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Lipid-based Drug Delivery

A well researched and commercially proven technology, lipid based formulations have been shown to improve solubility and bioavailability. Lipid-based drug delivery systems (LBDDS) are a group of technologies that utilize lipid molecules, alone or in combination with other biocompatible materials, to present drugs in a more harmonious form to the biological system. LBDDS include:

  • Lipid solutions
  • Emulsions
  • Self emulsifying systems (SEDDS and SMEDDS)
  • Liposomes
  • Solid lipid-particles.

These formulations provide greater bioavailability due to increased solubilization of a compound and increased surface area resulting in emulsification and micro-emulsification of the lipid formulation in the gastrointestinal tract (GIT).

Lipid drug delivery is also an attractive option for controlled drug release and targeted drug delivery.  Using molecular assembly and coating technologies, formulations can be tailored to achieve a desired release profile and target a specific area in the GIT.

Advantages

In addition to improving solubility and bioavailability, lipid drug delivery also offers other clinical advantages over conventional formulations for poorly soluble compounds, including:

  • Lowering of therapeutic dose due to improved drug absorption
  • Reduction or elimination of intra- and inter-subject variability due to reduced effects of gastrointestinal variability on solubilization
  • Reduction or elimination of food effects on bioavailability of a compound thus improving dosing flexibility
  • Reduction in hepatic metabolism due to potential transport of compounds through lymphatic system
  • Improved dose uniformity

Pii Capabilities

Thanks to the diverse and unlimited number of possible combinations of lipid molecules, we can provide endless choices of tailored, highly reproducible release profiles for your compound. Pii can design LBDDS as simple assemblies, such as emulsions and solutions, or  a higher degree of design complexity with formulations such as self emulsifying systems and solid lipid nanoparticles. Pii’s lipid drug delivery capabilities include:

  • Emulsions, including dry emulsions
  • Self emulsifying systems (SEDDS and SMEDDS)
  • Liposomes
  • Lipid assisted Nanotechnology
  • Solid lipid-carriers

From Prototype to Launch

Most lipid-based formulation excipients and resulting formulations are liquid or semi-solid in nature. Therefore, final dosage forms are typically softgels or lipid-filled hard capsules (both gelatin and HPMC). However, lipid formulations can also be solid oral forms, such as tablets and capsules. Pii is capable of developing and manufacturing the spectrum of dosage forms for lipid-based formulations. For early phase development, Pii offers lab-scale prototypes and animal testing supplies. Once a formulation strategy is chosen, Pii can scale up supplies for clinical studies (Phase I-III) and then commercial launch. Our FDA inspected and DEA licensed facilities offer containment capabilities for potent and cytotoxic compounds and special handling for controlled substances.

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