van Hoogevest, Peter, Tiemessen, Harry, Metselaar, Josbert and Fahr, Alfred (2021) The Use of Phospholipids to make Pharmaceutical Form Line Extensions. European Journal of Lipid Science and Technology. ISSN 1438-76971438-9312

Abstract

This review describes the use of phospholipid excipients to make Pharmaceutical Form (Dosage Form) Line Extensions of existing drugs. as part of a Product Life Cycle. We provide product examples and development candidates, which show the versatility of phospholipids as key excipients in formulations to develop line extension drug products for any administration route by reformulating existing products. The resulting products enable the application of a drug substance for another administration route or show an increased efficacy and/or reduced toxicity of the formulated drug substances, or enable a more convenient use, through reduction of dosing frequency, or adapt a product for regulatory requirements for specific patient populations. The patents related to the product examples are used to protect the substantially improved products. Parenteral line extensions for lipophilic drugs using non-toxic phospholipid-based solubilising formulations are clearly a better alternative to products with solubilising synthetic detergents with anaphylactic properties.

Item Type:	Article
Keywords:	Phospholipids Line Extension Product Life Cycle Management Oral Parenteral Dermal Inhalation
Date Deposited:	23 Mar 2021 00:45
Last Modified:	23 Mar 2021 00:45
URI:	https://oak.novartis.com/id/eprint/43599