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22 pages, 4659 KB  
Article
Syringic Acid Alleviates Doxorubicin-Induced Hepatotoxicity Through PI3K/Akt-Mediated Nrf-2/HO-1 Signaling Pathways in Male Rats
by Maha Abdullah Alwaili, Thamir M. Eid, Amal S. Abu-Almakarem, Alaa Muqbil Alsirhani, Noorah Saleh Al-Sowayan, Rabab Mohamed Aljarari, Effat A. Al-Judaibi, Aljazi Abdullah AlRashidi, Maysa A. Mobasher and Karim Samy El-Said
Int. J. Mol. Sci. 2025, 26(16), 7779; https://doi.org/10.3390/ijms26167779 - 12 Aug 2025
Viewed by 237
Abstract
Syringic acid (SYA) is a significant phenolic compound with the potential for various biomedical uses, including uses of its hepatoprotective properties. Doxorubicin (DOX) is a drug used in the treatment of several tumors, but its side effects, particularly hepatotoxicity, limit its effectiveness. This [...] Read more.
Syringic acid (SYA) is a significant phenolic compound with the potential for various biomedical uses, including uses of its hepatoprotective properties. Doxorubicin (DOX) is a drug used in the treatment of several tumors, but its side effects, particularly hepatotoxicity, limit its effectiveness. This study investigated the therapeutic effects of SYA on DOX-induced hepatic injury in rats. Molecular docking studies were performed using AutoDock Vina. Five groups of Sprague–Dawley rats (eight in each group) were studied. Gp1 was a negative control group; Gps2–5 was administered intraperitoneally (i.p.) with DOX at a dosage of 4 mg/kg once a week for a month; and Gp2 was left as a positive control group. Gps3–5 received oral SYA at doses of 25, 50, or 75 mg/kg/day, respectively, for a month. Histopathological, molecular, and biochemical analyses were conducted one month after the last SYA dosages were given. The findings demonstrated that by reversing biochemical changes and reducing oxidative stress and inflammation, SYA therapy considerably reduced DOX-induced hepatotoxicity in rats. These results implied that SYA may lessen the hepatotoxicity that DOX causes in rats. Full article
(This article belongs to the Section Molecular Toxicology)
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14 pages, 1694 KB  
Article
Development and Characterization of Cannabidiol Gummy Using 3D Printing
by Arvind Bagde, Mina Messiha and Mandip Singh
Gels 2025, 11(3), 189; https://doi.org/10.3390/gels11030189 - 8 Mar 2025
Viewed by 1413
Abstract
Oropharyngeal dysphagia and pain are prevalent concerns in the geriatric population. Therefore, this study investigates advances in the development of cannabidiol (CBD) gummies using 3D printing technology and compares them to commercially available molded gummies for pain management. A gelatin-based CBD formulation was [...] Read more.
Oropharyngeal dysphagia and pain are prevalent concerns in the geriatric population. Therefore, this study investigates advances in the development of cannabidiol (CBD) gummies using 3D printing technology and compares them to commercially available molded gummies for pain management. A gelatin-based CBD formulation was prepared and printed using a syringe-based extrusion 3D printer. The formulation’s rheological properties were assessed, and the printed gummies were characterized using a texture analyzer. Drug content was analyzed using HPLC, and in vitro dissolution studies were conducted in phosphate buffer (pH 1.2 and 6.8). Our results demonstrated that the gelatin-based formulation had shear-thinning rheological properties for 3D printing at a temperature of 38.00 °C, filament diameter of 26 mm and flow of 110%. The optimized printing parameters produced gummies with higher elasticity compared to marketed gummies and comparable toughness. Drug content analysis showed 98.14 ± 1.56 and 97.97 ± 2.14% of CBD in 3D-printed and marketed gummies, respectively. Dissolution studies revealed that both gummy types released 100% of the drug within 30 min in both pH 1.2 and 6.8 buffers. Overall, 3D printing enables customizable CBD gummies with optimized release and offer a personalized and patient-friendly alternative to traditional oral forms for geriatric care. Full article
(This article belongs to the Special Issue State-of-the Art Gel Research in USA)
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19 pages, 5230 KB  
Article
Development and Characterization of Niaprazine-Loaded Xanthan Gum-Based Gel for Oral Administration
by Elena Giuliano, Emanuela Longo, Agnese Gagliardi, Silvia Costa, Federica Squillace, Silvia Voci, Mario Verdiglione and Donato Cosco
Gels 2025, 11(2), 101; https://doi.org/10.3390/gels11020101 - 1 Feb 2025
Cited by 2 | Viewed by 1146
Abstract
Niaprazine is a sedative-hypnotic drug initially developed as an antihistamine and used for its notable sedative effects, particularly in children. Following its withdrawal from the market by the producer, the drug has been administered as magistral formulations available in syrup form, but there [...] Read more.
