Efficacy of Herbal Medicine Administration using Neem (Azadirchta indica L) Leaves as Case Study

Plants used for treatment of diverse ailments primitively are concocted and used indiscriminately. The efficacy of "Herbal medicine" which is an ancient tradition, used in some parts of Nigeria was investigated to establish herbal applications of Neem (Azadirachta indica) leaves. Neem leaves (Azadirachta indica) was popularly recognised for the treatment of malaria fever. The leaves were plucked at appropriate peak period of the day when oil and moisture contents were recorded maximum. The peak period of contents was found to occurred between 8am-10am on a very sunny days, 10am to 12 on cool days, and 3:00pm to 5:00pm on cloudy days. Aqueous extract from macerated Neem leaves was subjected to qualitative and quantitative analysis. Available phytochemicals evaluated include; saponin (34.89mg/g), tannin (31.715mg/g), flavonoid (31.835mg/g), phenol (43.59mg/g), terpernoid (14.585mg/g), cardiac glycosides (39.335mg/g), steroid (16.185mg/g) and alkaloid (28.76mg/g). These values differ significantly to recommended oral dosage formulation for human consumption: Saponin (1.433ml), Tannin (1.418ml), Flavonoid (13.91ml), Phenol (2.29ml), Terpernoid (8.23ml), Cardiac Glycosides (0.003177ml), Steroid (0.62mg/g). Consequently, local consumption of herbal resources should be regulated to avoid abuse and long or short-term effects of drug contents as proven in the neem leaves as local herbs.

A Validated Reversed-Phase HPLC Analytical Method for the Analysis of Fenofibrate in Bulk Drug and Tablet Dosage Formulation

Aims: A accurate, precise, and stability-indicating Reversed-Phase HPLC technique has been established for the estimation of fenofibrate in tablet formulation. Study Design: Experimental study. Place and Duration of Study: Department of Pharmaceutical Sciences, RTM Nagpur University, Nagpur-440033, Maharashtra, India between June 2019 and March 2020. Methodology: The chromatographic separation was attained on RP Princeton column (C18) (250 mm x 4.6 mm, 5 µ) with mobile solvent system as a mixture of water (pH 3.0 along o-phosphoric acid) and acetonitrile in the proportion (40:60) v/v, flow rate 1.0 ml per minute, at 240 nm. The retention time of fenofibrate was 3.905 minutes. Results: The method demonstrated linearity in the concentration range of 87-232 µg/ml with a coefficient of correlation (r2) of 0.9994. The % RSD was ˂2% and percentage recovery was found to be 99.13-100.74%. The assay of marketed tablet formulations was found to be 99.98%. Conclusion: The developed and validated technique as per ICH rules for specificity, accuracy, precision, linearity, and system suitability. Reverse Phase-HPLC technique was utilized to the market formulation.

UV Spectrophotometric Method Development and Validation of Luliconazole in Bulk and Formulation

Objective: A new, simple, economical, sensitive, precise and reproducible UV visible spectrophotometric method was developed for the estimation of luliconazole in pure form and pharmaceutical formulation as per ICH guidelines. Method: A UV spectrophotometric method has been developed using methanol and water as solvent to determine the luliconazole in bulk and pharmaceutical dosage formulation. The λmax of luliconazole in methanol and water was found to be 297nm. Results: The drug was proved linear in the range of 3-15µg/ml and exhibited good correlation coefficient (R2= 0.9993) and excellent mean recovery (98-99%). The % RSD for intra-day and inter-day precision was found to be 1.051288 and 1.138658 respectively. The LOD and LOQ of Luliconazole was found to be 1.1168µg/ml and 3.3845µg/ml respectively. This method was successfully applied to luliconazole content in marketed brands and results were in good agreement with the label claims. Conclusion: The method was validated for linearity, precision, repeatability and reproducibility. The obtained results proved that the method can be employed for the routine analysis of luliconazole in bulks as well as in commercial formulations.

A Validated Reversed-Phase HPLC Analytical Method for the Analysis of Rosuvastatin Calcium in Bulk Drug and Tablet Dosage Formulation

Aims: The current research work has desired the validated reversed-phase analytical technique for the assurance of rosuvastatin calcium in bulk and tablet formulation. Study design: Experimental research work. Place and duration of study: UDPS, RTM Nagpur University, Nagpur, Maharashtra State, India between June 2019 and March 2020. Methodology: The segregation was obtained on a reversed-phase Princeton (C18) column with dimensions (250mm × 4.6mm, 5μ). The solvent system employed was a mixture of buffer, and methanol in the proportion (20:80) v/v, flow rate one ml per minute. Detection wavelength at 240 nm. The retention time (RT)beneath the developed chromatographic condition was found to be 2.848 minutes for rosuvastatin calcium. Results: The technique indicates linearity within the range of 2-16 µg per ml with a correlation coefficient (r2) is 0.9999. The analysis of marketed tablet formulations was erect to be 99.98%. The percentage RSD was ˂2% and % recovery was found to be 97.94-100.37%. Conclusion: The advanced reversed-phase HPLC technique was erect to be simple, specific, linear, sensitive, rapid, accurate, precise, economical, and can be utilized for daily quality control of rosuvastatin calcium in tablet and bulk formulations.

