Savjani Ketan T, Gajjar Anuradha K, Savjani Jignasa K
Institute of Pharmacy, Nirma University, Sarkhej Gandhinagar Highway, Gujarat, Ahmedabad 382481, India.
ISRN Pharm. 2012;2012:195727. doi: 10.5402/2012/195727. Epub 2012 Jul 5.
Solubility, the phenomenon of dissolution of solute in solvent to give a homogenous system, is one of the important parameters to achieve desired concentration of drug in systemic circulation for desired (anticipated) pharmacological response. Low aqueous solubility is the major problem encountered with formulation development of new chemical entities as well as for the generic development. More than 40% NCEs (new chemical entities) developed in pharmaceutical industry are practically insoluble in water. Solubility is a major challenge for formulation scientist. Any drug to be absorbed must be present in the form of solution at the site of absorption. Various techniques are used for the enhancement of the solubility of poorly soluble drugs which include physical and chemical modifications of drug and other methods like particle size reduction, crystal engineering, salt formation, solid dispersion, use of surfactant, complexation, and so forth. Selection of solubility improving method depends on drug property, site of absorption, and required dosage form characteristics.
溶解度是溶质在溶剂中溶解形成均匀体系的现象，是在体循环中达到所需药物浓度以产生预期药理反应的重要参数之一。低水溶性是新化学实体制剂开发以及仿制药开发中遇到的主要问题。制药行业开发的超过40%的新化学实体实际上不溶于水。溶解度是制剂科学家面临的一项重大挑战。任何要被吸收的药物都必须以溶液形式存在于吸收部位。人们使用了各种技术来提高难溶性药物的溶解度，包括药物的物理和化学修饰以及其他方法，如减小粒径、晶体工程、成盐、固体分散、使用表面活性剂、络合等。溶解度提高方法的选择取决于药物性质、吸收部位和所需剂型特征。