Niaprazine is a sedative-hypnotic drug initially developed as an antihistamine and used for its notable sedative effects, particularly in children. Following its withdrawal from the market by the producer, the drug has been administered as magistral formulations available in syrup form, but there are several important disadvantages to this, including instability, taste issues, lack of controlled release, and the potential for unreliable dosing due to incomplete swallowing. There is also an increased risk of dental caries, as well as the fact that these formulations are not suitable for children who suffer from diabetes. The purpose of the current investigation is to prepare and characterize xanthan gum-based gels for the oral administration of niaprazine. Niaprazine gels appear as transparent-whiteish, non-sticky substances, with the drug uniformly dispersed throughout the systems. They are also stable over time. Dynamic rheology revealed their advantageous shear-thinning properties, which enable the formulation to be flexibly dosed orally through administration via syringe. During experimentation, the evaluation of the mucoadhesion features and the in vitro drug release profile were also performed. The results demonstrate that the formulation may represent an alternative to niaprazine syrup, allowing easy preparation, administration, and increased compliance in various categories of patients, including pediatric. Full article
(This article belongs to the Special Issue Advanced Gel Materials for Bioengineering)
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14 pages, 2802 KB  
Article
Fabrication of a Controlled-Release Core-Shell Floating Tablet of Ketamine Hydrochloride Using a 3D Printing Technique for Management of Refractory Depressions and Chronic Pain
by Tahmineh Karami, Emad Ghobadi, Mohammad Akrami and Ismaeil Haririan
Polymers 2024, 16(6), 746; https://doi.org/10.3390/polym16060746 - 8 Mar 2024
Cited by 6 | Viewed by 2536
Abstract
In this study, a novel floating, controlled-release and core-shell oral tablet of ketamine hydrochloride (HCl) was produced using a dual extrusion by 3D printing method. A mixture of Soluplus® and Eudragit® RS-PO was extruded by a hot-melt extrusion (HME) nozzle at [...] Read more.
In this study, a novel floating, controlled-release and core-shell oral tablet of ketamine hydrochloride (HCl) was produced using a dual extrusion by 3D printing method. A mixture of Soluplus® and Eudragit® RS-PO was extruded by a hot-melt extrusion (HME) nozzle at 150–160 °C to fabricate the tablet shell, while a second nozzle known as a pressure-assisted syringe (PAS) extruded the etamine HCl in carboxymethyl cellulose gel at room temperature (25 °C) inside the shell. The resulting tablets were optimized based on the United States pharmacopeia standards (USP) for solid dosage forms. Moreover, the tablet was characterized using Fourier-transform infrared (FTIR) spectrum, scanning electron microscopy (SEM), differential scanning calorimetry (DSC), and buoyancy techniques. The results showed a desired dissolution profile for a 100% infill optimized tablet with total drug release (100%) during 12 h. Weight variation and content uniformity of the tablets achieved the USP requirements. SEM micrographs showed a smooth surface with acceptable layer diameters. According to the FTIR analysis, no interference was detected among peaks. Based on DSC analysis, the crystallinity of ketamine HCl did not change during melt extrusion. In conclusion, the floating controlled-release 3D-printed tablet of ketamine HCl can be a promising candidate for management of refractory depressions and chronic pain. Additionally, the additive manufacturing method enables the production of patient-tailored dosage with tunable-release kinetics for personalized medicine in point-of care setting. Full article
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15 pages, 993 KB  
Article
Design of Viscosity and Nozzle Path Using Food 3D Printer and Pneumatic Pressure Syringe-Type Dispensing System
by Changuk Ji, Areum Cha and Dongbin Shin
Appl. Sci. 2023, 13(22), 12234; https://doi.org/10.3390/app132212234 - 11 Nov 2023
Cited by 1 | Viewed by 2241
Abstract
Recent advancements in 3D printing technology have integrated with Fourth Industrial Revolution technologies such as robotics and artificial intelligence, aiming to overcome the limitations of conventional manufacturing methods. In the field of functional foods, solvent casting, a common manufacturing technique, has been adopted [...] Read more.
