Skilled in the development of pharmaceutical formulations for oral, topical and injectable dosage forms, our formulation development group brings significant experience performing risk assessment and statistically designed experimentation to identify the quality attributes that impact the clinical performance and safety of formulations, manufacturability of dosage forms and stability in primary packaging. Access our formulation development services individually or integrated with AMRI’s discovery, development or manufacturing solutions.
Our range of capabilities includes:
- Drug substance in capsules/bottles
- Blends in capsules/bottles
- Dry granulation in capsules/bottles
- Sterile liquid formulation
- Sterile freeze-dried formulation
- Sterile colloidal formulation
- Sterile viscous formulation
- Sterile suspension feasibility
- Formulation composition design and development, including compatibility, stability and degradation mechanism elucidation
- Topical ointment, cream and lotion development
- Solid dosage form development for tablets and capsules using high/low-shear granulation roller compaction, fluid bed and dry blend processes
- Tech transfer and manufacturing science support
Liquid and Suspension Dosages
Our experts possess the experience and specialized technology to develop liquid and suspension dosage forms, which are appropriate in many cases where there is sufficient solubility and stability with the target drug substance. We offer aseptic fill and finish services, including aseptic lyophilization for both clinical supplies and commercial manufacturing.
Oral Solid Dosages
Manufacturing a drug product in tablet or capsule form can provide many advantages, such as increased chemical and physical stability, unique brand recognition, convenience of handling and controlled-release options.
AMRI possesses the expertise and equipment necessary to develop oral solid dosage forms. We help you understand the mechanical and physicochemical properties of all the components, including how these properties relate to product performance and bioavailability.