International Journal of Advances in Pharmaceutics
Not a member yet
90 research outputs found
Sort by
Recent trends and harmonization of quality risk management
No full textThe World Health Organization (WHO) of the United Nations finalized the Annex 2 of the new technical Report 981 that is called as WHO guideline on the implementation of a Quality Management System, in July 2013. WHO requirements with the harmonized guidelines concern with harmonized European, US and Asian regulations. This article includes the role of Quality Risk Management in pharmaceutical quality system
Standardisation Of Marketed Herbal Fromulation Of Muscle And Joint Hrx Pain Relieving Oil
Get PDFForced degradation studies show the chemical behavior of the molecule which in turn helps in the development of formulation and package. A forced degradation study is an essential step in the design of a regulatory compliant stability program for both drug substances and products, and formalized as a regulatory requirement in ICH Guideline Q1A in 1993. Forced degradation is a degradation of new drug substance and drug product at conditions more severe than accelerated conditions. It is required to demonstrate specificity of stability indicating methods and also provides an insight into degradation pathways and degradation products of the drug substance and helps in elucidation of the structure of the degradation products. Thus, this review discusses the current trends in performance of forced degradation studies by providing a strategy for conducting studies on degradation mechanisms
The Study of Hypoglycemic effect of microencapsulated Glimepiride In Long Evans Rats
Get PDFIn this study glimepiride was used as a model drug to evaluate the hypoglycemic effect of microencapsulated or mucoadhesive drug delivery system. Sodium alginate based Microbeads of Glimepiride was prepared using Glycerine monostearate (GMS) for oral sustained release by Orifice-ionic gelation method. The microbeads were evaluated for physical appearance, floating properties, In-Vitro release study and In-Vivo evaluation. The microbeads were free flowing, spherical in shape and have the good content of uniformity of drugs. The spherical microbeads of 2 mm diameter were prepared by dropping sodium alginate incorporated with Glimepiride solution into aqueous solution of calcium chloride, causing the precipitation of calcium alginate. These Microbeads released the drug for a prolonged residence time of more than 2 hours. The hypoglycemic effect of the mucoadhesive floating drug delivery system is a valuable method for the long term delivery of Glimepiride on Long Evans Rats
Carbon Allotrope Graphene: Superstar In Nano- World
Get PDFGraphene is a substance made of pure carbon, with atoms arranged in a regular hexagonal pattern similar to graphite, but in a one-atom thick sheet. It is an allotrope of carbon whose structure is a single planar sheet of sp 2 -bonded carbon atoms that are densely packed in a honeycomb crystal lattice. Hence, graphene may be considered as the mother of graphite, fullerene and carbon nanotubes. Graphene can also be considered as the final member of the series of fused polycyclic aromatic hydrocarbons, such as naphthalene, anthracene and coronene It has many exceptional features which make it a superstar in the world of nanotechnology as thinnest material, practically transparent (3,000,000 sheets equal to 1mm), stiffest, strongest (Youngs modulus >0.51 TPa, tensile strength ~130 Gpa) largest surface-to-weight ratio (~2,700 m2/gram) very stretchable (stretch up to 20%), conducts heat and electricity better than any metal, impermeable to gases, large specific surface area, non-toxic, low cost and drug can attach on both sides of its sheet. Graphene can be successfully used as a non-toxic nano carrier for efficient gene transfection, a novel gene delivery, nano- vector with low cytotoxicity and high transfection efficiency, which is promising for future applications in non-viral-based gene therapy. Experimental studies have demonstrated that the shape of carbonaceous nanomaterials plays an extremely important role in how they interact with cells and potentially other biological systems, such as tissues and organisms. The cytotoxicity of graphene depends on the exposure environment and mode of interaction with cells as bacteria came directly contact with graphene, intensive physical interactions between graphene and bacterial cells may cause physical damages on cell membranes, and result in the release of intracellular contents and cytotoxicity and genotoxicity occur
Design and evaluation of floating drug delivery systems of Metformin with natural gums as release retarding polymers
Get PDFMetformin hydrochloride floating tablets were prepared by wet granulation method by using optimized concentrations of gas generating agents, binding agents and natural gums as polymers like gum kondagogu and gum karaya. The formulations F1-F4 with concentrations 2-3.5% were prepared to optimize binding agent and formulations F5-F7 with concentrations 15-20% to optimize gas generating agent where optimum percentage of binding agent was found around 2.3% and gas generating agent was found around 17.25% to get quick floating lag time. The prepared granules evaluated for various parameters showed good results in which the Carrs index, hausner ratio and angle of repose, the values were found in between 9.05-16.78, 1.02-1.46 and 23.17-32.64 respectively. All compressed formulations were evaluated for various parameters and results of hardness, friability, drug content, were found around 7.1-8.8kg/cm2, 0.56-1.48% and 499.3-499.8mg respectively. The tablets prepared by these granules of two natural gums as polymers showed desired floating properties. F6 formulation containing gum kondagogu and F11 formulation containing gum karaya showed good release retardation with release 99.42% and 99.75% respectively after 12 hours in in vitro drug release studies. Formulations F6 and F11 after stability studies showed good results proving stable. In vivo studies also showed good correlation with the results of in vitro and X-ray pictograms proved the formulations is stable in vivo. Formulations F6 and F11 contains natural gums Kondagogu and karaya with 17.25% concentration were considered as best formulation as they showed good release retardation and, in release kinetic studies the n-value found appropriate for controlled release formulations
