The objective of this present investigation is to design and evaluate the gastroretentive bilayer floating tablets of Simvastatin as controlled release and Telmisartan as immediate release. The combination therapy of Telmisartan and Simvastatin is useful in serious cardiovascular adverse effect such as hypertension, congestive heart failure and exacerbation of angina which may occur along with increasing cholesterol level in the blood, while the fixed dose combination remain the preferable choice to the patient as compared to the individual dosage form. Bi-layer tablet is suitable for sequential release of two drugs in combination, two incompatible substances and also for controlled release of drug. The bilayer tablets are prepared using different super disintegrants like Sodium Starch Glycolate, Cross Carmellose Sodium, Crospovidone for Telmisartan immediate release and xanthan gum, guar gum and HPMC K4M for Simvastatin controlled release. Sodium Bicarbonate is used as a gas generating agent. The precompression parameters like angle of repose, bulk density, tapped density; compressibility index and hausner’s ratio were studied. The tablets were characterized by physical and chemical parameters such as tablet Uniformity of weight, thickness, hardness, diameter, friability, drug content, swelling index and In vitro drug release. The optimized formulation based on all the parameter T-3(Crospovidone) was selected for immediate release layer, S-5(Xanthan gum and HPMC K4M) for controlled release layer and bilayer tablets were prepared. The dissolution data was subjected to various release kinetic models to understand the mechanism of drug release.
Jaipur food designed and developed by Dr. P.K. Sethi is second most widely used foot piece in the world after SACH foot (Solid ankle cushion heel). SACH foot was designed for use in colder climate of western countries. The work on culture specific innovation, The Jaipur foot started with the modification of SACH foot. Jaipur foot made up of microcellular rubber and wooden ankle block with iron bolt held together by using varieties of rubbers used in making automobile tyres at different locations and assembled in a metal die to vulcanize the rubber by autoclaving.
The use of animals in various fields including biomedical research, product safety testing, and education has increased for the development of medical technology, and advancement of science knowledges. According to the EU and US government statistics (http://www.usda.gov/, http://eur-lex.europa.eu), over 100 million animals, including mice, rats, frogs, dogs, cats, rabbits, hamsters, guinea pigs, monkeys, fish, and birds are used for research each year, of which 80% of animals were used for drug developments and toxicity test to evaluate novel drugs.
The specific objective of this research is to study the reaction of eugenol with formaldehyde and aniline and to perform in silico and biological activity studies on the obtained products. All the obtained structure compounds was confirmed by 1 H-NMR, 13 C-NMR, IR, MS and UV-Vis spectroscopic methods and then were tested for biological activity screening using in silico study by Molegro virtual Docker v 5.5 as a software. Docking process was used by Check point kinase 1 receptor (PDB ID: 2YWP) for screening biological anticancer activity. We have been using brine shrimp lethality test (BST) as in vitro study for anticancer activity screening The result of synthesis, compound (2):4-Allyl-2-methoxy-6-((phenylamino)methyl)phenol, compound (3):6-Allyl-8-methoxy-3-phenyl-3,4-dihydro-2H-benzo-[e][1,3]oxazine and compound (4):6,6'-(Phenylazanediyl)bis(methylene)bis(4-allyl-2-methoxyphenol) were obtained by mannich reaction on eugenol using formaldehyde and aniline was stirred at room temperature for 0,5 h and reflux at 65 o C for 4 h with the yield product were 26 %, 52 % and 18 %. The results of docking process were benzoxazine and aminomethyl derivatives from eugenol have potential as anticancer activity based on their rerank score. The result of BST, It was found that all compounds have potential anticancer activity based on Meyer’s criteria, therefore benzoxazine and aminomethyl derivatives have potential to be further studied for their bioactivity.