Recent advancements in 3D printing technology have integrated with Fourth Industrial Revolution technologies such as robotics and artificial intelligence, aiming to overcome the limitations of conventional manufacturing methods. In the field of functional foods, solvent casting, a common manufacturing technique, has been adopted to produce film-like structures with desired sizes and uniform thickness. However, the typical method of coating or injection on a conventional continuous film is difficult to produce in small amounts. To address this limitation, in the study, we developed a pneumatic pressure syringe-type dispensing system integrated with a food 3D printer utilizing fused deposition modeling (FDM) technology. A syringe type is needed to discharge crude liquid manufactured in the food field in a hygienic environment, and a 3D printing method that is easy to manufacture in small quantities or on demand was utilized. Through simulation and experiment, we wanted to confirm whether stable ejection results are generated according to the selected nozzle-based viscosity, inflow conditions, and the nozzle movement path of the food 3D printer. Based on the nozzle selected through simulation, it was confirmed that the fluid and flow velocity distribution of the viscous material were uniformly distributed and discharged under the conditions of 30,000 cps and inflow rate. By setting the parameters of the food 3D printer and preparing a coenzyme Q10 (CoQ10) sample, we achieved a stable oral dissolving film (ODF) extrusion shape through the design of viscosity and 3D printer nozzle path. The optimal viscosity range for the ODF solution was found to be 25,000 to 35,000 cps, exhibiting precise dimensions and shapes without distortion and yielding the most stable extrusion results. We defined four different nozzle path designs based on minimizing the movement of the 3D printer nozzle. Among them, a 16-step path design demonstrated a stable extrusion method, showing no tailing phenomenon under the conditions of 0.2 MPa pressure and −15.4 KPa vacuum pressure. In future research, we plan to conduct additional research to determine whether the discharge results vary depending on conditions such as viscosity of the crude liquid, nozzle path combination, and ODF thickness. Full article
(This article belongs to the Special Issue Recent Advances in 3D Printing and Additive Manufacturing Technology)
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12 pages, 1712 KB  
Article
Treatment of Scleroderma-Related Microstomia Using Hyaluronic Acid: An Interventional Study
by Ofir Shir-az, Ariel Berl, Din Mann, Biader Samih Bilal, Yair Levy and Avshalom Shalom
Life 2023, 13(11), 2176; https://doi.org/10.3390/life13112176 - 7 Nov 2023
Cited by 3 | Viewed by 3045
Abstract
Systemic sclerosis (SSc) or scleroderma is a rare, systemic, autoimmune connective tissue disease. It causes increased collagen synthesis, leading to multi-organ sclerosis, including the skin and joints. Patients’ overall health and quality of life are harmed dramatically. Involvement of the face and, especially, [...] Read more.
