Parenteral
The parenteral route of administration is the most effective route for the delivery of active pharmaceutical ingredients which exhibit poor bioavailability. ABITEC offers parenteral grade lipid excipients for improved solubilization of lipophilic drugs in the development of stable microemulsions and in the development of oleaginous solutions for use in parenteral dosage forms for controlled or modified drug delivery applications.
INJECTA™ parenteral grade lipid excipients enable improved solubilization of injectable active pharmaceutical ingredients (APIs). INJECTA lipid excipients undergo secondary sterile filtration and aseptic processing in state-of-the-art facilities to ensure products are of the highest quality. The entire INJECTA product line is tested for pyrogens, microbial contaminants, elemental impurities, and particulate matter by validated testing protocols.
Overview
The majority of new chemical entities (NCEs) being considered for therapeutic applications are BCS (Biopharmaceutics Classification System) Class II, Class III, or Class IV, indicating that these potential API’s will exhibit solubility and/or permeability challenges. Functional lipids are one of the most widely employed excipient classes for overcoming reduced bioavailability due to both solubility and permeability challenges. Many API’s which are insoluble in aqueous media can be dissolved in functional lipids improving their solubility by means of generating an oil in water emulsion carrier system for the API. Additionally, functional lipids can overcome certain permeability issues associated with delivering API's.