Abstract
Recently, the development of soft gelatin capsules (SGCs) dosage forms has attracted a great deal of interest in the oral delivery of poorly water-soluble drugs. This is attributed to the increased number of poorly soluble drugs in the pipeline, and hence the challenges of finding innovative ways of developing bioavailable and stable dosage forms. Encapsulation of these drugs into SGCs is one of the approaches that is utilized to deliver the active ingredients to the systemic circulation to overcome certain formulation hurdles. Once formulated, encapsulated drugs in the form of SGCs require suitable in vitro dissolution test methods to ensure drug product quality and performance. This review focuses on challenges facing dissolution test method development for SGCs. A brief discussion of the physicochemical and formulation factors that affect the dissolution properties of SGCs will be highlighted. Likewise, the influence of cross-linking of gelatin on the dissolution properties of SGCs will also be discussed.
Highlights
Drug compounds with poor aqueous solubility present several challenges with respect to formulation and dosage form design, mainly because solubility influences the amount of drug that can be dissolved and available for absorption
The quality of the soft gelatin capsules (SGCs) dosage form is ensured by meeting the United States Pharmacopeia (USP) acceptance criteria for the acid stage, i.e., less than 10% of the active pharmaceutical ingredient (API) is released from the drug product during the first step of the developed dissolution technique, and the coating is considered to have passed the acid-step test
Prospects have been made around formulation of poorly soluble drugs in the form ofhave
Summary
Drug compounds with poor aqueous solubility present several challenges with respect to formulation and dosage form design, mainly because solubility influences the amount of drug that can be dissolved and available for absorption. One of the techniques proposed to solve this problem is to formulate drugs using lipid-based drug delivery systems. The distinct advantage of self-microemulsifying drug delivery systems (SMEDDS) is to improve the delivery of lipophilic drugs with poor bioavailability. These systems are capable of stabilizing the active pharmaceutical ingredient (API), improving intestinal permeability, increasing bioavailability, and protecting the API from enzymatic hydrolysis and minimizing food effects [2,3,4,5,6]. Apart from the commercial drug products listed, SGCs are widely used in the formulation of herbal drug products [11] The use of these products has recently increased and they make a significant contribution in the global market of pharmaceuticals [12].
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