Systemic sclerosis (SSc) or scleroderma is a rare, systemic, autoimmune connective tissue disease. It causes increased collagen synthesis, leading to multi-organ sclerosis, including the skin and joints. Patients’ overall health and quality of life are harmed dramatically. Involvement of the face and, especially, the oral opening can limit patients’ ability to speak and eat, oral hygiene, and cosmetic appearance. Profhilo® (NAHYCO®) is an over-the-counter product consisting of pure hyaluronic acid. It is used to improve skin quality by increasing collagen production and adipocyte vitality. This interventional study evaluated the results of perioral injections of hyaluronic acid in terms of improved skin quality, elasticity, and increased oral opening. Patients diagnosed with SSc received an injection of one syringe of Profhilo® (2 mL of hyaluronic acid) at each of two clinic visits at one-month intervals. The oral opening was measured between the upper and lower central incisors before and after treatment. Quality of life was assessed using the modified Rodnan Skin Score and Health Assessment Questionnaire-Disability Index. A total of 14 patients received the first treatment, and 11 received the second treatment. The mean oral opening increased from 31.6 mm (range 17–50 mm) prior to therapy to 35.8 mm (range 21–56) 2 months following the second injection. Statistical analysis showed that there was a significant increase in the oral opening as observed one week (36.2 mm, p = 0.011), one month (36.2 mm, p = 0.007), and three months (31.6 mm, p = 0.023) after the second injection, at the 5-month follow-up. Treatment of SSc patients’ perioral area with Profhilo® can result in significant improvements in oral opening and quality of life. Full article
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11 pages, 2671 KB  
Article
Efficient Removal of Dental Plaque Biofilm from Training Typodont Teeth via Water Flosser
by Yue Wang, Hongyu Gao, Lili Chang, Jingchen Xu, Xueer Zhou, Chaoliang Zhang and Qiang Peng
Bioengineering 2023, 10(9), 1061; https://doi.org/10.3390/bioengineering10091061 - 8 Sep 2023
Cited by 5 | Viewed by 5379
Abstract
Plaque biofilms play critical roles in the development of dental caries. Mechanical plaque control methods are considered to be most effective for plaque removal, such as brushing teeth or using flosser. Recently, water flosser has been paid much attention. Here, we tested the [...] Read more.
Plaque biofilms play critical roles in the development of dental caries. Mechanical plaque control methods are considered to be most effective for plaque removal, such as brushing teeth or using flosser. Recently, water flosser has been paid much attention. Here, we tested the ability of a water flosser to remove the adhered sucrose and the dental plaque biofilms formed by Streptococcus mutans, Streptococcus sanguinis, and Actinobacillus viscosus. We found that the residual sucrose concentration was 3.54 mg/mL in the control group, 1.75 mg/mL in the syringe group (simulating the ordinary mouthwash), and 0 mg/mL in water flosser group. In addition, the residual bacterial concentration was 3.6 × 108 CFU/mL in the control group, 1.6 × 107 CFU/mL in the syringe group, and only 5.5 × 105 CFU/mL in the water flosser group. In summary, water flosser is effective for cleaning the teeth, which may have significant potential in preventing dental caries and maintaining oral health. Full article
(This article belongs to the Special Issue Engineering of Oral Biofilms)
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12 pages, 16456 KB  
Article
Chlorhexidine-Containing Electrospun Polymeric Nanofibers for Dental Applications: An In Vitro Study
by Luana Dutra de Carvalho, Bernardo Urbanetto Peres, Ya Shen, Markus Haapasalo, Hazuki Maezono, Adriana P. Manso, Frank Ko, John Jackson and Ricardo M. Carvalho
Antibiotics 2023, 12(9), 1414; https://doi.org/10.3390/antibiotics12091414 - 6 Sep 2023
Cited by 9 | Viewed by 1965
Abstract
Chlorhexidine is the most commonly used anti-infective drug in dentistry. To treat infected void areas, a drug-loaded material that swells to fill the void and releases the drug slowly is needed. This study investigated the encapsulation and release of chlorhexidine from cellulose acetate [...] Read more.
