International Journal of Advances in Pharmaceutics
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Preparation and evaluation of iopamidol Parenteral formulation
Get PDFParenteral administration offers many advantages over therapy, given by non parenteral routes. Most notably, therapeutics can reliably predict with considerably accuracy, the Pharmacokinetic and Pharmacology of the agents. Despite of these advantages, parenteral administration is not without certain, measurable risks and limitation that the professional must intelligently weigh in terms of risks benefits, and costs. Iopamidol is radio opaque Nonionic contrast media used parenterally for diagnostic purpose. Solubility of iopamidol is very limited in water. Various Marketed formulations suffer the problem of crystallization of Iopamidol; such crystallization is very crucial as it will vary the dose and also effective drug in the solubilized form is minimized
Six Sigma: A novel approach to pharmaceutical industry
Get PDFThe statistical concept, six sigma is used to define problems systematically, provides tools to measure and influential factors and identifies the improvements that can be implemented easily. It is quality management tool which can be considered as a vision, a philosophy, a symbol, a metric, a goal, a methodology. It simply means a measure of quality that struggle for near perfection. It is a highly disciplined process that focuses on developing and deliveringNear perfect product and services It is based on three element Process improvement, Process. Design/re-design and Process management. When we use this technique for a process then process variation reduced to 3.4 DPMO (Defects per million Opportunities).Six sigma is divided in two sub methods DMAIC (Define, Measure, Analyze, Improve and Control) is improvement system for existing processes that doesnt meet specification. DMADV (Define, Measure, Analyze, Design, Verify) is used to develop new processes at six sigma level
Review: Ion mobility spectroscopy a new method of analysis, its application and reproducibility problems
Get PDFIon Mobility Spectrometry (IMS) is a mass-selective technique in which the sample is vaporised, ionised, and with given initial velocity moved along a drift region towards a collector electrode. The drift times (milliseconds, ms) needed by the ions to reach the collector are proportional to their masses: the higher the mass, the longer the drift times. During our evaluation of ion mobility spectrometry in the screening it was found that reproducibility problem may occurred which is solve easily by using some methods, described in this review. Ion mobility spectroscopy is widely use for the drug analysis, hair analysis and other applications
A review on gastroretentive floating tablets of Quinapril HCl
Get PDFQuinapril HCl is a prodrug that belongs to the angiotensin-converting enzyme (ACE) inhibitor class of medications. It is metabolized to quinaprilat (quinapril diacid) following oral administration. Quinaprilat is a competitive inhibitor ofACE, the enzyme responsible for the conversion of angiotensin I (ATI) to angiotensin II (ATII).ATIIregulates blood pressure and is a key component of the Renin-Angiotensin-Aldosterone System (RAAS). Quinapril hcl has a short biological half-life of 2 hrs with a prolonged terminal phase of 25 hours. So the floating tablet formulations are needed for Quinapril hcl to prolong its duration of action, to increase its oral bioavailability and to improve patient compliance . Many methods are used for preparing floating tablet preparations of Quinapril hcl by using various grades of Hydroxypropyl methyl celluloses (HPMC K4M, K15M, K100M) at various concentrations 10%, 20% and 30%. This review article comprises of the research materialized in the field of formulation and evaluation of floating tablets of Quinapril HCl
Microsponge A Novel New Drug Delivery System: A Review
Get PDFMicrosponge is recent novel technique for control release and target specific drug delivery system. Therefore many scientist or researcher attracted towards the microsponge drug delivery system. Also Microsponge technology has been introduced in topical drug products to facilitate the controlled release of active drug into the skin in order to reduce systemic exposure and minimize local cutaneous reactions to active drugs. More and more developments in delivery systems are being integrated to optimize the efficacy and cost-effectiveness of the therapy. Microsponge technology offers entrapment of ingredients and is believed to contribute towards reduced side effects, improved stability, increased elegance, and enhanced formulation flexibility. In addition, numerous studies have confirmed that microsponge systems are non-irritating, non-mutagenic, non-allergenic, and non-toxic. MDS technology is being used currently in cosmetics, over-the-counter (OTC) skin care, sunscreens and prescription products. One of the best feature of microsponge is it is self-sterilizing. This review is focused on method of preparation, characterization and application of microsponge
