Development and validation of UV spectrophotometric method for estimation of naringenin in phytosomal formulation: interlaboratory comparison, capability, and statistical analysis.

The goal of the current work was to establish a simple, reproducible, and reliable UV spectrophotometric method for determining naringenin in phytosomal formulations. The solvent methanol was optimized and spectrophotometric analysis was carried out at 289 nm. The proposed method was also validated for linearity, specificity, accuracy, precision, ruggedness, and robustness in accordance with the International Council for Harmonisation (ICH). With a correlation coefficient of 0.9982, the concentration of naringenin in the range of 2-14 µg/ml follows Lambert-Beer rule. The accuracy ranged between 99.33 and 99.75%. The predicted percent recovery was found to be 99.48 ± 0.41. It was found that the limits of detection (LOD) and quantification were 0.54 µg/ml and 1.66 µg/ml, respectively. The normality of the data is accepted by the Shapiro-Wilk test (P = 0.9065) and Shapiro-Francia test (W = 0.9866). On the Bland-Altman plot, an acceptable repeatability coefficient was found. The remarkable inter-laboratory repeatability was proved by the Youden plot, which was also utilized to spot random and total errors. Levey-Jennings charts and other control diagrams have demonstrated that the method is statistically controlled. Greater values of Cp (1.03) and Cpk (0.83) were seen in the capability analysis, indicating that the method could analyze the samples reliably and consistently with minimum variation. The validation report demonstrated that the proposed method was appropriate for naringenin detection and analysis in phytosomal formulations, indicating that it can be employed for routine laboratory analysis as well.

Increasing Abnormal Involuntary Movement Scale (AIMS) Screening for Tardive Dyskinesia in an Outpatient Psychiatry Clinic: A Resident-Led Outpatient Lean Six Sigma Initiative.

Objective To increase compliance with Abnormal Involuntary Movement Score (AIMS) documentation for patients taking antipsychotics to recognize and treat tardive dyskinesia in the psychiatry outpatient clinic. Methods The Lean Six Sigma quality improvement (QI) model, utilizing DMAIC steps of define, measure, analyze, improve, control, was followed. Psychiatry attendings and residents were surveyed to assess reasons for AIMS non-documentation, and they ranked their preferred solutions to increase compliance. A random sample of patient charts for individuals on antipsychotic medications was obtained to determine AIMS documentation compliance prior to and following the implementation of improvements. Results The most highly ranked solution was implementing a one-hour AIMS training session. Three months post-intervention, a random sample of 60 patient charts showed that 87% (52/60) of patients had AIMS documented which was a significant increase compared to 3% (1/30) pre-intervention (p<0.001). Conclusion An annual, one-hour AIMS training session for residents improved rates of AIMS documentation.

Ozone disc nucleolysis in the management of herniated lumbar intervertebral disc: A retrospective analysis.

Background: Various minimally invasive surgeries were proposed for the management of herniated lumbar intervertebral disc. However, to choose optimal treatment modality to maximize patient benefit is a clinical challenge for the treatment givers. Objective: The objective was to study the role of ozone disc nucleolysis in the management of herniated lumbar intervertebral disc by retrospective analysis. Methodology: We conducted a retrospective analysis of patients of lumbar disc herniation treated by ozone disc nucleolysis during May 2007-May 2021. There were total of 2089 patients with 58% of males and 42% of females. The age ranged from 18 to 88 years. Outcome was measured on the Visual Analog Scale (VAS) and the Oswestry Disability Index (ODI) along with modified MacNab method. Results: The mean baseline VAS score was 7.73, which became 3.07 at 1 month, 1.44 at 3 months, 1.42 at 6 months, and 1.36 at 1 year. Similarly, the mean ODI index was 35.92 at baseline, which improved to 9.17 at 1 month, 6.14 at 3 months, 6.10 at 6 months, and 6.09 at 1 year. VAS score and ODI analysis was found to be statistically significant with P < 0.05. Modified MacNab criterion showed successful treatment outcome in 85.6% with excellent recovery in 1161 (55.58%), good recovery in 423 (20.25%), and fair recovery in 204 (9.77%). Mediocre or no recovery was seen in the remaining 301 patients amounting to a 14.40% failure rate. Conclusion: This retrospective analysis confirms that ozone disc nucleolysis is an optimally effective and least invasive treatment option for herniated lumbar intervertebral disc with a significant reduction in disability.

