The University of Iowa

UI Pharmaceuticals Offers Small Scale Solid Oral Dosage Form Commercial Manufacturing and Testing Services

Although the bulk of UI Pharmaceuticals projects over the years have supported clinical studies, small scale pharmaceutical manufacturing and testing of commercial products has been performed for most of the last 20 years.  Solid oral dosage forms that have been produced and tested in our facility include both tablets and capsules.

man at solids machine
UI Pharmaceuticals is registered as a drug product manufacturing and testing facility with FDA and a number of tablet and capsules products have been produced at our facility and sold commercially over the past 25 years.  We are currently working with additional customers working through the commercial product registration process for solid oral dosage form products intended to be produced and tested by UIP. Such products are produced and tested under strict master batch record, standard operating procedure, and cGMP controls and are completely audited after manufacturing by the Quality Assurance Group. 

Each manufacturing room has its own gowning/entry way that opens from a staging area.  Differential air pressures and single pass air, along with other measures including cleaning verification, are used to prevent cross-contamination. 

Special protective suites, wireless intercoms and video feeds, and supplied air respirators are used to protect employees from exposure to potent/toxic materials. The area is supported with a clean, dry compressed air system and a hot loop USP Purified Water system. 

All incoming air is HEPA filtered and humidity controlled and exhausted air is double HEPA filtered. UIP can process controlled substances schedules I-V and most potent/cytotoxic compounds.

Operator using fluid bed to granulate.

Tablet and capsule dosage forms can be produced using a variety of processes including roller compaction, wet granulation, and simple blending. Batch sizes can range up to 1,000,000 dosage units, depending on the dosage form unit weight and formulation blend density.

Processing techniques available to prepare products include:

Screening, Milling or Micronizing

Roller Compaction

Low or High Shear Wet Granulation

Fluid Bed Granulation or Coating

Fluid Bed or Conventional Drying

Holt Melt Capsule Filling

Tablet or Capsule Pan Coating

Low or High Shear Blending

Capsule Banding

Once dosage forms are produced, UIP can sort them by weight to ensure the weight of every dosage unit is within the specified weight range. UIP has the ability to package finished products into bottles or bulk containers and apply labeling as desired. For more information about our small scale commercial manufacturing capabilities please Contact Us.