Simultaneous estimation of atenolol and chlorthalidone in combine tablet dosage form by absorption ratio method using UV-Vis spectrophotometry
Get PDFA simple, precise, reproducible, accurate, economical and rapid UV-VIS Spectrophotometric method have been developed and validated for the simultaneous estimation of ATN and CTN in tablet dosage form. This paper describes the absorption ratio method as a quantification parameter. The absorption ratio method (ARM) involves measurement of absorbance of sample solution is measured at 240.0 nm (Isobestic Point) and 251.0 nm (? max of CTN) and based on E 1% 1cm values at these wavelengths two set of equations were framed. The developed method obeys the beers law in the concentration range of 40-80g/mL for ATN and 10-50 g/mL for CTN. The recovery studies shows %RSD for ATN 0.21 and for CTN 1.34 by ARM method. The results of analysis have been validated statistically for accuracy, precision, repeatability, specificity and ruggedness. The method was successfully applied to the determination of these drugs in pharmaceutical dosage form
Evaluation of anti-moisture effect of HPMC, Kollidon CL and Aerosil - 200 in hydrolysis affinity Clopidogrel-Aspirin tablet using Delta T Moister Sensor
Get PDFThe combined therapeutic effect of aspirin and clopidogrel is more potent than single one. This combined formulation is not stable due to their moisture affinity toward the hydrolysis reaction. The presence of moisture is a crucial factor in any formulation and causes sticking, picking, microbial growth, stability issues, lamination, friability. This combination formulation was designed using hydroxypropylmethyl cellulose 15 cps, Kollidon CL and Aerosil 200 in a controlled clean room class-I to stop the hydrolysis reaction. The tablets were made using slug method and hardness, disintegration, friability, dissolution, drug content, water activity, moisture content was determined. Kollidon CL and Aerosil 200 showed greater moisture reduction rate than HPMC 15 cps. The better anti-moisture effect of the excipient of Kollidon CL and Aerosil 200 was assured by the calculation of water activity using delta T sensor and isotherm, hysteresis. The quantity of excipients in the tablets was demonstrated for the significant affinity to moisture. The investigated simulated amount of Kollidon CL and Aerosil 200 showed the effective lower water activity in the delta T sensor. The mean moisture specification range was considered as 0.5-4.0% while the kollidon CL and Aerosol 200 showed moisture content of 1.32% and water activity (aw)of 0.014. In this study the Delta T sensor is used due to its significant reduction of dead time from 30% to 45% and moisture variation reduced at least 30% than other models treatment
Recent approaches for impurity profiling of pharmaceuticals
Get PDFImpurities must be monitored carefully to assure the quality of drugs. It is important to identify potential sources of such impurities. Selective analytical methods need to be developed to monitor them. Methodology aspects for impurity investigations are discussed along with an emphasis on understanding the origin and fate of impurities to guide decisions on process controls and specifications. Orthogonal analytical approaches for impurity investigations to provide a complete understanding of a drug substance impurity profile. Considerations for control of toxic impurities include sensitive and selective analytical methodology and determination of the process capability for removing the impurity. New impurities may be observed as changes are made in the synthesis, formulation, or production procedures, albeit for improving them. At times it is necessary to isolate and characterize an impurity when hyphenated methods do not yield the structure or when confirmation is necessary with an authentic material
In-Vitro Study of Low Viscosity, and High Viscosity Direct Compression and conventional Grade Hypromellose for Modified Release Gliclazide tablets
Get PDFSix different low to high viscosity hypromellose were used with lower soluble Gliclazide, alone to investigate the dissolution study and flow property. Dissolution behavior of formulated tablets was tested to identify the better efficacy. Dose dumping, pH dependency also was examined. Anti-diabetic Gliclazide tablets were prepared by direct compression method and the results of dissolution was found good in Methocel K100M DC for 73.25%. Tablets showed uniform weight, thickness, and lower percent ( 0.5%) friability. Result of Carrs index and Hausner ratio indicated good flow properties of powder granules. The percent release of the Gliclazide was analyzed by kinetic models. Release of the drug was higher using the higher viscosity grade. Gliclazide tablets were determined with the goodness of fit test of kinetic models. The release showed linearity in Higuchi Model with correlation coefficient value of R 2 = 0.973. In-vitro study demonstrated improved release profile using DC grade than CR grade alone
Review: Development of forced degradation studies of drugs
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