Nanostructured Lipid Carrier-Based Gel for Repurposing Simvastatin in Localized Treatment of Breast Cancer: Formulation Design, Development, and In Vitro and In Vivo Characterization.

Simvastatin (SMV) is noticed as a repurposed candidate to be effective against breast cancer (BC). However, poor solubility, dose-limiting toxicities, and side effects are critical hurdles in its use against BC. The above drawbacks necessitate the site-specific (localized) delivery of SMV via suitable nanocarriers. Therefore, the present study intended to develop SMV nanostructured lipid carrier (NLC)-based gel using carbopol-934 as a gelling agent to achieve local delivery and improve patient compliance while combating BC. The SMV NLCs were fabricated by melt-emulsification ultrasonication technique using stearic acid as solid lipid, olive oil (OO) as liquid lipid, tween 20 as a surfactant, and PEG-200 as a co-surfactant, and optimized by Box-Behnken design. The optimized SMV-loaded NLCs displayed % entrapment efficiency of 91.66 ± 5.2% and particle size of 182 ± 11.9 nm. The pH of NLC-based gels prepared using a 2.0% w/v of carbopol-934 was found in the range of 5.3-5.6 while the viscosity was in the range of 5.1-6.6 Pa.S. Besides, NLC-based gels exhibited higher and controlled SMV release (71-76%) at pH 6.8 and (78-84%) at pH 5.5 after 48 h than SMV conventional gel (37%) at both pH 6.8 and 5.5 after 48 h. The ex vivo permeation of SMV from NLC-based gel was 3.8 to 4.5 times more than conventional gel. Notably, SMV-loaded NLCs displayed ameliorated cytotoxicity than plain SMV against MCF-7 and MDA-MB-231 BC cells. No substantial difference was noticed in the cytotoxicity of NLC-based gels and pure SMV against both cell lines. The SMV NLC-based gel exhibited the absence of skin irritation in vivo in the mice following topical application. In addition, the histopathological study revealed no alteration in the mice skin anatomy. Furthermore, the SMV-loaded NLCs and NLC-based gels were stable for 6 months at refrigerator conditions (4°C ± 2°C). Thus, the present research confirms that NLC-based gel can be a safe, efficacious, and novel alternative to treat BC.

Ozone disc nucleolysis in cervical intervertebral disc herniation: A nonrandomized prospective analysis in 246 patients.

Background: Inherent complications associated with surgery and limited success of percutaneous minimally invasive procedures make researches wanting for an ideal treatment for cervical disc herniation. Objective: We prospectively study the role of ozone disc nucleolysis in cervical intervertebral disc herniation. Patients and Methods: From January 2008 to December 2020, we prospectively study 246 consecutive patients of cervical disc herniation treated by a single session of intradiscal injection of ozone-oxygen mixture (ozone disc nucleolysis). There were 55% of females and 45% of males. Age ranged from 28 to 68 years with a mean of 47. The outcome was measured on visual analog scale (VAS) scale and neck disability index (NDI) along with Mcnab method. Results: The mean baseline VAS score was 7.87 which became 3.09 at 1 month, 1.42 at 3 months, 1.40 at 6 months, and 1.35 at 1 year. The mean NDI was 36.27 at baseline which improved to 9.24 at 1 month, 6.25 at 3 months, 6.20 at 6 months, and 6.22 at 1 year. This was found to be significant with P < 0.05. Modified McNab criterion showed excellent recovery in 138 (56.10%), good recovery in 50 (20.32%), and fair recovery in 22 (8.94%), resulting in a successful rate of 85.36%. Mediocre recovery was seen in the remaining 36 patients amounting to a 14.64% failure rate. Conclusion: This study showed that ozone disc nucleolysis significantly reduces the pain related to cervical disc herniation along with a significant reduction in disability.

Comparative evaluation of the levels of nod-like receptor family pyrin domain-containing protein (NLRP) 3 in saliva of subjects with chronic periodontitis and healthy controls.