In a regulatory set up for biological products the symbiotic relationship for assuring the quality of test results is required to be addressed for a step wise laboratory improvement towards accreditation or inspection of facility compliance with current Good Manufacturing Practices. Pharmaceutical laboratories play a pivotal role in clinical or public health domain by providing accurate and reliable results for the quality attributes of the drug under consideration. Various strategies are adopted by testing laboratories to assure that the test results are accurate, precise, and reproducible. National Institute of Biologicals (NIB) functions as Central Drug Laboratory in India and responsibly assures and reviews the quality of number of biological products available through domestic manufacturers and imports. In this report we present the results of an inter-laboratory comparison (ILC) study coordinated by the Quality Management Unit of NIB during January-September 2014 for assuring the quality of results of bacterial endotoxin test (BET) by gel clot method. Eight laboratories participated in the ILC study and six laboratories provided satisfactory results while results from two laboratories were unsatisfactory in terms of errors in calculation of maximum valid dilution and expression of final results indicating the need for improvement in the technical competence of testing laboratories for assuring the quality of safety test parameter by BET.
A medication error is any preventable event that may cause or lead to inappropriate medication use or cause patient harm while the medication is in the control of the healthcare professional, patient or consumer. The patient must actually receive the drug for it to be classified as a medication error. The aim of the present study was to identify medication errors if any in the diabetology and general medicine departments of a multispecialty hospital. The data was collected from both in and out-patients. A total of 1946 prescriptions were selected from diabetes and general medicine departments over 10 months for analysis. Prescriptions from men accounted to 80.3% and that of women were 19.7%. Out of the total 1946 patients, 136 patients experienced at least one type of error. Lack of awareness and improper work procedures made way to medication errors. Errors were mainly caused by clinician (30%) and others (32%). The main cause of medication error was inadequate staff education (41%). These errors could be reduced by simple changes of existing procedures or by implementing automated technologies in the prescription, dispensing and administration processes. The addition of a clinical pharmacist can be considered as an essential requirement in such a scenario to identify and to prevent the medication errors. Medication errors are insidious failures that cause silent damage to the health of the patients as well as the quality of delivery of healthcare to the patients that may be avoided by the intervention of the pharmacist.
Residual solvents in pharmaceuticals are termed as organic Volatile Impurities. These are the chemicals that are used in the manufacture of drug substance or excipients or use in the preparation of final formulation. Analysis of organic volatile impurities is of key importance for Active Pharmaceutical Ingredients (API). Most of the available methods use liquid chromatography which could be expensive and time consuming. Hence, an analytical method for the quantification of residual solvents in Glipizide was established using a headspace gas chromatography (HSGC) coupled with a flame ionization detector (FID). Methanol, acetone and ethylene dichloride as residual solvents were determined in Glipizide. Analysis was performed by headspace GC/FID method on Agilent GC 7820A system. Nitrogen was used as a carrier gas with constant flow rate of 4.2 mL/min and the separation of residual solvents was achieved on DB-624 column. The thermostat temperature was 100 °C for 30 minute for each vial and after the equilibration the vials were pressurized and injected on GC column. The %RSD for six injections obtained in acceptance criteria. The percentage recovery ranges obtained from 92.49 and 106.69%.The correlation coefficient R2 obtained greater than 0.99. The method parameters were validated included specificity, limit of detection and quantification, accuracy, linearity, precision, and robustness. A new, simple, specific, accurate and precise method was validated according to the International Conference on Harmonization (ICH) guidelines.
Across the world, a heavenly use of chemical fertilizer is major environmental issue in agricultural fields for sustainable growth of plants. Hence, the chemical fertilizers show adverse environmental effects in human life along with degrade the quality of soil fertility and polluting the water. So there is a need to develop an alternative approach to minimize the high consumption of chemical fertilizers. Now nanotechnology is an alternate approach, touching nearly all aspect of modern life of human welfare as well as plants growth. In the various fields of sciences, nanotechnology based devices are frequently used for the sustainable development of agriculture, clinical medicine, environmental cleaning, food processing, targeted drug delivery and enhancer of plant growth with safe and successful by different ways. However, use of nanomaterials in agriculture field especially for plant protection and production, is an under-explored area in the research community. This review summarizes the utility the known nanomaterials in plant growth from seeds to complete plant in agricultural production. This review also highlights the key role of mode of action of nanoparticles/nanomaterials in plants growth enhancer. The appropriate elucidation of physiochemical, biological and molecular mechanistic approach of nanoparticles in plant leads to better growth in plant with safe and eco-friendly agriculture.