Chlorhexidine is the most commonly used anti-infective drug in dentistry. To treat infected void areas, a drug-loaded material that swells to fill the void and releases the drug slowly is needed. This study investigated the encapsulation and release of chlorhexidine from cellulose acetate nanofibers for use as an antibacterial treatment for dental bacterial infections by oral bacteria Streptococcus mutans and Enterococcus faecalis. This study used a commercial electrospinning machine to finely control the manufacture of thin, flexible, chlorhexidine-loaded cellulose acetate nanofiber mats with very-small-diameter fibers (measured using SEM). Water absorption was measured gravimetrically, drug release was analyzed by absorbance at 254 nm, and antibiotic effects were measured by halo analysis in agar. Slow electrospinning at lower voltage (14 kV), short target distance (14 cm), slow traverse and rotation, and syringe injection speeds with controlled humidity and temperature allowed for the manufacture of strong, thin films with evenly cross-meshed, uniform low-diameter nanofibers (640 nm) that were flexible and absorbed over 600% in water. Chlorhexidine was encapsulated efficiently and released in a controlled manner. All formulations killed both bacteria and may be used to fill infected voids by swelling for intimate contact with surfaces and hold the drug in the swollen matrix for effective bacterial killing in dental settings. Full article
(This article belongs to the Special Issue Nanocarriers-Based Antimicrobial Drug Delivery)
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14 pages, 934 KB  
Article
Evaluation of Roasting and Grilling Effects on Chemical Composition, Volatile Profiles, and Toxicity of Stink Bugs (Tessaratoma papillosa): Implications for Utilization as Functional Food Ingredients
by Hua Li, Theeraphan Chumroenphat, Parinya Boonarsa, Jantana Yahuafai, Colin Wrigley and Sirithon Siriamornpun
Foods 2023, 12(16), 3053; https://doi.org/10.3390/foods12163053 - 15 Aug 2023
Cited by 10 | Viewed by 2666
Abstract
The stink bug (Tessaratoma papillosa) is a highly popular edible insect in Thai traditional cuisine, but little research has investigated the effects of heat treatment on the quality of stink bugs. Therefore, we aimed to evaluate the effects of roasting and [...] Read more.
The stink bug (Tessaratoma papillosa) is a highly popular edible insect in Thai traditional cuisine, but little research has investigated the effects of heat treatment on the quality of stink bugs. Therefore, we aimed to evaluate the effects of roasting and grilling on the chemical changes and volatile compounds of late nymph and adult stink bugs. In general, all treated samples showed increases in phenolic acid, tocopherols, and amino acid contents and a decrease in the content of fiber compared with raw stink bugs (p < 0.05). Cinnamic acid significantly increased by over 200% in late nymph insects and 30% in adult insects after roasting, whereas syringic acid decreased after cooking (p < 0.05). The most predominant volatile compound found in all samples was 5-methyl-octadecane and it decreased after cooking, while volatile alkane compounds increased after cooking. The processed sample extracts showed higher toxicity on oral cancer KB and cervical cancer Hela cells than on Vero cells. We have demonstrated that different cooking methods affected the chemical components which may result in quality attributes if stink bug is to be used as a functional ingredient/food. It may be helpful to improve the nutritional and functional values of stink bugs during deep processing. Full article
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9 pages, 421 KB  
Article
A Comparison of Slow Infusion Intermittent Feeding versus Gravity Feeding in Preterm Infants: A Randomized Controlled Trial
by Funda Yavanoglu Atay, Ozlem Bozkurt, Suzan Sahin, Duygu Bidev, Fatma Nur Sari and Nurdan Uras
Children 2023, 10(8), 1389; https://doi.org/10.3390/children10081389 - 15 Aug 2023
Viewed by 2823
Abstract
Background: The transition to full enteral feeding is important for ensuring adequate growth in preterm infants. Aims: The aim of this study was to investigate the effects of two different intermittent feeding methods on the transition to full enteral feeding in preterm infants. [...] Read more.