Context: Periodontitis is an inflammatory disease which is ubiquitous. When there is an onset of infection, the innate immunity gets activated followed by the adaptive immune system. Inflammasomes identify the pathogen-associated molecular patterns or danger-associated molecular patterns and initiate inflammation. Nod- like receptor family pyrin domain-containing protein 3 (NLRP 3) is a protein belonging to the intracellular innate immune sensors that act against bacteria. The inflammasome acts along with the toll-like receptor pathways to initiate an action against pathogens. NLRP3 (also known as PYPAF-1 or cryopyrin) acts via apoptosis-associated speck-like protein (ASC). Aims: The study aimed at finding out the relation between levels of NLRP3 in chronic periodontitis and healthy subjects via the enzyme-linked immunosorbent assay (ELISA). Settings and Design: This was a Cross-sectional study. Materials and Methods: Clinical examination and saliva sampling of the study population was done. Reagents were prepared and NLRP3 levels were estimated using ELISA analysis. Statistical Analysis: Intergroup comparison was initiated using the unpaired t-test and for within the group (intragroup), the two-way analysis of variance was used. The Pearson correlation coefficient helped to determine the strength of linear association. Results: Increased levels of NLRP3 were seen in subjects suffering from chronic periodontitis. NLRP3 was also seen to be positively correlated to probing pocket depth, clinical attachment loss, gingival index, and plaque index. Conclusions: A positive correlation exists between NLRP3 and chronic periodontitis, and hence, NLRP3 can be a potential biomarker.

Inhalation delivery of repurposed drugs for lung cancer: Approaches, benefits and challenges.

Lung cancer (LC) is one of the leading causes of mortality accounting for almost 25% of cancer deaths throughout the world. The shortfall of affordable and effective first-line chemotherapeutics, the existence of resistant tumors, and the non-optimal route of administration contribute to poor prognosis and high mortality in LC. Administration of repurposed non-oncology drugs (RNODs) loaded in nanocarriers (NCs) via inhalation may prove as an effective alternative strategy to treat LC. Furthermore, their site-specific release through inhalation route using an appropriate inhalation device would offer improved therapeutic efficacy, thereby reducing mortality and improving patients' quality of life. The current manuscript offers a comprehensive overview on use of RNODs in LC treatment with an emphasis on their inhalation delivery and the associated challenges. The role of NCs to improve lung deposition and targeting of RNODs via inhalation are also elaborated. In addition, information about various RNODs in clinical trials for the treatment of LC, possibility for repurposing phytoceuticals against LC via inhalation and the bottlenecks associated with repurposing RNODs against cancer are also highlighted. Based on the reported studies covered in this manuscript, it was understood that delivery of RNODs via inhalation has emerged as a propitious approach. Hence, it is anticipated to provide effective first-line treatment at an affordable cost in debilitating LC from low and middle-income countries (LMIC).

The antiplaque efficacy of lantibiotic Nisin extract mouthrinse.

AIM: This study aimed to determine the antiplaque efficacy of Nisin Z extract mouth rinse (Test) as compared to 0.2% chlorhexidine gluconate mouthrinse (Positive control) and distilled water (Placebo) and to assess minimum inhibitory concentrations (MICs) and minimum bactericidal concentrations (MBCs) of Nisin Z against Prevotella intermedia (Pi), Porphyromonas gingivalis (Pg), and Aggregatibacter actinomycetemcomitans (Aa) in vitro. MATERIALS AND METHODS: Forty-five individuals were randomly divided into three groups (15 in each group). The baseline plaque scores were brought to 0 with scaling and polishing. They were asked not to use any kind of mechanical oral hygiene aid for 4 days and advised to use mouthwashes A, B, or C (Group A: Nisin Z; Group B: distilled water; Group C: chlorhexidine) for 4 days. Following the 4-day plaque re-growth model, Plaque Index was checked on days 1 and 5. RESULTS: In intergroup comparison, a statistically significant difference was seen between Nisin and placebo groups and chlorhexidine and placebo groups, with Nisin and chlorhexidine showing superior antiplaque activity. There was also statistically significant difference between Nisin and chlorhexidine groups, with chlorhexidine showing superior antiplaque activity. In vitro Nisin showed effective inhibition against all three bacterial strains Pi, Pg, and Aa exhibited the highest sensitivity to Nisin with a MIC of 2.5 µg/ml and MBC of 15 µg/ml. CONCLUSION: Nisin Z mouthrinse was found to be a potent plaque inhibitor, though less effective than chlorhexidine mouthrinse. However, it can serve as a good natural alternative to the gold standard.

The effect of indocyanine green-mediated photodynamic therapy as an adjunct to scaling and root planing in the treatment of chronic periodontitis: A comparative split-mouth randomized clinical trial.