Prednisolone (Wysolone), a corticosteroid drug with glucocorticoid and mineralo -corticoid activity. The drug is mainly used for the treatment of inflammatory and auto-immune conditions. The drug will produce some side effects like visual, auditory defects, fluid retention of face etc. It is a case of a lady of 38 year old presented with multiple conditions after started Prednisolone 60mg OD for rheumatoid arthritis. Now she is admitted in the emergency department of our hospital with signs and symptoms of seizures. Her past medication history includes leviterecetam 500mg BD for seizures and Prednisolone 60mg OD for rheumatoid arthritis. Thereafter she progressively complained about loss of vision. Her vitals were stable. Ophthalmology consultation was given to the patient who revealed steroid induced cataract for which she was started with Carboxyl methyl cellulose sodium eye drops (Refresh tear drops). The patient experienced a partial recovery after having treated for 10 days and was discharged. We all know that steroids will be able to produce side effects; some of them were serious ones. So Clinicians and Ophthalmologists should be aware of the ocular side effects of steroids. This case report highlights the occurrence of adverse outcomes with Prednisolone therapy thus giving an insight to proper use of steroids.
In the design of dosage forms, comforts of drug administration and patient conformity have considerable prominence. Recent and rising technologies can manufacture robust, versatile tablets with extraordinary taste masking and controlled release. Orally disintegrating tablets (ODTs) are solid dosage forms that disintegrate in the mouth in less than 60 s, and are thus swallowed without the need for water. Rapid disintegration of tablet cause quick dissolution and thus fast onset of action. ODTs are suitable dosage form for special populations like pediatrics, geriatrics, psychotic, dysphagic, bedridden patients, unconscious patients, young patients with under developed muscular and nervous system, patients with hand tremors problems and frequent traveller patients. It provides good stability, accurate dosing, easy manufacturing, decreased packaging size; self-administration is possible during the journey, as water is not required. ODTs are an economical method of drug delivery. ODTs are very important drug delivery system in cases where drug absorbed from buccal cavity. Various scientific techniques including spray drying, sublimation, freeze drying, molding, direct compression etc. have been employed for the development of ODTs. Today, ODTs are more widely available as over the counter products for the treatment of numerous diseases. The aim of this article is to review the advantages, limitations, formulation challenges, manufacturing techniques, patented technologies, marketed formulations and evaluation tests of ODTs.
For the past few decades, there has been a considerable research interest in the area of drug delivery using particulate delivery systems as carriers for small and large molecules. Particulate systems like Nanoparticles have been used as a physical approach to alter and improve the pharmacokinetic and pharmacodynamic properties of various types of drug molecules. Due to their small sizes, they exhibit unique physicochemical and biological properties like an enhanced reactive area as well as an ability to cross cell and tissue barrier, that make them a favourable carrier for novel drug delivery. They have been used to protect the drug entity in the systemic circulation, restrict access of the drug to the sites and to deliver the drug at a controlled and sustained rate to the site of action. Nanoparticles have been developed as an important strategy to deliver conventional drugs, recombinant proteins, vaccines and nucleotides. Therefore nanoparticles in the pharmaceutical biotechnology sector improve the therapeutic index and provide solutions for future delivery problems for new classes of so called biotech drugs including recombinant proteins and oligonucleotides. Various polymers have been used in the formulation of Nanoparticles for drug delivery to increase therapeutic benefit and minimizing side effects. This paper aims to review various aspects of Nanoparticle formulation, characterization, effect of their characteristics and applications of nanoparticles as carrier system in the field of pharmaceuticals.
“Nutraceutical” was coined from “Nutrition” u0026 “Pharmaceutical” in 1989 by Stephen DeFelice. Nutraceuticals: “A food or a part of food or nutrient, that gives fitness benefits, consisting of the prevention and remedy of an ailment.”