Background: The transition to full enteral feeding is important for ensuring adequate growth in preterm infants. Aims: The aim of this study was to investigate the effects of two different intermittent feeding methods on the transition to full enteral feeding in preterm infants. Study design: A prospective, randomized controlled study was conducted in a neonatology and perinatology center. Subjects: Preterm infants with a gestational age between 24 + 0/7 and 31 + 6/7 were included in this study. They were divided into two groups: the SIF (slow infusion feeding) group and the IBF (intermittent bolus feeding) group. In the SIF group, feed volumes were administered over one hour using an infusion pump through an orogastric tube, with feeding occurring every three hours. The IBF group received enteral feeding using a gravity-based technique with a syringe through an orogastric tube, completed within 10 to 30 min. Outcome measures: The primary outcome was the achievement of full enteral feeding and the occurrence of feeding intolerance. Results: A total of 103 infants were enrolled in the study (50 in SIF and 53 in IBF). The time to achieve full enteral feeding did not differ significantly between the two groups (p = 0.20). The SIF group had significantly fewer occurrences in which gastric residual volume exceeded 50% (p = 0.01). Moreover, the SIF group had a significantly shorter duration of non-per-oral (NPO) status than the IBF group (p = 0.03). Conclusions: It is our contention that the use of the SIF method as an alternative feeding method is appropriate for infants with feeding intolerance and those at high risk of feeding intolerance. Full article
(This article belongs to the Special Issue Infant Feeding: Advances and Future Challenges)
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16 pages, 4078 KB  
Article
In Vivo Toxicity Assessment of the Probiotic Bacillus amyloliquefaciens HTI-19 Isolated from Stingless Bee (Heterotrigona itama) Honey
by Fatin Aina Zulkhairi Amin, Mohamad Zulhafiz Shafiq Cheng, Suriana Sabri, Norsharina Ismail, Kim Wei Chan, Norhaizan Mohd Esa, Mohd Azmi Mohd Lila, Saulol Hamid Nur-Fazila, Shaden A. M. Khalifa, Hesham R. El-Seedi and Norhasnida Zawawi
Nutrients 2023, 15(10), 2390; https://doi.org/10.3390/nu15102390 - 19 May 2023
Cited by 4 | Viewed by 3312
Abstract
This study evaluated the acute and sub-acute toxicity of B. amyloliquefaciens HTI-19 (isolated from stingless bee honey) in female Sprague Dawley rats. In an acute toxicity study, the rats received a low dosage (1 × 109 CFU·mL−1), medium dosage (3 [...] Read more.
This study evaluated the acute and sub-acute toxicity of B. amyloliquefaciens HTI-19 (isolated from stingless bee honey) in female Sprague Dawley rats. In an acute toxicity study, the rats received a low dosage (1 × 109 CFU·mL−1), medium dosage (3 × 109 CFU·mL−1), or high dosage (1 × 1010 CFU·mL−1) of B. amyloliquefaciens HTI-19 daily orally by syringe-feeding for 14 days. For the subacute toxicity study, rats received a low dosage (1 × 109 CFU·mL−1) or a high dosage (1 × 1010 CFU·mL−1) for 28 days. The probiotic feeding in acute and sub-acute toxicity studies showed no mortality or significant abnormalities in rats throughout the experimental period. In week 2 of the acute study, the body weight of the rats showed a significant increase (p < 0.05) compared to the control. By gross and microscopic examination of organs, no evidently significant changes were observed in the morphology of organs. Serum biochemical tests and blood hematology tests also revealed no treatment-related changes. Overall, these data indicated that oral administration of B. amyloliquefaciens HTI-19 up to 1 × 109 CFU·mL−1 for 28 days can be considered safe. Full article
(This article belongs to the Section Nutrition and Public Health)
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13 pages, 3087 KB  
Article
Anti-Inflammatory Activity of Chlorogenic Acid on Macrophages: A Simplified Simulation of Pharmacokinetics Following Ingestion Using a Windup Syringe Pump
by Lei Cao, Won Han, Sang Gil Lee and Joong Ho Shin
Appl. Sci. 2023, 13(1), 627; https://doi.org/10.3390/app13010627 - 3 Jan 2023
Cited by 11 | Viewed by 3457
Abstract
Cell-culture-based drug tests are usually performed in an instantaneous delivery manner. However, in vivo pharmacokinetic studies have shown a steady increase in the concentration of bioactive compounds in the plasma following oral administration, with the maximum concentration observed after several hours. Here, a [...] Read more.
