The Current States, Challenges, Ongoing Efforts, and Future Perspectives of Pharmaceutical Excipients in Pediatric Patients in Each Country and Region

A major hurdle in pediatric formulation development is the lack of safety and toxicity data on some of the commonly used excipients. While the maximum oral safe dose for several kinds of excipients is known in the adult population, the doses in pediatric patients, including preterm neonates, are not established yet due to the lack of evidence-based data. This paper consists of four parts: (1) country-specific perspectives in different parts of the world (current state, challenges in excipients, and ongoing efforts) for ensuring the use of safe excipients, (2) comparing and contrasting the country-specific perspectives, (3) past and ongoing collaborative efforts, and (4) future perspectives on excipients for pediatric formulation. The regulatory process for pharmaceutical excipients has been developed. However, there are gaps between each region where a lack of information and an insufficient regulation process was found. Ongoing efforts include raising issues on excipient exposure, building a region-specific database, and improving excipient regulation; however, there is a lack of evidence-based information on safety for the pediatric population. More progress on clear safety limits, quantitative information on excipients of concern in the pediatric population, and international harmonization of excipients’ regulatory processes for the pediatric population are required

Gel meloksikama za topičku primjenu: In vitro i in vivo vrednovanje

Skin delivery of NSAIDs offers several advantages over the oral route associated with potential side effects. In the present investigation, topical gel of meloxicam (MLX) was formulated using N-methyl pyrrolidone (NMP) as a solubilizer and Carbopol Ultrez 10® as a gelling polymer. MLX gel was evaluated with respect to different physicochemical parameters such as pH, viscosity and spreadability. Irritation potential of MLX gel was studied on rabbits. Permeation of MLX gel was studied using freshly excised rat skin as a membrane. Anti-inflammatory activity of MLX gel was studied in rats and compared with the commercial formulation of piroxicam (Pirox® gel, 0.5 %, m/m). Accelerated stability studies were carried out for MLX gel for 6 months according to ICH guidelines. MLX gel was devoid of any skin irritation in rabbits. After 12 h, cumulative permeation of MLX through excised rat skin was 3.0 ± 1.2 mg cm2 with the corresponding flux value of 0.24 ± 0.09 mg cm2 h1. MLX gel exhibited significantly higher anti-inflammatory activity in rats compared to Pirox® gel. Physicochemically stable and non-irritant MLX gel was formulated which could deliver significant amounts of active substance across the skin in vitro and in vivo to elicit the anti-inflammatory activity.Primjena nesteroidnih protuupalnih lijekova na kožu ima nekoliko prednosti nad peroralnim načinom primjene uz koju se vežu određene nuspojave. U radu je opisana priprava gela meloksikama (MLX) za topičku primjenu. U pripravi gela korišten je N-metil pirolidon (NMP) kao otapalo i Carbopol ultrez 10® kao polimer za geliranje. Određivani su različiti fizikokemijski parametri kao što su pH, viskoznost i razmazljivost. Potencijalna iritacija MLX gela testirana je na kunićima, a svojstvo permeacije na svježim izrescima kože štakora. Protuupalno djelovanje praćeno je na štakorima i uspoređeno s registriranim pripravkom piroksikama (Pirox® gel, 0,5 % m/m). Testovi ubrzanog starenja MLX gela rađeni su tijekom 6 mjeseci prema ICH protokolu. Dobiveni rezultati ukazuju da MLX gel nimalo ne iritira kožu kunića. Kumulativna permeacija nakon 12 h bila je 3,0 ± 1,2 mg cm2, s odgovarajućem vrijednošću fluksa 0,24 ± 0,09 mg cm2 h1. MLX gel pokazao je značajno jače protuupalno djelovanje u odnosu na Pirox® gel. Pripravljeni gel je stabilan, ne iritira kožu, te in vitro i in vivo doprema kroz kožu ljekovitu tvar u dovoljnoj količini da ispolji protuupalno djelovanje

Co-infection associated with SARS-CoV-2 and their management

SARS-CoV-2 was discovered in Wuhan, China and quickly spread throughout the world. This deadly virus moved from person to person, resulting in severe pneumonia, fever, chills and hypoxia. Patients are still experiencing problems after recovering from COVID-19. This review covers COVID-19 and associated issues following recovery from COVID-19, as well as multiorgan damage risk factors and treatment techniques. Several unusual illnesses, including mucormycosis, white fungus infection, happy hypoxia and other systemic abnormalities, have been reported in recovered individuals. In children, multisystem inflammatory syndrome with COVID-19 (MIS-C) is identified. The reasons for this might include uncontrollable steroid usage, reduced immunity, uncontrollable diabetes mellitus and inadequate care following COVID-19 recovery

