinical breast cancer models. Liposomes, epirubicin-loaded DDS, and aptamers are promising, but variability in study designs necessitates more rigorous and standardized methodologies for better translational relevance.</p></div>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"20 5","pages":""},"PeriodicalIF":2.7,"publicationDate":"2025-09-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144927082","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":"Topical Wound Healing Effects of Bauhinia Purpurea and Ficus Carica Extracts Compared to Povidone-Iodine in Sprague Dawley Rats","authors":"M. Shilpa,&nbsp;Jamal Moideen Muthu Mohamed,&nbsp;Yahya I. Asiri,&nbsp;Krishnaraju Venkatesan,&nbsp;Swathi Gurajala,&nbsp;Pooja Muralidharan,&nbsp;Gamal Osman Elhassan,&nbsp;Hassabelrasoul Elfadil,&nbsp;Rehab Ahmed,&nbsp;Nizar Sirag,&nbsp;Premalatha Paulsamy","doi":"10.1007/s12247-025-10062-z","DOIUrl":"10.1007/s12247-025-10062-z","url":null,"abstract":"<div><p>This study aims to evaluate the wound-healing potential of <i>Bauhinia purpurea</i> Linn (B. purpurea L.) leaf extract and <i>Ficus carica</i> (F. carica) latex in comparison to povidone-iodine. Topically, the rat excision wounds were treated with ointments of 2.0% and 5.0% of the extract. Acute dermal toxicity, haematology and biochemistry tests like RBC, hemoglobin, liver and renal function tests, and biochemistry markers were carried out. The reepithelisation, rate of contraction of the wound was quantified, and an MTT assay in MCF-7 and RAW 264.7 cell lines was conducted to assess cytotoxicity. The ethanolic extract (14.28 ± 1.45% w/w) was examined in ointments with 2% and 5% concentrations on rat excision wounds. Acute dermal toxicity tests at 5000 mg/kg for 14 days were non-toxic and did not exhibit any physiological changes. Haematology and biochemistry tests also specified safety. Wound contraction rates were 81 ± 7.11% (2% extract) and 85 ± 7.09% (5% extract), as compared to 89 ± 5.14% for povidone-iodine. MTT assay exhibited cytotoxicity of 82.76 ± 6.91 µg/mL (MCF-7) and 46.26 ± 2.24 µg/mL (RAW 264.7). The extract exhibited antibacterial, anti-inflammatory, and collagen-stimulating activity, and serves as a fine alternative to wound care.</p></div>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"20 5","pages":""},"PeriodicalIF":2.7,"publicationDate":"2025-08-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144918297","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":"Quality by Design for Cost Effective Production of Pregabalin Extended-Release Tablets: in vitro and in vivo Study","authors":"Mohamed Ebeed,&nbsp;Gehan F. Balata,&nbsp;Hanaa A. El-ghamry,&nbsp;Noura G. Eissa","doi":"10.1007/s12247-025-10058-9","DOIUrl":"10.1007/s12247-025-10058-9","url":null,"abstract":"<div><h3>Purpose</h3><p>Pregabalin (LYRICA^®) is a centrally acting neuromodulating agent for the management of neuropathic pain and fibromyalgia. Owing to its short half-life, LYRICA^® controlled release (CR) tablets have been approved to be administrated once daily. However, the tablets are prepared by a multi-step process using a combination of release-controlling, wetting, pore-forming, and gelling agents. Hence, there is a need to develop a simple cost-effective environment-friendly methodology for the manufacturing of pregabalin extended release (ER) tablets.</p><h3>Methods</h3><p>Quality by design (QbD) was applied for simple manufacturing of pregabalin extended release tablets with comparable efficacy to the reference product LYRICA^® CR (82.5 mg) utilizing hydrophilic and lipid components and hot-melt granulation. The design of experiment (DoE) based on Taguchi model was utilized to investigate the effect of combination of various hydrophilic and lipophilic matrices, fillers and compression forces on the release of pregabalin ER tablets. Pre-compression blends were evaluated for micrometrics while tablets were evaluated for drug content, average weight, hardness, friability, thickness, dissolution and release kinetics. A pharmacokinetics study was performed to evaluate the pharmacokinetics profile of the optimized formulation as compared to the reference marketed product.</p><h3>Results</h3><p>Results, analyzed using Minitab software^® 18, determined significant and non-significant variables. The lipophilic meltable binder displayed significant effects on the pre-compression blend characters, yet not able to attain an extended release profile for pregabalin. Combination of hydrophilic and lipophilic matrices efficiently developed pregabalin tablets of extended-release pattern. The optimized formulation (composed of 80 mg of stearic acid, 100 mg of Methocel K15M and lactose with compression value of 10 KN) showed a comparable pharmacokinetics profile to the reference drug in terms of AUC (4.12 and 4.78 µg.h/mL, respectively) and C_max (0.31 and 0.36 µg/mL, respectively) using a pilot-scale bioequivalence study in albino rabbits.</p><h3>Conclusion</h3><p>QbD and DoE can be effectively applied for the design and development of a timesaving and eco-friendly methodology for the preparation of pregabalin ER tablets as an alternative to the marketed product.</p></div>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"20 5","pages":""},"PeriodicalIF":2.7,"publicationDate":"2025-08-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1007/s12247-025-10058-9.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144880931","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}