Journal of Drug Delivery and Therapeutics (JDDT)
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Formulation, Optimization and Characterization: Thermosensitive Intranasal Nanostructured Lipid Carrier (NLC) In-situ Gel of Novel Agomelatine to Overcome the Limitations of Oral Delivery
Get PDFAgomelatine (AG), the first-in-class melatonergic antidepressant used in Major Depressive Disorder (MDD), belongs to BCS Class-II with low oral bioavailability (<5%) due to extensive hepatic metabolism. This research work developed a thermosensitive in-situ gel using nanostructured lipid carriers (NLC) for intranasal delivery as alternate route, aiming to bypass hepatic metabolism, enable controlled release, and enhance cerebral distribution. FTIR ensured compatibility with lipids, surfactants and polymers. AG-NLCs were synthesized utilizing hot high-speed homogenization with 5 mg agomelatine dose and optimized with 32 factorial design with total lipids (Precirol® ATO 5:Oleic acid – 70:30) and surfactant concentration (% of Poloxamer 188) as independent two-factor variables. The optimized AG-NLC (AF8) showed particle size of 159.3 nm, zeta potential of -37.0 mV, and 58.14% entrapment efficiency. AF8 was further fabricated into in-situ gels using thermosensitive polymer Poloxamer 407 and sodium alginate as mucoadhesive polymer, with NLCG-4 (with 8% Poloxamer 407) as the optimized in-situ gel formulation. NLCG-4 had 95.16±0.90% drug content, excellent viscosity (1690.65 ±0.40 cP at 37℃), and gelled at 33.24±0.11℃ in 10.3±0.38 seconds, ideal for nasal mucosa. NLCG-4 exhibited a complete, prolonged release of 100.01±0.2% over 6 h, and SEM images confirmed spherical particles without aggregation. The above findings suggest that thermosensitive NLC in-situ gel could be a potential novel approach for enhanced direct nose-to-brain delivery of agomelatine, bypassing first-pass metabolism to treat depression. Further in vivo investigations are ongoing to establish and justify clinical applicability of the novel system.
Keywords: thermosensitive, in-situ gel, NLC, agomelatine, major depressive disorder, intranasal delivery, Design Expert, poloxamer 407
Gum Arabic: Can it replace sodium fluoride in toothpaste? “Comparison of their antibacterial activity against Streptococcus mutans”
Get PDFBackground: The effectiveness of fluoride in caries prevention isenhanced by its ability to reduce demineralization, promote remineralization, and antibacterial properties against streptococcus mutans. Interestingly, Gum Arabic has a remineralization effect similar to that of sodium fluoride.
Objectives: This study aimed to investigate the antibacterial activity of Gum Arabic processed by two methods against Streptococcus mutans and compare it to the antibacterial activity of various concentrations of sodium fluoride in order to compare their caries prevention capability.
Design: Antibacterial susceptibility tests for 200mg ethanolic extracts of mechanically ground and spray-dried Gum Arabic, as well as sodium fluoride at concentrations of 0.05% and 1.23% against S. mutans (ATCC 25175) were performed using the agar disc diffusion method. Chlorhexidine and Antibiotic multi-disc for gram-positive bacteria were used as positive controls, while ethanol 20% as a negative control. The diameters of the inhibition zones were measured for all the materials under investigation.
Results: The diameters of the inhibition zones of the spray-dried and the mechanically ground Gum Arabic were (10.67 mm & 9.67mm), respectively, almost approximating each other. In comparison, sodium fluoride (0.05% wash and 1.23% gel) showed inhibition zones of diameters (0mm& 2.33mm), respectively.
Gum Arabic, with both processing methods, exhibited significantly higher antibacterial activity against S. mutans than sodium fluoride (0.05%, 1.23%)
Conclusion: Gum Arabic, either mechanically ground or spray-dried, is a partially active antibacterial against S. mutans. Gum Arabic is a more potent antibacterial against S. mutans than sodium fluoride.
Keywords: Gum Arabic, Anti-caries, Sodium fluoride, Streptococcus mutans, Antibacterial activit
Gels Containing Poloxamer 407 and Sodium Alginate as Vehicles for Vaginal Administration
Get PDFSodium alginate and poloxamer 407 were both studied in order to design a hydrogel-based delivery system as a platform for the formulation of vaginal medecines. Sodium alginate is a natural anionic mucoadhesive polymer while poloxamer 407 is a temperature-sensitive polymer. A commercial alginate was characterized. Then, its solutions (0.5-2 % w/w), poloxamer 407 solutions (16-21.5 % w/w) and their mixtures were prepared. Their rheological properties and the influence of vaginal simulated fluid were assessed. This commercial alginate had a mannuronate-to-guluronate ratio of 1.24, a weight-average molecular weight of 300 000 ± 2% g.mol-1, a polydispersity index of 1.8 ± 3%. Alginate solutions displayed a viscous behavior not suitable for a vaginal administration. Poloxamer solutions and their mixtures with alginate were temperature-sensitive, shear-thinning, non-thixotropic and had an elastic behavior suitable for a vaginal administration. Their resistance to dilution with vaginal fluid could prolonge vaginal residence.
