Bioadhesive Gel Research Articles

Validation of Analytical Method for Vitamin A in Bioadhesive Ocular Cationic Nanoemulsion Loaded into Thermosensitive Gel Using RP-HPLC

Various test methods have been previously documented for determining vitamin A levels in different dosage forms. This study specifically examines an isocratic reverse phase-high performance liquid chromatography (RP-HPLC) method designed for the direct extraction of vitamin A. The objective is to validate an analytical method for quantifying vitamin A in bioadhesive cationic nanoemulsions incorporated into thermosensitive gels. The method employs isocratic RP-HPLC with a YMC-Triart C18 column (L1), dimensions of 4.6 mm × 250 nm, particle size of S-5 µm, and a UV detector at λ = 265 nm. The mobile phase consists of HPLC-grade methanol, acetonitrile, and n-hexane in a ratio of 46.5:46.5:7. Validation parameters were assessed including selectivity, linearity, accuracy, precision, limit of quantification (LOQ), and limit of detection (LOD). Correlation coefficients were determined with an R2 value of 0.9995 in the concentration range of 264–396 μg/mL (w/v). Recovery percentages ranged from 99.295% to 99.878%. Repeatability and intermediate precision relative standard deviations (RSD) were found to be 0.318% and 0.254%, respectively. The LOD was established at 2.018 μg/mL, and the LOQ was determined to be 6.114 μg/mL. The results affirm cost-effective and well-suited for the accurate measurement of vitamin A levels in bioadhesive thermosensitive gel formulations.

Creation and Expansion of Bioadhesive Transdermal Gel of Levobupivacaine Loaded Nanoparticles for Enhancement of Anesthetic Effect.

The present research work aimed to prepare a bioadhesive gel containing Levobupivacaine-loaded nanoparticles (NPs) to improve local anesthesia as transdermal patches were patient-friendly and easy to therapy. This study focuses on developing a The NPs were created using the ionotropic gelation method and assessed for particle charge, vesicle size and its distribution, and surface morphology. The improved NPs were incorporated into a gel and evaluated for their physicochemical assets. Among the NPs, NP4 was identified as the best based on its physicochemical properties. The NG-6 bioadhesive gel formulation stood out as the top gel among those tested. The NG-6 gel exhibited superior skin permeation ended 14 hours compared to other NPs. This bioadhesive transdermal gel with Levobupivacaine nanoparticles offers a promising approach to enhancing anesthetic effects.

Bioadhesive gel containing 5 % acyclovir for the treatment of herpes labialis: Preclinical development

Acyclovir is widely indicated for the treatment of herpes labialis, an infection typically caused by herpes simplex virus 1 (HSV-1). The standard treatment is based on the use of this antiviral in conventional topical semi-solid formulations (ointments, creams or gels), which have limitations such as low skin adherence and poor patient compliance. On the other hand, therapeutic bioadhesive gels (TBG) are semi-solid formulations that form a thin and transparent polymeric film in situ, displaying superior cosmetic attributes than conventional semi-solid forms and offering improved skin maintenance and patient compliance. In this study, a TBG containing 5 % of acyclovir was developed and characterized in terms of assay, impurities, appearance, pH, viscosity, particle size and morphology and microbiology count, complying with specifications. Stability studies showed that acyclovir-TBG was stable for at least 3 years under the experimental conditions carried out according to the International Council for Harmonisation (ICH) guidelines. Moreover, its cosmetic attractiveness and film-forming ability were considered positive and the in vitro penetration studies revealed a 23.8-fold increase in acyclovir retained percentage in the skin compared to the reference product Zovirax® (11.9 vs 0.5 % after 24 h, respectively). Finally, in vivo skin and ocular irritation studies as well as dermal tolerance studies did not show any negative sign in the macroscopic and microscopic examination. Thus, the proposed formulation could be a good and safe alternative for the topical treatment of lesions caused by HSV-1.