OBJECTIVE: The aim of this study was to assess the effect of adjunctive photodynamic therapy (PDT) (using 810 nm diode laser and Indocyanine green as photosensitizer) in chronic periodontitis. MATERIALS AND METHODS: Patients with untreated chronic periodontitis were included. Treatment was done according to a split mouth design. All sites received periodontal treatment comprising scaling and root-planing (SRP). Test group were additionally treated with PDT. Plaque Index (PI), Gingival Index (GI), Probing Pocket Depth (PPD) and Relative Attachment Level (RAL) were evaluated at baseline, 1 month and 3 months. RESULTS: Mean baseline values for PI, GI, PPD and RAL were not different in the test group and control group. Statistical significant difference in PPD and RAL, 3 months after treatment was seen in test group as compared to the control group. CONCLUSIONS: In patients with chronic periodontitis, clinical outcomes of conventional SRP can be improved by adjunctive PDT.

To compare the effect of the local delivery of hyaluronan as an adjunct to scaling and root planing versus scaling and root planing alone in the treatment of chronic periodontitis.

BACKGROUND: Hyaluronan is a critical component of the extracellular matrix and contributes significantly to tissue hydrodynamics and cell migration and proliferation. Studies have demonstrated its anti-inflammatory, antibacterial, and regenerative effects. The present study aimed to assess the clinical effects of the subgingival application of 0.8% hyaluronic acid gel as an adjunct to scaling and root planing (SRP) in the treatment of generalized chronic periodontitis. MATERIALS AND METHODS: Patients with chronic periodontitis were recruited to participate in a study with a split-mouth design and provided informed consent. One hundred sites were included in the study and divided into fifty test sites and fifty control sites. These were assessed for plaque index (PI), gingival index (GI), pocket probing depths, and relative attachment level (RAL) at-pretreatment (baseline), 4, and 12 weeks posttreatment. The patients received full-mouth SRP. A 0.8% hyaluronan gel was administered subgingivally in the test sites at baseline and after 1 week. Significant differences between test and control were evaluated using the t-test, analysis of variance (test) followed by Bonferroni post hoc test. RESULTS: A significant reduction in PI and GI was observed in both groups at 12 weeks (P < 0.05). Significant reduction in the pocket probing depths and gain RAL was observed in both the groups as compared to baseline (P < 0.05). The hyaluronan group compared to control at 12 weeks showed statistically significant reduction in the probing pocket depth and gain in RAL (P < 0.05). CONCLUSION: The subgingival application of 0.8% hyaluronan gel in conjunction with SRP may have a beneficial effect on periodontal health in patients with chronic periodontitis.

Attitudes of dental professionals toward tobacco use.

BACKGROUND: The habit of tobacco consumption has plagued all nations from time immemorial. While tobacco use is decreasing in many developed countries, it is increasing in developing countries like India. Health care professionals have a key role to play to motivate and advise tobacco users to quit. AIM: The aim was to assess the attitudes and practice of dental professionals in Mumbai and Navi Mumbai toward tobacco cessation and the potential barriers faced. MATERIALS AND METHODS: Questionnaire-based survey was conducted with 500 dental surgeons in Mumbai and Navi Mumbai. The questionnaire contained close-ended questions and assessed the smoking status of the professional, whether they impart tobacco cessation advice to their patients, whether the professional is trained for basic intervention, whether they would be eager to undergo training and also the potential barriers encountered by the professional. STATISTICAL ANALYSIS USED: The SPSS version 17 was used. Frequencies and percentages were used to determine distributions of the responses for each of the variables. Chi-square test was used for analysis. RESULTS: It was observed that the majority of dental clinicians do not use tobacco and although 93% believed that it is the role of the dental professional to offer advice, 21% do not. Potential barriers reported were: Little chance of success, lack of training, lack of time, lack of remuneration, and the possibility of losing patients. CONCLUSIONS: Dental professionals must expand their horizon and armamentarium to tobacco intervention strategies inclusive of their regular preventive and therapeutic treatment modalities. Furthermore, the dental institutions (schools) should include tobacco intervention in the curriculum, but it should not be just theoretical knowledge rather it must have a practical component.

Preparation and characterization of rivastigmine loaded human serum albumin (HSA) nanoparticles.