Nebivolol hydrochloride and Cilnidipine is used for the treatment of hypertension. A simple, accurate, precise and sensitive HPTLC method has been developed and validated for simultaneous estimation of Nebivolol hydrochloride and Cilnidipine in combined pharmaceutical tablet dosage form. The chromatographic separation was performed on silica gel 60 F254 HPTLC plates using Toluene: Ethyl acetate: Methanol: Ammonia, (40:20:10:1, v/v/v/v) as a mobile phase. HPTLC separation of the two drug followed by densitometric measurement at 280 nm. The drugs were satisfactorily resolved with Rf values 0.39±0.02 and 0.74±0.02 for Nebivolol Hydrochloride and Cilnidipine, respectively. The method was found to be linear in range of 200-600 ng/spot and 400-1200 ng/spot for Nebivolol hydrochloride and Cilnidipine, respectively. The correlation coefficient was found to be 0.9995 and 0.9989 for Nebivolol hydrochloride and Cilnidipine, respectively. The LOD and LOQ were found to be 27.2 ng/spot and 82.6 ng/spot for Nebivolol Hydrochloride and 14.08 ng/spot and 42.67 ng/spot for Cilnidipine respectively. The mean recovery was found to be 97.8-99.3% and 97.4-99.4% for Nebivolol Hydrochloride and Cilnidipine, respectively. The intra-day and inter-day precision was found to be within limit. The proposed method has adequate specificity, sensitivity and reproducibility for quality control assay of Nebivolol hydrochloride and Cilnidipine in combined pharmaceutical tablet dosage form.
Simarouba glauca is a medium sized ever green tree with tap root system and cylindrical stem commonly known as paradise tree belonging to Simaroubaceae family; it has a long history in herbal medicine in many countries. All the parts of plant is used as some way to another. Which is used to cure a variety of diseases such as amoebiasis, malaria, cancer and ulcer. They also exhibited antibacterial, antifungal antioxidant and hepatoprotective activities, also to treat snake bites. This review article explores the phytoconstituents present in it and pharmacological profile of this particular plant and importance of Simaroubaceae family.
Natural products and their derivatives have been used as therapeutic agents from ancient times and in folklore for treatment of many diseases and illness. Many of the natural products from plants have been used as current drug candidates, either in their original or semi synthetic form and secondary metabolites of the plants also be serve as drug precursors, drug prototypes and pharmacological probes. Medicinal plants involve a multifaceted approach in current drug research as combining botanical, phytochemical, biological and molecular techniques. In drug discovery medicinal plants provides continually new and important lead constituents to against various pharmacological targets including cancer, HIV/AIDS, Alzheimer’s, Malaria, Pain and Immune alteration and etc. Although, medicinal plants continue provide a new drug leads in drug discovery, and numerous challenges are encountered in procurement and selection of plant materials, screening method and the scale up of active compound, hence this brief review work presents a study of the importance of natural products, especially those derived from higher plants and aims to the highlight the pharmacological significant of Laminaceae family in terms of drug development. Most of the plants in laminaceae family are aromatic plants, they posseses Immunomodulatory activites. Salvia species is one of species in this family, hence aimed to studied the immunomodulatry activity of one of the salvia species.
Poor bioavailability and therapeutic response exhibited by conventional ophthalmic solutions due to precorneal elimination of the drug may be overcome by the use of ocular gels enriched with microspheres. Microspheres involving drug loaded particles may enhance dosage form acceptability by providing sustained release in ocular milieu. The objective of the present study was to prepare and characterize microspheres formulation of Moxifloxacin Hydrochloride which is a synthetic broad spectrum flouroquinolone antibacterial agent used for treatment of conjunctivitis caused by susceptible strains of aerobic gram positive, negative and other organisms. Moxifloxacin Hydrochloride loaded microspheres were prepared by emulsion solvent evaporation technique using acrylate methacrylate copolymer Eudragit RS 100. The 32 factorial design along with response surface methodology was used to optimize microsphere formulation. The optimized microspheres were characterized for parameters like appearance, particle shape, particle size, percentage yield, drug loading, differential scanning colorimetry, Scanning electron microscopy (SEM) and in-vitro drug release. The drug release kinetics from developed microspheres was determined by calculating the correlation coefficients of percentage drug release versus time plot, percentage drug release versus square root time plot and log percentage drug retained versus time plots. The microspheres of Moxifloxacin Hydrochloride were successfully prepared for controlled ophthalmic drug delivery. These microspheres were able to sustain the in-vitro release of the drug. These optimized microspheres showing controlled drug release can be further incorporated into bioadhesive polymer to prepare ophthalmic gel. Controlled release with this formulation may reduce dose frequency and side effects as well as improve the patient compliance.