Standardization of Herbal Drugs – A Overview

The medicinal plants are important source for pharmaceutical manufacturing. Medicinal plants & herbal medicines account for a significant percentage of the pharmaceutical market. As the side effects of Synthetic medicine have started getting more apparent, majority of formulation are prepared from herbs. The herbal medicines however, suffer from lack of standardization parameters. The main limitation is the lack of standardization of raw materials, of processing methods and of the final products, dosage formulation, and the non existence of criteria for quality control. Herbal formulations have reached extensive acceptability as therapeutic agents for several diseases. The development of authentic analytical methods which can reliably profile the phytochemical composition, including quantitative analyses of marker/bioactive compounds and other major constituents, is a major challenge to scientists. Standardization is an important step for the establishment of a consistent biological activity, a consistent chemical profile, or simply a quality assurance program for production and manufacturing of herbal drugs.

Formulasi Sediaan Kombinasi Simplisia Daun Katuk, Daun Kelor, Dan Jahe Sebagai Minuman Instan

Daun Katuk, Daun Kelor dan Jahe merupakan bahan alam dari tanaman yang telah bayak dimanfaat kan oleh masyarakat. Daun Katuk telah diketahui berguna untuk melancarkan air susu ibu, daun Kelor mengandung senyawa-senyawa yang sanygat bermanfaat untuk meningkatkan gizi, sedangkan Jahe dengan kandungan senyawa kimianya terutama gingerol berguna untuk meningkatkan imunitas. Tujuan penelitian ini adalah memformulasi simplisia daun katuk, daun kelor dan jahe menjadi minuman instan yang dapat menyehatkan tubuh. Metode pembuatan simplisia dengan mengeringkan bahan basah di oven pada suhu 50oC dan metode formulasi ketiga simplisia dengan metode granulasi. Parameter penelitian yang digunakan adalah waktu larur, kadar air, warna, aroma, rasa, kemasan, dan khasiat. Hasil dari penelitian ini adalah waktu larut < 2 menit, kadar air simplisia daun katuk, daun kelor dan jahe berturut-turut adalah 3,5%, 3,5% dan 4%, sedangkan kadar air sediaan instannya sebesar 4%. Hasil Uji kesukaan terdiri dari warna hasil menarik, aromanya harum, rasanya enak, kemasan sangat menarik dan khasiat baik. Kesimpulan dari formulasi minuman instan kombinasi daun katuk, daun kelor dan jahe memenuhi syarat SNI dan hasil uji kesukaan (uji hedonik) adalah suka, menarik dan berkhasiat.. Kata kunci; Daun Katuk, Daun Kelor, Jahe, minuman instan, suka The Combination dosage Formulation of Saurapus Leaf Simplicia, Moringa Leaves, and Ginger as an Instan Drink Sauropus leaves, moringa leaves and ginger are natural ingredients from plants that have been used by many people.Sauropus leaves are known to be useful for breastfeeding, Moringa leaves contain compounds that are very useful for improving nutrition, while ginger with its chemical compounds, especially gingerol, is useful for increasing immunity. The purpose of this study was to formulate the simplicia of sauropus leaves, moringa leaves and ginger into instant drinks that can nourish the body. The method for making simplicia is by drying the wet material in an oven at 50oC and the third formulation method for simplicia is the granulation method. The research parameters used were elusive time, moisture content, color, aroma, taste, packaging, and properties. The results of this study were the dissolving time < 2 minutes, the water content of the simplicia of sauropus leaves, moringa leaves and ginger were 3.5%, 3.5% and 4%, respectively, while the water content of the instant preparations was 4%. The favorite test results consist of attractive color results, fragrant aroma, good taste, very attractive packaging and good properties. The results of this study were the dissolving time <2 minutes, the water content of the simplicia of sauropus leaves, moringa leaves and ginger were 3.5%, 3.5% and 4%, respectively, while the water content of the instant preparations was 4%. The favorite test results consist of attractive color results, fragrant aroma, good taste, very attractive packaging and good properties. The conclusion from the formulation of instant drink combination of sauropus leaves, moringa leaves and ginger meets SNI requirements and the results of the hedonic test are liking, attractive and efficacious Keywords: Sauropus leaves, moringa leaves, ginger, instant drinks, like

The use of photogenerated iodine for the determination of isoniazid in solid dosage formulation