A CROSS-SECTIONAL STUDY EVALUATING THE ASSOCIATION OF PATIENT LITERACY WITH THE STAGE OF PENILE CARCINOMA

<p><strong>Background:</strong> Penile carcinoma is a rare and often late-diagnosed malignancy associated with advanced-stage presentation and poor prognosis. Health literacy, the ability to understand and apply health information, is crucial in healthcare-seeking behavior and early diagnosis.</p><p><strong>Methods:</strong> This cross-sectional study, conducted over 12 months at a tertiary care center, included 150 patients diagnosed with penile carcinoma. Patient literacy was categorized into four levels based on educational background. Data on demographic and clinical variables, such as age, smoking status, circumcision status, HPV infection, and the time to medical consultation, were collected. The TNM classification system was used to determine the disease stage.</p><p><strong>Results:</strong> Lower patient literacy levels were significantly associated with an increased likelihood of advanced-stage penile carcinoma presentation (p < 0.001). Patients with limited literacy, particularly those with "No Education," exhibited longer delays in seeking medical attention, contributing to the advanced stage at diagnosis. Additional factors, such as circumcision status and the time to medical attention, were also linked to disease stage.</p><p><strong>Discussion:</strong> This study underscores the critical role of health literacy, categorized into distinct educational levels, in penile carcinoma presentation. Patients with lower literacy levels face barriers to recognizing symptoms and seeking timely medical attention, ultimately resulting in advanced-stage diagnosis. The findings highlight the need for tailored health education and awareness campaigns, especially in communities with varying educational backgrounds.</p><p><strong>Conclusion:</strong> Patient literacy is associated with advanced-stage penile carcinoma presentation. Addressing disparities in health literacy and promoting awareness of penile carcinoma symptoms may enhance early diagnosis and treatment outcomes. The study emphasizes the multifaceted nature of cancer risk factors, underlining the importance of considering cultural and healthcare-related elements in future research and public health efforts.</p&gt

Polymeric nanoparticles for targeted treatment in oncology: current insights

Rashmi H Prabhu,1 Vandana B Patravale,1 Medha D Joshi2 1Department of Pharmaceutical Sciences and Technology, Institute of Chemical Technology, Mumbai, India; 2Department of Pharmaceutical Sciences, Chicago College of Pharmacy, Midwestern University, Downers Grove, IL, USA Abstract: Chemotherapy, a major strategy for cancer treatment, lacks the specificity to localize the cancer therapeutics in the tumor site, thereby affecting normal healthy tissues and advocating toxic adverse effects. Nanotechnological intervention has greatly revolutionized the therapy of cancer by surmounting the current limitations in conventional chemotherapy, which include undesirable biodistribution, cancer cell drug resistance, and severe systemic side effects. Nanoparticles (NPs) achieve preferential accumulation in the tumor site by virtue of their passive and ligand-based targeting mechanisms. Polymer-based nanomedicine, an arena that entails the use of polymeric NPs, polymer micelles, dendrimers, polymersomes, polyplexes, polymer–lipid hybrid systems, and polymer–drug/protein conjugates for improvement in efficacy of cancer therapeutics, has been widely explored. The broad scope for chemically modifying the polymer into desired construct makes it a versatile delivery system. Several polymer-based therapeutic NPs have been approved for clinical use. This review provides an insight into the advances in polymer-based targeted nanocarriers with focus on therapeutic aspects in the field of oncology. Keywords: polymeric nanoparticles, cancer, passive delivery, ligand-based deliver

Enzymatic synthesis of fructose ester from mango kernel fat

317-321Fructose ester as a biosurfactant was successfully synthesized from the fatty acid fraction (olein fraction) of Mango Kernel Fat (MKF). The synthesis was carried out by reaction of sugar and fatty acid fraction in presence of the enzyme lipase from Candida rugosa which acted as a biocatalyst. Phosphate buffer (pH 7.0) was used as the reaction medium to realise maximum enzymatic action. The product was separated from the reaction medium by liquid- liquid extraction. Maximum conversion (36.52 %) was achieved at fructose to olein fraction molar ratio of 1 : 10 (mol/L), with the lipase concentration of 4g/L, at a temperature of 30oC at the end of 3 days. The presence of an ester band in the synthesized ester was confirmed by Fourier Transform Infrared (FTIR) analysis. Identity of the product was further confirmed by NMR studies and a colour identity test for the ester group

Formulation and Evaluation of Exotic Fat Based Cosmeceuticals for Skin Repair

Mango butter was explored as a functional, natural supplement and active skin ingredient in skin care formulations. A foot care cream was developed with mango butter to evaluate its medicinal value and protective function in skin repair. Qualitative comparison and clinical case studies of the product were carried out. Wound healing potential of foot care cream was investigated on the rat excision and incision wound models. Results of the clinical studies demonstrated complete repair of worn and cracked skin in all the human volunteers. Furthermore, foot care cream exhibited significant healing response in both the wound models. The project work could be concluded as establishment of high potential for mango butter to yield excellent emolliency for better skin protection. Improving the product features and medicinal functionality further validate mango butter as a specialty excipient in development of cosmeceuticals and has an immense value for its commercialization