Summary

Oral lipid-based formulations provide the formulation scientist with a significant opportunity to address the poor and variable gastrointestinal absorption typically associated with poorly water soluble drugs. In some instances, these formulations may be of benefit for increasing drug exposure resulting from low intestinal permeability or for delivering drugs subject to certain forms of chemical instability. Most lipid-based formulations would preferably deliver the drug in solubilized form. A number of physical and chemical factors including moisture, drug solubility in the excipient matrix, and the crystalline forms of both the excipient and the drug can potentially influence product performance and should be identified and controlled by the formulator. While both HGCs and SGCs can be used to deliver oral lipid-based formulations, a thorough understanding of differences in processing requirements and excipient compatibilities with the capsule shell is required to ensure successful development of a drug product. The mechanical properties and physical integrity of the capsule gelatin are dependent upon establishing a proper balance between water or other plasticizing agents within the gelatin film, controlling the heat and moisture to which the capsule is exposed during processing, and proper selection of the packaging components used to protect the product from the environment. In particular, the equilibrium established between environmental moisture and the pharmaceutical active or excipients contained in the formulation can have a significant impact on the physical and chemical properties of the drug, and the in vitro and in vivo performance of the dosage form. It is important for the formulation scientist to understand, anticipate, and screen for potential differences in equipment performance and processing parameters when scaling from bench top to production size batches. A number of suggestions have been presented in this chapter to enable the formulation scientist to screen for potential changes in drug solubility, physical form, content uniformity, and product performance during the earliest stages of product development. By developing a fundamental understanding of the differences, both subtle and obvious, between bench-top scale and manufacturing equipment and processes, the scientist should be able to develop oral lipid-based drug products that perform effectively and consistently between scales.

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