ABITEC develops and manufactures lipid-based excipients to enhance the bioavailability of poorly water-soluble and poorly permeable Active Pharmaceutical Ingredients (APIs) for the pharmaceutical industry. Applicable high-quality, monograph compliant lipid excipients for drug delivery applications are manufactured in ISO certified facilities in accordance with cGMP and applicable IPEC (International Pharmaceutical Excipient Council) guidelines.
The majority of New Chemical Entitities (NCEs) being considered for therapeutic applications are BCS Class II, Class III, or Class IV, indicating that these potential Active Pharmaceutical Ingredients (APIs) will exhibit solubility and/or permeability challenges. Functional lipids are one of the most widely employed excipient classes utilized in overcoming both solubility and permeability challenges. Many API’s which are insoluble in aqueous media can be emulsified in functional lipids improving their solubility by means of generating an oil/water emulsion carrier system for the API. The highly-functional lipid excipients that ABITEC manufactures are critical components in numerous lipid based drug delivery systems that are employed in a multitude of pharmaceutical formulations that are incorporated into a wide variety of dosage forms.
ABITEC’s functional excipients can be incorporated into a broad range of pharmaceutical formulations and dosage forms including; soft-gelatin capsules, tablets, parenteral, topical, transdermal, ophthalmic and suppository bases.
ABITEC's lipid excipients are utilized in the formulation of a Self-Emulsifying Drug Delivery System (SEDDS) as well as other applications such as carriers, solubilizers, encapsulation, tablet lubricants, etc.