Comparison Between the Effects of Alvogyl Paste and 0.2% Chlorhexidine Gel on Postoperative Swelling Following Mandibular Third Molar Surgery

Facial swelling, pain, and trismus are typical side sequelae of mandibular third molar surgery. These symptoms are all caused by tissue inflammation followed by trauma from surgery and the quality of life of these patients has been significantly impacted by these symptoms in the immediate post-operative period. Both Alvogyl and chlorhexidine bio-adhesive gel are routinely used in dental practice to reduce post-operative sequelae due to their antimicrobial and anti-inflammatory properties. The study was set up as a randomized controlled clinical study and conducted from February 2022 to September 2022. The study involved patients 18-39 years old who sought extraction of an impacted lower third molar attending the Oral Surgery Clinic in the College of Dentistry in Baghdad. The sample was divided into three groups, the first group received Alvogyl paste following third molar surgery while the second group received periokin chlorhexidine bio-adhesive gel and the last control group didn’t receive any medication. Results of a study with 51 patients, equally assigned into two study groups and a control group, indicate that in the study groups, there was a reduction in post-operative facial swelling in comparison with the control group and the reduction was statistically significant (P =0.001), and the Alvogyl paste was superior to chlorhexidine in swelling reduction but statistically not significant.

Design and characterization of nano sponges loaded vaginal gels of Voriconazole

Objectives: The current inquiry of this research job is to build and analyze a bio adhesive vaginal gel that is packed with Voriconazole Nano sponge for an extended residence duration at the point of infection, resulting in a positive drug release profile. Methods: Nano sponges were created using a solvent evaporation process in varied Voriconazole to β-cyclodextrin ratios. Zeta possibility, polydispersity, size of particles analysis, capture efficiency, and surface morphology of Nao sponges are all determined using scanning microscopes with electrons (SEM). FTIR and DSC investigations were used to determine drug excipient compatibility. Carbopol/Hypromellose/Sodium Carboxymethyl cellulose/HPC has been used to make the bio adhesive gel, while both propyl paraben and a methyl para were employed as antioxidants. Triethanolamine, also was used to regulate the pH, resulting in a transparent gel. The gel base has been incorporated with the improved Voriconazole Nano sponge mixture. The pH, viscosity, spread ability, extrudability, and medication content of Nano sponge in mixes of gels were all investigated. The gel's in vivo diffusion has been examined on goat vaginal mucosal. Cellophane membranes was used in an artificial drug release examination. Results: The improved generation of IDLNS12 Nano sponge (drug-polymer ratio 1:1) demonstrated 91.56% entrapment efficiency. The average particle diameter of all formulations was less than 310 nm. The SEM photographs revealed smooth and spherical particles. INSG4 (Carpool and HPC) gel formulation had a viscosity value of 4529 cps at 2-10 RPM, a gel strength of 92.65N load, and an expansion speed of 37.24 g.cm/seconds. At 12.0 minutes, INSG4 achieved 99.98% drug release. And a mucous adhesive time of in excess of 12 hours. Conclusion: These results suggest that Voriconazole-loaded β-cyclodextrin Nano sponge in mucous adhesive gel might be used for managing infections of vagina perpetually.

Mucoadhesive Pharmacology: Latest Clinical Technology in Antiseptic Gels.

Chlorhexidine (CHX) is one of the most widely used antiseptics in the oral cavity due to its high antimicrobial potential. However, many authors have stated that the effect of CHX in nonsurgical periodontal therapy is hampered by its rapid elimination from the oral environment. The aim of this study was to determine the antibacterial efficacy of a new compound of chlorhexidine 0.20% + cymenol (CYM) 0.10% on a multispecies biofilm. For this, an in vitro study was designed using a multispecies biofilm model of Streptococcus mutans, Fusobacterium nucleatum, Prevotella intermedia, and Porphyromonas gingivalis. Quantification of the microbial viability of the biofilm was performed using 5-cyano-2,3-ditolyl tetrazolium-chloride (CTC) to calculate the percentage of survival, and the biofilms were observed using a a confocal laser scanning microscopy (CLSM). It was observed that the bactericidal activity of the CHX + cymenol bioadhesive gel was superior to that of the CHX bioadhesive gel, in addition to higher penetrability into the biofilm. Therefore, there was greater elimination of bacterial biofilm with the new compound of chlorhexidine 0.2% plus cymenol 0.1% in a bioadhesive gel form compared to the formulation with only chlorhexidine 0.2% in a bioadhesive gel form.

