Current Issue : April - June Volume : 2013 Issue Number : 2 Articles : 7 Articles
Forced degradation studies (chemical and physical stress testing) of new chemical entities and drug products are essential to help develop and demonstrate the specificity of such stability-indicating methods. In addition to demonstrating specificity, forced degradation studies can be used to determine the degradation pathways and degradation products of the APIs that could form during storage, and facilitate formulation development, manufacturing, and packaging. Procedures for the preparation of specific degradation products needed for method validation often emerge from these studies. For marketing applications, current FDA and ICH guidance recommends inclusion of the results, including chromatograms of stressed samples, demonstration of the stability-indicating nature of the analytical procedures, and the degradation pathways of the API in solid state, solution, and drug product. The chemical structures of significant degradation products and the associated procedures for their isolation and/or characterization are also expected to be included in the filing. The experimental protocol for performing forced degradation studies will depend on the active ingredients and formulation involved because the chemistry of each compound is different. In general, a target of approximately 10%degradation of the API during forced degradation, or exposure to energy in slight excess of what is typically used in accelerated storage is recommended. This article discusses stress testing according to the regulatory guidance documents, with emphasis on what should be considered for late-clinical phases and for registration application dossiers....
Validation of an analytical procedure is the process by which it is established, by laboratory studies, that the performance characteristics of the procedure meet the requirements for its intended use. All analytical methods that are intended to be used for analyzing any clinical samples will need to be validated. The objective of validation of an analytical method is to demonstrate that the procedure, when correctly applied, produces results that are fit for purpose. Validation of analytical methods is an essential but time - consuming activity for most analytical development laboratories. It is therefore important to understand the requirements of method validation in more detail and the options that are available to allow for optimal utilization of analytical resources in a development laboratory. In this article the method validation process and the minimum requirements to be included in a regulatory method are discussed. Also a comparison between various parameters have been made i.e. in ICH, Pharmacopoeia & FDA. This article presents a discussion of the characteristics for consideration during the validation of the analytical procedures included as part of registration applications to be submitted....
Novel drug delivery systems (NDDS) constitute the main stay of pharmaceutical research and development. Various novel drug delivery systems are existing in the pharmaceuticals but they fail to overcome the problems like life cycle management, patient compliance, bioavailability, stability, difficulty in combination drug therapies and reduction in generic competition. Innercap technology which is also known as multi-phase and multi-compartment dosage form offers an opportunity to overcome those problems and increase their pipeline of products, utilize more promising compounds and increase the difficulty in counterfeiting high value products. This multi-phased, multi-compartmentalized capsular based drug delivery system will license to enhance pharmaceutical and biopharmaceutical products. It is a very effective way to deliver multiple active chemical compounds in different physical phases with controlled release profiles. This novel delivery system provides the pharmaceutical and biopharmaceutical industries with beneficial solutions to the industry’s highly publicized requirement to repackage and reformulate existing patented blockbuster drugs with expiring patents over the next five years. Innercap technology seeks combination drug products that provide meaningful patient, healthcare provider and physician benefits, and will be responsive to effective marketing campaigns. Innercap technology provides solutions to patients, healthcare providers, physicians, research and development through the development of combination drug therapies. It also offers partners the benefit of a strong intellectual property position, in relation to the Innercap delivery system and a range of delivery targets. With an aging population and healthcare costs on the rise, the healthcare industry will look for pharmaceutical products that increase compliance and decrease healthcare costs....