Keywords: Formulation, poloxamer 407, rheology, sodium alginate, temperature–sensitive, vaginal fluid, viscoelastic properties
A Traditional Review: The Utilization of Nutraceutical as a Traditional Cure for the Modern World at Current Prospectus for Multiple Health Conditions
Get PDFNutraceuticals refer to food products that have a positive impact on the well-being of individuals. This category includes dietary supplements, herbal products, probiotics, and prebiotics, as well as medical foods designed for disease prevention and treatment. The nutraceutical market is witnessing substantial growth worldwide, primarily due to the growing awareness among consumers about the connection between diet and health. Additionally, there is a rising demand for functional foods and dietary supplements. As consumers prioritize preventive healthcare, they are increasingly looking for products that provide targeted health benefits beyond basic nutrition. The rise of this trend can be attributed to various factors, including the aging population, rising healthcare expenses, and a preference for natural and organic ingredients. Nutraceuticals, as a major force in the industry, offer numerous beneficial effects with minimal undesirable impacts, thus attracting more consumer interest. The increasing shift towards preventive treatments, along with the growth in disposable income and a positive market outlook for the pharmaceutical sector, has primarily contributed to the expanding nutraceutical market in India. However, challenges such as the lack of regulation and awareness, high pricing, marketing, and distribution issues need to be addressed. Nutraceutical market is seeing flowing development chiefly in United States, India, and European nations. This review article primarily focuses on providing a concise overview of nutraceuticals, categorizing them, and discussing their significant roles in various health conditions. Additionally, it delves into the present and future status of nutraceuticals on a global scale.
Keywords: traditional cure; nutraceuticals; remedy; prebiotics; probiotics; regulatory compliance; supplementary diets; nutraceutical ingredients
Hepatitis Screening in Community Pharmacies as a Measure of Reducing the Rate of Infections
Get PDFThe burden of dealing with HBV and HCV still remain despite the progress that has been made in screening, vaccination, and treating the infections. On average, there about 354 million cases of hepatitis globally. Hepatitis has high mortality rates. On average, 1.1 million people lose their lives to the infections each year. Addressing hepatitis requires rigorous measures one of them being increasing screening. Hepatitis infections are identified through screening. As such, screening and taking the right preventative and treatment measures can help to reduce the risk of infections. However, screening is still a challenge. The number of people who screen for hepatitis remains low despite the efforts that have been put in place to increase uptake. The uptake of screening is low because of inadequate access to screening centers. Thus, increasing screening settings can help to increase uptake. Community pharmacies can help to bridge this barrier by making screening more accessible. They are accessible and in close proximity to vulnerable populations, which makes them ideal as screening settings. This review explores the potential of community pharmacies as screening settings for HBV and HCV and whether they can help to reduce the rate of infections.
Keywords: screening, hepatitis B, hepatitis C, community pharmacie
UV Spectrophotometric Method Development and Validation of Butorphanol Tartrate in Bulk Drug and Pharmaceutical Formulation
Get PDFThe present research work discusses the development and validation of a UV spectrophotometric method for butorphanol tartrate. Simple, accurate and cost efficient spectrophotometric method has been developed for the estimation of butorphanol tartrate in tablet dosage form. The optimum conditions for the analysis of the drug were established. The maximum wavelength (λ max) was found to be 278nm. The percentage recovery of butorphanol tartrate was in the 100.016±0.68. Beers law was obeyed in the concentration range of 2-12μg/ml. Calibration curves shows a linear relationship between the absorbance and concentration. The line equation y = 0.0674x - 0.0057 with r2 of 0.9998was obtained. Validation was performed according to ICH guidelines for linearity, accuracy, precision, LOD and LOQ. The sample solution was stable up to 36 hours. The proposed method may be suitable for the analysis of butorphanol tartrate in tablet formulation for quality control purposes.
Keywords: Butorphanol tartrate, Validation, Precision, Accuracy, LOQ, LOD, ICH guidelines
A Study on Impact of Self Medication in Adults and Paediatrics in COVID-19 Pandemic
Get PDFBackground: Self-medication is defined as the use of medicinal products by the consumer to treat self-recognized disorders or symptoms, or the intermittent or continued use of a medication prescribed by a physician for chronic or recurring diseases or symptoms, which often is accompanied by potential risks to the consumers, including toxicity, therapeutic failure and drug-drug as well as drug-food interactions. The practice of self-medication has exponentially risen during the Covid-19 pandemic due to fear of visiting healthcare setups and subsequently contracting infections.
Aim: The present study aims to determine the prevalence of self-medication in adults and pediatric patients during Covid-19. settings and Design: A cross-sectional community-based survey study was conducted among 556 participants, including pediatric and adult populations, for a period of 6 months, through an online platform.