Devlopment and validation of RP-HPLC Method for estimation of Metronidazole and Norfloxacin in suspension form
Get PDFA simple reversed- phase high-performance liquid chromatographic method (RP-HPLC) has been developed and validated for estimation of Development and Validation of Analytical method for Estimation of Metronidazole and Norfloxacin in pharmaceutical dosage form . Chromatographic separation was carried out on YL 9100 equipped with PDA detector using C 18 (250mm 4.6mm, 5) as stationary phase and mobile phase Triethylamine: 0.02M Potassium Dihydrogen phosphate (pH 3.5): Methanol (0.01:70:30) at flow rate of 1ml/min. Wavelength for UV detection was 292nm. The retention time for Metronidazole and Norfloxacin was found to be 6.10 and 3.50 min. The method was validated as per ICH guideline and and can be applied for estimation of Metronidazole and Norfloxacin in suspension. The linearity was found over concentration range of 12.5-37.5g/ml for Metronidazole and Norfloxacin
Nanotechnology and diabetes
Get PDFNanotechnology offers sensing technologies that provide more accurate and timely medical information for diagnosing disease, and miniature devices that can administer treatment automatically if required. Some tests such as diabetes blood sugar levels require patients to administer the test themselves to avoid the risk of their blood glucose falling to dangerous levels. Certain users such as children and the elderly may not be able to perform the test properly, timely or without considerable pain. Nanotechnology can now offers new implantable and/or wearable sensing technologies that provide continuous and extremely accurate medical information. In the long run, nanotechnology will clearly open up many routes to treatments and cures for diabetes, as it will for many of the diseases and conditions that currently plague mankind. Nanotechnology offers some new solutions in treating diabetes mellitus. Boxes with nanopores that protect transplanted beta cells from the immune system attack, artificial pancreas and artificial beta cell instead of pancreas transplantation, nanospheres as biodegradable polymeric carriers for oral delivery of insulin are just some of them. The abilities of nanomedicine are huge, and nanotechnology could give medicine an entirely new outlook. Whilst some of these technologies are quite far-fetched, there is evidence that we will see significant advances in the treatment and management of diabetes quite soon. The purpose of this review is to throw more light on the recent advances and impact of nanotechnology on biomedical sciences to cure diabetes
Chromatographic Development of validated analytical method for the estimation of tapentadol and paracetamol in combined dosage form
Get PDFA simple, sensitive an isocratic RP-HPLC method for the estimation of TAP (Tapentadol) and PARA (Paracetamol) in combined dosage form using Inertsil ODS C-18 column (250.6 mm, 5 ) in an isocratic mode with mobile phase comprising Buffer (1mL TEA) : ACN : MeOH in the ratio of (75:20:5 v/v/v). The flow rate was 1.2 mL/ min and effluent was monitored at 220 nm. The retention times were found to be 6.88 min for TAP and 3.78 min for PARA. The assay exhibited a linear dynamic range of 11.89- 28.55 g/mL for TAP and 64.95- 155.90 g/mL for PARA .The calibration curves were linear (r = 0.999 for TAP and r = 0.9996 for PARA) over the entire linear range
Optimizing Tabletting Processes with Quality by Design: An Overview
Get PDFhe elements of quality by design are examined and a consistent nomenclature for quality by design, critical quality attribute, critical process parameter, critical material attribute, and control strategy is proposed. A process is well understood when all critical sources of variability are identified and explained, variability is managed by the process, and product quality attributes can be accurately and reliably predicted over the design space. Quality by Design (QbD) is a systematic approach to development of products and processes that begins with predefined objectives and emphasizes product and process understanding and process control based on sound science, statistical methods and quality risk management. In an attempt to curb rising development costs and regulatory barriers to innovation and creativity, the FDA and ICH have recently started promoting QbD in the pharmaceutical industry [1, 3, 7,]. QbD is partially based on the application of multivariate statistical methods [2, 4, 6] and a statistical Design of Experiments strategy [4, 5, 6] to the development of both analytical methods and pharmaceutical formulations. The talk will review the basics of QbD with case studies from the pharmaceutical industr
Preformulation study of Levofloxacin
Get PDFoai:ojs.pkp.sfu.ca:article/1398Levofloxacin is the L-isomer of the racemate ofloxacin, a quinolone antimicrobial agent. Chemically levofloxacin, a chiral fluorinated carboxyquinolone, is the pure (S)-enantiomer of the racemic drug substance Ofloxacin.Preformulation studies are needed to ensure the development of a stable as well as therapeutically effective and safe dosage form. The Preformulation studies, performed in this research include identification of drug, solubility analysis, partition coefficient and drug compatibility.In present work complete preformulation study was carried out, which include identification of drug, quantitative estimation of drug, solubility determination, melting point determination,partition coefficient determination etc