Recombinant gene expression has been the most commonly used method to obtain large quantity of proteins such as enzymes and antigens for pharmaceutical and clinical applications. Although many genes have been efficiently expressed in Escherichia coli, low level of expression and inclusion body formation are still a bottle-neck problem in desired protein production. The expression vectors pHsh and pEXC are newly developed by using elements regulating the expression of a group of genes encoding heat-shock or coldshock chaperones to overcome the low expression level and the formation of inclusion body. Thermostable enzymes are obtained using the pHsh system for applications in the biosynthesis or modification of pharmaceutical chemicals, while unstable antigens are prepared in soluble form using the T-vector of the pEXC expression system. The successful development of these new vectors offers a convenient technique for the preparation of recombinant proteins being used in enzymatic drug production, as diagnostic markers and medicinal proteins.
Brimonidine Tartrate is used for the topical treatment of glaucoma to reduce intra ocular pressure (IOP). It can be used either in combination with other IOP lowering drugs or alone. So many methods have been developed for the determination of Brimonidine Tartrate in combination but there is no method for estimation of drug alone. For estimation of Brimonidine Tartrate in bulk drug and ophthalmic dosage form, reverse phase high performance liquid chromatographic method was developed and validated as per ICH guidelines Q2R(1). Chromatography was performed on Kromasil C-18column (250 mm X 4.6 mm i.d. , 5 μm particle size). Mobile phase was citric acid monohydrate buffer: water: methanol (30:50:20 v/v/v). The pH of buffer was maintained to 3 by using triethylamine. The flow rate was 1.0 ml/min. Elute was detected at 246 nm and it effectively separated at retention Time of 5.96 min. Method was validated for various parameters like calibration curve (linearity), accuracy, specificity, robustness, precision etc.A linear response was observed over the concentration range 40-80 μg/ml for Brimonidine Tartrate. The LOD and LOQ was 1.47 and 4.47 μg/ml respectively. Thus the proposed RP-HPLC method israpid, accurate, precise and economically viable for the estimation of Brimonidine Tartrate in pure form as well as in ophthalmic formulation.
Context: Increasing evidence suggest that routine pharmacogenetic testing for the general population at birth and routinely afterwards can decrease healthcare cost and improve patient care Objective: To systematically review and evaluate the possible economic impact of universal pharmacogenetic testing on the general population and its effects on quality of patient care measured by Adverse drug events. Data Sources and Extraction: Data was extracted using predefined categories of desired information. Using keywords, Boolean operators and Pubmed search engine, Medline and the National Library of Medicine was searched for indexed systematic reviews, meta-analysis, case reports and observational studies with information of interest Results: Nineteen articles met inclusion criteria. 2 articles reported economic benefits of pharmacogenetic testing, 8 articles reported positive relationship between pharmacogenetic testing and adverse drug reactions and the remaining articles had general and support information pertaining to the objective. I found evidence supporting cost effectiveness of pharmacogenetic testing and its possible impact on patient compliance as well as adverse drug events Limitation: This review was unable to provide evidence for acceptable time interval between pharmacogenetic testing to account for epigenetic changes to gene expression overtime. It was also unable to adequately account for how genetic profiles will be appropriately kept and who will have access to them to avoid discrimination from insurance companies. Conclusion and Discussion: Pharmacogenetic testing has made great strides in the past few decades and continues to do so as research in this field intensifies and the medical community strives to discover its usefulness and implication in medicine to the wellbeing of patients. However, the current standard way of prescribing most medications still remains the trial and error approach. It has been estimated that more than 770,000 people are injured or die each year in hospitals from adverse drug events (ADEs), costing over 4 billion dollars in healthcare costs each year[1]. Studies have shown that pharmacogenetic testing does not only decrease ADEs and the cost involved but also increases medication compliance in patients[2]. Some institutions such as Mayo Clinic, St. Jude Children’s Hospital and the NIH have already instituted a more generalized routine pharmacogenetic testing for sections of their patient population and are reaping the benefits of it[3]. Considering the cost and risk involved in the trial-and-error approach and the benefits associated with genetic testing, routine genetic testing for the general population at birth will not only save healthcare dollars but also optimize patient care. However, since epigenetics has the ability to turn genes on or off overtime, periodic updates will be needed to determine what medication is well suited for a specific patient and whether or not a patient is still responding the same way to a medication.