Multicentre prospective study to evaluate effectiveness and safety of gel-forming and hyaluronic-acid containing chewable tablets as add-on treatment in patients with gastroesophageal reflux disease (GERD) symptoms and unsatisfying proton pump inhibitor therapy

BackgroundGastroesophageal reflux disease (GERD) is a common disease which in the majority of patients is treated with proton pump inhibitors (PPI). However, up to 45% of the patients remain symptomatic on a standard dose of PPI. This study investigated the effectiveness and safety of an add-on therapy with the gel-forming chewable tablet Sobrade® in patients unsatisfied with PPI treatment. The bioadhesive gel covers the oesophagus and thereby protects the mucosa from reflux events.Methods47 patients with symptomatic GERD despite PPI treatment participated in this study. The gel-forming tablets were taken up to four times daily after meals and prior to bedtime. Severity and frequency of GERD symptoms were evaluated during two onsite visits prior and following 14 days of treatment and used to calculate the GERD score of the Reflux Disease Questionnaire. Furthermore, patients recorded symptoms as well as onset and duration of symptoms relief daily in their electronic dairies. Effectiveness of treatment was analysed using non-parametric paired Wilcoxon test. In addition, anchor-based minimal important differences (MID) were assessed.ResultsTreatment resulted in significant reduction of GERD symptoms. Severity and frequency of 8 of the 9 assessed symptoms improved significantly during the treatment phase whereby most pronounced improvement was observed for heartburn. In agreement, all three subscales of the GERD score improved significantly. MID results suggest that patients considered a mean improvement of symptoms > 30% of initial severity as beneficial. Self-assessments by patients revealed first significant improvements of symptoms like heartburn and regurgitation from day 5 of treatment onwards. 49% of patients reported relief of symptoms within 15 min which lasted on average for 3.5 h. During the study no treatment emergent adverse events were reported and in 98% of all cases tolerability of the product was rated as very good or good.ConclusionsThis study revealed a pronounced improvement of the symptoms after add-on treatment with the gel-forming medical device. The very good safety and tolerability profile indicate an advantageous risk-benefit ratio.Trial registrationThis non-interventional study was prospectively positively evaluated by the responsible ethic-committees.

Bio-adhesive Macroporous Hydrogels for In Situ Recruitment and Modulation of Dendritic Cells.

Biomaterials that enable in situ recruitment and modulation of immune cells have demonstrated tremendous promise for developing potent cancer immunotherapy such as therapeutic cancer vaccine. One challenge related to biomaterial scaffold-based cancer vaccines is the development of macroporous materials that are biocompatible and stable, enable controlled release of chemokines to actively recruit a large number of dendritic cells (DCs), contain macropores that are large enough to home the recruited DCs, and support the survival and proliferation of DCs. Bio-adhesive macroporous gelatin hydrogels were synthesized and characterized for mechanical properties, porous structure, and adhesion towards tissues. The recruitment of immune cells including DCs to chemokine-loaded bioadhesive macroporous gels was analyzed. The ability of gels loaded with granulocyte-macrophage colony-stimulating factor (GM-CSF) and tumor extracellular vesicles (EVs) to elicit tumor-specific CD8+ T cell responses was also analyzed. Here we develop a bioadhesive macroporous hydrogel that can strongly adhere to tissues, contain macropores that are large enough to home immune cells, are mechanically tough, and enable controlled release of chemokines to recruit and modulate immune cells in situ. The macroporous hydrogel is composed of a double crosslinked network of gelatin and polyacrylic acid, and the macropores are introduced via cryo-polymerization. By incorporating GM-CSF and tumor EVs into the macroporous hydrogel, a high number of DCs can be recruited in situ to process and present EV-encased antigens. These tumor antigen-presenting DCs can then traffic to lymphatic tissues to prime antigen-specific CD8+ T cells. This bioadhesive macroporous hydrogel system provides a new platform for in situ recruitment and modulation of DCs and the development of enhanced immunotherapies including tumor EV vaccines. We also envision the promise of this material system for drug delivery, tissue regeneration, long-term immunosuppression, and many other applications. The online version contains supplementary material available at 10.1007/s12195-023-00770-2.

