By many estimates up to 40% of new chemical entities (NCEs) discovered by the pharmaceutical industry today are poorly soluble or lipophilic compounds. As such, the delivery in acceptable pharmaceutical form is a challenge.

For poorly soluble compounds it is frequently difficult to develop intravenous dosage forms.

• Particle size reduction often imparts significant amounts of physical stress upon the drug product which may induce degradation.
• Cyclodextrins are still limited in their drug loading capacity and the volume of cyclodextrin complexes is often much greater than the volume of drug alone. The number of cyclodextrin-drug complexes currently on the market is limited also due to unfavourable regulatory positions in regard to toxicity and stability issues.
• Liposomal dosage forms are costly and technology demanding; maintaining physical and chemical stability of drug-loaded liposomes are often difficult task to achieve.

One of the most valuable options for parenteral administration of poorly soluble compounds is their formulation in micellar solutions.

With Soludis® Technology, Physica Pharma is experienced at finding solutions for active pharmaceutical ingredients early in the preclinical program in support of preclinical pharmacokinetic and toxicology investigations.

Soludis® Technology is based on the use of a customized blend of approved pharmaceutical ingredients which permits to form clear micellar solutions with high water content.
 
Benefits

• Flexibility : because each drug is unique, Soludis® is a flexible technology designed to fit to different drug profiles
  
  
• Safety: a major challenge while formulating insoluble parenteral drugs is to ensure that the composition should not induce any adverse effects. Your composition will be rationally designed to include minimum ingredients and maximum water content (usually >90%). Furthermore, no drug precipitation will occur following administration.
  
  
• Easy to produce : Soludis® formulations are easy to manufacture using traditional industrial equipment.
  
  
• Cost effective : due to ease of manufacturing.
  
  
• Patent protected : in any case (new chemical entities or existing drugs), Soludis® formulations offer patent coverage providing extension of market exclusivity.
  
  
  

Partnering with Physica Pharma offers the following benefits:

• A quick and convenient approach for your drug involved in a preclinical program :
• Fast development times : feasibility study including accelerated stability in only 2-3 months
• A rational study design

The execution of the formulation strategy follows a logical approach:

• Physico-chemical characterization of the drug
• Comprehensive excipient screening, compatibility studies with the drug
• Prototype development
• Preliminary stability study
• Selection of a prototype
• Production of pre-clinical batches