Disintegration Testing Our physico-chemical property team also provide disintegration tests which may be used to substitute for dissolution ICH Q6A , for example, when immediate release solid oral drug products, made from highly water soluble drug substances, have been demonstrated to have consistently rapid drug release characteristics. Friability Testing We also perform friability testing form compress, uncoated tablets, using the analytical procedures described in the official pharmacopoeial texts, Ph.
Friability is the measurement of the propensity of a tablet break-up or crumble following compression during handling or subsequent storage and allows assessment of the tablet processing, design, formulation or moisture content. Controlled Release Studies In combination with these dissolution approaches, we also offer imaging and spectroscopy techniques to support research such as confocal Raman fast mapping which allows mapping of the distribution of active ingredients and excipients in solid dosage systems and characterisation of controlled-release systems.
Microscopy techniques can also be used to identify and quantify key quality attributes such as coating uniformity, thickness and surface features. Through delivery of rugged and reproducible dissolution testing from our network of GMP compliant facilities in the USA and the UK, we can help you to identify any significant changes in product performance.
Our expertise in dissolution testing will allow you to accelerate your drug development and support your quality control or release testing programs. Bringing quality and safety to life, we offer Total Quality Assurance expertise to help you to meet and exceed quality, safety and regulatory standards. View our comprehensive collection of digital resources.
With recent expansion in our global ICH stability storage network, download our infographic to get a quick overview of our capacity and conditions. Intertek Pharmaceutical Services. Submit a Sample. Apparatus 3 consists of a set of cylindrical, flat-bottomed glass vessels, a set of glass reciprocating cylinders with inert fittings and screens at the top and bottom of the cylinders, and a motor and drive assembly to reciprocate the cylinders vertically inside the vessels; and if desired, the reciprocating cylinders can be moved horizontally to different rows of vessels 8, 9.
Unlike the baskets and paddles, agitation in Apparatus 3 comes from dipping within the vessel, rather than through a stirred media approach. The advantages of the reciprocating cylinder include the ability for pH profiling, which enables simulation of pH changes in the gastrointestinal tract; and the system can be programmed to run dissolution in different media and at different speeds at various times i.
Such flexibility allows for better in vitro-in vivo modeling. Apparatus 4 flow-through cell consists of a reservoir containing the dissolution medium, a pump that forces the medium upwards through the vertically positioned flow-cell, and a water bath to maintain the temperature of the dissolution medium 8, 9. The flow-through cell apparatus can operate in two different modes-an open system with continuous flow of solvent passing through the cell from the reservoir, and a closed system where a fixed volume of media is recirculated.
The open system is suitable for poorly soluble drugs, which require a high volume of media for dissolution. The closed system, on the other hand, is used when a low volume of medium is required. Dissolution testing should be carried out under physiological conditions 4. Media selection will be based on the purpose of the dissolution test, taking into account the solubility of the API.
Ideally, the dissolution media should meet sink conditions, ensure that the drug is stable for at least 24 hours, preferably avoid the use of surfactants and alcohol where possible, and be biologically relevant for the site of dissolution in vivo i.
Sink conditions are described as the volume of the media being at least three times of that required to form a saturated solution of the drug substance. Sink conditions ensure that the amount of drug already dissolved in the media does not affect the dissolution rate as the run progresses. If sink conditions are not met, the dissolution rate will artificially slow down as the API nears the saturated solution state, making the dissolution test overly discriminatory and not reflective of in-vivo environment Dissolution of four controlledrelease theophylline formulations in milk.
Mauger, J. Hydrodynamic characterization of a spin-filter dissolution device. McCarthy, L. Computational fluid dynamics modeling of the paddle dissolution apparatus: agitation rate, mixing patterns, and fluid velocities. Meyer, J. Human postprandial gastric emptying of millimeter spheres. Gastroenterology Miller, D. Hot-melt extrusion for enhanced delivery of drug particles. Mithani, S. Estimation of the increase in solubility of drugs as a function of bile salt concentration.
Moore, J. Gastric emptying of varying meal weight and composition in man. Evaluation by dual liquid- and solid-phase isotopic method. Nelson, E. Solution rate of theophylline salts and effects from oral administration. Nernst, W. Theorie der reaktionsgeschwindigkeit in heterogenen systemen. Ovesen, L. Intraluminal pH in the stomach, duodenum, and proximal jejunum in nor-mal subjects and patients with exocrine pancreatic insufficiency.
Peck, G. Tablet Formulation and Design. Pinnamaneni, S. Formulation approaches for orally administered poorly soluble drugs. Pharmazie Rekhi, G. Evaluation of in vitro release rate and in vivo absorption characteristics of four metoprolol tartrate immediate-release tablet formulations. Russell, T. Upper gastrointestinal pH in seventy-nine healthy, elderly North American men and women. Schott, H.
The role of surfactants in the release of very slightly soluble drugs from tablets. Shah, V. In vitro dissolution profile of water-insoluble drug dosage forms in the presence of surfactants. Shangraw, R. Compressed Tablets by Direct Compression. Sievert, B. Dissolution tests for ER products. This standardization helps to show consistent quality in production and may serve as a predictive measure of efficacy. A dissolution test uses an apparatus with specific test conditions in combination with acceptance criteria to evaluate the performance of the product.
Where specified in a monograph, USP dissolution tests are legal requirements. USP training and service are designed to help you meet regulatory compliance requirements while strengthening your quality standards.
Provides detailed descriptions of USP best practices for mechanical qualification and the performance verification test PVT of USP dissolution test assemblies basket and paddle.
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