Amelioration of acute radiation dermatitis in patients with breast cancer by a bioadhesive barrier-forming oral gel (Episil): A single-center, open, parallel, randomized controlled trial.

e12519 Background: Episil is a bioadhesive barrier-forming oral liquid gel that can relieve mucositis caused by radiotherapy (RT) and hence relieves pain effectively.The purpose of this trial is to compare the efficacy and safety of Episil in improving acute radiation dermatitis in breast cancer patients. Methods: Key eligibility criteria were as follows: Pathologically confirmed breast cancer; female ≥18 years of age; planning to receive postoperative radiation therapy; surgery with modified radical or breast-conserving surgery; fully healed surgical incision; intact skin in the irradiated area; KPS score ≥80; no severe endocrine or metabolic disease; voluntary participation and signed informed consent; ability to read and understand and good compliance. The primary endpoint was the grading of radiation dermatitis during treatment. Results: A total of 102 patients were included from January 2022 to December 2022. The patients were grouped in a 2:1 ratio by randomized number table method, 67 patients received Episil combined with conventional skin care and 35 patients served as the control group receiving conventional skin care only. Two patients in the Episil group dropped out halfway. According to the RTOG grading, the skin reaction rate and the degree were significantly better in the Episil group than control group (24.62%, 72.31%, 3.08, 0, 0 VS 0, 85.71%, 14.29%, 0, 0, 0) in the 0, 1, 2, 3 and 4 grades respectively (P<0.001). And the pruritus score was significantly lower in the Episil group than in the control group (P<0.05). The results of the EORTC QLQ-C30 Quality of Life Questionnaire showed that the overall health (P<0.05) and overall quality of life (P<0.05) were better in the Episil group than control group after radiotherapy. Relative to the control group, the Episil group produced significantly lower rates of stress, anxiety, and depression (P<0.05) and had less impact on family life and social activities (P<0.05). Most importantly, the Episil group produced fewer pain reactions after the end of radiotherapy. Conclusions: In breast cancer patients receiving radiotherapy, Episil may significantly reduce the grading of acute radiation dermatitis, reduce patient symptoms, and improve patient quality of life. Clinical trial information: ChiCTR2200059646 .

Clinical investigation of use of Episil® oral solution in oral mucositis during radiotherapy for head and neck cancer

ObjectiveEpisil® is a bio adhesive barrier-forming oral liquid gel that has been used in recent years to relieve pain of oral mucositis (OM) with radiotherapy (RT) or chemoradiotherapy (CRT) in head and neck cancer (HNC) patients. We conducted a retrospective analysis of the clinical effects of Episil® on OM in these patients. Study designBetween June 2018 and May 2020, 65 patients with HNC were treated with RT or CRT at our hospital. ResultsThe median total RT dose was 50 Gy (range, 30–70 Gy) and the completion rate was 63/65 (97%). The median time to OM resolution was 47 (6–90) days and was significantly longer (53 [27–90] days) when the total RT dose was ≥51 Gy (P < 0.001). Episil® was used in 26 patients. Among them, 10 discontinued its use due to ineffective pain relief, usage difficulties, and taste intolerance. The median duration of use was 30 days and was significantly longer (34.5 days) (P < 0.001) when patients experienced pain relief at treatment initiation. ConclusionAlthough Episil® has been shown to be effective in improving the pain of OM caused by RT for HNC patients, and medical professionals are required to give careful attention to each patient.

Biomimicry and 3D-Printing of Mussel Adhesive Proteins for Regeneration of the Periodontium-A Review.

