Shell Formulation in Soft Gelatin Capsules: Design and Characterization.

Soft gelatin capsules (SGCs) are the most widely used pharmaceutical form after tablets. The active components, active pharmaceutical ingredients (APIs), or nutrients are dissolved, dispersed, or suspended in a liquid or semisolid fill, which is covered with a gelatin shell. Several factors can modify the properties of the gelatin shell and subsequently affect their operative handling during manufacturing process and the stability of the soft gelatin capsules. Three elements appear to be crucial: the shell formulation (type and content of the different components such as gelatins-source, extraction method-plasticizers, or additives); the manufacture and storage conditions (temperature, humidity, light) as well as the interactions between fill-shell formulas. Mechanical and thermal analysis arise as straightforward but highly useful tools to monitor the properties of the gelatin shell. This review provides an updated overview on the shell formulation and design. Additionally, it presents the uses of mechanical and thermal techniques to characterize and evaluate the impact of different parameters on the gelatin behavior over the production and stability of these pharmaceutical forms. This will help to detect changes that are yet not visible by visual inspection ensuring a suitable finished product over its shelf-life.

Direct and Reverse Pluronic Micelles: Design and Characterization of Promising Drug Delivery Nanosystems.

Pluronics are a family of amphiphilic block copolymers broadly explored in the pharmaceutical field. Under certain conditions, Pluronics self-assemble in different structures including nanosized direct and reverse micelles. This review provides an overview about the main parameters affecting the micellization process of Pluronics, such as polymer length, fragments distribution within the chain, solvents, additives and loading of cargo. Furthermore, it offers a guide about the most common techniques used to characterize the structure and properties of the micelles. Finally, it presents up-to-date approaches to improve the stability and drug loading of Pluronic micelles. Special attention is paid to reverse Pluronics and reverse micelles, currently underexplored in the literature. Pluronic micelles present a bright future as drug delivery agents. A smart design and thorough characterization will improve the transfer to clinical applications.