PII has a broad knowledge and technical experience in the formulation development and manufacture of a wide range of pharmaceutical products. PII is able to provide clients with a wide range of options to develop small molecules into quality pharmaceutical products including several in-house drug development technologies. [Link to DDS site]. The key to our success is being able to provide a flexible approach for the client whether it is a step by step approach to development work or simply the transfer of a product into development at late stage.

Over the years PII has worked with over 400 NCE small having a range of physico-chemical characteristics such as:

• poorly aqueous soluble drugs by formulating into solutions; lipid based or micro/nano emulsions to improve solubility
• highly potent and cytotoxic drugs

 

Preformulation protocols are designed to meet each client’s requirements.

Pharmaterials, a PII company in Reading, UK, provides many of these services for our clients in Europe and the USA. Click here for further information.

Pre-Formulation Services

Prototype development formulations Problem solving of existing processes and formulations Process Development Lab scale to pilot scale manufacture Registration Batch manufacture Validation batch manufacture Packaging into Bottle or blister packs Analytical Methods Development and Validation Dissolution Testing Inhalation product development

Stability studies under ICH conditions at all stages of development Extrusion and Spheronization High Shear and Fluid Bed Processing Bead and tablet coating Over encapsulation Back filling of capsules Tablet in Tablet technology Preclinical supplies preparation Phase I – IV clinical trial supplies cGMP clinical manufacture for Phase I – IV clinical trials supplies

Dosage Forms

Conventional tablets/capsules Controlled/delayed release tablets and Capsules Hard gelatin/ HPMC liquid filled capsules Soft Gel capsules Coated Beads, Tablet and Capsules

Ointments/Creams/gels Suspensions/Syrups/Solutions Suppositories/Pessaries Sterile Injectable products Freeze dried products

 

PII’s Hunt Valley facilities are DEA registered to handle schedule I to V controlled substances.