Innovation in the healthcare profession to solve complex human problems has always been emulated and based on solutions proven by nature. The conception of different biomimetic materials has allowed for extensive research that spans several fields, including biomechanics, material sciences, and microbiology. Due to the atypical characteristics of these biomaterials, dentistry can benefit from these applications in tissue engineering, regeneration, and replacement. This review highlights an overview of the application of different biomimetic biomaterials in dentistry and discusses the key biomaterials (hydroxyapatite, collagen, polymers) and biomimetic approaches (3D scaffolds, guided bone and tissue regeneration, bioadhesive gels) that have been researched to treat periodontal and peri-implant diseases in both natural dentition and dental implants. Following this, we focus on the recent novel application of mussel adhesive proteins (MAPs) and their appealing adhesive properties, in addition to their key chemical and structural properties that relate to the engineering, regeneration, and replacement of important anatomical structures in the periodontium, such as the periodontal ligament (PDL). We also outline the potential challenges in employing MAPs as a biomimetic biomaterial in dentistry based on the current evidence in the literature. This provides insight into the possible increased functional longevity of natural dentition that can be translated to implant dentistry in the near future. These strategies, paired with 3D printing and its clinical application in natural dentition and implant dentistry, develop the potential of a biomimetic approach to overcoming clinical problems in dentistry.

Difference of Two Antiseptic Gels for the Treatment of Peri-Implant Mucositis on Plaque Index and Bleeding Score: A Randomized Controlled Clinical Study

Aim: To analyze and compare the effectiveness of two antibacterial gels in the treatment of mucositis. Methods: After signing the informed consent, in accordance with the Helsinki Declaration of 1975, revised in 2000, 21 patients were included in the study and divided by randomization into two groups. At the baseline, the modified bleeding index (mBI) and plaque index (PI) values were measured, and an oral hygiene and implant disinfection session was carried out. The session was repeated at 7, 15, and 30 days and after 2 and 3 months from the baseline. Two products were used—a bioadhesive gel in the test group and a 1% chlorhexidine gel in the control group. Results: Due to three dropouts, the final sample was composed of 18 patients. An improvement in periodontal indices was observed, similar to mBI and PI values, in both groups. There were no complications except for the appearance of pigmentations in the control group. Conclusions: The antibacterial power and effectiveness of the two gels are comparable. Considering the small sample size of the study cohort, further studies are needed to validate the results obtained from this pilot study.

Comparative Clinical Study Between Chlorhexidine Gel (0.2%) and Hyaluronic Gel (1%) in the Prevention of a Dry Socket After Tooth Extraction for Orthodontic Treatment.

Introduction Several articles have investigated the intra-alveolar applications of bioadhesive gels containing various medicines and active chemicals, such as chlorhexidine (CHX) and hyaluronic acid (HA) to minimize the numerous postoperative sequelae, such as a dry socket. The purpose of this study was to investigate the postoperative outcomes of intra-alveolar application of 0.2% chlorhexidine or hyaluronic acid following atraumatic extraction. Methods A randomized clinical trial was conducted on a sample of 36 patients who need extraction of lower first premolar for orthodontic treatment. The patients were assigned randomly into two groups: CHX group andHA group. The signs and symptoms of the dry socket were evaluated on the third day in two groups. Results There was no statistically significant difference between the study and control groups when comparing the CHX group (P=0.2.6). In contrast, a significant difference was seen between the study and control sides in the HA group. Conclusions Within the limitation of this clinical trial, using hyaluronic gel with a gelatin sponge may be a preventive strategy for a dry socket following tooth extraction. After non-surgical tooth extraction, the topical administration of CHX with a gelatin sponge as a carrier did not seem to act as a protective substance against a dry socket.

Water-Absorbing Bioadhesive Poly(Acrylic Acid)/Polyvinylpyrrolidone Complex Sponge for Hemostatic Agents.

