Cite this article as:Maurya SD, Arya RKK, Rajpal G, Dhakar RC, Self-micro emulsifying drug delivery systems (SMEDDS): a review on physico-chemical and biopharmaceutical aspects, Journal of Drug Delivery and Therapeutics. 2017; 7(3):55-65 DOI: http://dx.
ABSTRACTNearly 40% of new drug candidates exhibit low solubility in water, which is a challenge in development of optimum oral solid dosage form in terms of formulation design and bioavailability of new pharmaceutical products. Many strategies have been used to overcome these problems either by means of modifying the solubility or maintaining the drug in dissolved form throughout gastric transit time. Much attention has focused on lipid solutions, emulsions and emulsion pre-concentrates, which can be prepared as physically stable formulations suitable for encapsulation of such poorly soluble drugs. Recently, self-micro emulsifying drug delivery systems (SMEDDS) especially have attracted increasing interest primarily because these are physically stable, easy to manufacture, can be filled in soft gelatin capsules and then will generate a drug containing micro-emulsion with a large surface area upon dispersion in the gastrointestinal tract. The emulsions will further facilitate the absorption of the drug due via intestinal lymphatic pathway and by partitioning of drug into the aqueous phase of intestinal fluids. In the present review, an overview of SMEDDS as a key technology for formulating lipophilic drugs and various factors that potentially affect the oral bioavailability of such drugs are presented.
Process validation is an essential component for the safety of drug product and also to maintain the quality of the product. Process validation is the fundamental component for assuring the quality system used by pharmaceutical industries. Process validation is the key element to assure the identity, purity, safety, efficacy and also maintaining the quality of final product. The Process validation precisely focused on the aim, method of analysis, and knowledge. The Process validation establishes the flexibilities and limitations which are faced during the manufacturing process; the variables are controlled for attaining the desired attributes, which assures a consistency in quality of product throughout the product life. In this article an overview is given on process validation with special reference to tablet.
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