The aim of the present study was to develop and characterize rivastigmine loaded Human Serum Albumin (HSA) nanoparticles (NPs) for sustained release. Rivastigmine tartrate (RT) is a short acting cholinesterase inhibitor (ChEI) used for Alzheimer's disease (AD). In the present study sustained release nanoparticulate formulation of RT was prepared, optimized (using 32 factorial design) and characterized (using biodegradable polymer HSA as a carrier). HSA NPs were prepared by desolvation-crosslinking technique using ethanol with variable drug/polymer ratios (1:1, 1:2, 1:3, and 1:5) and using glutaraldehyde as a crosslinking agent. All prepared nanoparticles were coated with polysorbate-80 to facilitate brain targeting via endocytosis. Effect of key formulation variables on particle size (PS) and percentage drug entrapment (PDE) of NPs was studied by using 32 factorial design. Among different ratios studied, 1:2 showed minimum PS of 83.71 ± 4.2 nm with highest PDE of 81.46 ± 0.76 %. FTIR interpretation showed that there is no interaction between the drug and excipients used, DSC thermograms indicated that RT was dispersed as an amorphous state in HSA NPs. SEM studies indicated that the drug was completely entrapped in HSA NPs. In vitro studies showed 55.59 ± 3.80% release of drug from HSA NPs in 12 h. The experimental results showed the suitability of HSA nanoparticles as a potential carrier for providing sustained delivery of RT.

Implants in adolescents.

Implants have gained tremendous popularity as a treatment modality for replacement of missing teeth in adults. There is extensive research present on the use of implants in adults, but there is a dearth of data available on the same in adolescents. The treatment planning and execution of implant placement in adolescents is still in its infancy. This review article is an attempt to bring together available literature.

Familial progressive hyperpigmentation: a case report.

Familial progressive hyperpigmentation (FPH) is a rare genodermatosis characterized by hyperpigmented patches in the skin and mucous membranes, present in early infancy, and increase in size and number with age. The genetic basis for FPH remains unknown. We report an unusual case of familial progressive hypermelanosis in a 17-year-old male patient with family history, who presented with a peculiar progressive oral pigmentation disorder. Diagnosis was confirmed by a series of hematological, biochemical, and histopathological investigations. Our paper stresses the need for the dentist to be aware of the systemic conditions that can also manifest in the oral cavity.

Preparation and evaluation of aceclofenac topical microemulsion.

A topical preparation containing aceclofenac was developed using an o/w microemulsion system. Isopropyl myristate was chosen as the oil phase as it showed a good solubilising capacity. Pseudo-ternary phase diagrams were used to obtain the concentration ranges of the oil, surfactant (Labrasol) and co-surfactant (plurol oleique) for microemulsion formation. Five different formulations were formulated with various amount of the oil (5-25%), water (10-50%), and the mixture of surfactant and co-surfactant at the ratio of 4 (45-65%). In vitro permeability of aceclofenac from the microemulsions was evaluated using Keshary Chien diffusion cells with 0.45-µm cellulose acetate membrane. The amount of the aceclofenac permeated was analyzed by HPLC and the droplet size and zeta potential of the microemulsions was determined using a Zetasizer Nano-ZS. The mean diameters of the microemulsion droplets approximately ranged between 154 - 434 nm, and the permeability of aceclofenac incorporated into the microemulsion systems was 3 folds higher than that of the marketed formulation. These results indicate that the microemulsion system studied is a promising tool for percutaneous delivery of aceclofenac.

Pentoxifylline, Ciprofloxacin and Dexamethasone Improve the Ineffective Hematopoiesis in Myelodysplastic Syndrome Patients; Malignancy.

Twenty-five patients with a diagnosis of myelodysplastic syndromes (MDS) were randomized to either begin therapy with pentoxifylline, ciprofloxacin and dexamethasone (PCD) immediately (10 patients) or after a 12 week observation period (control arm, 15 patients). PCD was administered with the goal of suppressing cytokine-induced excessive intramedullary apoptosis of hematopoietic cells. No marked fluctuations of blood counts were noted during the period of observation. Twenty-two patients completed at least 12 weeks of therapy: 18/22 showed some type of hematologic response, 9/18 showing an improvement in absolute neutrophil count only (p = < 0.001) and 9/18 showing multi-lineage responses. No unique category of MDS responded better, however 19/25 patients had refractory anemia (RA)/RA with ringed sideroblasts. The median time to response was 6 weeks and 3/18 responding patients maintained their responses beyond a year. We conclude that hematologic improvement in response to PCD therapy supports the validity of this unique anti-cytokine approach. Future trials should combine PCD therapy with established approaches (growth factors/chemotherapy) and also should focus on identifying more effective ways of suppressing the pro-apoptotic cytokines in MDS.