Formulation Development

Preformulation

Pharmaceutical preformulation is a stage of drug development during which the physicochemical properties of Active Pharmaceutical Ingredients (APIs) are characterized.

At Dalton Pharma Services we recognize the importance of our clients’ requirements to develop robust formulations and tactically offer all the extensive preformulation studies relevant to selecting and advancing optimal dosage forms. Our goal is to help our clients minimize development problems, costs and timelines during their drug development performing full physico-chemical characterization using modern analytical techniques.

Working with our clients we offer and evaluate the following parameters when developing and manufacturing certain dosage forms / APIs:

Solubility in different media and solvents
Dissolution of the active pharmaceutical ingredients (API)
Stability in various conditions
Solid state properties (polymorphs, particle size, particle shape etc.)

Formulation Development

Pharmaceutical formulation is the development of a bioavailable, stable and optimal dosage form for a specific administration route. Our goal is to assist our clients in identifying the best form of delivery and the most viable manufacturing strategy for their lead candidate.

At Dalton Pharma Services, our team of formulation experts boasts experience in wide range of routes of administration:

• Solid dosage formulations (capsules, tablets for immediate or extended release)
• Semi-solid formulations for oral administration (syrups, suspensions)
• Sterile liquid dosage formulations (ophthalmic, oral, nasal)
• Injectables (intravenous, intramuscular, subcutaneous)
• Lyophilized formulations
• Topical formulations (creams, gels)

Formulation Services / Capabilities

• Formulation development for new chemical entities (NCE)
• Optimization of existing formulations
• Process development for selected dosage forms
• Novel formulations for improved delivery of existing dosage forms
• Controlled or sustained release formulations
• Self-emulsifying drug delivery systems
• Colloidal drug delivery systems
• Sub-micron and nano-emulsions

Liposomal Formulation

Lipid based drug formulations have been embraced as one of the most attractive vehicles of drug delivery designed to improve drug solubility and bioavailability, an innovative alternative to traditional formulation technologies.
The proven safety of liposomes as drug carriers makes them appealing candidates for a variety of pharmaceutical applications including oral, parenteral, topical and opthalmic administration.

In recent years, liposome formulations have become commercially viable for enhanced drug delivery and Dalton has positioned itself to be at the forefront of this approach to formulation and drug delivery technology.

At Dalton, we understand the opportunity as ongoing advances in manufacturing technologies continue to result in the rapid introduction of lipid-based drug formulations and have taken all necessary steps to capitalize on the increased demand for these manufacturing methods in the market. Our Formulation Development experience includes liposome formulation of small molecules, proteins and peptides.

Instrumentation

Malvern Mastersizer (with zetasizer)
LIPEX™ Extruder 10 mL (small scale unit)
LIPEX™ Extruder 800 mL (scale-up unit)
Key KG-5 Granulator
Fluid Bed Dryer, Niro/aeromatic Strea-1
Dissolution Apparatus
Bosch 701 Encapsulator
Hand-encapsulator and WAP vacuum for encapsulator
Virtis Unitop 800 L

If you haven't found what your looking for, please contact us at 1-800-567-5060 or 416-661-2102 or email us.