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Definition for different solubility terms are given in Table 1.Īlthough the oral route of drug administration is the most common and preferred method of delivery due to convenience and ease of ingestion, for many drugs it can be a problematic and inefficient mode of delivery for a number of reasons. The solubility issues complicating the delivery of these new drugs also affect the delivery of many existing drugs1,2,3. In the other words the solubility can also define as the ability of one substance to form a solution with another substance3. The solubility of a solute is the maximum quantity of solute that can dissolve in a certain quantity of solvent or quantity of solution at a specified temperature2. Currently only 8% of new drug candidates have both high solubility and permeability1. Solubility is one of the important parameter to achieve desired concentration of drug in systemic circulation for pharmacological response to be shown. Therapeutic effectiveness of a drug depends upon the bioavailability and ultimately upon the solubility of drug molecules. Limited drug absorption due to poor solubility of drugs resulting in poor bioavailability is paramount amongst the potential problems that can be encountered when delivering an active agent via the oral route. NCE, Amorphous state, characterization, dissolution enhancement.Īlthough the oral route of drug administration is the most common and preferred method of delivery due to convenience and ease of ingestion, for many drugs it can be a problematic and inefficient mode of delivery for a number of reasons. Solid Dispersion Technique and various types of solid dispersion systems have also been explained briefly.
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Novel drug delivery technologies developed in recent years for solubility enhancement of insoluble drugs are size reduction technologies, lipid based delivery system, micellar technologies, porous micro particle technology.
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The Traditional techniques that has been discussed in this article includes use of co-solvents, Hydrotropy, Micronization, change in dielectric constant of solvent, amorphous forms, chemical modification of drug, use of surfactants, inclusion complex, alteration of pH of solvent, use of hydrates or solvates, use of soluble prodrugs, application of ultrasonic waves, functional polymer technology, controlled precipitation technology, evaporative precipitation in aqueous solution, use of precipitation inhibitors, solvent deposition, precipitation, selective adsorption on insoluble carriers. The various traditional and novel techniques that that can be used for solubility enhancement of BCS Class II drugs are briefly discussed in this article. The solubility issues complicating the delivery of these new drugs also affect the delivery of many existing drugs. Traditionally, nearly 40% of the new chemical entities (NCEs) identified by pharmaceutical industry screening programs have failed to be developed because of poor water-solubility, which makes their formulation difficult or even impossible.
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