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R&D Platform for Nano-Drugs

The Platform for Nano-Drugs R & D, based on liposome technology, microemulsion technology and nanoparticles technology, improves drug's physical and chemical properties, pharmacokinetic properties, pharmacological and toxicological properties to prepare new reagent characteristic of suspended release, control release and targeting activities and then increase the efficacy of the conventional drugs, reduce the toxicities and improve the patient's compliance.

Introduction of the Technique
Liposomeis the single- or multi-layer microcells where the lipid bilayer orderly arranged, with the crystalline alike structure similar to phospholipid bilayer of the biologic membrane. The size is usually between nanometer grades to micrometer grades. The specification to designate liposome drugs involves the size of the granule, distribution, loading rates, drug release rates and so on.
   Compared with non-lipid reagent system, liposom possess noval and unique properties, which increase the therapeutic index and reduce the toxicity of the original reagent. These properties are formed by the way of the pharmacokinetic behavior modification. Drug molecules carried or entrapped in the liposome and delivered to the focus by the EPR (Enhanced Permeation and Retention) effect, have a different distribution rate, the higher concentration in the focus and then the higher efficacy and lower toxicity.
   As a drug delivery technology used in new formulation R & D, liposome technique aims at looking for the solution for the problem existing in the clinical usage, offering new features and upgrading the therapeutic position of the original drugs. The biggest difficulty in the R & D of the liposome drug is the industrial scale production of the dosage form.

Nanoparticaleis a dosage form. The actives are dissolved, absorbed or encapsulated in the carrier materials of phospholipids or synthesized materials with the particle size of nanometer grades. The form is characteristic of good bio-compliance and is able to be bio-depredated, then reaches the purpose of suspended and controlled release and targeting and improves the therapeutic index.

Microemulsion (ME)is an oil-water emulsifier system with transparent or translucent appearance, the thermodynamic and kinetic stability and phase to phase similarity, spontaneously formed by water, oil, emulsifier and co-emulsifier system.
   The microemulsion can be used as the carrier for lipophilic drug, promote the absorption of the drug administrated via oral or dermal route and possesses function of targeting. Compared with liposome drugs administrated via dermal rout, microemulsion drugs with higher loading efficiency and higher anti-oxidized properties have more advantages, such as: larger surface area, lower surface tension, higher thermodynamic stability, easier to be filtered for sterilization, lower requirement for preparation and storage, lower viscosity causing less pain when injected, easier absorption by lymphoma system to avoid first pass effect. It can be used as the media for drugs with different lipophilic properties in same system to prepare combined formulations with higher bioavailability, smaller size, more uniformly distribution and easier trans-dermal absorption. The formulation is spontaneously formed and the preparation is simple.

Introduction of the products made in the platform

1.Libod® is a liposomal formulation of doxorubicin hydrochloride.
   The active ingredient of doxorubicin hydrochloride is encapsulated in the PEG modified liposome. The average particle size is 70 – 130 nm. The loading rate is more than 95%. The strength of the preparation is 10 ml : 20 mg. Shelf life is 2 years.  
   Indication: AIDS-related Kaposi's sarcoma, breast cancer, ovarian cancer, multiple myeloma and other cancers
   Statues of the project: listed in market.

2.Vincristine sulfate liposome injection(concentrated)
   Vincristine sulfate liposome injection (concentrated) is non PED modified liposome preparation of vincristine sulfate. The package contains three battles: active, empty liposome and buffer. Mix the three bottles before use.
   The product is used for patients suffering from the aggressive form of NHL (non-Hodgkin's lymphoma) and leukemia.
   Statues of the project: clinical trial permission issued by SFDA.

3.Products in the stage of pre-clinical R & D
  
R & D projects of a series of nanometer grades antitumor drugs are carried out in the platform, including taxanes, platinum and so on.

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