A shot cut method for the determination of isoniazid in a solid dosage formulation (DF) has been developed. The method is based on isoniazid titration with a solution of photogenerated iodine obtained as a result of irradiation of an auxiliary solution containing potassium iodide, a mixture of sensitizers (sodium eosinate, fluorescein, auramine taken in a molar ratio of 1:1:1) and phosphate buffer solution (pH 7.5). Since the titrant content in the cell was controlled using the voltammetric method (amperometric titration with two polarized electrodes), the interaction of a physiologically active compound with the latter was accompanied by a decrease in the amount of titrant in the cell and, hence, in the current in amperometric circuit. Stabilization of the current in the circuit of the amperometric setup indicated the completeness of the reaction, and, therefore, provided estimation of the content of a physiologically active compound in the dosage formulation. Further irradiation of the solution and measurement of the generation time required to replenish the loss of titrant in the cell also made it possible to regulate the content of isoniazid in the preparation. The technique was tested on the samples of solid dosed formulations. It was shown that the components of the tablet mass (calcium stearate monohydrate, polysorbate, crospovidone and potato starch) do not affect the results of the determination of physiologically active compound provided that the analyzed form is obtained at room temperature. The determined content of isoniazid in a solid dosage formulation varies in the range of 286.0 – 296.0 mg and falls within the range recommended by the General Pharmacopoeia Monograph 1.4.2.0009.15 (285 – 315 mg), which indicates that the quality of the drug meets the GMP standards. The linear dependence of the analytical signal on the concentration of physiologically active compound is observed in the range of 161 – 1610 mg for the drug «Isoniazid. Tablets, 300 mg». The calculated detection limits and quantitative determination are 13.5 and 41.0 mg (both in terms of change in the current strength and in the time of titrant generation), respectively. The developed photochemical method for the determination of isoniazid in solid dosed formulation is easy to use, meets the requirements set out in the guidelines for validation of bioanalytical methods, and does not require expensive equipment. The method can be recommended for routine control of the DF quality indicators in any analytical laboratory.

Factors affecting serum phenobarbital concentration changes in pediatric patients receiving elixir and powder formulations

Background Phenobarbital (PB) is commonly used as elixir and powder formulations in pediatric care. Its dose adjustment is performed based on individual drug concentration monitoring. Few studies have comprehensively analyzed the variation factors for serum PB concentration. In this study, we retrospectively investigated the factors that influence serum PB concentration and assessed the impacts of dosage formulation and administration route. Methods This retrospective cohort study covered clinical data from January 2007 to September 2019 at Mie University Hospital. The present study included 60 pediatric patients administered the elixir and powder of PB through oral route and enteral tube. Simple and multiple linear regression analyses were performed to identify the risk factors that affect the weight-corrected PB serum concentration/dose (C/D) ratio in pediatric patients. Six subgroups were also established according to the concomitant use of drugs that potentially inhibit PB metabolism, dosage formulation, and administration route to investigate the difference in the PB C/D ratio among the subgroups. Results A significant regression equation to predict the PB C/D ratio was found through simple and multiple linear regression analyses, with an adjusted coefficient of determination of 0.53 (p < 0.001). Further, the concomitant uses of valproic acid (VPA) or amiodarone, which were the only two drugs seen in this study as potential inhibitors of PB, was found to have the greatest effect on the PB C/D ratio (standardized partial regression coefficient (β) = 0.543, p < 0.001). Furthermore, a significant difference in the PB C/D ratio was found between the subgroups classified by the concomitant use of VPA or amiodarone (p = 0.002). However, there were no significant correlations between the PB C/D ratio, dosage formulation, and administration route. Conclusions The most influential factor on the PB C/D ratio was the concomitant use of VPA or amiodarone with PB. This result could provide an important perspective in pediatric drug therapy where elixir and powder formulations are administered via the oral route and enteral tube.

Mental health nurses' confidence in applying pharmacological knowledge: a survey

Background/Aims The literature highlights gaps on how nurses apply pharmacology knowledge to their medication management, particularly in relation to knowledge on the mechanism of action and drug interactions. The aim of this study was to research a sample of mental health nurses to explore their confidence, knowledge and skills in applying their pharmacological knowledge. Methods A paper-based survey questionnaire was distributed to 209 mental health nurses working in direct patient care in Ireland. A total of 129 completed the questionnaire with a response rate of 61.7%. Results The vast majority of mental health nurses were confident in their knowledge of pharmacological principles to medication management, in relation to dosage, formulation, adverse effects, and predictable side effects, including patient education and medication information. Nurses were less confident in their knowledge of pharmacodynamics related to their knowledge on the mechanism of action, and on the pharmacokinetics of drug clearance. This may negatively impact on their ability to educate patients about their medications. Conclusions The findings suggest that there is need for an increased focus on continuing education on pharmacology for nurses at service level, particularly on the mechanism of action and clearance of commonly used medications in order for nurses to more effectively support patients to manage their medications.