Cell-culture-based drug tests are usually performed in an instantaneous delivery manner. However, in vivo pharmacokinetic studies have shown a steady increase in the concentration of bioactive compounds in the plasma following oral administration, with the maximum concentration observed after several hours. Here, a novel palm-sized syringe pump powered by the manual winding of a spring was utilized for sustained delivery of chlorogenic acid (CHA) to lipopolysaccharide (LPS)-challenged RAW 264.7 macrophages over 2 h. When delivered in a sustained manner and simulating the in vivo pharmacokinetics following oral administration, CHA showed a stronger inhibitory effect on LPS-induced expression of inducible nitric oxide synthase and the transcription and secretion of pro-inflammatory cytokines, such as tumor necrosis factor-α. It also enhanced the mRNA expression of the gene encoding heme oxygenase 1. The suppression of phosphorylation of p38 but not the nuclear translocation of nuclear factor-κB was affected by the sustained delivery of CHA. High-performance liquid chromatography analysis indicated that the sustained delivery model showed a higher concentration of CHA in the conditioned medium two hours after starting the delivery. A stronger anti-inflammatory effect of CHA was observed upon sustained delivery to the cell medium, simulating an in vivo pharmacokinetic release profile following oral administration. Full article
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18 pages, 5199 KB  
Article
Acceptability of Multiparticulate Dosing Using Sympfiny® Delivery System with Children (Age 1–12)
by Kate Abeln, Kate Cox, Laura Haggerty and Mary Beth Privitera
Pharmaceutics 2022, 14(11), 2524; https://doi.org/10.3390/pharmaceutics14112524 - 19 Nov 2022
Cited by 1 | Viewed by 2133
Abstract
This study investigated multiparticulate formulation administered over a two-week period of time via the Sympfiny® system with children of ages 1–12 years. The study was conducted with parent–child pairs (N = 120 total participants) following a specific dose strategy to mimic PURIXAN’s [...] Read more.
This study investigated multiparticulate formulation administered over a two-week period of time via the Sympfiny® system with children of ages 1–12 years. The study was conducted with parent–child pairs (N = 120 total participants) following a specific dose strategy to mimic PURIXAN’s dosing guidelines based upon the child’s age. PURIXAN® (mercaptopurine) and Methotrexate have been identified as potential chemotherapy drugs that could benefit from reformulation into multiparticulate. Multiparticulate drugs have advantages as they can be flavorless, and do not require liquid reconstitution and do not require refrigeration. The study included three parts: initial in-person session, 14 days of at-home use, and a final in-person session. The in-person sessions were conducted at HS Design’s (HSD) (Morristown, NJ, USA) offices located in Morristown, New Jersey, where a study moderator captured and recorded all subjective comments by participants and observed device use to identify use errors. The participants were instructed to administer a dose (placebo) for the next 14 days and at each dose delivery to fill out a daily survey regarding their experience. Overall, the cumulative survey responses and feedback collected during the in-person sessions suggest that child participants ages 5–12 years old found multiparticulate to be an acceptable formulation and would be willing to take this medication if they were sick. Over time, more children ages 1–4 did not open their mouths; consistently around 15–20% of 1–4 years olds spat the placebo. However, approximately 95% of parents found the Sympfiny® system acceptable and indicated that they would use it to deliver medication to their child. Full article
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14 pages, 1218 KB  
Article
Overcoming Challenges in Pediatric Formulation with a Patient-Centric Design Approach: A Proof-of-Concept Study on the Design of an Oral Solution of a Bitter Drug
by John Dike N. Ogbonna, Edite Cunha, Anthony A. Attama, Kenneth C. Ofokansi, Helena Ferreira, Susana Pinto, Joana Gomes, Ítala M. G. Marx, António M. Peres, José Manuel Sousa Lobo and Isabel F. Almeida
Pharmaceuticals 2022, 15(11), 1331; https://doi.org/10.3390/ph15111331 - 27 Oct 2022
Cited by 15 | Viewed by 3574
Abstract
Designing oral formulations for children is very challenging, especially considering their peculiarities and preferences. The choice of excipients, dosing volume and palatability are key issues of pediatric oral liquid medicines. The purpose of the present study is to develop an oral pediatric solution [...] Read more.