The aim of the work was to improve the dissolution rate of the practically insoluble antihypertensive drug, Olmesartan medoxomil (OLM) by adopting the liquisolid compact (LS) technique. This study was designed to evaluate the effects of different formulation variables, i.e. types of non-volatile liquid vehicles and drug concentrations, on drug dissolution rates. The liquisolid tablets were formulated with liquid vehicles, poly ethylene glycol 400 (PEG400) at five drug concentrations, 10% w/w, 15% w/w, 20% w/w, 25% w/w and 30% w/w. Avicel PH102 was used as a carrier material, Aerosil 200 as a coating material and cross carmellose sodium as a disintegrant. The method as introduced by Spireas and Bolton (1999) was applied strictly to calculate the amounts of coating and carrier materials required to prepare OLM liquisolid tablets. The prepared LS compacts were evaluated for their flow properties such as bulk density, tapped density, angle of repose, Carr’s compressibility index and Hausner’s ratio. Quality control tests, i.e. uniformity of tablet weight, uniformity of drug content, tablet hardness, friability test, disintegration and dissolution tests were performed to evaluate each batch of prepared tablets. In-vitro drug dissolution profiles of the liquisolid formulations were studied and compared with conventional formulation (olmezest), in simulated intestinal fluid (pH 6.8). The drug release rates of LS compacts were higher as compared to directly compressed tablets, which show significant benefit of LS in increasing wetting properties and surface area of drug available for dissolution. From this study it concludes that the LS technique is a promising alternative for improvement of dissolution property....
Permeability is defined as the ability of drug entity to get absorbed through physiological membrane. It is one of the important parameter to achieve desired bioavability of drug in systemic circulation for therapeutic result. Poor intestinal membrane permeability is result of physiochemical properties of drug molecule and intestinal membrane properties which continues to be a major obstacle to the oral delivery of many molecules with potential therapeutic utility. Poorly absorbed drugs generally are of bcs class III and IV, often require high doses in order to reach therapeutic plasma concentrations after oral administration. The challenge over the years has been to design techniques that will allow oral administration of these drugs, irrespective of their properties, to achieve a therapeutic systemic availability. Potential therapeutic utility and ease of administration by oral route have triggered scientist to develop methods to alter the environment around the drug, the membrane barrier property and to utilize transport system across the membrane which enhances the permeability of poorly absorbed drugs. The purpose of this article is to describe the techniques of permeability enhancement for the attainment of effective absorption and improved bioavailability....
From the view of environmental apprehension, supercritical fluid extraction technology (SFE) exhibits excellent opportunities to accomplish key objectives in the drug delivery sector. Due to increasingly stringent environmental regulations, SFE has gained wide acceptance in recent years as an alternative to conventional solvent extraction for separation of natural compounds in many analytical, herbal and industrial processes. SFE using carbon dioxide (CO2) has been recognized as a green technology. It is a clean and versatile solvent with gas-like diffusivity and liquid-like density in the supercritical phase, which has provided an excellent alternative to the use of chemical solvents. The efficient extraction can be obtained with shorter extraction time, less amount of sample and can be used for extraction of thermo labile compounds. Sophisticated modern technologies allow precise regulation of changes in temperature and pressure, and thus manipulation of solvating property of the Super Critical Fluids, which helps the extraction of natural products of a wide range of polarities....
In modern years, the wastewater generated from pharmaceutical industry and active pharmaceutical ingredients, solvents, intermediates and raw materials has gained increasing attention. Most of the pharmaceutical industry generally contain high organic load and the treatment is primarily conceded out using two main types of biological methods; aerobic and anaerobic. Traditional wastewater treatment methods, such as activated sludge, are not adequate for the complete removal of active pharmaceutical ingredients. Due to high strength, it is not possible to treat some pharmaceutical wastewater using aerobic biological processes. As a substitute, an anaerobic process is chosen to remove high strength organic matter. As an outcome, complementary treatment methods such as membrane filtration, reverse osmosis and activated carbon are regularly used in conjunction with the traditional methods for treatment of industrial wastewater. In this article we discuss about effluent testing and treatment in pharmaceutical industry. Biological treatment of waste water is commonly the most beneficial method for selecting various toxic compounds for the environment. Antibiotics are the major groups of pharmaceuticals. Amoung all the other pharmaceutical drugs and substances antibiotics are important compounds due to its serious irreversible increase the release to the environment. Validation of water treatment systems is necessary to obtain water with all desired quality attributes. This also provides a framework to establish a total control over the process which monitors safety, efficacy and ultimately, the process outcomes....
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