Formulation Development Services

Coldstream Laboratories offers formulation services for the following dosage forms:

• Solids
• Semi –Solids
• Topicals
• Liquids

We specialize in the following types of products:

• Radiolabelled
• Potent
• Cytotoxic

Preformulation Services

At Coldstream Laboratories Inc., preformulation is tailored to unique program development for every drug candidate. We value the importance of preformulation studies in conjunction with strong analytical methods to produce a successful development program. Preformulation studies include chemical and physical characterization, as well as compatibility (excipients, preservatives, and container closure). Coldstream Laboratories Inc. can evaluate physical properties, powder characterization, chemical reactivity/forced degradation, and excipient compatibility.

Formulation Services

Coldstream Laboratories scientists have years of development experience across a wide range of drugs. We have the expertise to formulate and develop a variety of specialized products, including oral solutions, suspensions and gels, topical ointments, creams and lotions, sterile injectables, ophthalmic formulations, and sterile lyophilized products. Formulation capabilities focus on formulation development for early safety studies, prototype formulations for clinical trials, preliminary process identification, and commercial formulation development. Our facilities are capable of handling very small batch sizes as well as highly toxic compounds and controlled substances through isolator technology.

Analytical Method Development Services

Coldstream Laboratories Inc. offers a variety of method development services, including analytical method development, qualification, and validation.

Our state-of-the-art instrumentation provides HPLC Assays and stability testing. Our Method services support pre-formulation and stability testing.

Qualifications and validations are conducted according to a written protocol pre-approved by the client and Coldstream Laboratories Inc. before project initiation. Types of analysis include identity, purity, content and dissolution assays.

Our Methods Development Services can be used for the following applications:

• Dissolution
• Impurities Assays
• Moisture
• Residual solvents
• Physical and chemical tests
• Cleaning assessment
• DMF updates
• Microanalysis
• Extraction & Leaching

Process Development Services

• Lab Scale Batches
• Pilot Research Batches - Complete Research Batch Record
• Pilot Scale GMP Batches - GMP Batch Record (typically)
• Accelerated Stability - Typically performed on selected developmental batches
• Cleaning Validation - Cleaning procedures for all API's are required.