Designing oral formulations for children is very challenging, especially considering their peculiarities and preferences. The choice of excipients, dosing volume and palatability are key issues of pediatric oral liquid medicines. The purpose of the present study is to develop an oral pediatric solution of a model bitter drug (ranitidine) following a patient centric design process which includes the definition of a target product profile (TPP). To conclude on the matching of the developed solution to TPP, its chemical and microbiological stability was analyzed over 30 days (stored at 4 °C and room temperature). Simulation of use was accomplished by removing a sample with a syringe every day. Taste masking was assessed by an electronic tongue. The developed formulation relied on a simple taste masking strategy consisting in a mixture of sweeteners (sodium saccharine and aspartame) and 0.1% sodium chloride, which allowed a higher bitterness masking effectiveness in comparison with simple syrup. The ranitidine solution was stable for 30 days stored at 4 °C. However, differences were noted between the stability protocols (unopened recipient and in-use stability) showing the contribution of the simulation of use to the formation of degradation products. Stock solution was subjected to acid and alkali hydrolysis, chemical oxidation, heat degradation and a photo degradation stability assessment. The developed pediatric solution matched the TPP in all dimensions, namely composition suitable for children, preparation and handling adapted to hospital pharmaceutical compounding and adequate stability and quality. According to the results, in-use stability protocols should be preferred in the stability evaluation of pediatric formulations. Full article
(This article belongs to the Special Issue Development of Medicines for Rare Pediatric Diseases)
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10 pages, 1323 KB  
Article
Effectiveness of 38% Silver Diamine Fluoride in Reducing Dentine Hypersensitivity on Exposed Root Surface in Older Chinese Adults: Study Protocol for a Randomised Double-Blind Study
by Alice Kit Ying Chan, Manisha Tamrakar, Chloe Meng Jiang, Yiu Cheung Tsang, Katherine Chiu Man Leung and Chun Hung Chu
Dent. J. 2022, 10(10), 194; https://doi.org/10.3390/dj10100194 - 19 Oct 2022
Cited by 9 | Viewed by 2698
Abstract
Background: Dentine hypersensitivity on an exposed root surface induces pain, affects daily oral hygiene practice, limits dietary choices and negatively affects quality of life. Silver diamine fluoride is marketed in the United States as a desensitising agent, but well-designed clinical trials are limited. [...] Read more.
Background: Dentine hypersensitivity on an exposed root surface induces pain, affects daily oral hygiene practice, limits dietary choices and negatively affects quality of life. Silver diamine fluoride is marketed in the United States as a desensitising agent, but well-designed clinical trials are limited. This study evaluates the anti-hypersensitivity effect of silver diamine fluoride on hypersensitive teeth due to an exposed root surface in older Chinese adults. Methods/design: We will conduct a randomised double-blind clinical trial with a sample size of at least 148 Chinese older adults aged 65 or above who have dentine hypersensitivity due to an exposed root surface. We will collect written consent before the study. A trained examiner will examine the participants’ teeth with a blast of compressed air from a 3-in-1 syringe. Those adults who report a self-perceived sensitivity score (SS) (0 to 10) of 8 or more on at least one tooth with an exposed root surface will be recruited. The recruited older adults will be randomly allocated into two groups using a block randomisation of six. Group 1 participants will receive the application of 38% silver diamine fluoride solution every 4 weeks. Group 2 participants will receive the application of 5% potassium nitrate solution every 4 weeks. Dietary advice, oral hygiene instruction and fluoride toothpaste at 1450 ppm will be provided to participants in both groups. The same trained examiner will perform follow-up examinations for the participants and determine the dentine hypersensitivity in SS of the most hypersensitive tooth (with the highest pre-treatment SS) immediately after the intervention and at 4-week and 8-week intervals. Discussion: There is no consensus on the standard of care for a professionally applied desensitising agent in older adults. This trial will provide evidence for clinicians to devise an effective dental care plan for older adults with dentine hypersensitivity. Trial registration: NCT05392868 Registered on 22 May 2022. Full article
(This article belongs to the Special Issue Preventive Dental Care, Chairside and Beyond)
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