"Multiple Technology Platforms = Multiple Product Opportunities"
AlphaRx is engaged in developing novel formulations of existing drugs that are insoluble or poorly soluble in water, utilizing our proprietary colloidal dispersion drug delivery platforms. Our strategy is to develop patentable improved formulations of such drugs that are soluble in human medicines. Over the past 10 years, we have developed several platform technologies to improve the effectiveness of insoluble drugs and provide new methods of delivery:
- Colloidal Lipid Dispersion System (CLD) for topical and transdermal delivery,
- Self Emulsifying Controlled Release Tablet System (SECRET) for oral delivery
- Solid Lipid Nanoparticles (SLN) and Hybrid Lipid-polymer Nanoparticles (HLN) for site specific delivery.
Insoluble or poorly soluble drugs are a major problem for the pharmaceutical industry, with over one-third of the drugs listed in the United States' Pharmacopoeia being insoluble or poorly soluble in water. Further, most approaches used to overcome insolubility result in clinical problems ranging from poor and erratic bioavailability to serious side effects. Our drug delivery technology is designed to develop drugs with major medical advantages, such as lower dosing, fewer side effects and alternative dosage forms, as well as commercial advantages, such as extended patent protection and broader use.
Colloidal Lipid Dispersion (CLD) is a topical drug delivery technology. CLD compounds, when properly combined with drugs, provide pharmaceutical formulations (creams, gels, solutions, etc.) that enhance the transdermal delivery of drugs into the skin or into the bloodstream. CLD formulations combined with polymers and adhesives can also be used with patch formats to achieve the transdermal delivery of selected drugs.
Self-Emulsified Controlled Release Tablet (SECRET) drug delivery system enhances poorly water-soluble drugs that do not satisfy one or more of the following requirements:
- High potency at the site-of-action.
- Sufficient solubility to support dissolution of a therapeutic dose in the gastrointestinal tract.
- Sufficient intestinal wall permeability for included drug.
- Sufficient metabolic stability to permit a therapeutic concentration to be maintained at the site-of-action for the duration necessary.
- The ability to reach its site-of-action.
- Sufficient chemical stability to provide adequate shelf-life.
More specifically, 'SECRET' is a self-emulsifying, controlled release pharmaceutical delivery system for the systemic oral administration of hydrophobic (lipophilic) drugs. Oral absorption improvement and bioavailability enhancement of said drugs are achieved using self-emulsifying oily preparations; and in combination with a biodegradable polymeric matrix, ‘SECRET’ is capable of administering these drugs at their biological targets in a sustained-release manner over prolonged periods of time without losing bioavailability.
Nanoparticulate Drug Delivery Systems
Solid Lipid Nanoparticles (SLN) & Hybrid Lipid-polymer Nanoparticles (HLN)
AlphaRx is one of the leaders in the development of nanoparticulate drug delivery systems to enhance the bioavailability of the drugs towards targeted diseased cells, promoting the required response while minimizing side-effects. Our 2 nano drug platforms include a class of particle made of FDA approved polymers or lipids that, because of their size and chemical composition, permit systemic and local treatment.
In general, our nano platform technologies are expected to: protect a drug from degradation, enhance drug absorption by facilitating diffusion through epithelium, modify the pharmacokinetic and drug tissue distribution profile and/or improve intracellular penetration and distribution. Such drugs can be administered by all current routes of administration, generally improving both bioavailability and therapeutic efficacy of the carried drug. Our nanoparticulate drug delivery systems represent an alternative class of vehicles to liposomes to transport drugs straight to the targeted diseased cells in the body.
Our nano platform technologies may address a range of applications includes the treatment of all major public health diseases including severe infections and cancer. Further more, they can potentially solve the problem of the in vivo
delivery of biomimetic molecules such as nucleic acids, proteins, peptides and other very insoluble drugs, which is very difficult by current technological means.