Methods and Material: The data was collected using a self-administered questionnaire, which included informed consent, questions on patient demographics and self-medication practices, and plausible reasons for it. The collected data was analyzed using SPSS 22.0, and R environment ver.3.2.2 software.
Results: Out of 556 participants the prevalence of self-medicating with paracetamol was considered to be high both in adults and paediatrics which was found to be 72.6% (319) and 66.6% (117) respectively. During Covid-19 symptoms, it was reported that Azithromycin consumption was found to be more than paracetamol. It also showed that 62.9% (439) were self-medicating before the Covid-19 pandemic and 20.5 % (439) were not aware of the risks associated with self-medication. The major source of self-medication was found to be Google (46.5%) followed by using old prescriptions (121.5%) and using family or friends’ prescriptions (10.9%).
Conclusions: The study showed a conclusive rise in self-medication practices during the Covid pandemic among the SM-naïve population.
Keywords: Self-medication, Prevalence, Prescription, Covid-1
The pattern of cardiovascular disease in River Nile State (October 2019-April 2020)
Get PDFBackground: The rise of cardiovascular diseases poses a significant global threat, not only in terms of morbidity and mortality but also due to their substantial economic burden. Understanding the specific patterns of CVDs within various populations is crucial for effective prevention, early diagnosis, and management.
Objective: This study aimed to determine the pattern of cardiovascular disease using echocardiography in River Nile State.
Methods: This prospective cross-sectional hospital-based study conducted from October 2019 to April 2020 aimed to ascertain the pattern of cardiovascular diseases using echocardiography in River Nile State. A sample of 1000 participants from Atbara Teaching Hospital, Atbara Complex, and Shendi Teaching Hospital was included. The study population comprised all Sudanese patients undergoing echocardiography in the region. Inclusion criteria involved patients presenting for echocardiography who consented to participate, while refusal to participate constituted exclusion criteria. Data collection involved obtaining written consent from patients and recording echocardiographic findings, including age, gender, and patterns of heart disease, using standardized data sheets.
Results: The findings revealed a mean age of 72±6.8 years, with females comprising 64.7% of the sample. Hypertensive heart disease (31.5%) and valvular lesions (29.8%) emerged as the most prevalent cardiovascular diseases. Ischemic heart disease (11.2%), rheumatic heart disease (8.3%), and cardiomyopathy (5.7%) were also notable. Patterns of cardiovascular diseases showed significant associations with age and gender, with hypertensive heart disease and valvular lesions more prevalent in older age groups, while congenital heart disease was more prevalent among younger individuals (20–40 years).
Conclusion: The study revealed that hypertensive heart disease (31.5%) and valvular lesions (29.8%) as the dominant CVD patterns. Focusing on these conditions with tailored prevention, early diagnosis, and management is crucial, especially for older individuals.
Keywords: Cardiac diseases, Comorbidity, Nile State, Pattern
Formulation Development of Medicated Chewing Gum by Direct Compression utilizing the SeDeM Diagram Expert System
Get PDFThe main objective of this study was to prepare and characterize the MCG of Ondan HCl which helps to improve the effectivity of the drug and to investigate the applicability of the SeDeM system for the formulation of MCG. The Ondan HCl was formulated into directly compressed MCG utilizing the SeDeM Diagram Expert System. The MCG was optimized using 32 factorial design. Performance evaluation was carried out by evaluating different parameters. Statistical analysis showed that micromeritic properties were improved after inclusion of appropriate excipient in optimum amount. In-vitro drug release study showed 90.01% drug release whereas ex vivo buccal permeation study exhibited significant drug permeation within 15 min indicating its potential for increasing bioavailability. It was concluded that various characteristics of powder material at pre formulation level can be successfully predicted by SeDeM diagram expert system. The developed medicated chewing gum is more effective than mouth dissolving and conventional tablet formulation.
Keywords: Ondansetron HCl; Medicated chewing gum; direct compression; SeDeM diagram expert system
Development and optimization of Lamotrigene containing Liposomal Transdermal Patches
Get PDFAntiepileptic drugs are generally available as tablets for oral administration, but this can pose problems for patients who are unable to consume medications orally. Transdermal drug delivery is useful in such cases. There is therefore an unmet need for enhancement techniques with the potential of delivering high dose medications across the skin. The transdermal route of drug administration ensures systemic delivery of drug by applying a drug formulation onto intact as patch on healthy skin thus ensuring sustained drug release and bypass of first-pass metabolism. Transdermal drugs significantly deliver molecules in a potent quantity that overcome the conventional problems of oral dosing. Thus, the objective of the proposed study is to develop lamotrigene-loaded transdermal patch an effective substitute for the existing maintenance therapies used for controlling epileptic seizures. We embarked on the transdermal delivery of lamotrigene upon this scientific basis.
Keywords: Lamotrigene, Antiepilepsy, Transdermal patch, Liposomes, Vesicular syste