Poly(acrylic acid) (PAA) is a water-soluble synthetic polymer with tissue-adhesive properties. When PAA is mixed with polyvinylpyrrolidone (PVP) in water, it forms a water-insoluble precipitate that neither swells nor adheres to tissues. We developed a novel solid/solution interface complexation method to obtain a water-swellable PAA/PVP complex. First, PAA solution was dried up in a vessel to form a film. The PAA film was then immersed in an aqueous PVP solution to obtain a highly swollen PAA/PVP hydrogel. Heat drying of the hydrogel yielded a transparent film, while freeze-drying the hydrogel provided a soft sponge. Both the PAA/PVP film and sponge could be re-swelled by water to obtain a bioadhesive gel. A relatively larger specific surface area of the sponge than that of the film led to a more rapid swelling and water absorption behavior and quick adhesion to tissues. The addition of hyaluronic acid (HA) improved the mechanical characteristics of the sponges. PAA/PVP/HA sponges had low cytotoxicity, and they exhibited high hemostatic efficiency in clinical studies after dialysis treatment or tooth extraction, even in patients on antithrombotic drugs. Such bioadhesive materials consisting of low-toxicity polymers have a high potential for use in medical hemostatic devices.

Bioadhesive Perivascular Microparticle-Gel Drug Delivery System for Intimal Hyperplasia Prevention: In Vitro Evaluation and Preliminary Biocompatibility Assessment.

Intimal hyperplasia (IH) is an undesirable pathology occurring after peripheral or coronary bypass surgery. It involves the proliferation and migration of vascular smooth muscle cells, leading to a reduction in the diameter of the vascular lumen, which can lead to stenosis and graft failure. Topically applied atorvastatin (ATV) has been shown to slow down this process. To be effective, the drug delivery system should remain at the perivascular site for 5-8 weeks, corresponding to the progression of IH, and be capable of releasing an initial dose of the drug followed by a sustained release. Ideally, bioadhesion would anchor the gel to the application site. To meet these needs, we encapsulated ATV in a 2-component system: a hyaluronic acid-dopamine bioadhesive gel for rapid release and biodegradable microparticles for sustained release. The system was characterized by scanning electron microscopy, rheology, bioadhesion on porcine arteries, and a release profile. The rheological properties were adequate for perivascular application, and we demonstrated superior bioadhesion and cohesion compared to the control HA formulations. The release profile showed a burst, generated by free ATV, followed by sustained release over 8 weeks. A preliminary evaluation of subcutaneous biocompatibility in rats showed good tolerance of the gel. These results offer new perspectives on the perivascular application towards an effective solution for the prevention of IH.

Design and Optimization of a Natural Medicine from Copaifera reticulata Ducke for Skin Wound Care.

In this study, we developed a bioadhesive emulsion-filled gel containing a high amount of Copaifera reticulata Ducke oil-resin as a veterinary or human clinical proposal. The phytotherapeutic system had easy preparation, low cost, satisfactory healing ability, and fly repellency, making it a cost-effective clinical strategy for wound care and myiasis prevention. Mechanical, rheological, morphological, and physical stability assessments were performed. The results highlight the crosslinked nature of the gelling agent, with three-dimensional channel networks stabilizing the Copaifera reticulata Ducke oil-resin (CrD-Ore). The emulgel presented antimicrobial activity, satisfactory adhesion, hardness, cohesiveness, and viscosity profiles, ensuring the easy spreading of the formulation. Considering dermatological application, the oscillatory responses showed a viscoelastic performance that ensures emulgel retention at the action site, reducing the dosage frequencies. In Vivo evaluations were performed using a case report to treat ulcerative skin wounds aggravated by myiasis in calves and heifers, which demonstrated healing, anti-inflammatory, and repellent performance for the emulsion-filled gel. The emulgel preparation, which is low in cost, shows promise as a drug for wound therapy.

