Clinically Proven Oral Delivery Technology for Water Insoluble Drugs
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Water insoluble drugs present significant challenges in product design and compliance, including
Poor bioavailability leading to high dose and/or multiple dosage units per dose Highly variable pharmacokinetics leading to inadequate therapy and/or safety concerns Significant food effects on bioavailability leading to dosing restrictions in labeling and consequent patient compliance problems Slow or delayed absorption
These challenges may be attributed to inadequate drug dissolution/solubilization in vivo leading to poor and inconsistent bioavailability.
Lip'ral is a patented technology based on lipidic compositions which form the optimal dispersed phase in the gastrointestinal environment for improved absorption of the insoluble drug. Lip'ral presents insoluble drugs efficiently to the intestinal absorption site, thus bringing the absorption process under formulation control and making the product robust to physiological variables such as dilution, pH, and food effects. In some cases, solubilization in the dispersed phase can also improve aqueous stability allowing for improved gastrointestinal residence time of highly unstable drug molecules.
Lip'ral utilizes a wide range of proprietary compositions with bioacceptable excipients.
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Lip'ral can be extended with Lipocine's Synchronized Solubilizer Release technology, Lip'ral-SSR, to enable controlled release of insoluble drugs and drugs with pH-sensitive solubility.
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Lip'ral in combination with Lipocine's solid lipid dispersion technology, Nanosplode, supports a wide variety of dosage form configurations including capsules, tablets, beads and multicomponent systems for a combination of different release/absorption profiles.
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Lip'ral technologies use conventional manufacturing processes that are easy to scale-up and commercialize, thus reducing time to market.
Lip'ral enables development of superior products with:
Improved solubilization and high drug loading capacity Improved bioavailability leading to reduced dose Faster and more consistent absorption leading to reduced variability Reduced sensitivity to food effects potentially improving patient compliance
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