Drug Formulation Challenge 5

Formulation Development of Active Pharmaceutical Ingredient (API)

 

Our client requested formulation development for several different lots of drug product material, all displaying different characteristics, which impacted the solubility of each.

 

Velesco solution:

• A pharmaceutical formulation was successfully developed for the first lot of material using HP-γ-CD. The next lot we received was not stable in HP-γ-CD however was successfully formulated in SBE-β-CD with pH titration.  The next two lots were also successful in SBE-β-CD with subtle variations on the formulation procedure and pH titration.  A common vehicle was identified for all four lots and stability of one of the lots was confirmed for six months at 5°C.
• Velesco explored a series of stability testing experiments and paths to determine the cause of the varying solubility and physical stability of different lots of the compound.  Using previous drug formulation experience and knowledge of the compound, Velesco was able to fine-tune each formulation to achieve the targeted concentration and pH within tight time lines. 
• Velesco identified suitable vehicles for both intravenous and intrathecal routes of administration.
• Clinical supplies were prepared for 14 different toxicology studies. Formulations have been well tolerated by animals and studies have been successful to date. 
• Velesco improved the scalability of the drug formulation in preparation for future larger scale manufactures.

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