Use of Chlorhexidine Bioadhesive Gel to Reduce Infection and Discomfort in Alveolar Bone Graft Wound: A Randomized Pilot Study

Use of Chlorhexidine Bioadhesive Gel to Reduce Infection and Discomfort in Alveolar Bone Graft Wound: A Randomized Pilot Study

Nature‐Derived Okra Gel as Strong Hemostatic Bioadhesive in Human Blood, Liver, and Heart Trauma of Rabbits and Dogs (Adv. Healthcare Mater. 18/2022)

Bioadhesives In article 2200939, Malcolm Xing, Shiming Yang, and co-workers report a robust hemostatic bioadhesive gel from okra. Okra gel is biocompatible and biodegradable. It promotes wound healing. The gel can activate platelets and release the coagulation factors XI and XII, which leads to a strong hemostatic efficiency. The okra gel shows efficay in treating the bleeding trauma model of the liver and the heart of rabbits and beagle dogs.

Formulation Design and Evaluation of Ornidazole Microsphere in a Bioadhesive gel for Local Therapy of Vaginal Candidiasis

The aim of present work is to design a novel vaginal drug delivery system composed of Ornidazole microspheres incorporated in a bioadhesive gel. Microspheres were prepared by solvent evaporation method by using Eudragit RS 100 and Eudragit RL 100 polymers with different drug/ polymer ratios. The microspheres were found to be discrete, spherical with free flowing properties and evaluated for particle size analysis, shape (SEM), drug entrapment efficiency, percentage drug loading, and in vivo drug release studies. The selected microsphere formulation (F7 and F8, containing drug polymer ratios 1:1:1 and 1:0.25:1.75 respectively) was incorporated in a bioadhesive carbopol 934P gel. The formulation (F8.ODZ-MG) which showed maximum of 91.03% release at 8h was then subjected to stability studies and antifungal activity. The antifungal activity of the F8.ODZ-MG and placebo gel was evaluated against Candida albicans 1012 by using cup plate method. This showed that ODZ-MG was capable to control the growth of Candida albicans for more than 14h. Placebo gel did not show any zone of inhibition. Stability studies were done as per ICH guidelines for a period of 6 months. Initial and third month studies were done and evaluated for parameters such as pH, drug content, drug content uniformity, extrudability, spreadability, viscosity and in vitro drug release. The results showed that there were no significant changes in the drug content and in vitro drug release. It may be concluded from the present study that ODZ-MG can be used as a novel delivery system for local therapy of vaginal candidiasis.

Efficacy and safety of a bioadhesive gel containing propolis extract, nanovitamin C and nanovitamin E on desquamative gingivitis: a double-blind, randomized, clinical trial

ObjectivesTo evaluate the efficacy of a gel-containing propolis extract, nanovitamin C, and nanovitamin E as adjuvants to professional plaque removal on desquamative gingivitis (DG).Materials and methodsA randomized clinical trial was conducted on patients suffering DG due to mucocutaneous diseases. Patients received professional supragingival prophylaxis with oral hygiene instructions and were randomly assigned to use test or control gels as toothpaste and to apply it on DG lesions 3 times/day for 4 weeks. DG clinical score (DGCS), clinical periodontal variables, and visual analog scale (VAS) for pain and oral health impact profile (OHIP-14) were collected at baseline, 2 and 4 weeks.ResultsTwenty-two patients were randomly assigned to test (n = 11) or control group (n = 11). Eighteen had diagnosis of oral lichen planus and four of mucous membrane pemphigoid. DGCS statistically decreased in both groups after treatment with no significant differences between groups. Clinical periodontal outcomes decreased in both groups, but no significant differences were observed. Periodontal variables statistically improved only in test group after treatment. VAS and OHIP-14 scores decreased in test and control groups without significant differences. However, only one test group showed a statistically significant decrease in VAS and OHIP-14 scores after treatment. No adverse effects were reported.ConclusionsTest gel may alleviate DG and improve quality of life without side effects.Clinical relevanceA gel-containing propolis extract, nanovitamin C, and nanovitamin E as adjuvants to mechanical debridement may improve both clinical and patient related outcomes in DG patients without side effects.Clinical trial registration.The study protocol was registered at clinicaltrials.gov with the following number: NCT05124366 on October 16, 2021.